TV ads for most prescription drugs must be submitted to FDA for pre-review 45 days before the manufacturer intends to air them, according to an FDA draft guidance
in tomorrow's Federal Register.
The guidance isn't a bolt from the blue but rather a case of the agency catching up on old business – in this case, a clause in the 2007 FDA Amendments Act (FDAAA) authorizing the agency to “require the submission of any television advertisement for a drug … not later than 45 days before dissemination of the television advertisement.”
The agency specified six categories of drugs for which TV ads must be submitted 45 days in advance, including those for new drugs, for drugs with Risk Evaluation and Mitigation Strategies, for Schedule II controlled substances, etc. – in short, for most any prescription drug. The 45-day review “clock” would start when CDER or CBER recieves a complete review package, including annotated storyboards and other materials.
What happens if agency reviewers can't get to it before the scheduled air date?
“FDA will notify the sponsor if the Agency is not able to provide comments within the 45 calendar day time frame,” said the draft guidance. “FDA's notification will include an estimate of the date on which FDA expects to provide its comments. In such situations, the sponsor should determine whether it will wait for FDA's comments before disseminating the TV ad or whether it will disseminate the TV ad without waiting for FDA's comments. The sponsor should notify FDA of its decision. Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA's comments.” The agency will discontinue its review in that instance, the guidance said.
Violators may be subject to criminal penalties, the agency said, and failure to comply will be factored into any penalties for advertising found to be in violation of the FD&C Act.
The devil will be in the details, said Coalition for Healthcare Communication executive director John Kamp, but the proposed rule change isn't good news for the industry.
“This guidance creates an FDA ‘shot clock' that doesn't allow you to take a shot at broadcast marketing for an additional 45 days,” said Kamp. “And unfortunately, there's no ‘overtime' tacked on at the end of the patent period to recoup the lost sales opportunity.”