A former cabinet secretary and a public health advocate announced Tuesday that they have formed an organization to push Congress for pharmacy compounding reform.
Tommy Thompson, Health and Human Services secretary under President George W. Bush, and pharmacist Sarah Sellers said they founded the Working Group on Pharmaceutical Safety to ensure that all the medications taken by U.S. consumers are safe and effective.
Thompson said he supports legislation co-sponsored by Kansas Republican Sen. Pat Roberts and recently passed by a Senate health committee to give authority to regulate large-scale compounding pharmacies to the Food and Drug Administration instead of the states, where it currently resides.
“We need strong legislation to give the FDA authority to regulate some pharmacies,” Thompson said.
The Senate began considering the bill after a meningitis outbreak, traced to contaminated injections compounded in Massachusetts, killed 58 people nationwide and sickened more than 700 others during the past year.
Compounding is a traditional part of pharmacy practice in which pharmacists create customized medications from scratch, but without having to meet the same safety and quality standards that large drug manufacturers must follow.
The new law would clarify that the Food and Drug Administration is responsible for enforcing safety and manufacturing standards for large compounders, such as the one in Massachusetts that produced contaminated steroid injections.
Traditional compounding in smaller settings, such as neighborhood pharmacies, would continue to be regulated by state boards.
If enacted, the new law would be the first significant revision of federal compounding law since The Kansas City Star exposed deep problems within the industry more than a decade ago in the wake of the Robert Courtney drug dilution scandal.
Thompson and Sellers predicted that even though the bill passed unanimously out of the Senate’s Health, Education, Labor and Pensions Committee last month, getting it signed into law will be a “slugfest.”
“Attempts to address this issue (in the past) have been stymied and blocked by the compounding interests who have a strong interest to grow their markets beyond the scope of traditional practice,” said Sellers, who worked in the FDA’s safety office before founding her own quality assurance company.
And the debate is sharpening.