FDA Commissioner Urges Congress to Expand FDA Authority to Regulate Compounding Pharmacies; GOP Demands Document Release

GOP Demands Document Release

November 21, 2012

The head of the U.S. Food and Drug Administration testified in front of Congress last week on the FDA’s role in overseeing compounding pharmacies, especially the New England Compounding Center (NECC), the pharmacy federal officials blame for the outbreak of fungal meningitis that has claimed at least 34 lives.

FDA Commissioner Margaret Hamburg admitted to the House Energy and Commerce Committee that there was a decade of documented safety and other violations at the NECC and wished that the FDA’s responses had been timelier and better coordinated with the states. The FDA, along with the Massachusetts Board of Pharmacy, had investigated NECC in the past and had issued a warning letter in 2006 over NECC’s selling of drugs already available from manufacturers and the nonsterile conditions they found at NECC.

Hamburg clarified, however, that the authority the FDA has over compounding pharmacies like NECC is “limited, unclear and contested” and urged Congress to help clarify and reinforce the FDA’s regulatory powers. Hamburg advocated a tiered, risk-based framework for combined state and federal regulation that would leave traditional small-scale compounding mostly to state authorities, forbid the compounding of certain drugs and impose federal quality standards on compounders that produce sterile drugs.

Hamburg also recommended to Congress that compounding drugs should be labeled as such and that the FDA’s authority be expanded to permit inspection of facilities access to company records, registration requirements for compounders be increased and adverse-event reporting associated with their drugs be made compulsory.

A bipartisan group of senators expressed support for the FDA’s position and expressed desire to issue legislation clarifying or increasing the FDA’s authority by early next year. Certain Republican lawmakers, however, have been skeptical of the need for expanded authority and believe the FDA could have acted under its existing authority to shut down NECC.

In a letter released Monday, several top-ranking Republicans on the House Energy and Commerce Committee required that the FDA release documents, including internal FDA communications, legal memoranda and briefing materials produced by or for the FDA staff, referring to FDA’s authority over compounding drugs and compounding facilities since 2002, before they would be willing to agree to expand or clarify the FDA’s authority.

The FDA has yet to respond to the demand for documents.