Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 91

DECLARATION of Jennifer A. Sorenson in Support re: 89 Memorandum of Law in Opposition,. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I)(Sorenson, Jennifer)

EXHIBIT B
TO THE THIRD DECLARATION
OF JENNIFER A. SORENSON

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C2nQnrdC
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
------------------------------x
NATURAL RESOURCES DEFENSE
COUNCIL, INC., CENTER FOR
SCIENCE IN THE PUBLIC
INTEREST, FOOD ANIMAL CONCERNS
TRUST, PUBLIC CITIZEN, INC.,
UNION OF CONCERNED SCIENTISTS,
INC.,
Plaintiffs,
v.
UNITED STATES FOOD and DRUG
ADMINISTRATION, MARGARET
HAMBURG, CENTER FOR VETERINARY
MEDICINE, BERNADETTE DUNHAM,
UNITED STATES DEPARTMENT of
HEALTH and HUMAN SERVICES,
KATHLEEN SEBELIUS,
Defendants.
------------------------------x

11 CV 3562 (THK)

New York, N.Y.
February 23, 2012
3:15 p.m.
Before:
HON. THEODORE H. KATZ,
Magistrate Judge
APPEARANCES
NATURAL RESOURCES DEFENSE COUNCIL
Attorneys for Plaintiffs
BY: JENNIFER SORENSON
MITCHELL S. BERNARD
UNITED STATES DEPARTMENT OF JUSTICE
Attorneys for Defendants
BY: AMY A. BARCELO

ALSO PRESENT
THOMAS COSGROVE - FDA Associate Chief Counsel

SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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(In open court)
THE COURT: Do you want to state your names?
MS. BARCELO: Good afternoon, your Honor. Amy Barcelo
for the defendants and Tom Cosgrove of the FDA.
THE COURT: Hello.
MS. SORENSON: I'm Jennifer Sorenson representing the
plaintiffs.
THE COURT: Hi, Ms. Sorenson.
MR. BERNARD: Mitchell Bernard for the plaintiffs.
THE COURT: Hi. Have a seat, everybody.
You requested oral argument, Ms. Sorenson, are you
going to be handling it?
MS. SORENSON: Yes.
THE COURT: Want to begin?
MS. SORENSON: Your Honor, FDA pulled the trigger when
it made findings in 1977 that penicillin and tetracyclines in
animal feed are not shown safe to be for human health. Those
findings set in motion a statutorily mandated process for
withdrawing approval of that drug uses.
The first step in that process was issuing notices of
opportunity for hearing. Now, under the press of litigation,
FDA has withdrawn the notices, but that doesn't change the fact
that the trigger has been pulled.
FDA's position on the science has only gotten
stronger, but FDA has veered away from the statutory process
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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because it would prefer to address this acknowledged danger to
human health through voluntary measures. That's not what the
Food and Drug Act commands.
Plaintiffs ask the Court to restore the statutory
process by ordering the FDA complete withdrawal proceedings
promptly for these drug uses.
THE COURT: I know this issue isn't before me on this
motion, but are you saying that the FDA does not have
discretion as to the remedy?
MS. SORENSON: No, your Honor, FDA does not. FDA has
to conduct these withdrawal proceedings that are required by
the statute because it has made these findings that penicillin
and tetracyclines are not shown to be safe for human health.
Plaintiffs are not asking this Court to prejudge the
outcome of the hearing that the FDA holds, if the agency holds
a hearing, but the agency does have to complete the process,
and that's what plaintiffs asking this Court to order.
THE COURT: These findings were made more than 30
years ago. Did the FDA have discretion to amend the findings?
MS. SORENSON: Yes, your Honor. FDA could change its
view on the findings if it addressed the science and revised
its view of the scientific evidence. The agency hasn't done
that.
Instead, over the years it has continued to reinforce
its position that these drug uses present a danger to human
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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health. It did that in 2010 when it issued its draft guidance.
It spent ten pages summarizing 40 years' worth of science on
this issue and concluding that these drug uses are not in the
interest of protecting and promoting the public health. In the
government's responses in this litigation, the government has
continued to reinforce its conclusion that these drug uses are
dangerous. It has never moved off of the findings nor would it
have the scientific justification for doing so.
Your Honor, plaintiff's view of the statute, which is
that it requires FDA to conduct these withdrawal proceedings,
having made the findings that the drugs aren't shown to be
safe, is the same understanding of the statute that FDA itself
has adopted and put into a regulation that has force of law.
That regulation is 21 CFR 514.115. It says the Commissioner
"shall afford an opportunity for a hearing on a proposal to
withdraw approval of an animal drug if he finds that new
evidence shows that the drug is not shown to be safe."
That's precisely what happened here. The government's
position now that only a finding after a hearing requires it to
do anything is a new position that it is advancing for the
first time in this litigation, and it is not deserving of this
Court's deference.
THE COURT: They argue though that they have
historically interpreted that differently than what it actually
says.
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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MS. SORENSON: Your Honor should reject that argument
for two reasons: First of all, the regulation is clear on its
face, which the government acknowledged in its brief. It said
on its face, this regulation appears to predicate the issuance
of a notice of opportunity for hearing on a finding that a drug
is not shown to be safe. And the Supreme Court has held that
when a regulation is clear on its face, then the Court
shouldn't defer to the government's contrary interpretation of
the regulation.
Second of all, FDA's litigation position is contrary
to its own historical practice. It has consistently initiated
withdrawal proceedings on finding that a drug is not shown to
be safe. That's clear in the adjudications that FDA cites in
its briefs. So there is really no evidence that the agency has
presented that it has any practice that's contrary to the
position that its own regulation sets out.
THE COURT: The government tries to create a
distinction between a preliminary finding and a final finding.
Does the statute allow for that?
MS. SORENSON: No, your Honor. The statute doesn't
make any distinction between a finding triggering the
obligation to hold withdrawal proceedings and a final finding.
FDA's only support for that argument is these administrative
adjudications where the government mentions that its
interpretation of the not-shown-to-be-safe standard is that
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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there are serious questions about the safety of the drug. FDA
argues in its brief that these are two different standards, but
the adjudication is made clear that they are the same standard.
Once FDA finds that a drug is not shown to be safe, it is
required to conduct withdrawal proceedings.
THE COURT: So, if it then proceeds with a hearing,
presumably it could take evidence that might cause it to alter
its conclusion, correct?
MS. SORENSON: Correct, but it has to hold a hearing,
your Honor, because the structure of the statute is to require
drug sponsors to carry the burden of showing that a drug is
safe. So, once FDA has concluded that a drug is not shown to
be safe, the drug sponsor then has an opportunity to come
forward and show that the drug is safe. FDA could decide in a
hearing that the drug sponsor had carried its burden, but it
has to require the drug sponsor to show that the drug is not
safe. It can't say a drug is not safe and then leave it on the
market for decades without ever requiring the drug sponsor to
come forward and prove safety.
Your Honor, the government argues for the first time
in its reply brief that the action that plaintiffs seek is not
a discrete agency action. The Supreme Court has made clear in
Norton v. Southern Utah Wilderness Alliance that an agency
adjudication is a discrete agency action and that the discrete
action can involve multiple steps, and it can be an action with
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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an uncertain outcome, but that doesn't mean that it's not a
discrete agency action.
THE COURT: So what is the discrete action you are
asking me to order them to conduct or to do?
MS. SORENSON: The discrete action is to conduct this
adjudication that may result in an order withdrawing approval
for these drug uses.
THE COURT: To do that, would I have to direct the FDA
to reinstate the notices?
MS. SORENSON: FDA would have to issue new notices of
opportunity for hearing now that it's withdrawn them, and
because the science since 1977, as the agency has acknowledged,
has grown even stronger in support of the agency's conclusion
that these drug uses are not shown to be safe. So the agency
has to give the drug sponsors notice that it will be relying on
this new science in addition to the science as of 1977.
But that shouldn't be any significant burden for the
agency because FDA has been continually reviewing the science
on this issue. As recently as 2010, it devoted ten pages on a
review of the science and its draft guidance, and it also in
the early 2000s conducted a risk analysis on the use of these
drugs and asked drug sponsors to give it more information. So
updating the notices shouldn't be a significant burden.
THE COURT: So if they are merely directed to hold the
hearings, theoretically they do also have discretion as to what
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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steps to take as a predicate to the hearings? I guess they'd
have to have a notice.
MS. SORENSON: Right. FDA's own regulation says that
if the agency finds that a drug is not shown to be safe, it has
to issue a notice of opportunity for hearing on a proposal to
withdraw approval of the drug, and then the hearing procedures
are set out in FDA's regulations. There is a hearing officer
who will have discretion over how to schedule and conduct the
hearing but the broad outlines of the procedure are set out in
regulation.
THE COURT: You're saying by simply withdrawing the
notice, that doesn't mean they withdrew the conclusion that it
was unsafe.
MS. SORENSON: Correct, your Honor. FDA didn't
withdraw its scientific findings that triggered the notices.
Those findings had a consequence under the statute, and FDA
can't undo that consequence simply by pulling the notices away.
The agency has an enforceable duty under the statute
to act on its scientific findings. And there are cases where
courts ordered agencies to act on their scientific findings.
We cited two of them in our opening brief: NRDC v. Train and
American Public Health Association v. Veneman.
One wonders why anyone would have bothered if the
agency could have mooted the whole business by just getting rid
of its findings without changing its position on the science.
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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THE COURT: Theoretically, they are in the process of
implementing these voluntary guidelines, I guess, or maybe
they've been issued already, do you know?
MS. SORENSON: They're draft, your Honor. They
haven't been finalized.
THE COURT: So, if they had issued these voluntary
guidelines ten years ago and there was compliance with those
guidelines, could that have affected the validity of the
initial finding?
MS. SORENSON: Only if FDA had decided based on that
compliance that the risk had changed and the agency no longer
viewed these drug uses as not shown to be safe for human
health. But as long as FDA hasn't moved off of those findings,
then it has a statutory duty to conduct withdrawal proceedings,
and the statute doesn't give it an alternative option of
addressing that safety problem through voluntary measures.
THE COURT: I know this is couple of steps down the
line, but you're saying once they hold that hearing, if they
don't alter the conclusion that it hasn't been shown to be
safe, the only option is to withdraw it, not to condition it -they don't have the discretion to condition the use in certain
ways?
MS. SORENSON: No, your Honor. The statute says that
they must withdraw approval of an animal drug if they find
after notice of opportunity -SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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THE COURT:

So they really have no discretion as to

remedy.
MS. SORENSON: No, they don't. This is the route that
Congress has chosen to ensure that animal drugs are safe for
human health. FDA could then potentially re-approve some drug
uses with conditions, but at this point, once it's made a
finding that drug uses are not shown to be safe, it has to
withdraw its approval for them.
THE COURT: OK. Anything else you want to bring to my
attention?
MS. SORENSON: Your Honor, as far as a deadline for
taking this action, plaintiffs believe that a deadline is very
important if your Honor grants plaintiff's motion for summary
judgment because this is a serious danger to human health.
We're talking about people getting sick and antibiotics not
working, and the agency has delayed for over three decades in
acting on this.
Plaintiffs would recommend that the Court order
postjudgment briefing on the deadline and give both parties an
opportunity to weigh in, and then your Honor could decide on
updating deadlines for taking this action.
THE COURT: Thank you.
MS. SORENSON: Thank you.
THE COURT: Go ahead, Ms. Barcelo.
MS. BARCELO: Good afternoon. The decision by a
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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subsidiary bureau of FDA to propose the withdrawal of two
classes of antibiotics 34 years ago cannot form the basis for
this Court to order FDA to pursue such withdrawals today.
That is particularly the case because in December of
2011, FDA withdrew those 34-year-old proposals. Moreover,
before their withdrawal, those 34-year-old proposals were so
outdated and based on such a stale description of the science
surrounding antimicrobial resistance and use of antibiotics in
livestock that they could not possibly form the basis for FDA
to move forward with the withdrawals it proposed 34 years ago.
THE COURT: But the notice got stale because of the
agency's own inaction. Did the findings become less valid or
did they get stronger?
MS. BARCELO: That issue is not before the Court right
now. I'm not sure that I understand -THE COURT: You're saying no matter what the finding
about safety is, as long as they withdraw the notice, FDA has
no obligation.
MS. BARCELO: That is the law. Under the regulation
that plaintiffs rely on so heavily, the 514. -THE COURT: Yes.
MS. BARCELO: 514.115(b) only requires that the
commissioner afford an opportunity for a hearing on a
proposal -- excuse me -- hold an opportunity for hearing on a
withdrawal where that withdrawal is proposed. That there is no
SOUTHERN DISTRICT REPORTERS, P.C.
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longer an outstanding FDA withdrawal of a proposal -THE COURT: So you mean because the commissioner
failed to follow the procedures it's supposed to follow under
the regs, it now doesn't have to do anything.
You said only if they have a hearing. They issued a
notice; they didn't have a hearing. So they can defeat the
purpose by just taking no action. Wouldn't that be a violation
of their own reg?
MS. BARCELO: It wouldn't, your Honor, for the
additional reason that there is no finding that triggers a
statutory duty. In addition, that is the underlying -THE COURT: Wait. In order to have the notice, they
had to have been applied, isn't that correct?
MS. BARCELO: There had to be the BVM's decision to
issue an NOH, which, yes, the regulation does use the word
finding to describe it.
THE COURT: You're not saying the BVM was acting ultra
vires, are you?
MS. BARCELO: Not at all, your Honor. BVM was
certainly delegated the authority to issue the NOH. The very
moment, however, that the drug companies and drug sponsors
requested a hearing on that proposed notice, BVM was divested
of its authority to move forward and no longer was delegated
the authority to do anything, hold a hearing, do anything at
all.
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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THE COURT: No, but the agency had to hold a hearing,
didn't it?
MS. BARCELO: The regulation contemplated holding a
hearing, which was never held for a number of reasons, and now
we are in the position where there is no more proposed
withdrawal. While the regulation talks about a finding, that
finding that formed the basis for BVM's decision to issue the
NOH is different than the finding that the statute actually
talks about because the statutes's finding could only happen
after those procedural rights have been fulfilled. Obviously,
something needed to start process.
THE COURT: Yes.
MS. BARCELO: The regulation uses the word finding to
talk about that.
THE COURT: Yes.
MS. BARCELO: That finding, however, was no more than
the equivalent to a complaint in a civil case. It was BVM
saying that we believe we have the evidence to support this
withdrawal. That is all that they had authority to do. They
could no longer move forward as soon as the hearings were
requested, and they -- they could have moved forward as soon as
the hearings were requested. Here, the fact is -THE COURT: What would happen normally once a hearing
is requested after a notice?
MS. BARCELO: Normally a hearing would be held.
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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THE COURT: OK.
MS. BARCELO: In this case, hearings weren't held for
a number of different reasons that are all historical and date
back to the Seventies and the Eighties and the whole history
of-THE COURT: And none of the reasons was that the
agency came to the conclusion that whether you call it
preliminary, final, or whatever, that the use of these drugs
was safe.
MS. BARCELO: The agency -THE COURT: Never changed that conclusion. Didn't the
agency reiterate it several times?
MS. BARCELO: The agency has continually expressed
concern about this issue and has moved forward in a path to
address this issue which is different than the path that 34
years ago it originally expected would be the path. It has
since the early -- which is, I think, all the more reason that
this antiquated 34-year-old -- nobody thought for the last 30
years or, so nobody thought this was the way it was going to be
done, this withdrawal procedure because it has been so stale
for so long. Throughout the Seventies, Eighties and Nineties,
there was continual research that was done that continued to
raise more uncertainty in this area.
THE COURT: Did it raise more uncertainty or did it
strengthen the original conclusion?
SOUTHERN DISTRICT REPORTERS, P.C.
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MS. BARCELO: There was plenty of indirect evidence
that there was cause for public health concern. All of these
things -- there was concern, and FDA has moved forward and
acted on those concerns in a way that is different than the way
that they proposed in 1977. The real issue that is before the
Court on this motion, there are additionally -- there will be
further briefing on FDA's decision to deny the citizen
petitions, and I think the Court's concerns will probably be
more fully developed there because that's the real heart of -that is what FDA is doing now to go forward.
The only issue here in this case is what the FDA said
34 years ago can compel them to move forward on withdrawal
proceeding even though it has withdrawn those withdrawal
proceedings, and BVM had no authority to move forward
whatsoever with the withdrawal as soon as the drug sponsor
requested.
THE COURT: So, when the FDA is made aware through
scientific studies that it finds persuasive, at least
initially, that there is a threat to public safety, you're
saying under the statute they have no obligation at that point?
MS. BARCELO: Their regulations do contemplate moving
forward, and I think another -- something that might help sort
of clarify the difference between the claims that plaintiffs
are making here and I think perhaps the type of claim that your
Honor is discussing, I think it would have been different if
SOUTHERN DISTRICT REPORTERS, P.C.
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they had been making an unreasonable delay claim perhaps which
would say you need to move forward and complete the
proceedings, and there would be obviously lots of different
legal issues there and arguments there, and we are not in that
world. And that would be, I think, does the government have
the obligation to move forward. But the only thing that they
are asking for now -- now, I think today for the first time
they have explicitly requested a hearing. They have been sort
of couching what the relief is that they're requesting in
different ways, I suspect, to get around the problems with the
type of relief that they're asking for, but the only thing
they're here for today is the specific request now to compel
the government to hold hearings.
That is not relief that they're entitled to. First,
because it's not required where the proposal has been
withdrawn. And, second, because even that isn't actually
what -- that isn't even the next step. The next step, as
everyone acknowledges, would be the updates, would be, as the
Court recognized, a requirement that we would have to issue an
entirely new NOH and do updates of the last 34 years of
scientific research to be able to do that. That would be the
first step in the process.
Then, keeping in mind also that while we can talk
generally about the penicillin and tetracycline classes of
drugs, it is actually approximately 73 drug products that would
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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actually be at issue here. So it would require scientific
updates for all 73 of those products, which would be a
substantial undertaking, particularly to put the drug sponsors
and drug companies on notice of the basis for a proposed
withdrawal. It would then -THE COURT: I'm not moving on to that. The original
notices had to do with tetracycline and penicillin. Why is it
now 70 others?
MS. BARCELO: Because my understanding is penicillin
and tetracyclines are used in -- it's the animal drug products
themselves; it's not just one type of drug product and another
type of drug product. They are used in a variety of types of
drug products, and there are classes of drugs. My scientific
knowledge of all of this is a little limited, but that's my
general -- we are talking about 73 different products.
THE COURT: Right.
MS. BARCELO: So it would be a variable process to
update them and then publish -THE COURT: When the FDA began considering -- I don't
know whether they actually took action, voluntary action, but
they did that on the basis of updated findings, didn't they?
MS. BARCELO: They have certainly stayed on top of
this for the last 34 years, and they made a number of
statements, and there is a lot out there on FDA's view on this,
but the precise scientific -- for each one of these 73 classes
SOUTHERN DISTRICT REPORTERS, P.C.
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and their resources out there, that is no small undertaking
because the drug sponsors and drug companies would be -- the
point of it all would be to put them on notice of what -THE COURT: So that goes more to how much time they
should have to re-issue them.
MS. BARCELO: That goes to whether what plaintiffs are
asking for is really discrete relief or not. This update, then
publication, then notice of hearings, then holding the hearings
is this really substantial programmatic attack and FDA's entire
regulation of antibiotics and animal feed. And I also don't
think it's fair to say that the first time the government made
this programmatic attack argument was in our reply brief.
Plaintiffs, as I suggested earlier, have sort of
continually been changing what the relief is that they're
requesting because they aren't really entitled to what it is
that they're requesting. They initially in their opening brief
said that they were requesting withdrawals in a year,
withdrawals of these drugs in a year. Once we in our
opposition brief said you can't do that, you have to do
hearings, there's a number of procedural rights that need to be
protected.
THE COURT: Of which there's no dispute.
MS. BARCELO: There is no now dispute about that,
which plaintiffs didn't originally acknowledge. Now we're in
the world where they are admitting that they need these
SOUTHERN DISTRICT REPORTERS, P.C.
[phone]

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scientific updates and publications of these hearings, and that
is an extremely broad attack on FDA's entire regulation of
antibiotics in animal feed, which is not the type of discrete
action that their claim to compel agency action unlawfully
withheld, but the only thing that would be allowed to would be
discrete and required action.
THE COURT: Let's go back to the language of the
actual basic statute. It does provide for some compulsory
action by the FDA, doesn't it?
MS. BARCELO: It uses the word "shall."
THE COURT: Yes.
MS. BARCELO: Its use of the word shall is in
connection with a finding by the secretary. It is plain from
the language of the statute that that finding could only happen
after the drug sponsors' procedural rights have been fulfilled
because it doesn't have to happen after that. Not only does -THE COURT: Well, I'm not show sure it's clear.
Something has to happen after, but maybe the thing that happens
after is the decision to withdraw or not to withdraw.
MS. BARCELO: That decision -THE COURT: Not a new finding. I mean, I guess if
it's a decision not to withdraw, they'd have to make a new
finding, but as long as they may come forward and made a
preliminary showing that it hasn't shown to be safe, the burden
then falls upon the companies to demonstrate otherwise. Even
SOUTHERN DISTRICT REPORTERS, P.C.
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the notices say if you don't come forward and show anything,
we're going to withdraw it. So what's the choice here? Isn't
it a compulsory act?
MS. BARCELO: There are sort of two questions tied up
in that. First, BVM has not made that preliminary showing yet.
All that they've done is issue a complaint, a document on paper
saying we think -- 34 years ago we think that we had enough to
do it. They have not -- because the hearing hasn't been held,
they have not made that showing, and that would be -- they said
that they think they have enough evidence. They haven't made
the showing.
THE COURT: Are you saying they didn't make a
sufficient showing to issue the notice?
MS. BARCELO: I'm not saying that at all. They
unquestionably did have sufficient showing to make the notice.
The question I am getting at is what was the effect of that
notice, and what did that notice really do. It was BVM stating
its position that -THE COURT: Either that the drug is unsafe or it
hasn't been shown to be safe. It had to make one of those
findings or both in order to issue the notice.
MS. BARCELO: The regulation talks about it as a
finding. On the face of the NOH, it talks about it as a
proposal to withdraw.
THE COURT: OK.
SOUTHERN DISTRICT REPORTERS, P.C.
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MS. BARCELO: This is all, I think, sort of a game of
word choice and what we really need to be focusing on is what
is the effect of each of these things.
THE COURT: But the FDA couldn't propose to withdraw
unless it made that finding, correct?
MS. BARCELO: BVM made the finding.
THE COURT: Are you making a distinction between BVM
and the FDA?
MS. BARCELO: I'm not -- the reason I am so focused on
the fact it was BVM is because BVM had such limited authority
here.
THE COURT: But it was delegated that authority,
right?
MS. BARCELO: It was delegated that authority and
nothing more.
THE COURT: To make a determination and issue a
notice, OK; and it did that.
MS. BARCELO: That's correct.
THE COURT: OK.
MS. BARCELO: Yes.
THE COURT: So, are you saying the determination has
no weight?
MS. BARCELO: Now, well, I'm not -- I'm not saying
that at all. It has -- it is what it is. It's equivalent, as
we've explained it and as the hearing procedures -- FDA's
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regulations that explain the hearing procedures, it is the
beginning of a process that has now been completed with the
withdrawal of that proposal.
THE COURT: Didn't the commissioner actually endorse
the preliminary finding, whether you call it preliminary or
final?
MS. BARCELO: In the sense that the commissioner
denied the drug sponsor's request to withdraw those proposals
earlier back, I believe it was in 1983, the commissioner, the
only -- so, the commissioner, yes, did say -- did endorse it in
the sense that they denied the drug sponsor's request to
withdraw that. The commissioner did not endorse it in the
statutory sense of having made a finding at the end of the
required procedural hearings.
THE COURT: I guess this agreement is whether the only
thing that the commissioner is left to do is either to withdraw
or not withdraw versus make a second finding about safety.
MS. BARCELO: Again, I think this is just a question
of word choice. Even the plaintiffs describe in their brief,
they say that the secretary has to make a determination at the
end of these hearings. Whether that determination is the same
thing as a finding, we all agree that these procedural rights
would have to be fulfilled, and then at the end of that so BVM
has a burden -- if this hearing had been held, BVM would have
had a burden, and the drug sponsors would have had a contrary
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burden, and at end somebody would have needed to to protect the
drug sponsor's rights, make a determination or a finding or
whatever it is you want to call it. The statute uses the word
finding. But that is what has to happen in the end to protect
the procedural rights of those drug sponsors and to say that,
yes, that we can in the beginning whatever our position is
without having heard all of the evidence is enough to trigger
withdrawal is -- I don't think -THE COURT: At that point though once the
determination to propose withdrawal is made, then the burden is
upon the companies to demonstrate that it's safe; and if they
don't do it, as the notices say, if they don't come forward
and -- if you don't ask for a hearing, if you don't come
forward and do this, it's going to be withdrawn, right?
MS. BARCELO: It's like a default judgment, that's
right, yes. If we had been in the world where no one came
forward and said "we'd like a hearing," this would be
different.
THE COURT: But they did request it.
MS. BARCELO: And it was granted.
THE COURT: So why weren't the hearings held?
MS. BARCELO: For a variety of -- for a variety of
different reasons. Going back historically, we explained some
of it. Congress -- there is a completely new issue of science
at the time back when these proposals were initially put out
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there. Congress got involved and said, "Could you please do
more research." FDA wanted to do some more research on its own
and commissioned a number of studies and looked into this a lot
more, and at some point along the way after decades of
research, FDA made this sort of inform internal decision we're
not going to move forward with these now-old NOHs; we are going
to move forward with this different regulatory path that FDA is
now on.
THE COURT: Maybe you can clarify this. When I was
looking back at the old notices, I think particularly with the
tetracycline one, it looked like even before that notice
issued, there was a real preliminary finding where the drug
companies were given a chance to come forward with information,
and they didn't. Isn't that true?
MS. BARCELO: There was, if I have my history right,
there were in the early Seventies, right -- at some point in
the Fifties, these drugs were approved; in the Sixties FDA
became concerned; in the Seventies, a task force, if I have my
dates right, I believe a task force was pulled together and did
give -- did ask for more input from the drug sponsors.
THE COURT: And their failure to come forward with
anything then led to the issuance of this notice, right?
MS. BARCELO: I am not sure that I have my history
right on that. That sounds right to me, but I don't think that
anybody is arguing that that sort of initial request for more
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information from the drug sponsors was a finding that could
trigger any obligation on behalf of -THE COURT: Because I'm looking at it and it says the
director finds that the holders of approved NADA's for
subtherapeutic tetracycline use have failed to show that
widespread subtherapeutic tetracycline use in animal feed is
safe.
So that was actually -- they did get to do something
preliminarily, and then they still issued the second notice,
which I guess is the more formal process.
MS. BARCELO: It is this notice that is the notice of
opportunity for a hearing, which is what the regulation talks
about and what the statute talks about. And that notice that
instituted this process, whatever was done before then this
preliminary concern -THE COURT: You're saying at this stage it's still
preliminary.
MS. BARCELO: That was still -- yes, the 1977 was
still preliminary and could not form the basis for withdrawal
at all in the world that we're in -THE COURT: Yes.
MS. BARCELO: -- where the sponsors requested hearing
and those hearing -- the second they requested those hearings,
BVM's authority was divested completely. The fact that those
hearings were granted and everybody recognizes -SOUTHERN DISTRICT REPORTERS, P.C.
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THE COURT: OK. So BVM is out of the picture, but the
FDA is still in the picture. What's their obligation?
MS. BARCELO: Their obligation at this point standing
here today because they -- I mean, for a number of reasons,
it's -- with respect to these 34-year-old NOHs, they can't hold
a hearing. There is no basis to order them to hold a hearing.
THE COURT: Because they didn't do anything for 37
years, but they have not withdrawn the finding that led to the
notice.
MS. BARCELO: They've withdrawn the proposal to
withdraw, and that is -THE COURT: But the safety issue remains.
MS. BARCELO: The safety issue -THE COURT: The public safety is still at risk.
MS. BARCELO: The FDA has concerns regarding public
safety and is addressing them on another route using a
different route -THE COURT: But not because it found that these are
safe or that the companies demonstrated that they can be safe.
MS. BARCELO: Those hearings -- right. Hearings in
which those determinations were made have not been held, but, I
mean, I think that this concern that I am hearing is probably
better for the next round of briefing where plaintiffs are
focused more on what FDA -- plaintiffs claim is a challenge to
what FDA has done, rather than -SOUTHERN DISTRICT REPORTERS, P.C.
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THE COURT: Yes, go ahead.
MS. BARCELO: -- which is, again, I think the
difference would be the different types of actions that you can
bring under EPA.
THE COURT: In this proceeding they're not asking for
specific remedy on this motion.
MS. BARCELO: That's right.
THE COURT: They're asking that the FDA complete the
process.
MS. BARCELO: Right. While their next claim is a
challenge to FDA action, which has all sorts of other legal
problems and questions -THE COURT: Let me ask you something: If the court
were to agree them and say, let's say, after hearing from both
parties that within 18 months a new notice will issue and
hearings must be held, would that sort of moot the other part
of it?
MS. BARCELO: That would be for plaintiffs, I think,
to -- we would have to think about what our arguments would be.
I had not -THE COURT: OK. Maybe ms. Sorenson will address that.
I am assuming if this Court gave an imprimatur to what they are
proposing here, which is go ahead with the hearings and then,
you know, you have to make a decision to withdraw or not to
withdraw, I guess until that happened, the FDA is free to do
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whatever they want experimentally in terms of voluntary
conduct. I don't know there would be a ban on it, as long as
they were following what -- if I say the regulations require to
do this, you know.
MS. BARCELO: Right. And I think -- well, of course I
think that the regulations do not -- the regulations do not
require FDA to move forward with the hearing nor does the
statute require FDA to move forward with the hearing.
THE COURT: And that's because you think there has
been no determination made that these drugs are either not safe
or have not been proven to be safe.
MS. BARCELO: Well, it's because FDA withdrew the
proposals, and if FDA -- it's hard for me to answer that
question because we're not in the world where the NOHs are
still outstanding.
THE COURT: Would it be a lot different case or more
difficult case if the FDA had never drawn any conclusions about
these drugs, then, you know, what the Court -- I mean, I guess
there would be a different form of relief being requested if
they thought that there was all this scientific evidence. But
the agency did draw some conclusions. It inevitably withdraw
those conclusions. We're not talking about the ultimate
withdrawal decision. And it just seems to itself cited all the
updated scientific evidence that gave greater strength to the
initial conclusion.
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So, I would be surprised to hear if anybody in the FDA
would argue that they came to the conclusion that the use of
these drugs is safe or has been proven to be, you know, not to
be unsafe.
MS. BARCELO: That conclusion has not been reached
because these hearings haven't been held. I do think -- maybe
there would also be another government that the government
would have if these NOHs have not been withdrawn, which they,
of course, have.
THE COURT: OK.
MS. BARCELO: That the government's decision with
respect to how to move forward on the NOHs was not subject to
judicial review because it was committed to agency discretion
by law. We aren't I don't think in that world because the NOHs
have been withdrawn, and there is no basis to move forward with
the hearing, and the findings -- and, additionally, the
findings that FDA made cannot compel withdrawal or compel the
completion of it -THE COURT: We are sort of talk technically, but isn't
their basic mission under the statute to protect public safety?
MS. BARCELO: That is their basic mission -THE COURT: When they make a determination that the
use of certain drugs had not been shown to be safe for humans,
don't they have to do something.
MS. BARCELO: If that's the Court's concern, FDA
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certainly is doing something. The question here is -THE COURT: For 37 years they have been.
MS. BARCELO: They have been doing something. They
have been doing research for decades.
THE COURT: OK. And strengthened their original view.
MS. BARCELO: And determined that the most effective
way to go about addressing this issue is to go on the path that
they are going on now: Issuing these draft guidance, issuing
veterinary oversight, trying to work -- rather than incur the
cost of these 73 hearings and scientific updates and all these
sort of massive undertakings the plaintiffs would prefer, FDA
has in its expertise and discretion determined that the route
it is on is a better one. And that these -- that the best way
to get this done as quickly and efficiently and in the public
interest that this is -- that's what we have FDA for is to
answer these -- their expertise of working with the drug
sponsors and working with all of the industry they work with to
figure out -THE COURT: And what if they weren't doing it because
of public interest? What if they were doing it because of
political pressure?
MS. BARCELO: Well, they are doing it here. That is
what I think -- they are doing it, and they have left open the
possibility, they explicitly said and an NOH withdrawal -- they
have left open the possibility for pursuing more formal
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withdrawal proceedings if necessary. That is certainly still
out there.
THE COURT: Right. I get that you've changed your
position somewhat in the briefs too because are you conceding
that there was a determination made about -- that there was a
potential -- that they had not been shown to be safe?
MS. BARCELO: No. What we, I think, are all on the
same page about is that BVM had authority to issue these NOHs
in 1977, and that what those NOHs are whatever it's -- what
those NOHs are is equivalent to complaint that starts a
proceeding and says we would be able to -- it's BVM's position
that they would be able to meet a burden that they may
eventually need to meet if hearings were held. And it is
nothing more than -THE COURT: I mean, as you have readily conceded if
the drug companies didn't request a hearing or come forward
with anything, then the only thing that could follow would be
the withdrawal once BVM did that.
MS. BARCELO: If we were in that world, that would be
right.
THE COURT: So it's not exactly just a complaint.
MS. BARCELO: Well, I mean, a complaint, you can get a
default judgment. If a defendant doesn't show up to defend -THE COURT: It has to on its face state a valid claim
for relief, and here it's based upon the agency making a
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determination that it hasn't shown to be safe.
MS. BARCELO: Which is BVM's statement. I mean, once
we get in -- maybe it's helpful to go at it this way: Once we
get into the hearings, BVM and the drug sponsors would be
adversaries in that hearing, and the commissioner would be the
adjudicator.
So it would be BVM -- it really is similar to civil
proceedings with BVM stating its case and then an evidential -BVM having not at this point put on any evidence whatsoever or
met any burden whatsoever. As soon as the hearing started,
there would be a wall between BVM and the commissioner with the
commissioner making the conclusion first whether BVM met its
burden, and, second, whether the drug sponsors met their burden
in response.
THE COURT: All the plaintiffs are asking is, so let
that happen. Let the commissioner make the final decision.
MS. BARCELO: There is no basis at that point to
compel -- not only would it be much more complex than it
sounds, if you phrase it that way, all the different steps that
would be required, but there is no statutory or regulatory
basis to require that to happen.
THE COURT: They would have never been able to issue
this notice if it was just a complaint. They based it upon
many years of scientific study, did they not?
MS. BARCELO: They did base it on -- yes.
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THE COURT: So it wasn't like, OK, here's the opening
round of discovery. They said there have been these studies,
we've reviewed these studies, we've accepted some, we don't
accept others, but the ultimate conclusion is that it hasn't
been shown to be safe. Now you show us otherwise.
MS. BARCELO: Well, we need to put on our burden to
actually carry that. It could be -- I mean, you could hold a
hearing and the commissioner could say, BVM, you've not -- you
wrote it all down on paper, but when it was time to show your
evidence, you've got nothing.
Another thing, I think -THE COURT: Who is the hearing officer of these?
MS. BARCELO: The commissioner. It may be delegated
from -- the commissioner may delegate the running hearings, but
that's my understanding is that the commissioner is overseeing
the hearings.
Another thing I think that -- one thing that might be
an assumption that the Court is taking in our discussion and I
just want to make sure I am clear on. This finding that the
regulation talks about, the regulation using the word finding
that is the decision to issue the NOH is different than the
finding that the statute is talking about. They both use the
word finds, but it is not the same finding, and that may be the
fundamental thing that we haven't been talking about but that's
very important to recognize
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THE COURT: You're saying it's a lower standard.
MS. BARCELO: It's the preliminary finding that starts
the process. The only finding that triggers any mandatory duty
by FDA on the face of the statute is a finding that can only
happen at the end of this hearing process after the drug
sponsors have had their procedural rights fulfilled. And that
is something that is consistent -- to the extent that the Court
finds any ambiguity whatsoever in the language of the statute,
that position -- this is how the process works. The BVM only
has authority to issue the NOH, but not to withdraw approval
where someone has requested hearings. All this sort of the
procedure -- the effect of the NOH and the procedure that it
sets in motion and the fact that it is not a final finding that
requires any mandatory obligation on behalf of FDA is
consistent throughout all of FDA's regulations, throughout the
delegation of authority to BVM, throughout the hearing
procedures, and to -THE COURT: The only thing that is inconsistent is
whether it's a different or lower standard. I mean, yes, there
has to be a subsequent finding after a hearing, but, I mean,
the plaintiff's position is the only finding to be made at that
point is whether to withdraw approval.
MS. BARCELO: Which can only be based on a
determination of the evidence.
THE COURT: OK. So let's assume that's the case, but
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doesn't that process have to go forward? I mean, we are not
talking about the ultimate outcome, but doesn't the
commissioner have an obligation once it's noticed to make that
determination?
MS. BARCELO: There is no statutory or regulatory
basis to find that obligation, particularly where the statute
on which plaintiffs rely so heavily only requires a hearing
where there is a proposal for withdrawal, and there is no
longer a proposal for withdrawal.
And FDA explained in its proposal for withdrawal the
basis for its decision to withdraw, in part because the science
was so old and stale, we all, I think, agree what was said 34
years ago couldn't actually be the basis to move forward with
anything.
FDA has also stated its discretion -- its position
that it has discretion to determine -- if it decided to
reinstitute these proceedings, it would have discretion to
determine which drugs to move forward with, which drugs not to
move forward with.
Were the Court now to now today say 34 years later,
you need to go forward with all 73 of them, that would, I
think, be a problem in light of FDA's authority and discretion
to determine what it's going to pursue and whatnot.
Then the third reason was that FDA, as we have been
talking about, has pursued this different regulatory path to
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accomplish what its regulatory goals are now which it has
determined will be the most effective method for the time being
and for the present to address this issue.
THE COURT: Again, are you able to say whether the
substantive position of the FDA at this point has changed in
terms of whether it has found that there is no question -either that the use of these drugs is safe or it hasn't been
shown to be safe?
MS. BARCELO: I think the only real question before
this Court -- that, I think, is too general of a question for
me to answer. What I can answer for you is whether there's
been a finding within the purpose of the meaning of this
statute that would require FDA to go forward, and that
definitely FDA has not -THE COURT: Because they withdraw that finding.
MS. BARCELO: Because BVM finding back in 1977 wasn't
the finding that the statute talks about, and because they
withdrew the NOH, so they are -- not only would it have been
within FDA's discretion to determine whether to move forward
with these NOHs or take some ultimate path which it has chosen,
but also because FDA withdrew the NOHs, there's no statutory
regulatory, nothing; no basis to compel FDA to move forward
with this will initial step -- with any of the steps let alone
this initial step of the massive scientific undertaking.
THE COURT: I'm a little confused about the
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commissioner's role here. I know it came out of BVM, but
didn't the commissioner put his imprimatur on that finding?
MS. BARCELO: In the informal sense of the decision
not to withdraw the NOHs, that was not a decision that was made
within the statutory are sense here of a finding after a
hearing. So the commissioner at that point said we would
rather have -- it was I think in 1983, five years after the
NOHs were issued the commissioner said that -- the commissioner
denied the drug sponsor's request to withdraw them in light of
the fact that there was going to be additional scientific
research out there.
That was the point back in the Seventies and Eighties
after the NOHs were published, Congress requested additional
research. FDA itself wanted to do additional research. The
drug sponsor said if there is going to be additional research,
withdraw the 1977 NOHs, and the commissioner said we would like
to have these still outstanding. That was also not the finding
within the meaning of the statute which could only happen after
the drug sponsor's procedural rights were satisfied.
THE COURT:
OK. Anything else you want to bring to
my attention?
MS. BARCELO: I think that's it. Thank you, your
Honor.
THE COURT: Thank you.
Ms. Sorenson.
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MS. SORENSON: May I have one moment, your Honor to
confer with counsel?
THE COURT: Sure.
(Pause)
MS. SORENSON: Your Honor, I'd like to start by
clarifying the issue with the 73 drug products that the agency
has been talking about. This action may involve 73 drug
products, but it only involve three drugs, and all of those
products contain those drugs. The issue is whether the drugs
are not shown to be safe, not the drug products. The initial
notices of opportunity for hearing covered three dozen drug
products that contain those drugs, and the agency proposed to
dispose of the determination on whether those drugs are shown
to be safe in a single hearing because the safety -- the
dangers to human health presented by all the drugs was the
same. So, the government's contention that suddenly this is
not a discrete action because it involves multiple drug
products is simply false.
Second, your Honor is correct that in the Seventies,
the commissioner was concerned about the safety of these drug
uses and asked drug sponsors to come forward and give evidence
to the agency that these drug uses were shown to be safe for
human health. The drug sponsors did come forward with what
they considered to be that evidence, and BVM examined and
rejected that evidence and came to the conclusion that these
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drugs were not shown to be safe.
The agency has no evidence for its distinction that
it's a drawing between preliminary findings and final findings,
and even if the agency were correct that the word finding in
the statute and regulation is somehow different, FDA still has
an obligation under its own regulation to conduct these
proceedings in light of the findings that the agency has
already made.
THE COURT: But you accept that post hearing some
further determination has to be made?
MS. SORENSON: Of course, your Honor. That's the
outcome of an agency adjudication. But unless the agency finds
that the drug sponsors have carried their burden, it is
required by the statute to withdraw approval for the drug uses.
Your Honor asked how a decision in favor of plaintiffs
would affect the further briefing on plaintiff's third claim
for relief.
If this Court were to order the agency to proceed with
the penicillin and tetracycline withdrawal proceedings, then
that would moot out that part of the third claim for relief,
but the third claim for relief also covers other forms of
antibiotics that are also used in livestock feed, so that part
of the claim would still have to be briefed.
Finally, the government repeatedly says that it is on
a -- it is pursuing a different path to addressing this danger
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to human health, but the path the agency has to follow is set
out by the statute. What plaintiffs are asking is for the
Court to play its traditional role in returning the agency to
the statutory path.
THE COURT: What were the plaintiffs doing for the
last 37 years after these notices came out? Why was there
never any prior proceeding to compel action?
MS. SORENSON: Your Honor, plaintiffs have advocated
on this issue with FDA for years. They submitted citizen
petitions 12 and six years ago to try to get the agency to act
on these drugs. The agency ignored the petitions for all this
time until plaintiffs brought a lawsuit. FDA continued to do
research over the years that reinforced its findings that these
drug uses are not shown to be safe. But then instead of taking
action, it came out in 2010 with this draft guidance that
promotes voluntary reform, and that lack of action on this
critical issue is what compelled plaintiffs finally to bring a
suit here.
THE COURT: So, do you agree though that the 1977
notice is outdated?
MS. SORENSON: Your Honor, I would like to point out
that the only person who has ever used the word outdated is the
agency's litigation counsel. In withdrawing the notices of
opportunity for hearing in December, the agency didn't actually
say the notices were out dated. What it said was that the body
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of scientific evidence examining the effects of these drugs -these drug uses on human health has expanded considerably over
the years, and were the agency to withdraw approval now, we
would have to supplement the notices to give the drug sponsors
notice that the agency would be relying on the more recent
science as well. But the agency never stepped off of its 1977
findings, and the agency itself, as opposed to litigation
counsel, has never said those findings are in any way sale.
Plaintiffs agree that the notices would need to be
updated to take account of the developing science which is now
virtually a consensus throughout public health and governmental
authorities that these drugs uses present a danger to human
health, but that doesn't mean that the 1977 findings don't
still have validity; they do.
THE COURT: Is it conceivable that in the 30-some-odd
years, practices could have changed which that made the use of
it less -- made it safer?
MS. SORENSON: Not given the facts of what's
happening. The use of antibiotics in livestock has increased
exponentially even since the Seventies and now constitutes
80 percent of the antibiotics used in the United States.
In that scenario -- public health authorities have
come out stronger and stronger against that misuse and overuse
of in livestock. The danger certainly hasn't lessened. HHS -the director of Health and Human Services, FDA's parent agency,
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has said that the weight of the evidence shows that this drug
use has consequences for human health, and that there is little
evidence to the contrary.
THE COURT: Again, I think your position was that the
Court was inclined to entertain -- to accept your position,
there should be further consideration of time frame?
MS. SORENSON: That's entirely within your Honor's
discretion, but if your Honor seeks guidance on how long it
should take the agency to conduct these withdrawal proceedings,
then postjudgment briefing would be appropriate.
Thank you.
THE COURT: Anything else?
MS. BARCELO: If I may, just a few quick points.
I just want to be clear about one thing that I may
have misspoken about earlier, which is, just to be clear, the
regulation that we're talking about that everyone is focused on
does not require FDA to necessarily move forward with the
hearings once it's issued an NOH.
This is a classic example -- the decision -- as this
has played out, it's a classic example of FDA's enforcement
discretion, discretion to decide to move forward with NOHs as
opposed to -- or to do what it has done, which is move forward
with an alternate regulatory path of trying to see, first, if
voluntary compliance will work, to save the expense -- the
massive undertaking and the expense of the process that it
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initially began in 1977. And this issue of whether FDA had the
discretion to determine to take the alternate path instead of
the path that it originally thought it was going to take, that
discretion issue is what's going to be at issue in the next
round of briefing.
So that the regulation here to be -- if I did say
earlier, which I may have, that the regulation required us to
move forward with those hearings, that was an incorrect
statement by me; that FDA had the discretion to move forward or
not to move forward. It exercised its discretion by not moving
forward, but regardless of that, now that the proposals to
withdraw have been withdrawn themselves, that's all the more
reason that there's no basis for FDA to be compelled to move
forward.
THE COURT: So you're saying that the regulation which
talks about the commissioner shall notify in writing the
holder, if he finds that experience or scientific data show
that the drug is unsafe, you're saying he didn't -- the
commissioner doesn't have to do that if he finds that -MS. BARCELO: The NOH was -- I do think the NOH is
what is contemplated by subpart B in 514.115, but whether or
not after issuing that NOH, the commissioner needed to -- was
there by compelled to move forward with the process is
something that was within FDA's discretion, enforcement
discretion not to do, and instead do what they did do, which is
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take this alternate path and try voluntary compliance rather
than requiring this issue again with the 73 products versus the
three products, there would be 73 drug sponsors at issue here,
each of whom would be required to have a hearing, so it could
be that it would be fewer than 73 but more than three.
THE COURT: Would they be separate hearings?
MS. BARCELO: That is all something that would -THE COURT: It's up to the commissioner to decide.
MS. BARCELO: Yes, that's something yet to be
determined.
THE COURT: I mean, even if the commissioner uses this
voluntary approach, ultimately is it going to have to go
through that same complex process? How will it evaluate?
MS. BARCELO: That, again, is -- we are not in that
world, and that is yet to be determined, and FDA has explicitly
said that if this voluntary compliance doesn't work to save us
ten years of -- however, I don't want to put a time frame out
there, but however long these hearings would take and however
millions of dollars of resources it would take up, FDA is
trying its other voluntary compliance method first, and it's
within its enforcement discretion to make that decision, and
specifically the issue of whether it is in its enforcement
discretion is what we're about to brief, so that those issues
will be before the Court.
THE COURT: Well, I think though on this motion, the
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plaintiff's position is, is once there was a finding,
preliminary or otherwise that it wasn't shown to be safe, it
didn't have discretion; it had to act.
MS. BARCELO: And there is no statutory or regulatory
basis for that. There is no regulation or statute that says
you can't, you know -- that says what they would like it to
say; that you need to keep updating these -- you know, you need
to hold the hearing immediately or you need to update your NOHs
as science evolves and you need, you know, there's just -there is nothing that -THE COURT: So, under this statutory scheme if there
is something that is found to be a clear threat to human
health, and the commissioner just decides not to do anything
about it, that's his discretion.
MS. BARCELO: If there -- I'm not sure what your Honor
means by the word find. I mean, I think that's what this whole
case is about. It's hard for me to -THE COURT: But I think the record suggests that the
commissioner has never withdrawn or stepped away from finding
that these drugs have not been shown to be safe.
MS. BARCELO: It's never withdrawn or stepped away
from its expression of concern on this issue, and it has also
addressed its concern on that issue by doing something that's
different than what 34 years ago it originally thought was the
right path. It's changed -- as science has evolved and as the
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word has evolved, and facts have evolved, the FDA has been
working with drug sponsors and is very keyed into this issue,
and what's happening over time has determined in its expertise
that the way to pursue this is first through this voluntary
compliance.
THE COURT: Theoretically, it could hold the hearings,
and if the evidence didn't come forward to rebut the finding;
say we are going to withdraw the approval except in conditions
where the drugs are prescribed by a veterinarian. They could
accommodate -- they have flexibility there, right?
MS. BARCELO: That would be a massive undertaking.
THE COURT: Why?
MS. BARCELO: The holding that the enrofloxacin
withdrawal, which I think happened in 2005 and was just one
drug, took five years and I cannot remember how many millions
of dollars, but I think millions and millions. I think about
five million dollars. And this was a much less -- I don't know
much about enrofloxacin withdrawal, but this is an extremely
substantial process that we're talking about here.
THE COURT: Are there any regs that specifically deal
with what happens at a hearing?
MS. BARCELO: There are. They are at 21 CFR 12.80 is
the beginning of a hearing procedure regulation. It sets forth
the filing of submissions, the oral and written testimony and
burdens of proof. These hearings are extensive -SOUTHERN DISTRICT REPORTERS, P.C.
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THE COURT: Does the commission have the discretion to
set time frames for submissions?
MS. BARCELO: I don't know off the top of my head, but
I would assume so.
THE COURT: All right.
MS. BARCELO: Even after this massive undertaking of
updating the last 34 years of science.
THE COURT: Well, doesn't the commissioner have to do
that anyway? I mean, is the commissioner not going to update
the science where it has concern about public safety?
MS. BARCELO: These are all, I think -THE COURT: I mean, this is something they have been
doing all along, haven't they? Haven't they been updating the
science?
MS. BARCELO: They have been on top of this issue as a
general matter. In terms of the update that would be required
to hold a hearing and pursue a trial on the matter and the
burdens and the resources that that would take are very, very
substantial. It is within FDA's enforcement discretion to
decide to forego that enormous burden and try to do it this
other way.
THE COURT: Right. Let me ask you something. I don't
know or I don't remember if anybody cited any precedent one way
or the other in terms of are there any other cases where
findings have been made that have sparked the notice of hearing
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where the agency then chose to just go a different route?
MS. BARCELO: The closest case to that -- there was
the case I think of it as the Veneman case, which is a case in
which -- it was not animal drugs, but it was an FDA drug case
in which -- it was a different process. It was this process
where after the law changed, FDA needed to determine whether
drugs were effective in addition to being safe, and they set up
this whole regulatory scheme of deadlines. There was this
whole process. And the Court told FDA that they needed to
operate within that structured process.
Here there is no structured process. There is no
structured regulatory framework in this case. In addition to
that, that case I think was a 1972 decision.
THE COURT: And it's not been updated?
MS. BARCELO: Not that I'm aware. It wasn't just that
it's old, which is not helpful, but in addition to that, since
then there has been a lot of additional case law. Heckler v.
Chaney by the Supreme Court, which very much clarified the
presumption of unreviewable discretion when we're talking about
matters of enforcement, which is what this is. So a district
court case from 1972 with a different regulatory and
legislative framework.
THE COURT: So there isn't a lot of experience with
issuing these notices of hearing?
MS. BARCELO: I don't know how many. I know the
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enrofloxacin, which was in 2005. I don't think it's a
regular-THE COURT: So this is a pretty unusual process?
MS. BARCELO: That's my understanding.
And, finally, on the issue of the scientific update
that would be required, it really would, I think, require FDA
to make new findings based on all of this evidence, and there
really is no regulatory or statutory basis to require FDA to
conduct that scientific update and then make new findings. The
statute and the regulation talk about the findings that are
already made. Anything that the regulation calls a finding in
this preliminary sense of beginning the process is the 34 year
old document which has no current validity in terms of what the
world is like today.
THE COURT: Thank you.
MS. BARCELO: Thank you.
THE COURT: Want to add anything?
MS. SORENSON: A couple of quick things, your Honor.
You asked about FDA hearings regulations. 21 CFR 12.7E gives
FDA's hearing officer a lot of discretion over the process. It
says: The presiding officer has all powers necessary to
conduct a fair, expeditious and orderly hearing, and it sets
forth those powers. That is a matter that will be within the
hearing officer's power to determine.
This is the first time that FDA has invoked Heckler v.
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Chaney and called this a discretionary and unreviewable
enforcement action. This is not an enforcement action. There
is a section of the Food and Drug Act that sets out enforcement
actions for violations of the statute. This is FDA having to
exercise its own authority to withdraw its previous approvals
of an animal drug that is not shown to be safe.
The agency has been citing enrofloxacin withdrawal
proceeding which took five years. In that adjudication, the
agency's own hearing officer chided the agency for proposing a
schedule that provides for "an unduly prolonged process that
would extend this proceeding." The hearing officer has the
discretion to shorten the time frame and to cut short the
agency's time of delay.
THE COURT: So after the taking of all the evidence,
does a hearing officer issue a recommendation to the secretary,
is that how it works?
MS. SORENSON: The hearing officer makes an initial
determination, and then only if that determination is appealed
does the question go to the commissioner. The initial hearing
officer is someone different from the commissioner, who is
appointed to that position, and an appeal goes to the
commissioner who makes a final decision.
THE COURT: So it's an adversary proceeding where
there is the agency and the -MS. SORENSON: It is, your Honor.
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I would like to briefly address the APHA v. Veneman
case that the government mentioned. This is a case where the
District of D.C. ordered the agency to conduct withdrawal
proceedings for human drugs that were not shown to be
effective.
The agency is right that it was a different process
that led to the agency's findings that the drugs were not shown
to be effective, but once the agency made those findings, it
was confronted with almost identical statutory language that we
have here, which said that the agency must after noticing an
opportunity for hearing withdraw approval for drugs if he finds
that the drugs -- there's not substantial evidence that the
drugs are effective.
FDA had made those findings and published them in the
Federal Register, but instead of conducting withdrawal
proceedings, the agency had asked drug sponsors to come forward
with more evidence, and the agency was sued.
Just like it does here, the agency argued that the
findings that it published in the Federal Register weren't
findings that triggered action under the statute, and the Court
said, no, the statute is perfectly clear that once the agency
makes these findings, it must proceed immediately with
withdrawal proceedings for these drugs. That is what Congress
has ordered because the agency's duty is to protect public
health.
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THE COURT: Is that a D.C. Circuit or District Court?
MS. SORENSON: That was the District of D.C.
THE COURT: No appeal?
MS. SORENSON: No appeal. That case is still good
law, your Honor. Thank you.
THE COURT: Thanks folks. Very interesting question.
See you.
(Adjourned)

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