Marketing off-label uses to physicians: FDA's draft (mis)guidance.

The American Journal of Bioethics, 8(3): 1–3, 2008 Copyright c Andy Gass and Jennifer Wilson ISSN: 1526-5161 print / 1536-0075 online DOI: 10.1080/15265160802116624 Editorial Marketing Off-Label Uses to Physicians: FDA’s Draft (Mis)Guidance Andy Gass, University of California, Berkeley Jennifer Wilson, University of California, San Francisco When President Clinton signed the United States Food and Drug Administration (US FDA) Modernization Act into law in 1997, he hedged his support for several of its more contro- versial elements. “While I am satisﬁed with the resolution of the issues in this legislation,” he asserted, “I am also pleased that Congress included sunsets to certain of the Act’s pro- visions so that, at the appropriate time, we can evaluate whether the appropriate compromises were reached.” 1 One such provision, which relaxed the previously operative pro- hibition against promoting off-label uses of drugs to physi- cians, expired in the fall of 2006. 2 This February, the FDA promulgated a draft policy to replace the defunct statute 3 — so the “appropriate time” to assess the effectiveness of the relevant compromises, past and present, seems to be now. The 1997–2006 regime looked like this: Industry repre- sentatives could give physicians peer-reviewed journal ar- ticles assessing the effectiveness of a drug for uses other than those for which it had been approved—subject to the condition that the manufacturer begin or continue the pro- cess of earning regulatory approval for the new indications. 4 Exceptions to that requirement were available in a vari- ety of cases, including when the patient population that might beneﬁt from the off-label use was so small that it was not worth the company’s resources to conduct the neces- sary studies. 4 The point was to balance competing concerns. On one hand, Congress wanted to ensure that “health care practitioners [could] obtain important scientiﬁc information about uses that are not included in the approved labeling of drugs.” 5 On the other, the legislature took care to “encour- age that these new uses be included on the product label,” by insisting on the statute’s “strong incentives to conduct the research needed and ﬁle a supplemental application for [regulatory approval of] such uses.” 5 The new proposed policy would do away with the need for companies to work toward approval for the off- label uses they promote to physicians. While acknowledg- ing that such marketing efforts technically may violate laws against hawking “misbranded” food, drug, and cosmetic products, 6 the FDA has effectively announced that, going forward, it will not be bothered by the promotion of off- label drug uses in the form of companies’ giving peer- reviewed journal articles to physicians. The agency, in other words, has decided that it cares about only one of the is- sues that Congress expressed concern with in 1997: the “im- portant public policy reasons for allowing manufacturers to disseminate truthful and non-misleading medical journal articles.” 7 Address correspondence to Andy Gass, University of California, Berkeley. E-mail: gass@berkeley.edu Acknowledgment: This article is published under the terms of Creative Commons Attribution License V. 3.0. 1. President William Jefferson Clinton, Signing Statement on FDA Modernization Act, 21 Nov 1997. 2. 21 U.S.C. §360aaa NOTE (e). 3. See United States Food and Drug Administration. 2008. Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientiﬁc Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. Available at: http://www.fda.gov/oc/op/goodreprint.html (accessed 16 May 2008). Federal Register, February 20, 2008, Vol. 73 No. 34 at 9342. Hereinafter “Draft Guidance”. 4. 21 U.S.C. §360aaa et seq. The statute imposed several more modest demands as well, among them that companies submit materials to FDA prior to distributing them to physicians. Id. 5. Food and Drug Administration Modernization Act of 1997, H.R. Conf. Rep. 105-399, 9 Nov 1997, at 99-100. 6. See Draft Guidance, supra n.3, §III (“the [Food, Drug & Cosmetics] Act and FDA’s implementing regulations generally prohibit man- ufacturers of new drugs or medical devices from distributing products in interstate commerce for any intended use that FDA has not approved as safe and effective or cleared through a substantial equivalence determination”). 7. See Draft Guidance, supra n.3. ajob 1