The bicameral Drug Quality and Safety Act, announced Wednesday night, would allow compounders that mix sterile drugs without a prescription and ship across state lines to choose whether to register as outsourcing facilities. Those pharmacies then would be regulated by the Food and Drug Administration rather than by state boards of pharmacy. It also seeks to clarify the FDA's oversight role, permitting the agency to follow a national standard while regulating facilities making adulterated, misbranded or unapproved products and allowing the FDA to establish a list of drugs that may not be compounded for safety reasons. In addition, the bill also mandates the formation of a national drug-tracking system.
“This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards,” said Senate HELP Committee Chairman Tom Harkin (D-Iowa) in a written statement.
But some patient safety advocates expressed reservations about the bill.
“Because it's voluntary, it's not going to create a sweeping change immediately in how these facilities operate,” said Allan Coukell, senior director of drugs and medical devices for the Pew Charitable Trusts, which supports the bill.
What the bill is likely to do is create a market where hospitals and clinics choose to buy drugs from registered compounders because they would be expected to have higher quality standards, Coukell said. “Many compounders may continue to produce large volumes of sterile products primarily under state oversight, which is highly variable,” she wrote in a Sept. 26 letter to lawmakers.
The practice of drug compounding has received intense scrutiny in the year since a multistate meningitis outbreak was first reported. More than 60 people have died and another 750 were sickened from the contaminated injections.
The New England Compounding Center, the Framingham, Mass.-based compounding pharmacy that mixed and distributed the contaminated drugs, is now in bankruptcy protection and is facing hundreds of lawsuits. In the year since the outbreak was first reported, lawmakers and patient groups have called for a new regulatory framework that would put oversight of large, high-risk compounders under the purview of the FDA.
Congress had been grappling over how best to define this class of compounders, many of which ship thousands of drugs to multiple states. Issues included where to draw lines between state and federal authorities and how to balance questions about patient access to medications against the safety of compounded drugs.
In an e-mail, a spokeswoman for the American Hospital Association, which had supported the earlier Senate bill, said: “We are still talking with our members and we are discussing the bill and have questions that we will work with Congress on but we support the goal of the bill and are hopeful a good bill can pass.”
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