For The Defense, November 2012 - DRI Today

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Drug and Medical Device Fitting a Round Peg into a Square Hole By Frederick H. Fern and Kelly E. Jones It is time for the FDA to rethink policy, as the prohibition on off-label marketing and the recent Guidance on responding to unsolicited requests for information do little to advance the agency’s mission to ensure that all drugs and devices are safe and effective. 22 ■ For The Defense ■ November 2012 FDA Off-Label Promotion Rules in the World of Social Media The Food and Drug Administration (FDA) released new draft guidance on December 23, 2011, entitled, “Responding to Unsolicited Requests for Off- Label Information about Prescription Drugs and Medical Devices.” The guid- ■ Frederick H. Fern, a registered pharmacist, is a member of Harris Beach PLLC in New York City and the leader of its Medical & Life Sciences Practice Group and a member of the DRI Drug and Medical Device Committee. Kelly E. Jones is a senior associate with Harris Beach PLLC and focuses her practice in New York and New Jersey on litigation and consulting involving FDA- regulated products. Ms. Jones serves on the steering committees for the DRI Drug and Medical Device and Young Lawyers Committees. A special thank you to Andre Major, a third-year law student at Brooklyn Law School, for his assistance with this article.
ance advises how firms such as manufacturers and distributors of pharmaceuticals and medical devices should respond to requests for information about unapproved or “off- label” uses for FDA- approved drugs and medical devices. The impetus for the guidance has been the continuing expansion and prevalence of the Internet and social media, and the industry’s resulting uncertainty regarding how to respond to information posted publicly and questions about off- label uses in light of the strict FDA ban on marketing for off- label indications. Though the FDA has not yet finalized the guidance, in its current form it will do little to resolve uncertainties. First, the guidance doesn’t clearly distinguish between solicited and unsolicited requests for off- label information and will chill the dissemination of valuable information about off- label uses. Second, the guidance unduly limits the permitted exchanges of valuable medical information that may adversely affect the public health. Finally, the guidance does not take into consideration the burgeoning case law, particularly the recent Supreme Court decision Sorrell v. IMS Health, which strongly suggests that the FDA ban on truthful marketing of off- label uses is an unconstitutional restriction of commercial speech. Background The Food, Drug and Cosmetic Act (FDCA) prohibits manufacturers from marketing or promoting off- label drug uses. The FDA had interpreted a combination of provisions as effectively having made it illegal for manufacturers to disseminate information regarding indications for use that the FDA has not approved. The FDCA makes it illegal for a manufacturer to introduce a drug into interstate commerce unless the product has undergone clinical trials demonstrating safety and efficacy for its intended uses. See 21 U.S.C. §355(a), (b) (2006). Furthermore, the FDA must approve the labeling of a new product for all of its intended uses; namely, the product’s directions for use, its indications, and its side effects. 21 U.S.C. §352(f) (2006). Moreover, the FDA interprets a manufacturer’s intended use by examining “labeling claims, advertising matter, or oral or written statements by such persons or their representatives.” 21 C.F.R. §201 (2012). Accordingly, if a manufacturer markets an approved drug for an indication not yet approved by the FDA, it “becomes an unapproved new drug with respect to that use.” 65 Fed. Reg. 14,286 (2000). An unapproved new drug by definition would have insufficient labeling and inadequate use directions. See 21 U.S.C. §352(f) (2006); Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 54–55 (D.D.C. 1998). Consequently, a manufacturer must seek and obtain FDA approval for any new indication; otherwise any marketing of that off- label use is considered misbranding and violates the FDCA labeling mandates, regardless of the truthfulness of the information. See 21 U.S.C. §352 (2006); John E. Osborn, Can I Tell you the Truth A Comparative Perspective on Regulating Off- Label Scientific and Medical Information, Yale J. Health Pol’y & Ethics 299, 329 (2010). Violating the FDCA misbranding provisions also potentially subject violators to treble damages and qui tam actions under the False Claims Act (FCA) for “knowingly mak[ing], us[ing], or caus[ing] to be made or used, a false record or statement material to a false or fraudulent claim.” 31 U.S.C. §3729(a)(1)(B) (2006); Osborn, supra, at 310–11. Furthermore, any person convicted of illegally marketing a drug is guilty of a misdemeanor. See 21 U.S.C. §331 (2006). For The Defense ■ November 2012 ■ 23
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