FDA Issues More Guidance Regarding Distribution of Reprints. Is It "Fair and Balanced?"

FDA seems obsessed with the distribution of reprints by the pharmaceutical industry.In January, 2009, FDA "finalized" its "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices U.S." (see "FDA Finalizes Guidance on Distribution of Reprints").That guidance, however, was not well-received by the pharma industry and in February, 2014, the agency released a new draft guidance document entitled "Distributing Scientific and Medical Publications on Unapproved New Uses - Recommended Practices," which addressed comments from stakeholders regarding the first, "finalized" version (see "WLF to FDA Regarding Distribution of Off-Label Reprints: See You in Court!").On Friday, FDA issued a THIRD guidance document regarding reprint distribution by pharmaceutic companies. This new document describes FDA’s recommendations for distributing reprints that convey "new risk information" for approved drugs (access the document here).According to the FDA Law Blog: "The guidance defines 'new risk information' as information that becomes available after a drug is marketed that rebuts or mitigates information about a risk already identified in the approved labeling. This term does not include information about a newly identified risk that was not previously included in the a...

Source: Pharma Marketing Blog - June 10, 2014 Category: Pharma Commentators Tags: Drug Safety FDA Guidance off-label promotion side effects Source Type: blogs