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Regulators, prosecutors shifting enforcement focus from off-label promotion to messages that raise safety issues, mislead.
Much has been made of the decline in FDA warning and “untitled” letters citing pharma companies for violating marketing and communications requirements and policies. It may be that marketers are being more careful to avoid serious violations, observe some experts. But the change may be due more to the agency’s shift in enforcement focus to actions that raise serious safety issues, as opposed to overstepping disclosure rules. In
recent comments, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), noted that FDA’s Office of Prescription Drug Promotion (OPDP) is being very careful to issue enforcement letters that challenge actions that could lead to patient harm, as opposed to practices involving unlabeled uses.
This approach was emphasized by FDA regulators and legal experts at the Advertising and Promotion Conference sponsored by the Food and Drug Law Institute (FDLI) in October in Washington, D.C. They noted that enforcement efforts now focus on marketing messages that raise safety concerns, such as minimization of risk on opioid medications and other therapies with boxed warnings on labels-as opposed to communications that convey off-label information that may be truthful and non-misleading. OPDP Director Tom Abrams cited a warning letter for sleep-aid therapy Zolpimist that omitted important risk information and labeled warnings on the product’s webpage. He also highlighted inadequate disclosures for opioid antagonist CONZIP, despite the product’s boxed warning describing extensive limitations of use. Recent OPDP letters similarly object to the failure to communicate serious risks related to an extended release oxycodone product and the minimization of serious risks for an epilepsy drug with a boxed warning describing important safety issues.
Similarly, the Center for Biologics Evaluation and Research (CBER) recently challenged the manufacturer of a recombinant Factor IX treatment for hemophilia B. The promotional material indicated that Idelvion may encourage patients to engage in possibly dangerous activities.
Attorney John Bentifoglio reported that the Department of Justice also has shifted the focus of its pharma marketing enforcement program to violations involving products with boxed warnings or Risk Evaluation and Mitigation Strategies (REMS), where false and misleading communications may pose serious risks to patient health, and away from cases related to off-label promotion. Recent DOJ enforcement actions have involved failure to communicate risks related to a diabetes medication and for a diagnostic that produced false test results. Peter Pitts, president of the Center for Medicine in the Public Interest, commented that FDA is shying away from challenging promotional activities that raise First Amendment issues and shifting enforcement actions to “egregious acts” that FDA needs to stop.
This shift in emphasis also reflects scientific advances that has made FDA’s evaluation of the benefits and risks of innovative drugs more complex and more sophisticated, observed FDA Chief of Staff Lauren Silvis at the FDLI conference. Approved labeling is the central tool in devising advertising and promotion messages, Silvis pointed out, but continued scientific and medical advances highlight the need for FDA to be able to update initial labeling as new information emerges, particularly in a world of digital technologies, smartphones, and social media platforms. In response, FDA medical product centers are taking steps to better align product labeling and communication to incorporate additional clinical findings important to public health.
Recent advisories aim to advance the accuracy and relevance of prescription drug promotion, Silva added, as seen in a new guidance on presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements. FDA describes strategies for sponsors to present such information on drugs and biologics that consumers can understand, including the use of charts and graphs to better illustrate quantitative data on drug benefits and side effects.
FDA also continues to refine strategies for evaluating and regulating drug promotion, including proposals for assessing how audiences respond to drug advertising and how physicians regard professional promotional pieces. The agency also is examining how well DTC advertising explains the benefits and risks of accelerate approval programs, as well as the value and impact of disease awareness broadcast messages (additional information on OPDP research available here).
Interestingly enough, an OPDP study on disclosure of risk information in TV ads indicates that consumers may recall important side effects better when exposed to a short list of most serious risks, as opposed the current lengthy information on a broad range of possible adverse events. Similarly, consumers seem to retain more information from briefer and more understandable print ads, while they pay less attention to multiple warnings in complex messages.
Jill Wechsler is Pharmaceutical Executive’s Washington Correspondent. She can be reached at email@example.com