Good Reprint Practices

According to the Pink Sheet, Ann Witt a former Acting Director of DDMAC (or its predecessor organization, I can’t remember the name) is returning to the FDA in CDER’s Office of Policy, Planning and Budget.  Ms. Witt was a key staffer for Waxman, who you might recall very vocally questioned the substance and guidance making process for FDA’s Good Reprint Practices guidance document.  I recall hearing Ms. Witt last year speak an an FDLI conference where she was very articulate about her opposition to the Guidance document. Her concerns were obvious– off-label promotion and pharma influence on policy.

Who knows how this might affect DDMAC’s enforcement policy in the future.  Its unclear to me what role Ms. Witt will be taking.  I will say this though, FDA’s guidance document remains a difficult document to use prolifically.  If you read the plain mechanical language of this guidance document and try to comply with it, it won’t lead to a waterfall of off-label reprints (at least under this guidance).  And remember, to the extent that FDA provided a safe harbor from following the guidance document, you still have to comply with the four corners of the document to claim any off-label promotion safe harbor.  FDA’s record of such a strict reading of the safe harbor stretches back to FDAMA 401 and the WLF.  If it complies, FDA will not use it as evidence of misbranding–if it doesn’t comply they reserve the right to use it as evidence of misbranding.

Nonetheless, I would expect this key Waxman staffer to have a significant impact on FDA’s policies in one way or another.

Regards,

John Murray

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