With the U.S. House expected Saturday to consider a compromise bill to regulate pharmacy compounding, interest groups have weighed in on the merits of the legislation.
Earlier this week negotiators from the House and Senate announced agreement on legislation that would clarify the authority of the Food and Drug Administration to regulate the practice. Pharmacists compound when they mix drugs from scratch to meet patient needs, but without having to adhere to the same safety standards that drug manufacturers must meet.
Congress’ action came in response to a year-old meningitis outbreak that has killed 64 and sickened more than 700 in 20 states. Investigators traced the outbreak to a batch of contaminated steroid injections compounded at a Massachusetts pharmacy.
A Kansas City Star series more than a decade ago first exposed the risks in pharmacy compounding.
The International Academy of Compounding Pharmacists, a professional group, announced its opposition Friday, saying the legislation was too restrictive and gave the FDA “sweeping, unprecedented authority in determining what pharmacies can compound.”
“This bill will not further the safety of compounded medication, which was its only purpose,” David G. Miller, the group’s executive vice president, said in a written statement.
From a different perspective, Public Citizen’s Health Research Group criticized the legislation, saying it wasn’t restrictive enough.
“It has misleadingly been presented to the American public as something that improves federal oversight over compounding pharmacies,” said Michael Carome, director of the health research group.
The National Community Pharmacy Association, which represents more than 23,000 independent pharmacies, announced its support for the bill in a letter to House leadership, calling it “a balanced and effective approach to address critical and complex issues surrounding compounded medications.”
And in a letter to House members, Kasey K. Thompson of the American Society of Health-System Pharmacists said the bill would clarify federal oversight of compounding.
“The ASHP believes this legislation will help the FDA focus their regulatory efforts on entities that are compounding outside the scope of traditional pharmacy compounding, while leaving traditional pharmacy compounding under the oversight of state boards of pharmacy,” Thompson wrote.
House Majority Leader Eric Cantor on Friday scheduled the Drug Quality and Security Act for floor consideration Saturday, but noted in his announcement that a vote could not be expected before noon Kansas City time.