The U.S. Food and Drug Administration would gain greater authority over pharmacies that compound sterile drugs and ship them across state lines under proposed legislation announced on Friday.
The proposal from a bipartisan group of U.S. senators comes in the wake of a meningitis outbreak last fall that killed 53 people and sickened more than 700. The outbreak was linked to a tainted steroid distributed by the New England Compounding Center.
The proposal would draw a distinction between traditional compounding pharmacies, which make drugs based on specific prescriptions for individual patients, and those such as NECC, which make products without prescriptions for physicians to keep for future use.
"By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," Iowa Democrat Tom Harkin, chairman of the Senate health committee that developed the draft legislation, said in a statement.
The bill would create a new class of drugmaker that would be regulated by the FDA but would be exempt from the full raft of regulations that apply to traditional pharmaceutical companies.
For example, these "compounding manufacturers" would not be required to submit their products to the FDA for approval before selling them. Nor would they be required to negotiate the labeling of their drugs with the FDA; they would only be required to indicate that the products are compounded and list certain other specified information.
These companies would no longer be licensed as pharmacies. They would be required to register with the FDA, and report to the agency any problems reported by patients or physicians. They would also be required to pay an annual fee to defray the cost of FDA inspections.
Compounding manufacturers would not be allowed to compound biologic products made from live organisms or other complex drugs. And they would be prohibited from compounding FDA-approved drugs unless they are in short supply.
Traditional compounding pharmacies would continue to be licensed and regulated by state boards of pharmacy.
A spokeswoman for the FDA, Erica Jefferson, said the agency was reviewing the draft "and looks forward to continuing to work closely with the committee to address existing limitations in the law."
It is unclear how many of the nation's roughly 2,800 compounding pharmacies would fall into the new category, but initial estimates put the number at fewer than 500. They would be defined not by their sales volume, but by whether they make products that are at high risk for contamination and sell them across state lines.
Ever since the meningitis outbreak, the FDA has been pilloried by Republicans in Congress, who say the agency should have been more aggressive in its oversight of NECC.
The FDA concedes as much but has argued that a complex legal landscape has hampered its ability to regulate the industry since compounding pharmacies have historically been regulated by the states and have not been required to register with the FDA.
The proposed legislation encourages greater communication among states and between states and the FDA.
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