A Massachusetts congressmen is proposing legislation that would give the Food and Drug Administration (FDA) greater authority over compounding pharmacies in the wake of a 19-state meningitis outbreak that has killed 29 people.
Rep. Edward Markey, (D., Mass.) last week announced the legislation, which would allow the FDA to inspect and regulate pharmacies partly based on their product volume.
Currently, states hold most of the authority over compounding pharmacies and the FDA is limited to inspections. It cannot require a compounding pharmacy to follow any operating standard.
Markey’s proposal aims to add oversight for compounding pharmacies which produce larger quantities. It does not target the traditional compounding pharmacy, which makes drugs for individual patients with a prescription.
The meningitis outbreak is being blamed on tainted steroid shots made by New England Compounding Center (NECC) of Framingham. As of Nov. 2, 395 people had contracted fungal meningitis, including the 29 deaths. Nine patients have fungal joint infections from steroid injections to the knee, hip, shoulder and elbow.
Officials say the defective drugs were shipped to 23 states and up to 14,000 patients may have been exposed. None of the contaminated product was distributed to Massachusetts healthcare providers or hospitals.
Markey’s proposal follows other attempts for regulation. In 1997, Congress passed a law giving the FDA authority to regulate large compounding pharmacies which advertised their products. But the U.S. Supreme Court struck down the law in 2002.
In Massachusetts, the Board of Registration in Pharmacy also moved to tighten controls last week, unanimously approving rules which allow the state to track drugs made by compounding pharmacies. The state’s goal is to determine whether a compounding pharmacy is violating its license and producing bulk quantities like a manufacturing facility. State officials say NECC was in violation of its license.
NECC has been shut down by the state and all of its products have been recalled. Another compounding pharmacy under the same ownership, Ameridose of Westborough, also recalled all of its drugs last week. On Oct. 10, Ameridose agreed to a temporary shutdown, which has been extended until Nov. 19.
State officials are seeking permanent surrender of NECC’s pharmacy license and permanent license revocation for NECC’s three pharmacists. The state has also started inspecting other compounding pharmacies, one of which has agreed to surrender its license after violations were found.
The Federal Bureau of Investigation (FBI) has launched a criminal investigation and at least three people have also filed personal injury lawsuits, reports USA Today.
Insight: How compounding pharmacies rallied patients to fight regulation, Reuters.
Harsh punishments rare for drug compounding mistakes, USA Today.
Pharmacy board adopts new rules, The Boston Globe.
Meningitis outbreak nears 400 infected as lawmakers push for tougher regulation, Associated Press/CBS News.