Off_label_Promos_AGG - Food and Drug Series :1 THomPson May...

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Unformatted text preview: Food and Drug Series :1 THomPson May 2008 | VOL. 16. N0. 3 Attorney Urges Caution on Off-label Promotion The government's dcfinition of the “false or mis- leading" claims is not as obvious or intuitive as most would assume —- just take into consideration the recent settlements of companies. such as Pfizer, Eli Lilly, and InterMune, where millions of dollars were doled out to the DOJ, patients and stakeholders over alleged off-label promotion. Alan Minsk, partner and chair of the Food and Drug Practice Team of Arnal] Golden Gregory LLP, cautioned pharmaceutical and medical device companies in a re- cent Thonipsonlnteractive audioconference, to be “very careful” when examining the laws and regulations re- garding off-label promotion. Definitions and Explanations Minsk said that scientific exchanges of infomia- Lion would include “the good, the bad and the ugly.” Promotion constitutes a marketing spin of a product’s “greatest hits,” particularly information that is unsolic- ited. He called off-label promotion “a fine line between clever and stupid," quoting from the film “This Is Spi~ nal Tap.” The primary statutory definition provided by the Federal Food, Drug and Cosmetic Act for labeling is a “display of written, printed, or graphic matter upon the immediate container of any article.” Labeling refers to “labels and other written, printed, or graphic matter (1) upon any article of any of its containers or wrappers, or (2] accompanying such article.” AlthOugh the typical graphic matter suggested are Web sites or tri—fold pieces, the definitions apply to anything from pens and mugs to stuffed animals. Minsk cautioned manufacturers to “appreciate the breadth of the definition.” He cited a case in which a client handed out a deck of cards with product specific information, that resulted in penalty. He suggested that all companies‘ basic operating procedures con- sider these areas. Off-label Dissemination and Misbrandlng The Food and Drug Administration Modernization Act’s (FDAMA) provisions relating to proactive off—label information dissemination are no longer in effect, he not- ed. The FDA released a draft guidance document regard- ing Good Reprint Practices entailing the dissemination of peer-reviewed medical journal articles and other publica- tions that involved unapproved uses of FDA-approved medical products (see “FDA Recommends ‘Safe Harbors‘ for Reprints," March 2008. p. 2). The FDA is soliciting comments for this document; however, Minsk does not believe that the provisions will go as far as the FDAMA‘s. Minsk provided a general list of “ways to get into trouble" with misbranding, including: inadequate warn- ings or directions for use; lack of fair balance; and the omission or minimization of risk of a drug or medical device. He added that an unapproved new drug is a separate violation. “False and misleading,” however, does not only mean that a claim is forged or fraudulent; it can go as far as to fall under the umbrella of creating or leading to a false impression to its audience. Minsk used the example of a pharmaceutical company that had used the image of a smiling baby on its Web site m not only does this icon give the impression that the marketed drug is approved for pediatric use, but that it also will cure the patient who uses it. Minsk added that this may seem somewhat silly, but that these are the types of violations that the FDA may find problematic and potentially penalise. Promotional Defects and Enforcement Options He also noted that more than 150 pharmaceutical and medical device companies are under investigation by the U.S. Department of Justice for aiieged o'ffulabel promo— tion. Several of these violations fall under what Minsk described as typical promotional defects, including: it The use of anecdotal testimonials based on clinical impression; See Promotion, p. 2 Reprinted with permission Thompson. Publishing Group. 805 I51}! St. NW. Washington. DC. 20005~220?; wum-Jhompmmcom fi thornpsoncom May 2008 | FDA Advertising & Promotion Manual 1 Promotion {continued from page 1) e The use of iii-vim) or animal data in a manner to suggest clinical significance, when it has not been established; ‘- Direct or implied comparisons of unlike products (“apples-to-oranges” comparisons); ' Inaccurate characterizations or inaccurate limita— tions of drug actions, indications or adverse effects (see related article on p. 2]; *- Half-truths, inadequate qualifications andi’or limita- tions regarding safety or effectiveness; and - Vague, open-ended claims or suggestions of superiority. Recommendations Given Despite the overt warnings and regulations regarding off-label promotion. companies continue to violate the FDA’s requirements; and despite million-dollar settle- ments, companies continue to commit serious infrac- tions. Minsk’s recommendations to avoid the possibility of violations resulting in fines may not be groundbreak- ing, however, they should be used as reminders and suggestions of the precautions that all medical product companies should employ when marketing their prod uct. Minsk simply advises compliance with the FDA’s labeling and promotional requirements by providing the necessary product information in a truthful presentation of information using fair balance. In addition, procedures should be established prior to the distribution of marketing and companies should have a team devoted to the review of all promotional material, regardless of the targeted audience. Minsk also stressed making sure “everyone is on the same page” regarding company policies, laws, and the roles of individuals. Company employees should avoid creating personal definitions and exaggerations. and be wary of oral state- ments. When new indications for drugs or medical devices are available, companies should file new appli— cations in order to make a legitimate comparative claim. As well, they should report all study findings, particular- ly adverse events. As demonstrated in the baby-smiling example, avoid images, logos, and symbols that may im— ply a different use than what was approved or intended. Minsk also recommended that companies monitor what the FDA is doing to competitors, and to remain vigilant aborit reviewing enforcement trends. Companies also need to be keenly aware of their marketing part~ ners’ promotional activities for the company’s product as "their violation becomes your violation." Training employees and auditing third-party employees. such as public relations firms, also is highly recommended. To Find Out More Minsk's 90—minute presentation is available from Thompsonlnteractive at httpzli’www.thornpsoninterac- I‘I Reprinted with permission Thompson Publishing Gmup, 805 35th SJ. NW: lett'ngrtm. D. C. 20005—2207; wwn:thonrproncrmt 2 May 2008 | FDA Advertising & Promotion Manual A n thornpsoncom ...
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This note was uploaded on 01/01/2012 for the course PHRM 7230 taught by Professor Tackett during the Spring '11 term at UGA.

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Off_label_Promos_AGG - Food and Drug Series :1 THomPson May...

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