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.
Just before an annual event earlier this month at which members of the International Academy of Compounding Pharmacists visited Washington to lobby members of Congress, the organization distributed talking points critical of the bill, saying that it would only confuse what agency is in charge of pharmacy regulation.
The bill also seeks to “micromanage” pharmacists’ decisions, the academy contended.
A compounding group that sells chemicals, equipment and training to pharmacists has taken a harder line, calling the bill “devastating,” “fatally flawed” and a “worst-case scenario for our profession, our prescribers and our patients.”
Jim Smith, president of Professional Compounding Centers of America, blasted the FDA in a letter to the bill’s sponsors last week and said the agency had sought to “hobble compounding pharmacy” and not encourage its growth.
Smith suggested that the FDA was too close to large drug manufacturers who must go through its approval process to market new medicines that are not compounded.
“As an agency both overseeing and being funded by mass manufacturers of pharmaceuticals, the FDA’s incentives are to limit or stunt the progress and expansion of compounding,” Smith wrote.
Thompson said his group would try to counter such arguments by marshaling the voices of patients, consumer advocates, medical societies and FDA-approved pharmaceutical manufacturers.
Thompson currently is chairman of TherapeuticsMD, a drug company that targets its products at women.
The Senate health committee’s leaders, Democrat Tom Harkin of Iowa and Republican Lamar Alexander of Tennessee, recently asked Senate leaders to bring the legislation before the full Senate for debate in July.
In a letter to Democratic majority leader Harry Reid and Republican minority leader Mitch McConnell, Harkin and Alexander said the bill was a bipartisan answer to a public health crisis.
“The legislation will ensure that there is no confusion about who is responsible for keeping America’s drugs safe, whether compounded or manufactured,” Harkin and Alexander wrote.