House Republicans looking into the deadly fungal meningitis outbreak have told the U.S. Food & Drug Administration (FDA) that the agency should not expect increased authority to help prevent future problems without the previously requested documents.
Yesterday, the House of Representatives Energy and Commerce Committee’s Republican majority staff released a letter giving the FDA until the end of this month to fulfill a document request it made in mid-October, said Reuters. Until the documents are provided, said the Committee, the agency should not expect new authority to prevent similar problems in the future. “We need these documents to identify any possible weaknesses in FDA’s regulatory system that can be immediately corrected administratively or legislatively,” said the letter, dated November 16 and addressed to FDA Commissioner Margaret Hamburg Committee Chair. “This committee has a long history of thoroughly and deliberately investigating problems and offering solutions. We cannot and will not be in a position to do so in this case until we have a full accounting,” the letter also said.
The FDA asked the lawmakers to clarify its authority to oversee larger compounders, such as the New England Compounding Center (NECC), which manufactured the steroid injections, which are at the center of the outbreak, explained Reuters. As we’ve explained, the filthy conditions at NECC likely led to the deadly fungal meningitis outbreak.
Early last month, the NECC issued a recall on three shipping lots of its methylprednisolone acetate epidural steroid injection because they were potentially contaminated with a fungus; these injections are prescribed in the treatment of back pain and inflammation. The company sent more than 14,000 vials to at least 70 pain management and health care centers in 23 states before issuing the recall. To date, according to the most recently released U.S. Centers for Disease Control and Prevention (CDC) data, 19 states are involved in an outbreak that has sickened 490 and killed 34. Of these, 12 cases involve peripheral joint infections. No deaths have been associated with peripheral joint infections.
FDA testing eventually confirmed the presence of a bacteria in 50 of the vials the agency tested. Soon after the recall, the company issued a recall on all its products produced recently and shut its doors as local, state, and federal investigators began to look for sources to the contamination. They didn’t have to look far, as conditions inside NECC’s facility were sure signs that the company’s facilities were to blame. For instance, standing water from leaking pipes and other traces of contamination were found everywhere investigators looked. As these inquiries unraveled, more details on the company and just how long it has been skirting safety regulations were made public.
Oversight for drug compounders currently resides with state pharmacy boards and FDA officials say their authority to oversee these firms has been routinely challenged in federal court, which has led to differing rulings nationwide, Reuters explained. Some House Democrats have asked Congress to clarify the situation before the end of the year; however, at a Committee hearing last week, some Republicans said the agency had the authority to avoid the outbreak but did not, despite ongoing issues at NECC. The Committee submitted a bipartisan request to the agency for documents related to the outbreak on October 17. The request also included for information for how the agency dealt with NECC and the Massachusetts pharmacy board, the primary regulator for pharmacy, said Reuters.
“FDA has provided the Committee with zero. In fact, when asked by Committee staff on November 16, FDA staff stated that they had not even begun to search for responsive emails,” the letter said, according to Reuters. Meanwhile, a similar request sent to health authorities prompted release of thousands of internal state emails, according to Republicans, Reuters said.
