Congressional Republicans are threatening to hold hostage new powers that could help the FDA prevent a future disaster like the recent fungal meningitis outbreak, indicating that they will not clarify the FDA’s authority until the agency turns over specific documents regarding its dealings with the pharmacy at the center of the controversy.
FDA Commissioner Margaret Hamburg went before the U.S. House of Representatives Energy and Commerce Committee on November 14, where Republicans grilled her over the agency’s lack of action in preventing a recent nationwide outbreak of fungal meningitis infections linked to tainted drugs distributed by the New England Compounding Center (NECC).
Hamburg and other health experts have said that compounding pharmacies exist in a legal bubble that makes it hard to police them. However, House lawmakers suggested Hamburg should have had the FDA intervene anyway.
During the meeting, Hamburg called for expanded FDA powers that would help it regulate compounding pharmacies. However, House Republicans have complained that the FDA has failed to turn over some internal memos regarding its interactions with NECC.
In a letter (PDF) sent out last week, the law makers threatened to hold up those powers unless those internal memos were received.
“In order to effectively and responsibly address the question of clarifying or enhancing FDA’s authority over compounding pharmacies, the Committee must identify what happened at the New England Compounding Center (NECC), and why FDA did not use its authority to take enforcement action against NECC until October 2012, after the meningitis outbreak,” the letter states. It was sent by four Republicans on the committee, including committee chairman Fred Upton.
Some Democrats have also expressed concern, with Henry Waxman, the committee’s ranking Democrat, suggesting Hamburg should have taken action to protect the public health, regardless of whether she thought the agency had the authority or not.
Hamburg has stated that the FDA had no such authority until the outbreak occurred and there was a clear threat to public health. However, the agency inspected NECC multiple times in the past and expressed concerns about some of its activities and sterility of its products.
It appeared from earlier inspection reports that the FDA believed it had some authority to act if changes were not made, however, Massachusetts health officials cut a deal with NECC that allowed it to stay open despite numerous problems.
Pharmacy Owner Pleads Fifth
NECC co-owner Barry Cadden was also called to testify before the House committee, but he exercised his fifth amendment right not to incriminate himself through testimony and refused to answer any questions from congress.
In September, health officials linked epidural steroid injections distributed by NECC to a nationwide outbreak of fungal meningitis. The outbreak has killed at least 33 people and sickened about 450 others.
The compounding pharmacy, which was only supposed to create drugs for local patients with prescriptions on an as-needed basis, shipped about 17,000 tainted vials of steroids to 23 states. U.S. health officials estimate about 14,000 people were injected with potentially contaminated drugs as a result.
Subsequent investigations of NECC’s facilities found serious sterility problems and detected the same fungi linked to the outbreak in still-sealed drug vials at the company’s Massachusetts facility. In some cases there were visible globs of fungus reportedly seen floating in supposedly sterile drug vials.
The compounding pharmacy has now been shut down, issued a steroid injection recall, and later recalled all of its products and lost its license.
A number of fungal meningitis lawsuits are now being pursued on behalf of individuals who received a steroid injection from NECC, however substantial concerns exist about the ability of this company to properly compensate all of the people who have been damaged.