GAO report on FDA's Response to Heparin Contamination Raises Questions of Seeking Input During a Crisis
On November 9, the Government Accounting Office (GAO) released a report, "Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health: Controls that Were Needed for Working with External Entities Were Recently Added". The report was requested by House Energy and Commerce Committee Ranking Member Joe Barton (R-Texas). Among other things, GAO's report finds that FDA worked with several external scientists during the heparin crisis but failed to address certain risks to the agency for engaging two "volunteer" scientists that responded to oral requests for uncompensated services by FDA's Center for Drug Evaluation and Research ("CDER") staff.
According to FDA, it sought the advice of external scientists, because the agency felt it lacked the necessary instrumentation and expertise to identify and develop new testing methods to detect the specific contaminant issues. Both these volunteers, however, had professional and financial ties to heparin firms. They served as paid consultants to two of the primary firms associated with contaminated heparin. In addition, one of the scientists was a co-founder and member of the board of directors, as well as an equity interest holder, in a third firm, which, at the time of the crisis, had a pending application for a heparin product before FDA. This scientist obtained assistance from this third firm, which dedicated approximately 30 staff members for periods ranging from a few weeks to 3 months to assist in the effort to identify the contaminant in heparin. Although GAO's report does not identify any of the firms or individuals by name, it appears that the latter company is Momenta Pharmaceuticals ("Momenta"), whose co-founder and board member Ram Sasisekharan and co-founder and chief scientific officer Ganesh, Venkataraman co-authored several articles on heparin contamination with FDA officials in 2008, as reported by The Pink Sheet, on November 10.
FDA officials were aware of the scientists' ties to heparin manufacturers, but GAO's report pointed out that FDA did not take adequate steps to consider whether these relationships exposed the agency to the risks before engaging them, such as consulting with the Office of Chief Counsel, agency ethics officials, or following procedures described in FDA's The Leveraging Handbook. FDA believed that there was insufficient time to address these ties in the midst of the crisis and that the CDER staff could independently assess the input from these scientists through robust, detailed, and transparent discussions.