More Guidance, Fewer Warnings on Drug Advertising

FDA officials have been busy rolling out advisories for pharma marketers, and there’s no let-up in sight, writes Jill Wechsler.

FDA officials have been busy rolling out advisories for pharma marketers, and there’s no let-up in sight. Policy and guidance development is a top priority for the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER), commented OPDP director Tom Abrams at the recent Marketing Pharmaceuticals 2015 conference sponsored by the Drug Information Association (DIA) in Washington, D.C. Abrams reported that his office issued five draft guidances in the past 12 months, two dealing with social media communications, and the most recent making important and long-awaited changes in requirements for providing a “brief summary” of drug labeling information in consumer print advertising.

Abrams also provided an update on OPDP actions to curtail violative advertising, which most often involves promotional pieces that fail to provide adequate risk information. But he acknowledged a recent drop in warning and untitled letters. The latest tally shows only 10 OPDP enforcement actions in 2014, compared to 26 in 2013, and many of these letters went to relatively small pharma companies. The number of new corporate integrity agreements also has declined, another trend that may reflect stronger company compliance programs for advertising and promotion.

The quality of OPDP enforcement actions is more important than the quantity, Abrams observed, adding that his office takes a risk-based approach to enforcement to target promotional campaigns where misinformation has the greatest potential to harm patients. That list includes advertising for newly approved products, drugs with significant safety concerns, and products that have been cited for violations or subject to complaints in the past. Another factor is that OPDP may be having more success in requesting voluntary correction of violative materials prior to taking stronger compliance action.

Despite progress in issuing new guidance this past year, OPDP still has some important topics on its “to-do” list. Another social media advisory on using links to provide further risk information is in the works, as is a new policy on how marketers can provide economic information on medical products to “educated” parties, such as formulary committees, insurers and payers. OPDP also hopes to finalize many of the draft guidances that have been out for review and comment by industry.

Marketers asked at the DIA conference if they should start revising brief summaries as proposed in the new draft guidance -- or wait ten years for a final version. The advice from OPDP regulatory counsel Julie Chronis is to start implementation now, even though some of the specifics may change in the future. And OPDP is here to help companies in adopting the new approach, she added.