Natural Resources Defense Coun v. United States Food and Drug Ad
Filing
OPINION, Dissenting, by RAK, FILED.[1278169] [12-2106, 12-3607]
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KATZMANN, Chief Judge, dissenting:
In 1977, nearly four decades ago, the Food and Drug Administration
(“FDA”) formally declared that the subtherapeutic use of penicillin and
tetracyclines in animal feed “ha[s] not been shown to be safe.” Penicillin‐
Containing Premixes; Opportunity for Hearing, 42 Fed. Reg. 43,772, 43,772 (Aug.
30, 1977) [hereinafter Penicillin NOOH]; Tetracycline (Chlortetracycline and
Oxytetracycline)‐Containing Premixes; Opportunity for Hearing, 42 Fed. Reg.
56,264, 56,264 (Oct. 21, 1977) [hereinafter Tetracycline NOOH]. It has never
abandoned that position. Indeed, the FDA has consistently reaffirmed that using
low doses of antibiotics on healthy livestock to promote growth could accelerate
the development of antibiotic‐resistant bacteria, causing “a mounting public
health problem of global significance.” FDA, Guidance for Industry #209: The
Judicious Use of Medically Important Antimicrobial Drugs in Food‐Producing
Animals 4 (April 13, 2012). The FDA has nevertheless refused to move forward
with the statutorily‐prescribed process for withdrawing approval from the
subtherapeutic use of penicillin and tetracyclines. It has also refused to begin the
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process of withdrawing approval from the subtherapeutic use of other medically
important antibiotics on animals.
The majority begins by recognizing that antibiotic resistance presents a
serious global health problem, and that the indiscriminate use of antibiotics on
animals contributes to that problem. Its ruling nevertheless seems to accept the
view that Congress gave the FDA discretion to do virtually nothing about that
problem for over 30 years—and then, when it finally decided to act, to adopt a
different regulatory strategy than Congress expressly provided. More precisely, it
permits the FDA to renounce the statutory withdrawal procedure in favor of its
own “voluntary compliance” strategy, which consists of asking animal drug
sponsors to voluntarily relabel their products in order to prevent them from
being used to promote animal growth. See FDA, Guidance for Industry # 213:
New Animal Drugs and New Animal Drug Combination Products Administered
in or on Medicated Feed or Drinking Water of Food‐Producing Animals
(December 2013).
I cannot agree with the majority’s conclusions. In light of the statutory
structure and its purposes, I am convinced that 21 U.S.C. § 360b(e)(1) requires the
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FDA to continue the proposed withdrawal proceedings for the subtherapeutic
use of penicillin and tetracyclines in animal feed. I am likewise convinced that the
agency’s decision to deny the citizen petitions was arbitrary and capricious under
Massachusetts v. EPA, 549 U.S. 497 (2007), because it failed to address the statutory
question of whether the animal drug uses at issue were shown to be safe.
Today’s decision allows the FDA to openly declare that a particular animal
drug is unsafe, but then refuse to withdraw approval of that drug. It also gives
the agency discretion to effectively ignore a public petition asking it to withdraw
approval from an unsafe drug. I do not believe the statutory scheme can be read
to permit those results, and I must therefore respectfully dissent.
I.
The Required Hearings Claim
A.
Text
Like the majority, I begin with the text of the statute:
The Secretary shall, after due notice and opportunity for hearing to
the applicant, issue an order withdrawing approval of an application
. . . with respect to any new animal drug if the Secretary finds—
. . .
(B) that new evidence . . . shows that such drug is not shown to be
safe for use under the conditions of use upon the basis of
which the application was approved . . . .
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21 U.S.C. § 360b(e)(1).
I agree with the majority that the bare text of this statute is ambiguous, and
that both plaintiffs and the FDA have presented plausible readings. In plaintiffs’
view, “if the Secretary finds . . . that new evidence . . . shows that [a] drug is not
shown to be safe” then “[t]he Secretary shall, after due notice and opportunity for
a hearing to the applicant, issue an order withdrawing approval of . . . [that]
drug.” Id. In that case, the FDA is statutorily required to institute withdrawal
proceedings whenever it makes a preliminary finding that a particular animal
drug has not been shown to be safe for its approved use. In the government’s
view, on the other hand, “if the Secretary finds,” “after due notice and an
opportunity for a hearing to the applicant,” “that new evidence . . . shows that
[any new animal] drug is not shown to be safe” then “[t]he Secretary shall . . .
issue an order withdrawing approval of . . . [such] drug.” Id. On that reading, the
FDA is never statutorily required to initiate or continue withdrawal proceedings
for a drug—no matter how terrifyingly unsafe that drug may be. Instead, the
FDA has complete discretion to decide when (and whether) to begin the process
of withdrawing approval for drugs that it has determined are not shown to be
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safe; the only statutory requirement is that if the FDA chooses to hold a hearing,
and finds after that hearing that a drug has not been proven safe for its approved
use, then the FDA must withdraw its approval.
In an ideal world, Congress would have written a statute that clearly
selects between one of these two possible readings. But as the statutory language
is ambiguous, we must do our best to determine which of these two meanings
Congress intended to convey. To answer that question, I turn to the purpose and
structure of the statute as a whole.
B.
Purpose and Structure
“[W]e begin . . . any exercise of statutory construction with the text of the
provision in question, and move on, as need be, to the structure and purpose of
the Act in which it occurs.” N.Y. State Conference of Blue Cross & Blue Shield Plans
v. Travelers Ins. Co., 514 U.S. 645, 655 (1995). The statute at issue here, 21 U.S.C.
§ 360b, is part of the Federal Food, Drug, and Cosmetic Act (“FDCA”), enacted in
1938 to protect American consumers from unsafe food, drugs, medical devices,
and cosmetics. See Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75‐717, 52
Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301–399f).
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“The FDCA statutory regime is designed primarily to protect the health
and safety of the public at large.” POM Wonderful LLC v. Coca‐Cola Co., 134 S. Ct.
2228, 2234 (2014); see also FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120,
133 (2000) (“Viewing the FDCA as a whole, it is evident that one of the Act’s core
objectives is to ensure that any product regulated by the FDA is ‘safe’ and
‘effective’ for its intended use. This essential purpose pervades the FDCA.”
(citations omitted)). The same purpose is reflected in the FDA’s mission, as
defined by Congress:
The Administration shall—
(1) promote the public health by promptly and efficiently
reviewing clinical research and taking appropriate action on
the marketing of regulated products in a timely manner;
(2) with respect to such products, protect the public health by
ensuring that—
. . .
(B) human and veterinary drugs are safe and effective . . . .
21 U.S.C. § 393(b). Of course, this broad statutory mandate to “promote the
public health” and “ensur[e] that human and veterinary drugs are safe and
effective” does not compel the agency to use any particular method to attain
those goals. After all, “no legislation pursues its purposes at all costs . . . and it
frustrates rather than effectuates legislative intent simplistically to assume that
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whatever furthers the statute’s primary objective must be the law.” Rodriguez v.
United States, 480 U.S. 522, 525–26 (1987). But in construing § 360b, we must
surely keep in mind that the primary purpose of the FDCA (and of the FDA
itself) is to protect the public by prohibiting commerce in unsafe food and drugs.
The structure of § 360b reflects that primary purpose, ensuring that no
animal drug can be sold on the national market for a particular use unless the
FDA is convinced that drug has been shown to be safe for that use. Speaking in
broad outlines, § 360b(a) generally prevents any person from distributing a new
animal drug unless that drug has been approved by the FDA.1 Section 360b(b)
requires any person applying for approval of a new animal drug to submit (inter
alia) studies showing that drug is safe and effective, and § 360b(c) then requires
the FDA to determine whether there is any statutory reason not to approve the
1
To be more precise, § 360b(a) declares that a new animal drug “shall, with
respect to any particular use or intended use of such drug, be deemed unsafe” unless it
has been approved by the FDA or a special exception applies. Section 351(a)(5) then
declares that any new animal drug deemed unsafe under § 360b(a) shall be deemed
“adulterated,” and § 331(a) prohibits introducing any adulterated drug into interstate
commerce. Throughout the discussion below, I omit similarly tangential details of the
FDCA’s intricate statutory scheme.
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new drug. Among the statutory grounds for disapproval, of course, is that the
drug has not been shown to be safe. 21 U.S.C. § 360b(d)(1)(B).
The statutorily‐defined process for approving a new animal drug is
marked by the strict limits it places on the FDA’s discretion. Within 180 days
after receiving an application, the FDA “shall either” enter an order of approval,
if it finds no reason to disapprove the application, or else give the applicant
notice of an opportunity for a hearing. Id. § 360b(c)(1)(A)–(B). If the applicant
requests a hearing, the FDA “shall” provide one within ninety days. Id.
§ 360b(c)(1). After the hearing, the FDA “shall” issue a final order within ninety
days. Id. If it finds that any of the statutory grounds for disapproval apply, it
“shall” refuse to approve the application; otherwise, it “shall” approve the
application. Id. § 360b(d)(1). At each step, the FDA is constrained to follow the
approval process laid out by the statute; and it is strictly forbidden at each stage
of the process from approving any drug that is not shown to be safe, or from
disapproving any drug without first giving its sponsor the opportunity for a
hearing. The initial approval provisions in § 360b(c)–(d) are thus designed to
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ensure that the FDA fulfills its statutory role of keeping unsafe drugs off of the
market, while also providing due process to drug sponsors.
On plaintiffs’ interpretation, the withdrawal provision at § 360b(e)(1)(B)
fits comfortably within that statutory scheme. It requires the FDA to commence
withdrawal proceedings whenever the FDA preliminarily determines that an
approved animal drug is no longer shown to be safe for its approved use. The
FDA must then provide notice and an opportunity for the drug’s sponsor to be
heard; and if, after the hearing, it continues to find that the approved drug use is
no longer shown to be safe, it must withdraw its approval of that use. In other
words, plaintiffs’ interpretation reads the initial approval provisions and the
withdrawal provision in parallel: both require the FDA, if it thinks a drug is not
shown to be safe for a particular use, to provide a hearing and then (if still
unconvinced) to disapprove that drug for that use. Both parts of the statute thus
work together to make sure there are no unsafe drugs on the national market.
The initial approval provisions ensure that the FDA will keep new animal drugs
off the market unless they are shown to be safe, while the withdrawal provision
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ensures that the FDA will withdraw approval from an existing drug if it is not
shown to be safe.
The FDA’s position, on the other hand, sets the approval provisions and
the withdrawal provision entirely at odds. The former provisions clearly indicate
that the FDA has no discretion to admit a new animal drug to the market if it
initially finds that drug is not shown to be safe for its proposed use; instead, the
agency must begin the rejection process by providing an opportunity for a
hearing. But according to the FDA, the withdrawal provision then gives the
agency complete discretion to leave an approved animal drug on the market even
if it later learns that drug is utterly unsafe. That interpretation cannot be
reconciled with the purpose of the FDCA, and it cannot be reconciled with the
mission of the FDA itself. I see no reason to believe that Congress carefully
cabined the FDA’s ability to admit new drugs to the market, but then sub silentio
left the agency entirely free to leave dangerous drugs on the market once
admitted. 2
2
The statute does contemplate certain grounds that would prevent a new drug
from being initially approved, but that would not require withdrawal of an approved
drug. Compare 21 U.S.C. § 360b(d)(1)(C) (barring approval of a new drug for which “the
methods used in, and the facilities and controls used for, the manufacture, processing,
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The FDA argues that the formal withdrawal process contemplated by the
statute can be expensive and time‐consuming, and that its voluntary compliance
strategy will reach the same result more quickly and at lower cost. There is a
certain irony in the FDA’s argument that the formal withdrawal process is too
time‐consuming, given that the agency has now delayed even beginning that
process for thirty‐seven years. In any case, the minimum due process protections
provided by the statute—notice and an opportunity to be heard—are the same
for both the initial approval process and for the withdrawal process. If the FDA
preliminarily determines that a new animal drug is not shown to be safe, it must
provide the drug’s sponsor with the opportunity to be heard, even though the
resulting hearings may be long and expensive. See id. § 360b(c)–(d). The agency
has no discretion to deny those hearings. So too here: if the FDA preliminarily
determines that an approved animal drug is not shown to be safe, it must
provide the drug’s sponsor with the opportunity to be heard, and then (if still not
and packing of such drug are inadequate to preserve its identity, strength, quality, and
purity”), and id. § 360b(d)(1)(H) (barring approval where a new drug’s “labeling is false
or misleading in any particular”), with id. § 360b(e)(2)(B)–(C) (giving the Secretary
discretion to decide whether to withdraw approval from drugs under those conditions).
That is, where Congress wanted to give the FDA the discretion that the agency seeks
here, Congress expressly granted it.
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convinced the drug is safe) must withdraw its approval. Id. § 360b(e)(1)(B).
Providing drug sponsors an opportunity to be heard may be tedious and costly,
but Congress has determined that the agency must use that process—both when
it finds a new animal drug is not shown to be safe, and when it finds an existing
animal drug is not shown to be safe.3 To the extent that statutory mandate
prevents the FDA from pursuing other regulatory strategies, “this is the
congressional design.” Massachusetts v. EPA, 549 U.S. 497, 533 (2007).
That same congressional design appears in 21 U.S.C. § 355, the FDCA
provision regulating the approval and withdrawal of approval for non‐animal
drugs. Sections 355 and 360b were once a single statutory section, see FDCA
§ 505, 52 Stat. at 1052–53, and the language of the latter was largely modeled on
the former. See H.R. Rep. No. 90‐875, at 5 (1967) (noting that the two sections
correspond); S. Rep. No. 90‐1308, at 5 (1968) (same). Both statutory sections apply
much the same process for the approval of drugs, using the same language to
prevent the FDA from approving new drugs unless they have been shown to be
3
The sole exception comes in § 360b(e)(1)’s “imminent hazard” provision, which
permits the Secretary of Health and Human Services to immediately suspend approval
of a particular animal drug use without a hearing if he finds that use presents an
imminent hazard to human or animal health.
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safe. Compare 21 U.S.C. § 355(c)–(d) with id. § 360b(c)–(d). And both use the same
syntax in their respective withdrawal provisions, meaning that both share the
same textual ambiguity as to whether the FDA is required to hold a withdrawal
hearing once it makes a preliminary finding that a particular drug is not shown
to be safe.4
But the available evidence indicates that courts have uniformly construed
§ 355(e) to require the FDA to move forward with withdrawal proceedings if it
makes a preliminary finding that a drug is not shown to be safe. In dicta, the
Supreme Court characterized § 355(e) in language that almost exactly mirrors the
plaintiffs’ interpretation of § 360b(e)(1)(B): “If the FDA discovers after approval
that a drug is unsafe or ineffective, it ‘shall, after due notice and opportunity for
hearing to the applicant, withdraw approval of’ the drug.” Brown & Williamson,
529 U.S. at 134 (quoting 21 U.S.C. § 355(e)). The precise interpretation of § 355(e)
was not before the Court in that case; but its analysis assumed that once the FDA
determines a product under its jurisdiction is not shown to be safe, it is
4
For comparison, the first sentence of § 355(e) reads: “The Secretary shall, after
due notice and opportunity for hearing to the applicant, withdraw approval of an
application with respect to any drug under this section if the Secretary finds that [any of
the listed statutory grounds apply].” 21 U.S.C. § 355(e).
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statutorily required to begin withdrawal proceedings.5 See id. at 135 (“[I]f tobacco
products were [covered] under the FDCA, the FDA would be required to remove
them from the market.”); see also American Public Health Ass’n v. Veneman, 349 F.
Supp. 1311, 1315–16 (D.D.C. 1972) (holding that the FDA must commence
withdrawal proceedings after announcing in the Federal Register that certain
drugs were not shown to be effective for their approved uses). Given the parallel
structure of the two statutes, § 360b(e)(1)(B) should be interpreted as § 355(e) has
been: to require the agency to commence withdrawal proceedings if it initially
finds that a drug has not been shown to be safe for its approved use.
C.
The Relevant Regulations
Like the statute, the regulations implementing § 360b(e)(1)(B) show that the
agency’s duty to institute withdrawal proceedings is mandatory. In particular,
21 C.F.R. § 514.115(b) states: “The Commissioner shall notify in writing the
5
The majority indicates that Brown & Williamson is inapposite because the FDA
had already made “findings” showing that tobacco products were unsafe. But the
“findings” referred to in that case were the result of a notice‐and‐comment rulemaking
procedure, not the formal evidentiary hearing process envisioned by § 355(e) (or §
360b(e)(1)) and its accompanying regulations. Compare Brown & Williamson, 529 U.S. at
126–28, 134–35, with 21 C.F.R. § 10.50(c)(16)–(17). In other words, Brown & Williamson
clearly assumes that the agency can be bound in this context by a finding that does not
result from any formal evidentiary hearing.
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person holding [an animal drug application] and afford an opportunity for a
hearing on a proposal to withdraw approval of such application if he finds . . .
that such drug is not shown to be safe . . . .” 21 C.F.R. § 514.115(b)(3)(ii). Unlike
the statute, the meaning of this regulation is entirely clear. If the FDA makes an
initial finding that a particular drug is not shown to be safe, it “shall” then
provide the drug’s sponsor with an opportunity to be heard. In sum, this
regulation imposes exactly the mandatory duty that plaintiffs see in the statute:
once the FDA makes a preliminary finding that a particular drug is not shown to
be safe, it must commence withdrawal proceedings.6
The majority asserts that § 514.115(b) does not represent an agency
interpretation of the statute, and so is not entitled to the deference we afford
6
The regulation is plainly mandatory. See Lopez v. Davis, 531 U.S. 230, 241 (2001)
(noting the use of the word “shall” to “impose discretionless obligations”). That alone
may well be enough to resolve this case, since “[w]here the rights of individuals are
affected, it is incumbent upon agencies to follow their own procedures.” Morton v. Ruiz,
415 U.S. 199, 235 (1974). I say “may well be enough” because some agency regulations
do not create judicially enforceable obligations. See Leslie v. Attorney General, 611 F.3d
171, 176 (3d Cir. 2010) (“[N]ot every promulgated regulation is of such a nature that a
violation should invalidate agency action.”). The parties have not thoroughly briefed
whether 21 C.F.R. § 514.115(b)(3)(ii) can, of its own force, require the FDA to carry out
withdrawal hearings. Because I think the statute provides sufficient grounds to reach
that result, I need not decide whether the regulation does as well.
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under Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837 (1984). I am not sure I agree. But
even if so, the regulation at least counsels strongly in favor of plaintiffs’
interpretation. It makes clear that the FDA expects the withdrawal procedure to
begin with an initial agency finding that a particular drug is not shown to be safe,
followed immediately by notice and an opportunity for a hearing.7 With or
without Chevron deference, I would still interpret the statute to accord with that
regulatory scheme.8
7
Other agency pronouncements confirm that the FDA has interpreted the
statutory finding described in § 360b(e)(1)(B) to be a preliminary finding that begins the
withdrawal process. See Guidance for Industry # 209, at 19 (“[I]nitiating action to
withdraw an approved new drug application . . . would require the agency to make the
showing required under [§ 360b(e)(1)].”); see also 21 C.F.R. § 514.80(a)(3) (“FDA reviews
the records and reports required in this section to facilitate a determination under
[§ 360b(e)] as to whether there may be grounds for suspending or withdrawing
approval . . . .”); Letter from Leslie Kux, Assistant Acting Commissioner for Policy,
FDA, to Sarah Klein, Center for Science in the Public Interest 2 (Nov. 7, 2011) (“If the
[agency] concludes that grounds exist to withdraw a new animal drug approval, . . .
FDA must provide the drug’s sponsor with notice and an opportunity for a formal
administrative hearing (‘NOOH’).”).
8
By contrast, I agree with the majority that none of the other regulations cited by
the FDA help our analysis, because none of them address the interpretive question
before us: whether the agency is required, after making an initial finding that a drug is
not shown to be safe, to commence withdrawal proceedings. I also reject the agency’s
bid for Auer deference to its argument that § 514.115(b) and the statute refer to different
findings, since “Auer deference is warranted only when the language of the regulation is
ambiguous.” Christensen v. Harris Cnty., 529 U.S. 576, 588 (2000).
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Counterarguments
For the reasons described above, I believe 21 U.S.C. § 360b(e)(1)(B) compels
the FDA to initiate withdrawal proceedings once it makes a preliminary finding
that a drug is no longer shown to be safe. I now turn to the counterarguments
that the majority finds persuasive.
1.
Text
The majority’s primary objection is that my interpretation of this provision
contravenes either basic principles of due process or else the statutory text. As I
construe the statutory text, “if the Secretary finds” that a drug is not shown to be
safe, “[t]he Secretary shall, after due notice and opportunity for a hearing to the
applicant, issue an order withdrawing approval of” the drug. 21 U.S.C.
§ 360b(e)(1). That reading grammatically links the agency’s pre‐hearing finding
to a mandatory withdrawal order. Taken literally, it would require the FDA to
withdraw approval from a drug whenever it made a pre‐hearing finding that
drug was not shown to be safe—making the hearing a pointless exercise. That
result would contravene basic principles of due process. See Hamdi v. Rumsfeld,
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542 U.S. 507, 533 (2004) (plurality opinion) (noting that due process requires
notice and a meaningful opportunity to be heard).
There is an easy solution to this due process problem, however: to read the
statute “against the background of our traditional legal concepts,” United States v.
U.S. Gypsum Co., 438 U.S. 422, 437 (1978), as implicitly guaranteeing the drug
sponsor a meaningful opportunity to rebut the agency’s preliminary finding. On
that reading, the statute adopts the following procedure: When the FDA makes a
preliminary finding that a drug is not shown to be safe, it must offer the drug’s
sponsor a hearing. If after that hearing the FDA continues to find that the drug is
not shown to be safe, then it must issue an order withdrawing approval of the
drug. Alternatively, if after that hearing the FDA finds the drug’s sponsor has
presented persuasive evidence that the drug is safe, it will announce that finding
and end the withdrawal process. This procedure constrains the FDA to proceed
to a hearing if it makes a preliminary finding that a drug is not shown to be safe,
but also preserves the right of the drug’s sponsor to rebut that preliminary
finding by presenting evidence at the hearing.
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The majority recognizes that this interpretation would solve the due
process problem, but objects that it is not true to the statutory text. It observes
that the text of § 360b(e)(1) only refers to a single finding, while this
interpretation implies both a pre‐hearing finding and a post‐hearing finding. It
also observes that the statute literally requires the agency to issue a withdrawal
order if it makes the finding described in the statute. The majority infers that the
finding described in the statute must therefore be a post‐hearing finding, since (to
preserve due process) only a post‐hearing finding can absolutely require a
withdrawal order.
If Congress were always perfectly precise in its language, the majority’s
argument would have some force. In fact, however, Congress does draft statutes
that refer only to a single finding but that obviously imply both a pre‐hearing
and post‐hearing finding. To list a few:
If . . . the Administrator [of the Environmental Protection Agency
(“EPA”)] determines that [a person has violated a rule governing an
exemption], the Administrator shall . . . after providing written
notice to the person who holds such exemption and an opportunity
for a hearing, by order terminate such exemption . . . .
15 U.S.C. § 2603(c)(4)(B).
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If the Secretary [of Education] determines that an accrediting agency
or association has failed to apply effectively the criteria in this
section, or is otherwise not in compliance with the requirements of
this section, the Secretary shall . . . after notice and opportunity for a
hearing, limit, suspend, or terminate the recognition of the agency or
association . . . .
20 U.S.C. § 1099b(l)(1).
[I]f the Secretary [of the Treasury] determines that any substantial
obligation under any agreement is not being fulfilled, he may, after
notice and opportunity for hearing to the person maintaining the
fund, treat the entire fund or any portion thereof as an amount
withdrawn from the fund in a nonqualified withdrawal.
26 U.S.C. § 7518(e)(2).
The Administrator [of the EPA] shall review approved plans from
time to time and if he determines that revision or corrections are
necessary . . . he shall, after notice and opportunity for public
hearing, withdraw his approval of such plan.
42 U.S.C. § 6947(a)(2).
Despite their literal text, none of these statutes (as far as I know) have been
interpreted to require or permit an agency to take action based solely on its pre‐
hearing finding. Instead, these statutes are naturally read in the same way that I
read § 360b(e)(1): as implying that the agency can only take final action after both
a pre‐hearing and a post‐hearing finding, even though the statutory text only
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explicitly mentions one such finding. Given these examples, I see nothing
“singularly odd,” supra, at ___ (majority slip op. at 26), in believing that Congress
used the same shorthand in this statute that it did in those statutes—especially
since the agency regulations implementing this statute explicitly envision a pre‐
hearing finding as well as a post‐hearing finding. See 21 C.F.R. § 514.115(b).
2.
Background Legal Concepts
The majority argues next that its interpretation is more consistent with our
ordinary understanding of administrative and judicial processes. In the
majority’s view, the normal administrative sequence runs “hearing, finding,
order,” and my interpretation violates that sequence by reading the statute to
refer to a pre‐hearing finding.
I concede that in many contexts, a “finding” is a post‐hearing
determination. But as the majority recognizes, see supra, at ___ (majority slip op.
at 42), the word “finding” can equally refer to a pre‐hearing determination—and
here, the agency’s own regulations clearly adopt that sense. Section 514.115(b)
explicitly states that the agency will only issue a notice of opportunity for a
hearing if it “finds” that one of the statutory grounds for withdrawal applies. 21
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C.F.R. § 514.115(b); see also Sterling Drug, Inc. v. Weinberger, 384 F. Supp. 557, 588
(S.D.N.Y. 1974) (referring to the agency’s pre‐hearing determination under 21
U.S.C. § 355(e) that a drug was ineffective as a “finding”).
Nearby provisions of the statute also explicitly contemplate pre‐hearing
findings. When the FDA receives a new animal drug application, if it “finds that
none of the grounds for denying approval” in the statute apply, it must approve
the drug; if it finds otherwise, it must give notice of an opportunity for a hearing.
21 U.S.C. § 360b(c)(1). The FDA’s own brief describes that pre‐hearing
determination as a “finding.” Br. for Defendants‐Appellants at 25; see also id.
(noting that a hearing is required “[o]nly if FDA preliminarily ‘finds’ . . . a reason
for disapproval”). Likewise, under the imminent hazard provision—as the
majority notes—the Secretary first “finds that there is an imminent hazard” and
then “give[s] the applicant prompt notice of his action and afford[s] the applicant
the opportunity for an expedited hearing. 21 U.S.C. § 360b(e)(1); see supra, at ___
(majority slip op. at 42–43).
These examples point to a larger problem with the majority’s analysis:
namely, that it takes too limited a view of the normal administrative sequence.
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Agency action often begins not with a hearing, but with a preliminary agency
finding that triggers notice and an opportunity for a hearing. After all, agencies
do not arbitrarily decide to initiate hearings; instead, they begin the hearing
process only when they find there is some reason to do so. As described above,
21 U.S.C. § 360b and 21 C.F.R. § 514.115(b) are not unique in explicitly
envisioning that a formal agency determination can occur before and lead to a
hearing. See 15 U.S.C. § 2603(c)(4)(B); 20 U.S.C. § 1099b(l)(1); 26 U.S.C.
§ 7518(e)(2); 42 U.S.C. § 6947(a)(2). And as the majority recognizes, administrative
enforcement proceedings often begin with the agency’s preliminary findings in
the form of “a case‐initiating document that sets forth the [agency’s] conclusions
or charges.” Supra, at ___ (majority slip op. at 45). In other words, the normal
administrative sequence in many cases is not simply “hearing, finding, order,”
but instead “preliminary finding, hearing, final finding, order.” In many cases,
the agency’s preliminary findings are not attached to any mandatory
consequences —especially not in the enforcement context, where agency
discretion is at its height. See Heckler v. Chaney, 470 U.S. 821 (1985). But if
Congress so chooses, it can require an agency to act on the basis of its preliminary
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findings. Cf. id. at 834 (explaining that Congress can “withdr[a]w discretion from
the agency and provide[] guidelines for exercise of its enforcement power”). That
in no way contravenes our basic understanding of the administrative process.
The majority argues next that the statute cannot refer to a pre‐hearing
“finding” because it will be impossible to determine when the agency has made
that finding. In the majority’s view, if the pre‐hearing finding triggers the
withdrawal process, it must precede (and require) the issuance of an NOOH.
Therefore, the majority concludes, that pre‐hearing finding can only exist as an
intangible conclusion in the mind of the Secretary (or perhaps the collective mind
of the agency); and it is hard to believe that Congress would compel an agency to
act based on the internal beliefs of its officers or employees. Alternatively, the
majority argues that if the pre‐hearing finding is embodied in an NOOH itself,
then plaintiffs cannot compel the FDA to act because the FDA has withdrawn the
two NOOHs it issued.
The majority’s first argument attacks a straw man. No one contends that
the statute can require the FDA to act based on “an entirely subjective and
unexpressed finding . . . made during internal agency deliberations.” Supra, at
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___ (majority slip op. at 50). Plaintiffs contend only that if the FDA does issue an
NOOH announcing that a drug is not shown to be safe, it must then move
forward with the withdrawal process.9 In other words, the statutory phrase “if
[the FDA] finds” does not mean “if the FDA subjectively believes”; it instead
means “if the FDA formally states a preliminary finding.” That interpretation in
no way requires courts to review the internal thoughts or beliefs of the
agency—only the agency’s official public statements about a particular drug. It
consequently raises none of the problematic reviewability issues that the majority
suggests. To the contrary, “the mandate that the courts are to enforce” under this
interpretation is just as “straightforward” as under the majority’s. Supra, at ___
(majority slip op. at 49).
Alternatively, the majority argues that the plaintiffs cannot compel agency
action based on the findings expressed in the 1977 NOOHs because those
NOOHs have now been withdrawn. That argument mistakes the medium for the
message. The findings that the FDA made in 1977 were that the use of penicillin
9
Because the FDA did issue two NOOHs in this case, we are not called on to
decide here whether the statute might require the FDA to commence withdrawal
proceedings if it used some other means to announce its position that a particular drug
had not been shown to be safe.
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and tetracyclines had not been shown to be safe; the NOOHs were the medium
through which the FDA announced those findings. As described above, the
statute does not compel the FDA to take any action until it makes some formal
public announcement of its preliminary findings. But once the FDA announces its
findings, it cannot avoid withdrawal proceedings just by retracting the
announcement. Instead, it can only avoid withdrawal proceedings by retracting
the findings—that is, by announcing that those preliminary findings were
mistaken.
Here, the FDA has never retracted its preliminary findings. To the
contrary, the agency “has not issued a single statement since the issuance of the
1977 NOOHs that undermines [its] original findings.” NRDC v. FDA (“NRDC I”),
884 F. Supp. 2d 127, 150 (S.D.N.Y. 2012) (opinion below). And the FDA made
clear in the notices withdrawing the 1977 NOOHs that its action was based on its
choice to pursue a new regulatory approach, rather than on any doubt about its
findings that the subtherapeutic use of these drugs in animal feed was not shown
to be safe. Because the agency has never formally repudiated the preliminary
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findings announced in the 1977 NOOHs, I would hold that it remains bound by
those findings under the statute.10
3.
Agency Discretion
Finally, the majority argues that its interpretation is more consonant with
our tradition of agency discretion in the enforcement context. The FDA puts this
position more strongly, arguing that its decision to refrain from withdrawal
proceedings is entirely immune from judicial review under Heckler v. Chaney, 470
U.S. 821 (1985).
The Administrative Procedure Act (APA) embodies a “basic presumption
of judicial review.” Lincoln v. Vigil, 508 U.S. 182, 190 (1993) (quoting Abbott Labs.
v. Gardner, 387 U.S. 136, 140 (1967)); see 5 U.S.C. § 702 (“A person suffering legal
wrong because of agency action . . . is entitled to review thereof.”); Bowen v. Mich.
Academy of Family Physicians, 476 U.S. 667, 670 (1986) (noting “the strong
presumption that Congress intends judicial review of administrative action”).
Under 5 U.S.C. § 701(a)(2), however, judicial review is not available for “agency
action [that] is committed to agency discretion by law.” Id. This “very narrow
10
For the same reason, I would also hold that the withdrawal of the NOOHs did
not moot plaintiffs’ claim. See NRDC I, 884 F. Supp. 2d at 149–51.
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exception” applies “in those rare instances where statutes are drawn in such
broad terms that in a given case there is no law to apply.” Citizens to Preserve
Overton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971) (internal quotation marks
omitted). In such circumstances, judicial review would be useless, because the
reviewing court “would have no meaningful standard against which to judge the
agency’s exercise of discretion.” Heckler, 470 U.S. at 830.
The Supreme Court has explained that § 701(a)(2) creates a presumption
against judicial review for “certain categories of administrative decisions that
courts traditionally have regarded as committed to agency discretion.” Vigil, 508
U.S. at 191 (internal quotation marks omitted). One such category of
administrative decisions are agency refusals to institute investigative or
enforcement proceedings. See Heckler, 470 U.S. at 830–31 (“[A]n agency’s decision
not to prosecute or enforce, whether through civil or criminal process, is a
decision generally committed to an agency’s absolute discretion.”). Although an
agency’s decision not to take enforcement action is presumptively unreviewable,
“the presumption may be rebutted where the substantive statute has provided
guidelines for the agency to follow in exercising its enforcement powers.” Id. at
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832–33. If Congress specifies by statute the conditions under which an agency
must bring enforcement proceedings, then a court can review whether the agency
has followed Congressʹs directions. But if Congress merely authorizes the agency
to bring enforcement proceedings, without specifying when the agency is
required to do so, then the agencyʹs decision not to bring a particular
enforcement proceeding is unreviewable. See id. at 834–35, 838; see also Vigil, 508
U.S. at 193 (“Congress may always circumscribe agency discretion . . . by putting
restrictions in the operative statutes . . . .”). Heckler therefore “requires careful
examination of the statute on which the claim of agency illegality is based,” to
determine the extent to which Congress has placed judicially enforceable limits
on the agencyʹs discretion. Webster, 486 U.S. at 600.
As I discuss in more detail below, it is not clear whether the withdrawal
proceedings contemplated by § 360b(e)(1)(B) should be characterized as
enforcement proceedings under Heckler. I believe they should not. But even if
withdrawal proceedings were a form of enforcement, I would still conclude that
§ 360b(e)(1)(B) places judicially enforceable limits on the FDA’s discretion over
whether to commence those proceedings. In my view, the statute precisely
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specifies when the FDA is required to commence withdrawal proceedings: when
the agency finds that a particular drug is not shown to be safe. Congress has thus
“indicated an intent to circumscribe agency . . . discretion, and has provided
meaningful standards for defining the limits of that discretion.” Heckler, 470 U.S.
at 834. Because the statute makes withdrawal proceedings mandatory under
particular circumstances, we have “law to apply” in determining whether the
agency has complied with the statutory command. See Citizens to Preserve Overton
Park, 401 U.S. at 410. I would therefore hold that even if Heckler’s presumption
against review applies, that presumption is overcome by the statutory text.
I recognize that Congress often affords great discretion to agencies in the
enforcement context, and rightly so. Enforcement decisions often require “a
complicated balancing of a number of factors which are peculiarly within [the
agency’s] expertise,” including the resources available to the agency, the
seriousness of the violation, the likelihood of a successful outcome, and many
others. Heckler, 470 U.S. at 831–32. Nevertheless, Congress also sometimes
decides to constrain agency discretion in order to ensure that its statutory
purposes are fully carried out. Cf. id. at 834–35. As the majority recognizes, there
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are particularly good reasons to believe that Congress would cabin the FDA’s
discretion in this context: “[G]iven the preeminent importance of health and
safety in the usage of powerful bioactive substances such as human and animal
drugs, it would hardly be surprising for Congress to impose limits on traditional
agency discretion or to mandate actions protective of human safety.” Supra, at
___ (majority slip op. at 53). In my opinion, § 360b(e)(1)(B) does indeed constrain
the FDA’s discretion in order to protect the public from unsafe drugs. I would
therefore affirm the district court’s decision that the agency must proceed to a
hearing on whether to withdraw approval from the subtherapeutic use of
penicillin and tetracyclines in animal feed.
II.
The Citizen Petitions
The second issue presented in this case is whether the FDA acted
arbitrarily and capriciously by denying the 1999 and 2005 citizen petitions. Those
petitions asked the FDA to initiate (and conclude) proceedings to withdraw
approval from the subtherapeutic use of medically important antibiotics on
animals. In effect, the petitions asked the FDA to make the same preliminary
finding for all medically important antibiotics that it had already made for
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penicillin and tetracyclines, and then to move forward on withdrawal
proceedings regarding the subtherapeutic use of all of those antibiotics. The FDA
denied those petitions. In so doing, it did not address the plaintiffs’ scientific
evidence that the subtherapeutic use of medically important antibiotics on
animals was not shown to be safe; instead, the agency said only that it preferred
to employ a voluntary compliance strategy rather than formal withdrawal
proceedings.
The FDA argues that withdrawal proceedings are a form of enforcement
action, and so its refusal to initiate those proceedings is presumptively
unreviewable under Heckler. It further argues that nothing in the statute rebuts
that presumption, because the statute places no limit on the FDA’s discretion
over whether to find that a particular drug is not shown to be safe.
While the majority opinion does not explicitly consider whether
withdrawal proceedings should be characterized as a form of enforcement action,
it implicitly accepts the FDA’s view by analogizing this case to N.Y. Public Interest
Grp. v. Whitman, 321 F.3d 316 (2d Cir. 2003), which dealt with the EPA’s
“discretion to determine whether to engage its formal enforcement mechanism.”
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Id. at 330. Whitman made clear that its logic was limited to the enforcement
context. Indeed, it relied on Heckler for the proposition that “an agency’s decision
not to invoke an enforcement mechanism provided by statute is not typically
subject to judicial review.” Id. at 331.
I agree with the FDA that if Heckler and Whitman governed this case, then
we could not disturb the agency’s decision to deny the citizen petitions. But
Heckler and Whitman do not govern here, because the withdrawal proceedings
contemplated by § 360b(e)(1)(B) are not a form of agency enforcement action.
Instead, this case falls squarely under the framework established by Massachusetts
v. EPA, 549 U.S. 497 (2007), which forbids an agency from relying on outside
factors in refusing to make a particular statutory determination.
A.
Nature of Withdrawal Proceedings
The Supreme Court has never clearly defined what agency actions are
“enforcement” actions within the meaning of Heckler. The prototypical
enforcement action, of course, is an action taken by the agency to punish a past
violation of the law that the agency administers, or to enjoin an ongoing violation
of that law. See Heckler, 470 U.S. at 831 (discussing “an agency’s decision not to
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prosecute or enforce, whether through civil or criminal process”); see also NRDC
II, 872 F. Supp. 2d at 333 (“[E]nforcement proceedings are traditionally
undertaken upon a finding that an entity has violated an existing regulation or
law.”). In this area, “an agency’s refusal to institute proceedings shares to some
extent the characteristics of the decision of a prosecutor not to indict,” Heckler, 470
U.S. at 832; the agency must weigh its resources and its priorities in determining
whether a particular violator should be pursued. Cf. Whitman, 321 F.3d at 332
(noting the impracticality of requiring the EPA to challenge every violation “no
matter how slight, isolated, or technical”). At the same time, Heckler indicates that
its concept of an “enforcement action” may extend somewhat beyond the
prototypical meaning of the term. In Heckler itself, the plaintiffs asked the FDA
not only “to recommend the prosecution” of those who used certain drugs for
lethal injection, but also (inter alia) “to affix warnings to the labels of [those]
drugs stating that they were unapproved and unsafe for human execution” and
“to send statements to the drug manufacturers and prison administrators stating
that the drugs should not be so used.” 470 U.S. at 824. The Court characterized all
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of these requests as seeking “investigatory and enforcement actions,” id., even
though the latter two do not directly punish or enjoin any statutory violation.
As it is unclear what qualifies as an “enforcement action,” it is doubly
unclear whether the withdrawal proceedings contemplated by § 360b(e)(1)(B) fall
into that category. These withdrawal proceedings share some characteristics with
a traditional enforcement action; for instance, they envision an adversarial
process, in which the agency attacks the safety of a particular drug and its
sponsor defends it. See 21 U.S.C. § 360b(e)(1); 21 C.F.R. §§ 12.1–.159, 514.201
(describing hearing procedures). And like traditional enforcement actions, they
implicate the agency’s ability to manage its resources and set administrative
priorities. See Heckler, 470 U.S. at 834.
At the same time, withdrawal proceedings are also similar in many ways
to rulemaking proceedings, which we know fall outside the Heckler presumption.
See Massachusetts v. EPA, 549 U.S. at 527–28. First, the FDA “has chosen to utilize
withdrawal proceedings as the primary means of formally regulating approved
drugs,” the function normally served by notice‐and‐comment rulemaking. NRDC
II, 872 F. Supp. 2d at 333. Second, withdrawal proceedings (like approval
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proceedings) establish a general standard of conduct; they apply to anyone
marketing a drug, not just the drug’s sponsor. Cf. A.L. Pharma, Inc. v. Shalala, 62
F.3d 1484, 1487 (D.C. Cir. 1995) (characterizing the approval of a new animal
drug as a “rule”). They also have only future effect; they can prevent regulated
entities from marketing a previously‐approved drug in the future, but they
cannot punish any past violation of the law. See Attorney General’s Manual on
the Administrative Procedure Act 14 (1947) [hereinafter Attorney General’s
Manual] (“Rule making is agency action which regulates the future conduct of
either groups of persons or a single person . . . . The object of the rule making
proceeding is the implementation or prescription of law or policy for the future,
rather than the evaluation of a respondent’s past conduct.”); see also
id. (contrasting rulemaking with adjudication, which normally involves “a
decision as to whether past conduct was unlawful, so that the proceeding is
characterized by an accusatory flavor and may result in disciplinary action”); 5
U.S.C. § 551(4) (defining a “rule” under the APA in part as an “agency statement
of general or particular applicability and future effect”). Because withdrawal of
approval has only future effect, the FDA must invoke a completely separate set of
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enforcement procedures in order to enjoin or punish any person who markets a
drug from which approval has been withdrawn. See, e.g., 21 U.S.C.
§ 335b(b)(1)(A) (establishing procedures by which the Secretary may assess a civil
penalty); see also Cutler v. Hayes, 818 F.2d 879, 893 & n.116 (D.C. Cir. 1987)
(distinguishing the “enforceable statutory directive” to withdraw approval for
unsafe drugs under 21 U.S.C. § 355(e) from typical FDA enforcement actions).
Finally, although I “hesitate to place too much significance on the location of a
statute in the United States Code,” Jones v. R.R. Donnelley & Sons Co., 541 U.S. 369,
376 (2004), it is worth noting that the FDCA’s traditional enforcement
mechanisms fall in a different subchapter (titled “Prohibited Acts and Penalties”)
from the substantive regulatory section governing withdrawal proceedings. In
sum, withdrawal proceedings are in many ways “essentially legislative in
nature,” Attorney General’s Manual at 14, rather than essentially enforcement‐
oriented.
Though I recognize the decision is close, I would hold that withdrawal
proceedings under § 360b(e)(1)(B) are not enforcement actions within the
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meaning of Heckler and Whitman.11 Given that these withdrawal proceedings
resemble rulemaking at least as much as they do enforcement, I think it better to
apply “the strong presumption that Congress intends judicial review of
administrative action,” Bowen, 476 U.S. at 670, rather than the “very narrow
exception” applicable for actions committed to agency discretion by law, Citizens
to Preserve Overton Park, 401 U.S. at 410. That strong presumption seems
particularly appropriate here, where there is every reason to believe that
Congress did not mean to give the FDA unlimited discretion to leave unsafe
drugs on the market for extended periods of time. Cf. Bowen, 476 U.S. at 670
(“[J]udicial review of a final agency action . . . will not be cut off unless there is
persuasive reason to believe that such was the purpose of Congress.” (quoting
Abbott Labs., 387 U.S. at 140)); A.L. Pharma, 62 F.3d at 1487, 1490–92 (reviewing the
FDA’s denial of a citizen petition asking it to withdraw approval of an approved
animal drug); cf. also supra, at ___ (majority slip op. at 53) (recognizing there is
good reason to believe Congress would limit the FDA’s discretion in this sphere
11
We are not called on to decide in this case whether withdrawal proceedings
initiated under the other subsections of 21 U.S.C. 360b(e) are likewise outside the scope
of Heckler and Whitman.
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“given the preeminent importance of health and safety in the usage of powerful
bioactive substances”).
B.
Arbitrary and Capricious Action
Given that the denial of the citizen petitions is subject to judicial review, I
think that Massachusetts v. EPA squarely requires us to hold that denial was
arbitrary and capricious. In Massachusetts v. EPA, the Court addressed a statute
with a discretionary determination that triggered a mandatory consequence:
The Administrator [of the EPA] shall by regulation prescribe . . .
standards applicable to the emission of any air pollutant from any
. . . new motor vehicles or new motor vehicle engines, which in his
judgment cause, or contribute to, air pollution which may
reasonably be anticipated to endanger public health or welfare.
42 U.S.C. § 7521(a)(1). As construed by the Court, that statute gives the
Administrator discretion to determine whether any particular air pollutant
causes or contributes to air pollution that might endanger public health or
welfare. But if the Administrator does judge that a particular air pollutant
endangers public health, then he must prescribe emission standards. See
Massachusetts v. EPA, 549 U.S. at 532–33.
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A group of concerned organizations filed a citizen petition asking the EPA
to issue regulations governing greenhouse gas emissions from motor vehicles, on
the ground that those emissions endangered public health by causing global
warming. 549 U.S. at 510. The agency responded by refusing to decide whether
greenhouse gas emissions from motor vehicles endangered public health;
instead, it denied the citizen petition based on “a laundry list of reasons not to
regulate,” including its belief that regulating motor vehicle emissions would not
be an effective means of addressing global warming. Id. at 533.
The Court held that the EPA’s action was arbitrary and capricious, because
its reasons for denying the petition were “divorced from the statutory text.” Id. at
532. The statutory provision authorizing the agency to exercise its judgment was
“not a roving license to ignore statutory text,” but only “a direction to exercise
discretion within defined statutory limits.” Id. at 533. Since the discretionary
“judgment” contemplated by the statute asked only whether a particular air
pollutant endangered public health, the EPA could not rely on other
reasons—such as the cost or inefficiency of new regulations—in deciding
whether or not to regulate. Instead, the EPA could only avoid regulating
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greenhouse gas emissions from motor vehicles if it found that “greenhouse gases
do not contribute to climate change,” or that “the scientific uncertainty is so
profound that it precludes [the agency] from making a reasoned judgment” on
that issue. Id. at 533–34. The agency’s discretion was thus limited to considering
the scientific question described in the statute, not any other factors the agency
might deem relevant. Cf. Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins.
Co., 463 U.S. 29, 43 (1983) (noting that an agency acts arbitrarily and capriciously
if it “has relied on factors which Congress has not intended it to consider”).
Like Massachusetts v. EPA, this case involves a statute that (as I interpret it)
follows a discretionary determination with a mandatory consequence. If the FDA
(in its discretion) determines that a particular drug is not shown to be safe, then it
shall commence (mandatory) withdrawal proceedings. See 21 U.S.C.
§ 360b(e)(1)(B). But just as in Massachusetts v. EPA, the agency’s discretion is
limited to making the determination required by the statute; it cannot refuse to
make that determination just because it would prefer a different regulatory
strategy than the statute specifies.
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The FDA offers reasons for inaction that are eerily similar to those rejected
by the Court in Massachusetts v. EPA; it complains that withdrawal proceedings
“would take many years and would impose significant resource demands,” and
claims that its voluntary compliance approach will work just as well. Letter from
Leslie Kux, Assistant Acting Commissioner for Policy, FDA, to Sarah Klein,
Center for Science in the Public Interest 3–4 (Nov. 7, 2011). Again, there is some
irony in the FDA’s protestation that withdrawal proceedings could take many
years; the agency failed to respond to the citizen petitions for twelve and six
years, respectively, and its own voluntary compliance strategy contemplates a
three‐year “phase in.” See NRDC II, 872 F. Supp. 2d at 339; Guidance for Industry
# 213, at 9. But that is beside the point. Even if the agency’s reasons were
indisputably sound, they are not contemplated by the statute. Because the FDA
must “exercise [its] discretion within defined statutory limits,” Massachusetts v.
EPA, 549 U.S. at 533, it must respond to the citizen petition by evaluating the
statutory question of whether the drug uses at issue are shown to be safe.
The majority contends that Massachusetts v. EPA is distinguishable because
the statute in that case “unambiguously compelled agency action” and “limited
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[the agency’s] ‘judgment’ to the scientific question.” Supra, at ___ (majority slip
op. at 58, 60). I respectfully believe that the first distinction is incorrect, and that
the second begs the question.
As for the first: The statute construed in Massachusetts v. EPA was just like
the statute at issue here—part discretionary (as to the agency’s “judgment”), and
part mandatory (as to the ensuing regulation). Indeed, the Court recognized in its
opinion that the EPA was not necessarily required to take any action beyond
adequately responding to the citizen petition. See 549 U.S. at 534–35 (“We need
not and do not reach the question whether on remand EPA must make an
endangerment finding, or whether policy concerns can inform EPA’s actions in
the event that it makes such a finding.”). I do not understand how that can be
read to “unambiguously compel[]” agency action.
As for the second: Nothing in the Clean Air Act explicitly “limited the
EPA’s Administrator’s ‘judgment’ to the scientific question,” supra, at ___
(majority slip op. at 60), any more than 21 U.S.C. § 360b(e)(1)(B) explicitly limits
the FDA’s judgment to the scientific question. See Massachusetts v. EPA, 549 U.S.
at 549–53 (Scalia, J., dissenting). Instead, the question presented in Massachusetts
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v. EPA was whether the statute implicitly limited the agency’s judgment to the
scientific question, by specifying only that question for the agency’s
consideration. The Court held that it did: although the agency may have
“significant latitude as to the manner, timing, content, and coordination of its
regulations with other agencies, . . . its reasons for action or inaction must
conform to the authorizing statute.” Id. at 533 (majority opinion). Exactly the
same logic applies here: the FDA’s “reasons for action or inaction” must conform
to the authorizing statute, meaning that they must rest on the statutory question
of whether the drugs have been “shown to be safe,” 21 U.S.C. § 360b(e)(1)(B).
Like the EPA with air pollutants, the FDA cannot “choose to regulate only those
[drugs] that it deem[s] feasible or wise to regulate.” Supra, at ___ (majority slip
op. at 59).
The majority apparently believes that the FDA’s approach is permissible
because although the agency regards “the indiscriminate and extensive use of
[medically important antibiotics] in animal feed as threatening, it does not
necessarily believe that the administration of antibiotics to animals in their feed is
inherently dangerous to human health.” Supra, at ___ (majority slip op. at 63). I
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see no reason why that should matter to our analysis. As the majority recognizes
at the opening of its opinion, antibiotic resistance “presents a serious threat to
human health,” and can result in “longer hospital stays, worse side effects of
treatment, and a greater likelihood of death.” Supra, at ___ (majority slip op. at
3–4). The FDA agrees. See J.A. 405 (reproducing statements from the FDA
website). The agency likewise agrees that the overuse of antibiotic drugs on
livestock can contribute to the development of antibiotic resistance. NRDC II, 872
F. Supp. 2d at 340. This problem, like global warming, is tied to the combined
effects of many small actions. Each individual animal dose of antibiotics may not
endanger human health; but that is no reason to think that Congress gave the
agency discretion to ignore the larger problem.
In any case, the 2005 citizen petition specifically asks the FDA to withdraw
approval from the indiscriminate “herdwide/flockwide” use of these antibiotics.
J.A. 262. If indeed the FDA regards such indiscriminate uses as threatening—or
more precisely, as “not shown to be safe,” 21 U.S.C. § 360b(e)(1)(B)—then it
should withdraw the relevant approvals. At the very least, it should be required
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to squarely address the scientific issue of whether those uses have been shown to
be safe, which is the sole issue that the statute makes relevant.
Today as in 1977, drug manufacturers have “failed to resolve the basic
safety questions that underlie the subtherapeutic use of [antibiotics] in animal
feed.” Supra, at ___ (majority slip op. at 8) (alteration in original) (quoting
Penicillin NOOH, 42 Fed. Reg. at 43,792); see Tetracycline NOOH, 42 Fed. Reg. at
56,288. In not addressing those safety questions, the FDA has shirked its statutory
responsibilities. I would hold that action was arbitrary and capricious.
III.
Conclusion
After thirty‐seven years of delay, the FDA has finally come up with a
strategy for confronting the dangers caused by the subtherapeutic use of
medically important antibiotics on animals. That strategy is to ask
pharmaceutical manufacturers to voluntarily relabel their drugs to prevent these
uses. See Guidance for Industry # 213. Meanwhile, the FDA continues to avoid
the withdrawal procedure contemplated by the statute, claiming that procedure
is too slow and too expensive. “One can only wonder what conceding the
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absence of an effective regulatory mechanism signals to the industry which the
FDA is obliged to regulate.” NRDC II, 872 F. Supp. 2d at 339 n.23.
I agree with the majority that it is not our duty to judge the wisdom of the
FDA’s approach. But it is emphatically our duty to judge whether the FDA’s
actions conform with the dictates of Congress. For the reasons I have given, I am
convinced that they do not. As I interpret 21 U.S.C. § 360b(e)(1)(B), it requires the
FDA to pursue formal withdrawal proceedings whenever it makes a preliminary
finding that an animal drug is not shown to be safe for its approved use. And
under Massachusetts v. EPA, it also requires the agency to address that
preliminary question based on the scientific evidence available—not based on its
preference for a different regulatory strategy. Whatever the merits of the FDA’s
voluntary compliance strategy, the agency may not escape its statutory
responsibilities “simply by asserting that its preferred approach would be better
policy.” Engine Mfrs. Ass’n v. EPA, 88 F.3d 1075, 1089 (D.C. Cir. 1996).
To be clear, the statute does not restrain the agency from employing other
strategies in tandem with formal withdrawal proceedings. As the district court
below noted, nothing prevents the agency from simultaneously initiating
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withdrawal proceedings and also seeking voluntary compliance. See NRDC II,
872 F. Supp. 2d at 340. But while the FDA is free to take any additional steps it
thinks are appropriate, it must at least carry out the minimum responsibilities
placed on it by the statute. If the FDA finds those statutory responsibilities are
unmanageable, then it should ask Congress—not us—to provide it with broader
discretion.
Because the majority decides otherwise, I respectfully dissent.
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