Oncology drugs on TV are the latest target on the FDA research radar. Wednesday, the agency’s Office of Prescription Drug Promotion (OPDP) unveiled plans for two tests to study the impact and effect of endpoint disclosures and superimposed text information with consumers.
Comments on the proposed DTC cancer research can be submitted through the end of February. The FDA previously posted a study of oncologists and the effect of cancer drug disclosures in advertising. That study, which closed to comments in late 2018, is listed as “research in progress” on the OPDP website.
The agency addressed the importance of cancer marketing as a research topic in response to comments then. When asked why the FDA had chosen to study oncology therapeutics and the doctors who prescribe them, the response noted the “dramatic rise in the number of oncology drugs brought to market” and the need to clarify endpoints used for FDA approval as well as those pharma companies use for their own assessments.
“In many cases, these endpoints are strictly exploratory and support only the reporting of descriptive results," the agency noted. "For clinicians who are not specifically trained in clinical trial design, interpreting these endpoints can be challenging. Pharmaceutical companies invest heavily in the development and distribution of promotional materials to educate oncologists about favorable clinical trial results.”
The proposed study is the third DTC research project announced by the FDA in less than two weeks. One of the other studies will investigate the impact of drug names in marketing, while the second—filed earlier this week—looks at the impact of endorsements from celebrities and online influencers.
But the new flurry of research proposals breaks an almost year-long lull. The last OPDP research project was proposed in March 2019, and it was the only one listed for the year on the OPDP research page. There are currently 12 total research-in-progress studies on the OPDP website, not including the three proposed this month.
Another five research projects, meanwhile, are listed as “research pending peer review and publication.” Some of those pending publication projects go back to 2013. It's possible that the results from some studies might not ever be publicly published, an FDA spokesperson said.