FDA issues new guidelines to Pharma, DME providers
The Food and Drug Administration ("FDA") has recently taken steps to ensure that both patients and healthcare professionals are properly forewarned of potential dangerous side effects of pharmaceuticals and medical devices. Specifically, through a set of proposed guidelines targeted at medical device and drug manufacturers, the FDA is cautioning drug companies to make sure that their "big picture" advertising methods are not misleading.
Titled "Presenting Risk Information in Prescription Drug and Medical Device Promotion", the draft guidance describes how the FDA evaluates prescription drug and DME promotional materials to determine if they adequately address risk information. The draft guidance was issued in reponse to industry concerns over how to avoid FDA warning letters and other enforcement actions triggered by misleading advertising.
Often, as addressed in the draft guidance, simply stating negative side effects is not enough to avoid FDA scrutiny if the remaining content of the ad overwhelms any warning info. For instance, one example of "true but misleading" marketing cited is a TV ad for a cholestorol-lowering drug. Although the ad contains a factually accurate audio risk statement describing the drug's side effects and contraindications, this audio statement is juxtaposed with images of the patient smiling and happy, while upbeat music blares in the background. Therefore, the risk information may not be adequately communicated to consumers or healthcare professionals.
The guidance is not yet final, and interested parties may submit comments on the draft guidance to the FDA up until August 27, 2009. Although not specially cited by the FDA in the draft guidance, one ostensible reason for drug/DME industry's compliance concerns is the Supreme Court's recent decision in Wyeth v. Levine.
In Wyeth, the high court held that drug manufacturers are not immune from tort liability for failure to warn simply because the FDA approved a warning label for a drug. Instead, the court reasoned that even if the FDA approves a drug warning label, federal law mandates that a drug manufacturer "bears responsibility for the content of its label at all times." .
In other words - given the new FDA protocols and this year's Supreme Court ruling in Wyeth, Pfizer just may need to rethink it's "Viva Viagra!" campaign.
