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An Overview of FDA’s Guidance for Industry:Presenting Risk Information in Prescription Drug andMedical Device Promotion
What is a Guidance for Industry?
From the FDA website: “Guidance documents represent the Agency's current thinking on aparticular subject. They do not create or confer any rights for or on any person and do not operate tobind FDA or the public. An alternative approach may be used if such approach satisfies therequirements of the applicable statute, regulations, or both.”In other words, a guidance provides insight into how the FDA will interpret/enforce regulations, butthe Agency is not committed to following the exact specifications of a guidance. The agency is alsonot ruling out the possibility that there are alternative ways (different from those discussed in theguidance) to comply with the regulations. It is, of course, advisable to follow a guidance when theAgency issues one, and pharmaceutical companies do not deviate from guidances lightly.
What is the difference between a Draft Guidance and a Final Guidance?
A guidance for industry is first published as a “draft.” Within a specified period after being published,comments are accepted from the public (including industry professionals, advocacy groups,concerned citizens, etc.). After receiving that feedback, FDA will update the guidance and release itas final. Releasing a draft guidance does NOT commit FDA to producing a final guidance, and manydraft guidances have lingered in that state for years. Currently, the oldest draft guidance aboutadvertising on FDA’s website has a draft date of January 1999. Even when not finalized, guidancesare relied upon by industry because they provide the latest official comment from the agency aboutthe subject.
How well does current advertising present risk information?
In this guidance, the FDA cites some findings of their recent research, which is itself worthconsulting.K. Aikin, J. Swasy & A. Braman, Patient and Physician Attitudes and Behaviors AssociatedWith DTC Promotion of Prescription Drugs – Summary of FDA Survey Research Results,Final Report, November 19, 2004, available at:
According to this research, “60 percent of patients believe ads directed at them do not provideenough information about risks, 60 percent of physicians believe that patients have little or nounderstanding from these ads about what the possible risks and negative effects of the productsare, and 72 percent of physicians believe that patients have little or no understanding from theseads about who should not use the product.” (page 3)
The overarching principle for all evaluations of risk information is the principle of Fair Balance. Thisprinciple entails that the overall presentation of information about a prescription drug must fairlybalance the information about the benefits and risks of using a drug. This guidance makes clear thatin addition to looking at specific claims and corresponding risk-related statements, the FDA alsoconsiders the
of the piece as a whole. It is possible for every sentence/word to beappropriate while conveying overall less risk than FDA requires. There are two examples of suchfailure to present risk information appropriately presented in the guidance:
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