Lawmakers probing the U.S. meningitis outbreak are focusing on why the pharmacy linked to this year’s infections didn’t receive greater scrutiny when potential regulatory violations were found six years ago.
The House Energy and Commerce Committee sent a letter yesterday to Margaret Hamburg, the commissioner of the Food and Drug Administration, asking her about inspections at New England Compounding Center dating to 2004. The committee cited an FDA warning in 2006 of “potential microbial contamination” and asked the agency to document what follow-up occurred.
At least 14,000 people have been injected with doses of the pain-killing steroid methylprednisolone acetate that were apparently contaminated during the mixing process at facilities owned by New England Compounding Pharmacy Inc., which operates as New England Compounding Center. The company suspended operations this month and recalled 17,676 doses of the drug after reports of fungal meningitis infections.
There have been 247 reported cases of infections in 15 states traced to the tainted shots, including 19 deaths, the Centers for Disease Control and Prevention said yesterday. The drug is mainly administrated through an injection into the spinal cavity to relieve neck and back pain. Meningitis is an inflammation of the lining of the brain and spinal cord.
The Justice Department is investigating the company. The House committee, led by Chairman Fred Upton, a Michigan Republican, and Representative Henry Waxman of California, the top Democrat on the panel, also is probing the outbreak.
FDA officials briefed the committee on Oct. 12. Officials said the agency inspected the Framingham, Massachusetts-based pharmacy from September 2004 through January 2005, according to the committee’s letter released yesterday.
Regulators sent New England Compounding Center a warning in December 2006, saying the pharmacy was using unauthorized practices that included “manipulation of a sterile injectable product.” They also questioned whether the company was operating as a traditional compounding pharmacy, or on a larger commercial scale.
The company responded a month later to assure the FDA it was in compliance. The House committee is asking for more details by Oct. 31 of that correspondence, inspection reports and other records to determine why the FDA couldn’t confirm whether additional checks were conducted to verify the company’s claims.
Compounding pharmacies are exempt from strict FDA oversight, since they’re only supposed to prepare individual prescriptions unavailable through regular avenues, such as those with a unique dosage. The drug linked to the meningitis outbreak was mixed by the company and sold to 75 hospitals and clinics in 23 states, the CDC has said.
Madeleine Biondolillo, director of the Massachusetts Department of Public Health’s Bureau of Health Care Safety and Quality, said last week that the company violated state regulation that forbids such pharmacies from mass-producing drugs. The House committee has requested a briefing from the compounding pharmacy by Oct. 18.
The FDA said last week it will work with Congress on new regulations that would grant the agency greater oversight of such compounding pharmacies.
“We want to sit down with pharmacists and lawmakers and think about a scheme that recognizes that the industry and practice of pharmacy have evolved over time, and put in place a risk-based scheme,” Deborah Autor, deputy FDA commissioner for global regulatory operations and policy, said Oct. 11.