The FDA is plotting a half-dozen new studies of drug advertising and marketing tactics, and among them is an analysis of TV ads promoting disease awareness and a look at drugs that sped their way to market using the agency's accelerated approval processes.
In their look at disease awareness, FDA researchers aim to compared the effects of unbranded TV ads on consumer perceptions with the effects of product-specific advertising.
The study comes several years after the FDA dropped its guidance for disease awareness promotions, which has been used by pharma for a decade. When asked why the agency was revisiting the topic, an FDA spokeswoman declined to answer. “We cannot comment specifically on the results of these particular upcoming studies," the spokeswoman said via email.
She added only that all of the research planned will be used to inform FDA policies and processes.
In all, the FDA has announced six new drug promotion studies for 2018. Researchers in the Office of Prescription Drug Promotion plan (PDF) to tackle issues related to accelerated approval, risk comprehension for new drugs, scientific versus promotional claims and TV ads.
One hot topic, visited by two of the planned studies, is accelerated approvals. The FDA has cleared a range of cancer drugs for marketing under a program that allows approvals based on response rates and phase 2 data, rather than waiting for phase 3 outcomes. One study will convene eight focus groups to gauge how well consumers understand accelerated approvals, while the other will assess whether consumers comprehend disclosures about the process. Participants will view a website for a fictitious oncology drug and answer questions about the drug’s accelerated approval disclosures.
“The FDA has prioritized a robust social and behavioral science research program to help us understand how people make decisions about the products we regulate. …This research has provided key information to inform our policies related to the proper regulation of prescription drug advertising,” FDA Commissioner Scott Gottlieb said in a statement. “I’m committed to continuing to invest in this critical research to help ensure we’re making informed, science-based decisions.”
The six planned studies fall in line with OPDP’s recent slate of work. In 2017, the office launched five studies and finished four; it launched four others in 2016 and finished four the same year. There are currently four FDA promotion studies pending publication.
The spokeswoman did not disclose when the studies would begin, only that they are planned for calendar year 2018.