For The Defense, November 2012 - DRI Today

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Drug and Medical Device While the FDCA serves nearly to ban offlabel marketing absolutely, a physician has limitless ability to prescribe a medication for an offlabel use. Physicians have the absolute discretion to prescribe a medication for any purpose that they deem medically appropriate, regardless of whether the FDA has approved the drug for that indication. Incongruity aside, this policy As the Internet and social media have expanded and facilitated the spread of information, the FDA policy on offlabel use marketing has become increasingly unrealistic. acknowledges that completely banning offlabel drug use is untenable because in many instances—particularly in pediatrics and oncology—such offlabel uses represent novel and cutting- edge treatment for certain medical conditions. See Osborn, supra, at 303–04. It is widely accepted that the time- consuming and costly nature of the FDA approval process means that it is often economically unfeasible for a manufacturer to test all potential offlabel usages for a drug. See Anna B. Laakmann, Collapsing the Distinction Between Experimentation and Treatment in the Regulation of New Drugs, 62 Ala. L. Rev. 305, 317– 18 (2011). Therefore, an outright ban on offlabel usage would invade the province of the practice of medicine and in many instances prevent patients from receiving the best or only drug available for treating a medical condition. Ostensibly, the FDA offlabel use marketing ban seeks to prevent manufacturers from promoting offlabel uses that have not endured the rigorous FDA screening process. Belying this justification, however, the FDA has failed to distinguish between “truthful” and “misleading” offlabel use marketing or to take into account 24 ■ For The Defense ■ November 2012 the unfettered discretion that physicians have to prescribe medication for offlabel uses. Furthermore, as the Internet and social media have expanded and facilitated the spread of information, the FDA policy on offlabel use marketing has become increasingly unrealistic. It ignores that the public has wide access to information about offlabel uses and widely seeks this information. See Susannah Fox, The Social Life of Health Information, Pew Internet & American Life Project 2 (May, 12 2011), http://pewinternet.org/~/media//files/ reports/2011/pip_social_life_of_health_info. pdf. Accordingly, this policy is unsustainable, as the recently released FDA guidance highlights in advising firms how to respond to unsolicited requests for information about offlabel uses. The FDA Draft Guidance On December 23, 2011, the FDA released a draft guidance document directed to the industry entitled, “Responding to Unsolicited Requests for Off- Label Information about Prescription Drugs and Medical Devices.” The FDA sought through the draft guidance “to describe the [FDA’s] current thinking about how manufacturers and distributors… can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use.” U.S. Food and Drug Admin., Guidance for Industry Responding to Unsolicited Requests for Off- Label Information about Prescription Drugs and Medical Devices, Draft Guidance, 1 (Dec. 2011), http://www.fda.gov/downloads/drugs/ guid ancecomplianceregulatoryinformation/guidances/ ucm285145.pdf. Specifically, the draft guidance explains how the FDA differentiates a solicited request for information from an unsolicited request and the proper procedures for responding to public and private unsolicited requests about offlabel uses. Solicited requests are those “requests for offlabel information that are prompted in any way by a manufacturer or its representatives.” U.S. Food and Drug Admin., Unsolicited Requests, supra, at 5. A firm cannot solicit requests for information for offlabel use, and the FDA may consider this evidence that the firm sought to market a medication for a new intended use in violation of the FDCA. See id. The draft guidance provides numerous examples of solicited requests. For instance, the FDA would view a manufacturer’s sales representative mentioning an offlabel use and inviting a health-care professional to request more information about the use as a solicited request. On the other hand, an unsolicited request is one “initiated by persons or entities that are completely independent of the relevant firm.” Id. at 4. Stated succinctly, a request for information is unsolicited when it was not “prompted in any way by [the] manufacturer or its representatives.” Id. The draft guidance further subdivides unsolicited requests into public and nonpublic requests and defines each. According to the draft guidance, “[a] nonpublic unsolicited request is an unsolicited request that is directed privately to a firm using a one-on-one communication approach.” Id. (mentioning an e-mail from an individual directed to the medical information staff of a manufacturer about an offlabel use as an example of a private communication). A public unsolicited request is one “made in a public forum, whether directed to a firm specifically or to a forum at large.” Id. (mentioning posting a question about an offlabel use of a specific product on a firmcontrolled website or third-party forum accessible to a broad audience as an example of a public forum). The draft guidance then delineates the proper way to respond to each type of request. The draft guidance lists the information that firms should include in all responses to nonpublic unsolicited requests about offlabel uses. The FDA directs firms to answer unsolicited requests with “truthful, balanced, non- misleading, and non- promotional scientific or medical information that is responsive to the specific request.” Id. at 6–7. Moreover, when a firm responds to a nonpublic request, the firm should distribute the information only to the person making the request “as a private, one-on-one communication,” and the information “should be tailored to answer only the specific question(s) asked.” Id. at 7 (indicating that if a firm receives a broad request the firm should narrow the response as much as possible). Furthermore, information in a response should be “truthful” and “scientific in nature,” independent medical or scientific personnel should generate it, and publications that
are contrary to or call into question the use at issue should accompany it. Id. at 8 (suggesting that to the greatest extent possible firms should rely on “published peerreviewed articles, medical texts, or data derived from independent sources”). As mentioned, a firm response to a nonpublic request should originate with medical or scientific personnel as opposed to sales or marketing personnel, and the following information should accompany it: a copy of the approved FDA labeling, a statement that the FDA has not approved the drug for the offlabel use, a statement detailing the FDA- approved uses of the drug, a statement listing all important safety information, and a complete list of all references for the information disseminated in the response. Id. at 9 (also imposing a responsibility on the manufacturer to maintain records, particularly of the nature of the request for information, the information provided responding to the request, and follow- up questions received from the requestor). The draft guidance makes a separate set of recommendations for responding to an unsolicited public request. Specifically, if the request for offlabel information is made in a public forum, then a responding firm cannot respond in the same forum, which would then make the information available to the public and which the FDA would consider evidence of an intended offlabel use. Id. at 10. (citing dual concerns that publicly posted information “is likely to be available to a broad audience for an indefinite period of time” and about the “enduring nature of detailed public online responses to offlabel questions because specific drug or device information may become outdated). Furthermore, the draft guidance directs that firms should not respond to any public inquiry unless the request specifically refers to a product by name, and if a firm decides to respond publicly to such a request, the response should be limited to providing the manufacturer’s contact information for the medical or science department and “should not include any offlabel information.” Id. at 11 (emphasis in original). Finally, anytime a representative of a manufacturer responds to an unsolicited request, the representative should disclose the involvement with the manufacturer and should refrain from adopting promotional tones. Id. at 12. The Shortcomings of the FDA Draft Guidance Unless the FDA makes major modifications before finalization, the guidance as it stands will potentially increase uncertainty for drug manufacturers. Right now it doesn’t achieve its stated purpose: to “clarif[y] [the] FDA’s policies on unsolicited requests for offlabel information, including those that firms may encounter through emerging electronic media.” U.S. Food and Drug Admin., Unsolicited Requests, supra, at 1. For example, two means by which the draft guidance differentiates a solicited request from an unsolicited request are troublesome. This is especially true given that firms cannot respond to unsolicited requests, and making a mistake distinguishing between a solicited and an unsolicited request could elicit a violation. The draft guidance twice emphasizes that the FDA considers a request solicited if it is “prompted in any way by a manufacturer or its representatives.” Id. at 4, 5. This distinction could potentially subject manufacturers to liability for a variety of innocent and widespread industry practices. For example, according to the broad language in the draft guidance, when a sales representative asks a group of physicians if the physicians have any questions and one or more of those physicians respond with questions about offlabel use, the FDA would consider this a solicited request. Technically, the sales representative’s question “prompted” the physicians’ inquiries. Moreover, if the FDA categorizes these inquiries as solicited, then the FDA might consider any response at all—even to convey truthful information or to offer the manufacturer’s contact information—evidence of promoting an offlabel use. See id. at 4–5. According to the draft guidance, the FDA will consider a request unsolicited only if it is “initiated by persons or entities that are completely independent of the [drug manufacturer].” Id. at 4. The FDA in the draft guidance does not clearly define “completely independent.” While the draft guidance lists some of the medical professionals that the FDA may consider independent, it does not acknowledge that exceedingly commonly a drug manufacturer will have interactions with physicians or health-care organizations or recommend how a drug Anytimea representative of a manufacturer responds to an unsolicited request, the representative should disclose the involvement with the manufacturer and should refrain from adopting promotional tones. manufacturer should interact with them. Id. For example, would the FDA view a physician or a health-care organization as relinquishing independence when they form purchasing or consulting agreements with a manufacturer Moreover, if that physician or organization suddenly becomes affiliated with a drug manufacturer, would any question they asked about offlabel usage become solicited, subjecting the manufacturer to liability for responding These ambiguities regarding the distinction between solicited and unsolicited requests can have a chilling effect on the dissemination of valuable medical information. If a drug manufacturer is found to have promoted an offlabel use illegally, it would potentially incur billions of dollars in fines. For example, in July 2012, GlaxoSmithKline agreed to pay $3 billion to settle claims it illegally promoted offlabel uses for Paxil and Wellbutrin. Jesse J. Holland, GlaxoSmithKline to Pay $3 Billion for Health Fraud, S.F. Chron., July 2, 2012, http://www.sfgate.com/ news/article/ GlaxoSmithKline-to-pay-3-billion-forhealth-fraud-3678945.php (last visited Sept. 10, 2012). Because drug manufacturers potentially face massive penalties for offlabel drug-use marketing, they will understandably err on the side of caution with ambiguous guidance activities which migh expose firms to those penalties. Inevitably healthcare professionals will not have access to vital medical information that they should have access to, and their patients will not For The Defense ■ November 2012 ■ 25
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