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Focus on Regulation

Updates from FDLI’s Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress

Recently, industry leaders, members of the FDA bar, and government officials convened at the Food & Drug Law Institute’s (FDLI’s) Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress. Topics included policy updates and enforcement priorities from FDA’s centers, Office of Inspector General (OIG) and Department of Justice (DOJ) current and future enforcement activity, a panel discussion featuring assistant U.S. Attorneys, updates on FDA guidances, comparative effectiveness research, and the use of social media in product advertising and promotion.

FDA, OIG, and DOJ officials offered insights into agency priorities and enforcement and the current agency thinking on a number of issues important to drug and device companies. Highlights of the conferences:

  • Tom Abrams, Director of FDA’s Office of Prescription Drug Promotion (OPDP), noted that OPDP is currently revising three draft guidances: “Help Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms; Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisement; and Presenting Risk Information in Prescription Drug and Medical Device Promotion.
  • FDA’s “bad ad” program, an outreach program designed to raise awareness among health care professionals (HCPs) about misleading prescription drug promotion and to provide HCPs with an easy way to report such activity to FDA, continues to receive agency attention and funding. Current FDA efforts to promote the program include journal ad campaigns, a continuing education program for HCPs, presentations at teaching institutions, and exhibits at medical conferences.
  • Mary Riordan, OIG Senior Counsel, mentioned that OIG is looking at companies’ communication with FDA during the approval process and evaluating whether FDA was misled. OIG, as well as the U.S. Attorney’s Office for the District of Massachusetts, is also interested in research and publication issues such as the manner in which companies handle negative studies, use misleading articles in promotion, exert undue influence over authors, and ghostwrite publications.
  • Riordan also noted that the government will continue to prosecute individual corporate officers for health care fraud, but will be thoughtful about the cases it pursues. Carmen Ortiz, U.S. Attorney for the District of Massachusetts, echoed these comments, stating that her office is focused on prosecuting individuals, “though these are very difficult cases.”
  • Ortiz also stressed the importance of self-reporting violations and full disclosure, both for companies under a CIA and those without CIAs.

At the FDLI conference, promotion of health care economic information (HCEI) came up as a discussion topic on several panels. Of note, Tom Abrams stated that HCEI and information disseminated to formulary committees is an area of interest for OPDP. OIG’s Mary Riordan noted that allegations in some cases emphasize interactions with government payors. An FDA guidance on economic claims may also be in the works.

At the Compliance Congress, OIG officials Mary Riordan and Greg Demske discussed future enforcement activity in the marketing practices area. They predict:

  • The large number of cases against pharmaceutical manufacturers will continue, but with more nuanced theories of liability.
  • Increasing numbers of cases against medical device manufacturers.
  • Adoption of the new features in recent pharmaceutical company plea agreements and corporate integrity agreements in future settlement agreements.

Riordan and Demske also provided recommendations for effective compliance programs for drug and device companies. Their recommendations:

  • Companies should find ways to hold individuals accountable within the compliance program, from the sales representative level up to corporate executives.
  • Companies should focus on drug price calculations, rebate practices, and promotional activities, including the use of coupons.