Off-label communications and prescription drugs

Ethics and the Pharmaceutical Industry

Volumn , Issue , 2005, Pages 184-195

  Danzis, Scott D ^a  

^a Department of International Practice   (United States)

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EID: 84926955400     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1017/CBO9780511610769.013     Document Type: Chapter

References (37)

1. U.S.C. §355(a).
2. C.F.R. §310.3(h).
3. U.S.C. §321(k) & (m).
4. U.S.C. §352(f); 21 C.F.R. §§201.5, 201.100(d)(1).
5. 335 U.S. 345 (1948).
6. 335 U.S. at 350. In United States v. Urbuteit, 335 U.S. 355 (1948), decided the same day, the Supreme Court similarly held that leaflets describing a therapeutic device were “labeling” even though the leaflets and devices were shipped separately from each other.
7. C.F.R. §202.1(1)(2). The FDCA specifically excepts advertising in newspapers, magazines, radio, television, and other electronic media from the definition of labeling.
8. C.F.R. §201.128 (“The words intended uses or words of similar import… refer to the objective intent of the persons legally responsible for the labeling of drugs. The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.”).
9. When an intended use for a product can be inferred from company promotional materials is a complex and often controversial issue, the complexities of which are not addressed here.
10. There are, however, a handful of narrowly defined exceptions to the general prohibition against communications about off-label topics that are recognized by the FDA. These exceptions describe categories of speech or conduct that the FDA has not traditionally regarded as promotional labeling. For example, the FDA has long recognized that companies may engage in “scientific exchange,” such as the publication in the scientific literature of study results regarding new uses for approved drugs. The study results may diverge from the FDA-approved labeling for the drug product. In addition, companies are permitted to respond to unsolicited questions about drug products, including questions about off-label topics. Responses to unsolicited questions will not be regarded as labeling. And finally, materials disseminated to company consultants and clinical trial investigators are not regarded as labeling.
11. Fed. Reg. 59820, 59821 (1994) (noting that the agency has restated this policy on numerous occasions).
12. First National Bank of Boston v. Bellotti, 435U.S. 765, 784 (1978) (observing that the First Amendment does not support “the proposition that speech that otherwise would be within the protection of the First Amendment loses that protection simply because its source is a corporation”).
13. “Commercial speech” is a category of speech that traditionally has received less constitutional protection than “core” political speech. Virginia State Board of Pharmacy v.Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976).
14. 447 U.S. 557 (1980).
15. Washington Legal Found. v. Friedman, 13 F. Supp.2d 51, 72-3 (D.D.C. 1998).
16. Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64074 (December 3, 1997);
17. Guidance to Industry on Dissemination of Reprints of Certain Published, Original Data, 61 Fed. Reg. 52800 (October 8, 1996);
18. Guidance for Industry Funded Dissemination of Reference Texts, 61 Fed. Reg. 52800 (October 8, 1996).
19. While the case was before the district court, Congress passed the Food and Drug Modernization Act (“FDAMA”), which contained provisions allowing manufacturers to disseminate peer-reviewed off-label reprints under a narrow set of circumstances. Washington Legal Found. v. Friedman, 36 F. Supp.2d 16, 18 (D.D.C. 1999). The district court concluded that like the Guidance Documents, the FDAMA provisions violated the First Amendment.
20. Washington Legal Found. v. Henney, 56 F. Supp.2d 81, 84 (D.D.C. 1999). When the case was appealed, FDA changed its position and stated that the Guidance Documents and FDAMA provisions were merely “safe harbors” and neither “independently authorizes the FDAto prohibit or to sanction speech.” As a result, because there was no longer a constitutional question, the appellate court vacated the core holdings of the district court, but stated that it was not criticizing “the reasoning or conclusions” of the district court’s First Amendment analysis.
21. Washington Legal Found. v. Henney, 202 F.3d 331, 335 (D.C. Cir. 2000).
22. FDA Response to Citizen Petition of Washington Legal Foundation, Docket No. 01P-0250 (Jan. 28, 2002). Of course, if peer-reviewed reprints contain false or misleading information, FDA still has the authority to bring an enforcement action to prevent their dissemination.
23. 164 F.3d 650 (D.C. Cir. 1999) (“Pearson I ”).
24. at 658 (1999);
25. 130 F. Supp.2d 105, 111-12 (D.D.C. 2001) (holding that FDA failed to comply with Pearson I and directing FDA to draft disclaimers);
26. Pearson v. Thompson, 141 F. Supp.2d 105, 112 (D.D.C. 2001) (holding that FDA “again seem[s] to ignore the thrust of Pearson I ”).
27. 535 U.S. 357 (2002).
28. 535 U.S. at 371, quoting Central Hudson, 447 U.S. at 566.
29. at §3730(b)(1).
30. Qui tam” is an abbreviation from the Latin “qui tam pro domino rege quam pro sic ipso in hoc parte sequitur” meaning “who as well for the king as for himself sues in this matter.
31. United States ex rel. Franklin v. Parke-Davis, 147 F. Supp.2d 39, 45 (D. Mass. 2001).
32. Reimbursement under the federal Medicaid program is, in most circumstances, available only for “covered outpatient drugs.” 42 U.S.C. §1396r-8(k)(3). Covered outpatient drugs include drugs that are used for a “medically accepted indication.” A medically accepted indication, in turn, includes a use “which is approved under the Federal Food Drug and Cosmetic Act” or which is included in specified drug compendia. §1396r-8(k)(6). Thus, unless a particular off-label use for a drug is included in one of the identified drug compendia, a prescription for the off-label use is generally not eligible for reimbursement under Medicaid.
33. The company disputed the relator’s factual allegations, but because the court considered Franklin’s allegations in the context of a motion to dismiss and motion for summary judgment, the court had to accept the relator’s allegations as true. The U.S. Department of Justice filed a “statement of interest” in support of the relator, but did not intervene in the case.
34. Franklin v. Parke-Davis, 147 F. Supp.2d at 53.
35. United States ex rel. Franklin v. Parke-Davis, 2003 WL 22048255, *4-5. (D. Mass. August 22, 2003).
36. 2003 WL 22048255 at *1-2. Although ambiguous, this language suggests that both off-label promotion and financial incentives would be required for FCA liability.
37. Rx Compliance Report, Oct. 31, 2003.