FDA defends heparin actions; sued by heparin firm

US Food and Drug Administration Commissioner Margaret Hamburg has once again been forced to defend the agency's actions in response to the 2008 contaminated heparin scandal.

The prompt for the renewed attack was the publication last month of a report by the federal government's General Accounting Office (GAO), which raised questions about the FDA's use of external collaborators - notably scientists from drugmaker Momenta Pharmaceuticals - in trying to trace the circumstances surrounding the contamination.

The main focus of the GAO concerns is the assistance provided to the FDA by Momenta, which went on to become the first company in the USA to win approval for a generic version of low-molecular weight heparin product Lovenox (enoxaparin). The branded version is sold by Sanofi-Aventis and had US sales of around $2.9bn in 2009.

Momenta staff helped the FDA over a period of several months during the 2008 probe into heparin contamination, work which the GAO considers "could have affected the public's confidence in FDA’s response efforts and in its other activities related to the regulation of heparin products."

The move could also have left the FDA open to "claims for payment for services provided by external entities," notes the GAO report, which also makes broader statements about the problems faced by the FDA in overseeing imported products and ingredients.

In response to the report, Commissioner Hamburg has insisted that the FDA was not influenced by Momenta's assistance when it decided to approve the company's enoxaparin product and was able to keep its review of the application dossier and heparin enquiry completely separate.

The agency also issued guidance on October 15 spelling out its policy for the use of free services from external experts in an emergency.

The issue looks et to rumble on though, given that generics company Amphastar Pharmaceuticals filed a lawsuit against the FDA late last month claiming that an agency block on imports of heparin API compromised its ability to bring its own enoxaparin generic to market.

Amphastar was the first to file for FDA approval for generic Lovenox in 2003, two years before Momenta Pharmaceuticals filed its application.


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