Two congressional committees will hold hearings Wednesday and Thursday as part of an investigation into the fungal meningitis outbreak that has killed 32 patients and infected more than 435 individuals in 19 states.
At the center of the investigation is New England Compounding Center (NECC) on Waverly St. The Framingham specialty pharamacy has had its license revoked in Massachusetts. The FDA, following a raid, said it discovered unsetrile conditions.
A subcommittee of the House Energy and Commerce Committee is slated to hear testimony from Food and Drug Administration Commissioner Margaret Hamburg today, Nov. 14. Also subpoenaed to appear is Barry Cadden, managing pharmacist of NECC, which manufactured and distributed the tainted steroids blamed for the deadly national outbreak.
Tomorrow, Nov. 15, the Senate Health, Education, Labor and Pensions Committee is scheduled to hear from Cadden, Massachusetts health officials, and experts from the U.S. Centers for Disease Control and Prevention.
Capitol Hill lawmakers want to know why the Framingham specialty pharmacy was allowed to continue operating even after federal and state officials found issues.
This week, the House Energy and Commerce Committee released a detailed history of NECC's relationship with regulators, including the FDA. The 25-page report summarizes and quotes FDA and state inspectors.
One part of the report states in 2003, FDA officials suggested the Framingham compounding pharmacy should be "prohibited from manufacturing" until it improved its operations. But instead of following through, the report states the FDA deferred to Massachusetts, which reached an agreement with New England Compounding Center about the quality of its injections.
In the congressional report, the FDA considered New England Compounding Center to be a pharmacy in 2003.
Pharmacies are regulated by the state, drug manaufacturers are regulated by the FDA.
Markey, who represents Framingham, is the senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA).
The two Washington committees may create legislation to shift oversight of compounding pharmacies from states to the FDA.
While Washington lawmakers are investigating New England Counpounding Center, state officials and lawmakers are conducting their own investigations.
Interim Commissioner Dr. Lauren Smith told Boston.com ‘‘troubling questions remain’’ about why the New England Compounding Center escaped a penalty proposed in 2004, which included an official reprimand and probation.
NECC protested that the penalty could destroy its business, and in 2006, the state’s pharmacy board agreed to impose a far weaker, non-disciplinary action on the company for reasons that remain unclear, Smith told Boston.com.
Today, Nov. 14 a hearing on the issue is scheduled at the Massachusetts Statehouse.
The FDA released a list of customers, who received products from NECC in Framingham on or after May 21.