Under pressure from the drug industry and "First Amendment" legal issues, the FDA has hinted in a recent public hearing notice that it may allow pharmaceutical and Medical device companies to engage in off-label communications directly to "patients and consumer audiences" and not just to physicians.
In the Federal Register Notice [Docket-FDA-2016-N-1149] announcing the public hearing ("Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products"), FDA asked these questions related to the off-label promotion of drugs and medical devices to consumers:
"To what extent is it appropriate for firms to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences? What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers' lack of medical training and expertise in critically evaluating this type of information?"
For more background, read "FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion"
The following preliminary results from the survey were submitted as comments to Docket-FDA-2016-N-1149 on 14-Oct-2016 (Comment Tracking Number: 1k0-8sge-hi48; download PDF). A more complete summary will be presented at the Public Hearing on November 7, 2016. Your de-identified responses and comments will be included.
Q1: Indicate your level of agreement/ disagreement with the following statements. Note: FDA regulations are legally-binding federal laws, whereas guidelines have no legal standing. "Promotions" include print and TV advertising as well as drug.com websites and other forms of digital advertising.
- FDA should create non-legally binding GUIDELINES for off-label direct-to-consumer promotions by pharma companies.
- FDA should create legally binding REGULATIONS for off-label direct-to-consumer promotions by pharma companies.
- Under NO circumstances should FDA allow off-label drug promotion to patients or consumers.
Q2: A Duke University think tank suggested that a new independent entity be created to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors. Should such an independent entity do the same with regard to off-label information shared with consumers?
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