The U.S. Senate this week will begin work on a law that would provide new oversight of the practice of pharmacy compounding.
If enacted, the law would be the first far-reaching piece of federal legislation to reform compounding since Kansas City pharmacist Robert Courtney shocked the nation more than a decade ago with his admission that he had diluted thousands of doses of chemotherapy medication.
Compounding is a traditional part of pharmacy practice in which pharmacists mix medications from scratch but without having to meet the same exacting safety and quality standards that large drug manufacturers must follow.
The legislation, written by Kansas Sen. Pat Roberts and three of his Senate colleagues, would clarify for the first time the roles of federal and state agencies in regulating compounding.
Though Roberts has worked steadily to strengthen compounding laws over the last 10 years, his new legislation received special urgency last fall when a spinal meningitis outbreak killed dozens and sickened hundreds more. The outbreak was traced to contaminated steroid injections prepared by the New England Compounding Center in Massachusetts.
Roberts, a Republican, said Friday that he is encouraged by the willingness he has seen in colleagues on both sides of the aisle to work on this issue again.
“It really is unfortunate that 53 people have to die and 700 get sick before we have the will to do this,” Roberts said. “We haven’t given up. We’re persevering, and we’re doing it the right way. We just have to get it done.”
The Kansas City Star first laid out concerns about the safety of compounded medications in a three-part series in 2002. Responding to that report and Courtney’s admissions, senators organized their initial hearing on compounding practices in 2003. But industry opposition blocked any significant changes.
The compounding industry remains mostly regulated by a patchwork of state boards of pharmacy, which often do not have the capacity to oversee large operations that compound thousands of doses of sterile medications and then ship them across the country.
The U.S. Food and Drug Administration argues that it is hamstrung by a lack of clear jurisdiction.
It is those large operations, described in the legislation as “compounding manufacturers,” at which the law is aimed. The FDA would, under the proposal, have clear authority to license and inspect those plants, while leaving traditional pharmacy compounding as practiced in local drugstores to the states.
“We’ve seen far too many deaths in this country because some pharmacies have acted more like drug manufacturers, without following rigorous safety rules,” Minnesota Sen. Al Franken, who has worked with Roberts on the legislation, said in a written statement.
The proposed law would compel those large compounders to use good manufacturing processes and ensure that a licensed pharmacist was overseeing the preparations.
Compounding manufacturers also would be subject to reporting requirements for adverse drug reactions similar to those of traditional pharmaceutical makers.
And the law allows the government to identify products that are particularly tricky to compound, such as extended release products, metered dose inhalers and transdermal patches, and prevent them from being produced until compounders demonstrate they can do them safely.
Sens. Tom Harkin of Iowa and Lamar Alexander of Tennessee joined Roberts and Franken in releasing the draft bill in late April, calling for comments from government agencies and private interests. Those comments were due Friday.
The Senate’s Committee on Health, Education, Labor and Pensions will hold a hearing Thursday to consider testimony and comment from industry leaders, government officials and public health advocates.
A likely voice in the process will be that of the International Academy of Compounding Pharmacists, which has consistently fought any federal encroachment on pharmacy practice.
In a statement on the draft bill, the academy applauded the committee’s work but said the bill could “create more confusion and further blur the jurisdictional authority of regulators.” Still, the academy pledged to work with the Senate to refine the legislation.
Public health experts appeared divided on the proposed bill.
Public Citizen, a consumer advocacy group founded by Ralph Nader, issued a stinging critique of the legislation, saying it would be “a major step backward for U.S. drug safety.”
The group encouraged the FDA to apply the same standards to compounding manufacturers that it does to traditional pharmaceutical companies.
But Sarah Sellers, an Illinois pharmacist and longtime proponent of compounding reform, said the senators’ draft legislation is aimed at a risky industry problem and represents a good step.
“Their work to further clarify the FDA’s authority and the responsibilities of the states is commendable and urgently necessary to protect the public,” Sellers said.