FDA again defends response to tainted heparin

The 2008 heparin contamination must be feeling like a big black cloud overhead to FDA Commissioner Margaret Hamburg. She continues to be in the position of having to defend the FDA's actions in response to the event, even though it predates her tenure at the agency.

She answered to Congress for it in May. Then last month she and her bosses at HHS received a draft of the Government Accountability Office report of the matter and provided their response.

That report was released on Tuesday and the matter has become a political issue, with Rep. Joe Barton, a Republican member of the House Energy and Commerce Committee, saying the GAO report shows problems with the FDA's ability to monitor foreign products and a "fundamental weakness," according to Reuters.

The GAO finds the FDA, with the help of outside experts, identified the contaminant and developed tests to screen for it. Within a few months, adverse events returned to pre-crisis levels.

But the agency didn't consider the risks involved in recruiting scientists from drugmaker Momenta in the effort, and it took no steps to ensure that existing standards governing such relationships were applied. Momenta at that time had a heparin drug application pending with the regulator.

"Agency officials ran the risk of undermining public confidence in the integrity of FDA's operations," the report says. "It is critical that the agency have clear and useful controls in place."

Hamburg defended the agency's actions. "FDA really was able to separate in important ways the work done in addressing the adulterated heparin concern and the review" of Momenta's drug," she said, according to Reuters.

Nonetheless, the FDA issued guidance in mid-October for working with external experts in emergency situations when the services are provided for free. The guidance includes procedures for the use of gratuitous services, screening for conflicts of interest and public disclosure.

- here's the GAO report
- see the story with Hamburg's statement