WASHINGTON — Battle lines on legislation to regulate drug compounders became clearer Tuesday as a new group lobbying on the issue announced its formation.
Called the Working Group on Pharmaceutical Safety, it will work to protect the interests of a handful of drug companies that want to prohibit compounders from making drugs similar to ones they make under U.S. Food and Drug Administration supervision.
The new group supports the bill coming out of the Senate Health Education Labor and Pensions Committee that would bring large-scale compounders under FDA regulation, particularly those that market products across state lines.
“It’s incredibly necessary, particularly right now,” said Sarah Sellers, a former FDA drug safety and compliance official helping lead the new group.
Republican Sen. Lamar Alexander of Tennessee, ranking minority member on the Senate committee, played a major role in drafting the legislation.
On the other side is the International Academy of Compounding Pharmacists, which sees the bill as failing to bring all compounders under the same rules, leaving exceptions for compounders such as those in hospital pharmacies.
“Safety regulations don’t work when they don’t apply to everybody,” said David Ball, spokesman for IACP.
The legislative struggle comes on the heels of many disease outbreaks linked to compounders in recent years, including the New England Compounding Center in Framingham, Mass., which last year shipped contaminated steroid products. They have so far caused 745 cases of fungal meningitis and other maladies nationwide, resulting in 58 deaths. Michigan, with 16, and Tennessee, with 15, have had the most deaths.
“We don’t know how many are out there doing the same thing,” Sellers said.
The FDA is also looking into illnesses recently linked to a compounding pharmacy in Tennessee.
But the IACP contends the bill gives the FDA too much authority over traditional compounding, such as that done by neighborhood pharmacies.
The group is widely credited with playing a major role in stopping legislation in 2007 that would have clarified FDA authority over large-scale compounders.
Meanwhile, in addition to Sellers, the Working Group on Pharmaceutical Safety is headed by Tommy Thompson, former secretary of Health and Human Services and former Republican governor of Wisconsin.
Both Sellers and Thompson have links to drug companies. Thompson is chairman of the board of TherapeuticsMD, which makes a variety of drugs to treat women’s health issues. Sellers, until June 10, worked for Ther-RX, the marketing and distribution arm of K-V Pharmaceuticals, which is angry about the FDA allowing compounders to make a low-cost form of its drug Makena, used to prevent premature births.
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