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FDA Withdraws Draft Disease Awareness Guidance

Meredith Manning

Meredith Manning,

Washington, D.C.

Nancy M. Parsons

Nancy M. Parsons,

Washington, D.C.

Heidi Forster Gertner

Heidi Forster Gertner,

Washington, D.C.

12 May 2015
FDA announced last week that it was withdrawing numerous draft guidance documents including its 2004 draft guidance on disease awareness activities. You can read the full Federal Register notice here.  We believe that this is largely a response to recent congressional pressure for the agency to finalize its many, long-standing draft guidances.   We spoke to an OPDP official who suggested that the decision to withdraw, rather than finalize, the existing disease awareness guidance was driven by the need to update the guidance to reflect advances in technology and incorporate new social science research.  He indicated that the withdrawal does not signify a significant departure from existing FDA policy concerning disease awareness activities.  We believe that the key legal principles underlying the draft guidance remain intact and anticipate that the agency will be hard pressed to take enforcement action against a company who has been relying in good faith on compliance with the now withdrawn guidance.  Similarly, companies who engage in disease awareness activities outside the four corners of the withdrawn guidance may be at some risk.  In other words, until we hear more from FDA – which may be some time coming – disease awareness communications should be governed by the standards articulated in the 2004 Draft Guidance.
FDA Withdraws Draft Disease Awareness Guidance
Meredith Manning

Meredith Manning,

Washington, D.C.

Nancy M. Parsons

Nancy M. Parsons,

Washington, D.C.

Heidi Forster Gertner

Heidi Forster Gertner,

Washington, D.C.

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