Source: https://law.justia.com/cases/federal/appellate-courts/cadc/99-5304/99-5304a-2011-03-24.html
Timestamp: 2019-04-21 04:06:08+00:00

Document:
Michael S. Raab, Attorneys, Wilma A. Lewis, United States Attorney, Eric M. Blumberg, Deputy Chief Counsel for Liti- gation, Food and Drug Administration, and Annamarie Kem- pic, Associate Chief Counsel for Enforcement.
Silberman, Circuit Judge: The government appeals a dis- trict court decision holding that the Food and Drug Adminis- tration Modernization Act of 1997, which establishes proce- dures by which drug and medical device manufacturers may disseminate information about "off-label" uses for their prod- ucts, violates the First Amendment. In light of the govern- ment'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.
__________ 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 treat- ment. 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 label- ing 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 regu- late 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., Citizen Petition Regarding the Food and Drug Administra- tion's Policy on Promotion of Unapproved Drugs and De- vices; 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 com- monplace in modern medical practice and ubiquitous in cer- tain specialties. See, e.g., James M. Beck & Elizabeth D. Azari, FDA, Off-Label Use, and Informed Consent: Debunk- ing Myths and Misconceptions, 53 Food & Drug L.J. 71, 80 (1998).
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 Mate- rials Guidances").2 The third guidance document, concerning manufacturer involvement in CME programs (the "CME Guidance"), set forth twelve factors that the FDA will consid- er in determining whether a program is independent of manufacturer influence. See Guidance for Industry: Indus- try-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,093, 64,096-99 (1997).
__________ 2 These Guidances provided that, while a manufacturer- distributed 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 dissemi- nation 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.
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 unpro- tected because it "proposed an illegal transaction," the court determined that the Guidance Documents regulated commer- cial 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 govern- ment'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 objec- tive. 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 "regard- less of whether such [materials] include[ ] a significant or exclusive focus" on off-label uses, and from proscribing manu- facturers from suggesting content to CME program provid- ers. Id. at 74-75.
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 ap- plication to the FDA seeking approval of the drug for the off- label 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. Impor- tantly, 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).
__________ district court's decision and injunction insofar as they pertain to the Enduring Material Guidances. See WLF I, 13 F. Supp. 2d at 74.
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 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 pressed government counsel about the significance of 21 U.S.C. s 331(z)--which specifically prohibits "the dissemina- tion of information in violation of section 360aaa"--he ex- plained 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 off- label uses to thousands of physicians tomorrow, the govern- ment agreed--indeed stipulated-that the agency would draw no independent prosecutorial authority from FDAMA to but- tress 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 con- duct as evidence in a misbranding or "intended use" enforce- ment 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 deter- mined 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 af- firm 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 to recur." Friends of the Earth, Inc. v. Laidlaw Environ- mental Servs. (TOC), Inc., No. 98-222, Slip Op. at 18 (U.S. Jan. 12, 2000) (quoting United States v. Concentrated Phos- phate 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.
__________ 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.
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. Ha- worth, 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 explana- tion 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).
__________ 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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