Since the release of FDA’s “fair balance” doctrine, which requires drug companies to split the length of a TV commercial equally between benefits and risks, many have questioned whether this policy is hurting or helping consumers. In a recent notice FDA explains, “There is concern that in direct-to-consumer ads, the major statement is too long, which may result in reduced comprehension, minimization of important risks, and potentially therapeutic non-compliance due to fear of side effects.”
With this in mind, FDA has proposed a change in regulation that would require companies to only list the most prominent side effects in the drug’s major statement while still providing consumers with information on risks that are “serious and actionable.”
Before going forward with these proposed changes, FDA has announced plans to conduct a study to “investigate the effectiveness of limited risks plus disclosure strategy.” Participants in the study will be presented with one of four advertisements, each ad will provide a different level of risk disclosure.
Click here to read Alexander Gaffney’s article from RAPS.org.