The probe led by the House Energy and Commerce Committee was announced yesterday after U.S. health agencies said the outbreak linked to steroid injections for back pain had spread to 120 people in 10 states. Three Democrats on the committee, led by Representative Henry Waxman of California, asked for the investigation.
"The committee is examining the facts surrounding the recent outbreak of fungal meningitis linked to contaminated steroid injections," Chairman Fred Upton, a Michigan Republican, said yesterday in letters to Food and Drug Administration Commissioner Margaret Hamburg and Thomas Frieden, the director of the Centers for Disease Control and Prevention.
The panel requested a briefing no later than Oct. 12 with the agencies and plans to question them about the contaminated steroid methylprednisolone acetate from New England Compounding Center of Framingham, Massachusetts. The pharmacy shipped the drug to 75 hospitals and clinics in 23 states, and about 13,000 people have been injected with the product, the CDC said.
New England Compounding Center has shut down operations and recalled its products, the company said in a statement. The pharmacy specializes in custom mixing versions of medications in ways that generally aren't otherwise available for sale.
Different Regulation Compounding pharmacies, which aren't subject to normal federal oversight, are supposed to respond to individual prescriptions. New England Compounding Center operated on a larger scale, evidenced by its recall of 17,676 single-dose vials of the steroid, the CDC said.
Representative Edward Markey, a Democrat from Massachusetts, wrote the FDA yesterday asking about the agency's oversight of compounding pharmacies. States take the lead in regulating pharmacies, though the FDA and states can inspect the facilities.
"Compounding pharmacies currently fall into a regulatory black hole," Markey wrote.
Markey and Representative Rosa DeLauro, a Democrat from Connecticut, each said they are introducing legislation that would beef up the FDA's authority over compounding pharmacies, according to statements.