Republicans on the Energy and Commerce Committee said Friday that the FDA has three weeks to turn over internal documents concerning its oversight of the New England Compounding Center. The pharmacy produced a contaminated steroid, used mainly to treat back pain, that is blamed for fungal meningitis that has killed 45 people and sickened more than 600.
The outbreak was first identified in September and Congress has been investigating the case since October. But their inquiry has been slowed by the complex overlap of state and federal laws and regulations that govern specialty pharmacies like the Framingham, Mass.-based NECC.
The FDA inspected the pharmacy three times between 2002 and 2005 and issued a warning letter in 2006 ordering NECC to stop mass-producing drugs outside the scope of its license. But regulators never shut the operation down. At a November hearing, FDA Commissioner Margaret Hamburg said the agency decided to defer the issue to Massachusetts Board of Pharmacy, which had more direct oversight of the company.
While the agency has turned over the documents related to its inspections, Republicans say they want to see internal memos about the agency's decision-making process.
"FDA has produced no communications from staff and officials at FDA headquarters, who were actually making the decisions about how to address the situation," according to the letter, signed by Chairman Fred Upton and four other Republicans. They point out that the Massachusetts Board of Pharmacy, "a much smaller entity than the FDA," produced all the documents requested by the committee before the November hearing.
Agency spokeswoman Erica Jefferson said late Friday that the FDA is working to respond to the committee, and has turned over more than 3,500 pages of documents to Congress since October.
"These documents include correspondence from FDA's district offices and FDA headquarters as well as inspectional documents and adverse event records from the 2002-2006 timeframe," Jefferson said in a statement.
The lawmakers say they will consider issuing a subpoena if the FDA doesn't turn over key internal memos related to the case by Feb. 25.
Compounding pharmacies produce specialized drug formulations for patients with unusual prescription needs, for instance those allergic to widely used ingredients. All Pharmacies have long been regulated by state pharmacy boards, many of which date back to the 19th century. But since the 1990s, the FDA has taken a larger role in policing compounding pharmacies, some of which have grown into large businesses. The NECC shipped more than 17,600 doses of a pain injection to 23 states. The firm has been closed since October and filed for Chapter 11 bankruptcy in December.