House Seeks Meningitis Docs from FDA

FDA asking for more regulatory power after meningitis outbreak

FDA Commissioner Margaret Hamburg / AP
• November 21, 2012 5:00 am


The Food and Drug Administration (FDA) has asked for more power to prevent crises such as the recent meningitis outbreak, but the House committee investigating the outbreak says the FDA is not complying with its investigation.

The House Committee on Energy and Commerce sent a letter to the FDA last week saying the FDA had not delivered the documents that the committee needed to review the administration’s oversight powers and make necessary changes.

"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 said.

"Your agency has not provided any internal communications or memoranda in response to the Committee’s bipartisan request letter of October 17, 2012," the letter said. "We need these documents to identify any possible weaknesses in FDA’s regulatory system that can be immediately corrected administratively or legislatively."

The meningitis cases first surfaced in September in Tennessee. Thirty-two people have died and over 400 have been infected. The Center for Disease Control and Prevention estimates that nearly 14,000 people received the contaminated injections.

At a hearing before the committee last week, FDA Commissioner Margaret Hamburg testified that the administration’s hands were tied because the Massachusetts officials overseeing the drug company had jurisdiction.

"FDA’s ability to take action against [medicinal] compounding that exceeds the bounds of traditional pharmacy compounding and poses risks to patients has been hampered by gaps and ambiguities in the law, which have led to legal challenges to FDA’s authority to inspect pharmacies and take appropriate enforcement actions," Hamburg’s written testimony said.

She proposed a new regulatory framework for specific drug manufacturers like the one that caused the meningitis outbreak.

The committee set Nov. 30 as a deadline to receive the documents. However, the letter did not detail actions the committee would take if it did not receive the documents by the end of the month.

"We need the FDA to be fully cooperative and prompt in its response so the Committee can immediately address your request for clearer and/or additional authority," the letter said.

Five Congressmen signed the letter.

The FDA said that they are working to cooperate with the investigation.

"While we have been working hard to contain this tragic outbreak and are still in the midst of our investigation of NECC, we are also working with Congress to provide them with important documents, including emails, to better understand the limits of our authority over compounding pharmacies," an FDA spokesman said in a emailed statement.

"We look forward to working with Congress and other stakeholders to ensure that all appropriate measures are made to prevent this type of harm in the future," the statement concluded.

Another official in the FDA, who asked to remain anonymous, said that the same people who are working on the meningitis response are working to collect the documents for the investigation, making it difficult to respond quickly to Congress’s request.

The House Committee on Energy and Commerce did not return a request for comment.

Published under: Congress, FDA, Media