Aug. 11, 2016 — The FDA announced Aug. 10 that it plans to issue four, much-awaited advertising-related guidance documents before the end of calendar year 2016. The specific new and revised draft guidance documents that are scheduled to be released this year are as follows:

• Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act

• Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites

• Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Licensed, or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices

• Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft

Industry has repeatedly asked for more guidance from the agency on the above matters. “The industry has been waiting for some time for the guidance on health care economic information,” APCO Worldwide’s Wayne Pines told the Coalition. “Hopefully this guidance will help facilitate communications with the payer community. In this environment that places so much emphasis on the cost of drugs, it should be beneficial if companies can communicate more health care economic information to the payers,” he said.

Just recently, the Pharmaceutical Manufacturers and Research of America (PhRMA) and the Biotechnology Innovation Organization (BIO) jointly issued nine principles that address communication with payers and healthcare professionals and call upon the FDA to clarify its positions on communications issues (see http://www.cohealthcom.org/?p=3403).

However, in the absence of that FDA guidance, industry has had little to go on as it navigates promotion on social media and the promotion of “truthful and non-misleading” promotion of unapproved uses.

“The FDA committed in 2014 to issuing further guidances on company promotion, so it’s a positive sign that the agency now has set a timetable,” Pines noted. “With PDUFA VI just around the corner, the agency needs to fulfill its commitments in this area or face pressure from the Congress.”