Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-99-05304/USCOURTS-caDC-99-05304-0/pdf.json

Nature of Suit Code: 440
Nature of Suit: Other Civil Rights
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued January 10, 2000 Decided February 11, 2000

No. 99-5304

Washington Legal Foundation,

Appellee

v.

Jane E. Henney, Commissioner,

Food and Drug Administration, and

Donna E. Shalala, Secretary,

U.S. Department of Health and

Human Services, Appellants

Appeal from the United States District Court

for the District of Columbia

(No. 94cv01306)

William B. Schultz, Deputy Assistant Attorney General,

United States Department of Justice, argued the cause for

appellants. With him on the briefs were David W. Ogden,

Acting Assistant Attorney General, Douglas N. Letter and

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Michael S. Raab, Attorneys, Wilma A. Lewis, United States

Attorney, Eric M. Blumberg, Deputy Chief Counsel for Litigation, Food and Drug Administration, and Annamarie Kempic, Associate Chief Counsel for Enforcement.

Bert W. Rein argued the cause for appellee. With him on

the brief were Daniel J. Popeo, Richard A. Samp, Andrew S.

Krulwich, Thomas W. Queen, Daniel E. Troy, and Michael

L. Sturm.

Matthew Van Hook, Peter Barton Hutt, Bruce N. Kuhlik,

and Michael S. Labson were on the brief for amicus curiae

Pharmaceutical Research and Manufacturers of America.

Arthur B. Spitzer and Daniel I. Prywes were on the brief

for amicus curiae American Civil Liberties Union of the

National Capital Area.

Before: Silberman, Williams, and Tatel, Circuit Judges.

Opinion for the Court filed by Circuit Judge Silberman.

Silberman, Circuit Judge: The government appeals a district court decision holding that the Food and Drug Administration Modernization Act of 1997, which establishes procedures by which drug and medical device manufacturers may

disseminate information about "off-label" uses for their products, violates the First Amendment. In light of the government's appellate position that the statute does not provide it

with independent authority to proscribe speech, we dismiss

the appeal and vacate the district court's injunction.

* * * *

To secure Food and Drug Administration (FDA) approval

for a drug or medical device,1 a manufacturer must demonstrate that its product is safe and effective for each of its

intended uses. See 21 U.S.C. s 355(d); id. at s 360e(e)(1)(A).

It will often be discovered after initial FDA approval, however, that a drug has uses other than those for which it was

__________

1 For brevity's sake we use the term "drugs" to encompass

drugs and medical devices, both of which are regulated under the

statute and guidance document at issue here.

approved. These so-called "off-label uses" are subject to

asymmetrical--if not necessarily inconsistent--regulatory treatment. On the one hand, it is unlawful for a manufacturer to

introduce a drug into interstate commerce with an intent that

it be used for an off-label purpose, see id. at s 331(d), and a

manufacturer illegally "misbrands" a drug if the drug's labeling includes information about its unapproved uses, see id. at

s 331(a); id at s 352(a); cf. Kordel v. United States, 335 U.S.

345, 348-50 (1948) (affirming broad definition of "labeling"

under the Food, Drug, and Cosmetic Act). On the other

hand, neither Congress nor the FDA has attempted to regulate the off-label use of drugs by doctors and consumers. A

physician may prescribe a legal drug to serve any purpose

that he or she deems appropriate, regardless of whether the

drug has been approved for that use by the FDA. See, e.g.,

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Citizen Petition Regarding the Food and Drug Administration's Policy on Promotion of Unapproved Drugs and Devices; Request for Comments, 59 Fed. Reg. 59,820, 59,821

(1994). Although the parties have differing views about the

health risks and benefits of off-label uses, it is undisputed

that the prescription of drugs for unapproved uses is commonplace in modern medical practice and ubiquitous in certain specialties. See, e.g., James M. Beck & Elizabeth D.

Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L.J. 71, 80

(1998).

While a manufacturer's direct advertising or explicit promotion of a product's off-label uses is likely to provoke an

FDA misbranding or "intended use" enforcement action,

manufacturers have sought to employ more indirect methods

of informing physicians about their products' off-label uses.

This case concerns the FDA's and Congress' attempts to

regulate two of these promotional strategies: manufacturer

dissemination to physicians of independent medical and scientific publications concerning the off-label uses of their products, and manufacturer support for Continuing Medical Education (CME) programs for doctors that focus on off-label

uses. The FDA's examination of these practices led to

publication of an agency enforcement policy set forth in three

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guidance documents. Two of these documents limited the

circumstances under which manufacturers could permissibly

distribute "enduring materials"--i.e., journal article reprints

and textbooks--to physicians. See Guidance to Industry on

Dissemination of Reprints of Certain Published, Original

Data and Guidance for Industry Funded Dissemination of

Reference Texts, 61 Fed. Reg. 52,800 (1996) ("Enduring Materials Guidances").2 The third guidance document, concerning

manufacturer involvement in CME programs (the "CME

Guidance"), set forth twelve factors that the FDA will consider in determining whether a program is independent of

manufacturer influence. See Guidance for Industry: Industry-Supported Scientific and Educational Activities, 62 Fed.

Reg. 64,093, 64,096-99 (1997).

Washington Legal Foundation (WLF) brought this action

asserting that the policies articulated in the Guidance Documents violated the First Amendment right of its physician

members to receive information about off-label uses from

manufacturers.3 Cf. Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748, 756-57

(1976) (First Amendment protections extend both to distribution and receipt of commercial speech). The district court, in

its decision granting summary judgment, began its discussion

__________

2 These Guidances provided that, while a manufacturerdistributed article could reference a product's off-label use, "the

principal subject of the article should be the use[ ] ... that has been

approved by FDA," 61 Fed. Reg. at 52,801; it also stated that the

manufacturer should indicate clearly to the recipient that the article

discusses "information that is different from approved labeling."

Id. The Guidances included similar provisions limiting the dissemination of medical textbooks where the textbook contains content too

extensively devoted to off-label uses. See id.

3 WLF's original complaint, filed before the FDA published the

Guidances, was based on a series of FDA actions taken against

manufacturers for their dissemination of off-label information that

WLF asserted constituted final agency policy. See Washington

Legal Foundation v. Kessler, 880 F.Supp. 26 (D.D.C. 1995). The

Guidance Documents were published during the course of the

litigation.

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of WLF's constitutional claim by classifying the speech being

regulated. Rejecting both the WLF's contention that the

policies restricted fully-protected scientific speech and the

FDA's argument that the speech was constitutionally unprotected because it "proposed an illegal transaction," the court

determined that the Guidance Documents regulated commercial speech. See Washington Legal Foundation v. Friedman,

13 F.Supp.2d 51, 62-65 (D.D.C. 1998) (WLF I). It then

applied the three-part test set forth in Central Hudson Gas &

Elec. Corp. v. Public Serv. Comm'n, 447 U.S. 557 (1980), to

determine whether the policies' restrictions on commercial

speech exceeded constitutional limits. It concluded that the

Guidance Documents satisfied the first and second parts of

Central Hudson, since they directly advanced the government's substantial interest in encouraging manufacturers to

seek FDA approval for off-label uses. They fell short of

satisfying the final part of the Central Hudson test, however,

because the policies restricted considerably more speech than

necessary to encourage manufacturers to achieve this objective. See WLF I, 13 F.Supp.2d at 65-74. Holding that the

Enduring Materials and CME Guidances violated the First

Amendment, the court enjoined the FDA from prohibiting

manufacturers' dissemination of enduring materials "regardless of whether such [materials] include[ ] a significant or

exclusive focus" on off-label uses, and from proscribing manufacturers from suggesting content to CME program providers. Id. at 74-75.

Shortly after the district court issued its injunction, the

Food and Drug Administration (FDA) Modernization Act of

1997, Pub. L. No. 105-115, 111 Stat. 2296 (FDAMA or the

Act), became effective. The Act includes provisions concerning manufacturer distribution of enduring materials on offlabel uses that supersede4 the Enduring Materials Guidances

__________

4 We emphasize that the FDA unequivocally stipulated in its

briefs and at oral argument that the Act and its implementing

regulations supersede, rather than supplement, the Enduring Material Guidances. And even if they were not superseded, they would

be unenforceable, since the FDA does not challenge on appeal the

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found unconstitutional in WLF I. See 21 U.S.C. ss 360aaa et

seq. It specifically authorizes a manufacturer to disseminate

"written information concerning the safety, effectiveness, or

benefit of a use not described in the approved labeling of a

drug or device," 21 U.S.C. s 360aaa(a), if it complies with

several requirements: the manufacturer must submit an application to the FDA seeking approval of the drug for the offlabel use; the manufacturer must provide the materials to the

FDA prior to dissemination; the materials themselves must

be in unabridged form; and the manufacturer must include

disclosures that the materials pertain to an unapproved use of

the drug, and, if the FDA deems it appropriate, "additional

objective and scientifically sound information ... necessary to

provide objectivity and balance." See 21 U.S.C.

s 360aaa(b)(1)-(6); id. at 360aaa(c); id. at 360aaa-1. Importantly, the Act amends the Food, Drug, and Cosmetic Act to

prohibit "[t]he dissemination of information in violation" of

these provisions. 21 U.S.C. s 331(z); see also id. at

s 360aaa-4(b)(1) (emphasis added).

After the Act became effective, questions arose concerning

the scope of the district court's decision and injunction in

WLF I. The government asserted that the district court's

ruling applied only to the Guidance Documents, two of which

had been superseded by the Act, and asked that the district

court confine the application of its injunction accordingly.

The court denied the FDA's motion, noting that its "decision

and injunction must be read to apply to the underlying

policies of the FDA, and not merely to the express provisions

of the Guidance Documents," Washington Legal Foundation

v. Friedman, 36 F.Supp.2d 16, 18 (D.D.C. 1999) (WLF II),

and requested supplemental briefing on the constitutionality

of the Act's provisions addressing manufacturer promotion of

off-label uses. In a subsequent opinion, the district court

held that those provisions, like the Enduring Materials Guidances that preceded them, violated the First Amendment.

See Washington Legal Foundation v. Henney, 56 F.Supp.2d

__________

district court's decision and injunction insofar as they pertain to the

Enduring Material Guidances. See WLF I, 13 F.Supp.2d at 74.

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81 (D.D.C. 1999) (WLF III). The FDA appealed, contending

that the district court erred in concluding that the FDAMA

and the CME Guidance are unconstitutional.

The stage therefore appeared set for us to consider a

difficult constitutional question of considerable practical importance. However, as a result of the government's clarification at oral argument, the dispute between the parties has

disappeared before our eyes. The parties' briefs were quite

confusing as to the meaning of the Act and the CME Guidance, perhaps because both provisions became effective during the later stages of the litigation in the district court.

While WLF clearly understood these provisions as independently banning both manufacturer dissemination of enduring

materials on off-label uses and support for CME conferences,

see, e.g., Appellee's Br. at 1, 12-13, 20, 33, the FDA's view of

the Act and the CME Guidance was somewhat unclear: At

times the FDA appeared to share WLF's assessment that

these provisions provide legal authorization to restrict manufacturer speech, but more frequently the FDA asserted that

they established nothing more than a "safe harbor" ensuring

that certain forms of conduct would not be used against

manufacturers in misbranding and "intended use" enforcement actions based on pre-existing legislative authority.

Compare Appellant's Br. at 34-35 (safe harbor) with id. at

46-47, 51 (describing provisions as restricting speech, and

noting that "enforcement of the FDCA's misbranding provision ... is a wholly inadequate substitute for the FDAMA").

In response to questioning at oral argument, the government

definitively stated that it subscribed to the "safe harbor"

interpretation and further explained that, in its view, neither

the FDAMA nor the CME Guidance independently authorizes the FDA to prohibit or to sanction speech.5 When we

__________

5 The government's position, articulated and repeated several

times during oral argument, is most succinctly presented by the

following colloquy:

THE COURT: .... I thought your whole explanation of this

statute and the guidance was that they have established a

procedure for manufacturers who distribute certain materials

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pressed government counsel about the significance of 21

U.S.C. s 331(z)--which specifically prohibits "the dissemination of information in violation of section 360aaa"--he explained that this provision provides that a manufacturer who

disregards section 360aaa's conditions cannot avail itself of

the FDAMA safe harbor, and might be liable in some fashion

if it breached an agreement with the Secretary pursuant to

that section. See Tr. at 34. Were a pharmaceutical company

to send out reprints of an article devoted to its drug's offlabel uses to thousands of physicians tomorrow, the government agreed--indeed stipulated-that the agency would draw

no independent prosecutorial authority from FDAMA to buttress any enforcement proceeding. See Tr. at 60--61. And

the FDA offers a similar view of the CME Guidance: If a

drug manufacturer wishes to suggest content to a CME

program provider in a manner that runs afoul of all the

Guidance's twelve "factors" that, by itself, is not a violation of

law. See Tr. at 73-74. Although the FDA retains the

prerogative to use both types of arguably promotional conduct as evidence in a misbranding or "intended use" enforcement action, cf. Action on Smoking and Health v. Harris, 655

F.2d 236, 239 (D.C. Cir. 1980) (observing that "it is well

established that the 'intended use' of a product, within the

meaning of the [Food, Drug, and Cosmetic] Act, is determined from its label, accompanying labeling, promotional

claims, advertising, and any other relevant source" (internal

citations omitted)), the agency insists that nothing in either of

the provisions challenged in this case provides the FDA with

independent authority to regulate manufacturer speech.

__________

regarding off-label uses in such a way that they will not be

used as evidence against them in a prosecution under the

misbranding provisions. I thought that's what this was about.

And that I thought that any manufacturer could distribute

anything they wanted, if they wanted to take a chance of

ending up a defendant in a mislabeling case. Isn't that right?

COUNSEL: That's all correct. That's all correct.

THE COURT: That's all correct.

COUNSEL: Yes.

Tr. at 31-32.

WLF responded that in light of the government's position

as refined and explained at oral argument it no longer has a

constitutional objection to the Act or the CME Guidance,6 see

Tr. at 52, 66-68, 69--a response that, it would seem, eliminates

entirely the only issues in dispute between the parties in this

case. WLF apparently believes we should nevertheless affirm the district court. It is a well-recognized principle that a

case will not become moot merely because a defendant agrees

voluntarily to cease engaging in the challenged conduct, as

there remains a risk that the defendant will merely resume

the challenged conduct after the case is dismissed. See, e.g.,

United States v. W. T. Grant Co., 345 U.S. 629, 632 (1953).

Voluntary cessation of challenged conduct will only moot a

case if "subsequent events made it absolutely clear that the

allegedly wrongful behavior could not reasonably be expected

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to recur." Friends of the Earth, Inc. v. Laidlaw Environmental Servs. (TOC), Inc., No. 98-222, Slip Op. at 18 (U.S.

Jan. 12, 2000) (quoting United States v. Concentrated Phosphate Export Assn., Inc., 393 U.S. 199, 203 (1968)). Relying

on this principle, and apparently concerned that the FDA will

prosecute manufacturers for violating a normative standard

set forth in the Act or CME Guidance notwithstanding the

agency's concession in this case that it has no authority to do

so, WLF indicates that we should still reach the merits of the

district court's decision and injunction.

We think that WLF misapprehends the nature and significance of the FDA's concessions, which do not in our view

implicate principles of mootness at all. This is not an instance of "voluntary cessation," since WLF has not alleged

that FDA engaged in any conduct pursuant to the challenged

statute and guidance document. The relevant question before us therefore is not whether certain enforcement activities

conducted under these provisions were unconstitutional (since

there were no such activities alleged), but instead whether the

statute and guidance document facially violate the First

__________

6 A manufacturer, of course, may still argue that the FDA's use

of a manufacturer's promotion of off-label uses as evidence in a

particular enforcement action violates the First Amendment.

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Amendment. Since both parties now agree that they do not,

there is no constitutional controversy between the parties

that remains to be resolved; we do not think it at all

appropriate to rule on the constitutionality of a hypothetical

interpretation of a statute, see Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 240-41 (1937) (distinguishing a justiciable

controversy from "a difference or dispute of a hypothetical or

abstract character"), which is what WLF in effect requests by

suggesting that we "reach the merits" of the district court's

decision. The government has announced here nothing less

than an official interpretation of the FDAMA which the

agency may not change unless it provides a reasoned explanation for doing so. See Amax Land Co. v. Quarterman, 181

F.3d 1356, 1365 & n.6 (D.C. Cir. 1999). It goes without

saying that an attempt to evade judicial review in this case

would hardly be a legitimate basis. Cf. AT & T v. FCC, 978

F.2d 727, 731-32 (1993).

Accordingly, we dismiss the FDA's appeal and vacate the

district court's decisions and injunctions insofar as they declare the FDAMA and the CME Guidance unconstitutional.7

So ordered.

__________

7 In disposing of the case in this manner, we certainly do not

criticize the reasoning or conclusions of the district court. As we

have made clear, we do not reach the merits of the district court's

First Amendment holdings and part of its injunction still stands.

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