Nearly a decade ago, federal health inspectors wanted to shut down the pharmacy linked to a recent deadly meningitis outbreak until it cleaned up its operations, according to congressional investigators.
About 440 people have been sickened by contaminated steroid shots distributed by the New England Compounding Center (NECC), and more than 32 deaths have been reported since the outbreak began in September, according to the Centers for Disease Control and Prevention. That has put the Framingham, Mass.-based pharmacy at the center of congressional scrutiny and calls for greater regulation of compounding pharmacies, which make individualized medications for patients and have long operated in a legal gray area between state and federal laws.
The House Energy and Commerce Committee released a detailed history of NECC's regulatory troubles on Monday, ahead of a Wednesday meeting to examine how the outbreak could have been prevented. The 25-page report summarizes and quotes from FDA and state inspection reports and internal memos, though the committee declined to release the original documents.
The report shows that after several years of problems, Food and Drug Administration officials in 2003 suggested that the compounding pharmacy be "prohibited from manufacturing" until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections.
The congressional report also shows that in 2003, the FDA considered the company a pharmacy. That's significant because since the outbreak came to light in late September, public health officials have charged that NECC was operating more as a manufacturer than a pharmacy, shipping thousands of doses of drugs to all 50 states instead of small batches of drugs to individual patients. Manufacturers are regulated by the FDA and are subject to stricter quality standards than pharmacies.
The report offers the most detailed account yet of the numerous regulatory complaints against the pharmacy, which date back nearly to its founding in 1998. Less than a year later, the company was cited by the state pharmacy board for providing doctors with blank prescription pads with NECC's information. Such promotional items are illegal in Massachusetts, and the pharmacy's owner and director, Barry Cadden, received an informal reprimand, according to documents summarized by the committee.
FDA Commissioner Margaret A. Hamburg and Massachusetts Department of Public Health interim Commissioner Lauren Smith are scheduled to testify at Wednesday's hearing.
According to the congressional report, lawmakers plan to ask the witnesses whether the FDA and state pharmacy board acted appropriately. Mr. Cadden also is scheduled to appear at the hearing, after lawmakers issued a subpoena to compel him to attend.
The NECC has been closed since early last month, and Massachusetts officials have taken steps to revoke its license permanently. The pharmacy has recalled all the products it makes, including 17,700 single-dose vials of a steroid that tested positive for the fungus tied to the outbreak.