By Jessica Dye
NEW YORK | Wed May 22, 2013 6:58pm EDT
(Reuters) – A U.S. Senate committee on Wednesday unanimously approved legislation that would increase federal oversight for companies that compound and sell sterile drugs across state lines.
The proposed legislation was introduced in response to a meningitis outbreak last fall that killed more than 50 people and sickened more than 700. The outbreak was traced to contamination found in steroid injections made by the New England Compounding Center.
The bill was passed unanimously on a voice vote by the Senate Health, Education, Labor and Pension Committee.
“Congress must take action to improve the safety of compounded drugs and prevent the next public health crisis, and this is exactly what our legislation would do,” Senator Tom Harkin, a Democrat from Iowa, said in a statement.
Compounding is a process in which a pharmacist combines or alters medicines to change the dosing or form to address specific patient needs – for instance, removing a dye or preservative, or changing a pill into a liquid. The practice has typically been regulated by states, as opposed to traditional drug manufacturing, which is regulated by the FDA.
The proposed legislation would distinguish traditional compounding pharmacies, which make drugs for individual patients based on specific prescriptions, and compounding manufacturers that, like the NECC, would make products without, or in advance of, prescriptions for national use.
Under the proposal, the compounding manufacturers would be regulated by the U.S. Food and Drug Administration. However, they would not be subject to the same regulations as traditional drug manufacturers, although they would be required to register with the FDA and report the products they sell, report and investigate any adverse events and pay a fee to offset the cost of inspections, under the proposal.
The FDA said it is working with the Senate committee to address some of its concerns about the clarity of its authority.
The FDA has been criticized for not taking greater steps to oversee companies like NECC in the wake of the meningitis outbreak. But the agency has argued that its legal authority over those companies and products has been plagued by gaps and ambiguities.
(Reporting by Jessica Dye; Editing by Bernard Orr)