Moderate Republican Tennessee Sen. Lamar Alexander and liberal Democratic lawmakers Tom Harkin and Rosa DeLauro are among those pushing for legislation that would expand the size and regulatory scope of the Food and Drug Administration (FDA), raising concern from experts who fear that the legislation would have adverse consequences for the pharmaceutical industry.
Connecticut Rep. Rosa DeLauro and New York Rep. Nita Lowey, both Democrats, introduced a bill in the House on Dec. 5 called the “Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act.”
DeLauro said the bill was a response to a fungal meningitis outbreak this fall caused by contaminated steroid injections produced at the now-defunct New England Compounding Center in Framingham, Mass. The outbreak reportedly resulted in more than 500 illnesses and 36 deaths.
A compounding pharmacy combines different ingredients to create new drug treatments for specific patients, based on specific prescriptions from doctors. The majority of all U.S. pharmacies provide compounding services, and 7,500 pharmacies specialize in compounding.
The New England Journal of Medicine pointed out that the New England Compounding Center was in clear violation of existing FDA policy on at least three major counts. The center essentially ignored the patient-by-patient nature of traditional compounding and acted instead as a drug manufacturer.
“It’s important to recognize that compounding pharmacies are already regulated fairly strictly. This is not a problem that arose from a lack of regulation. It arose from a willful effort to evade the regulations that already exist,” Gregory Conko, senior fellow at the Competitive Enterprise Institute, told The Daily Caller. “The New England Compounding Center has a history of evading those regulations.”
Nevertheless, the SAFE Compounded Drugs Act would give the FDA broad new regulatory powers over the entire compounding industry, including the thousands of pharmacies currently operating within the rules.
DeLauro and Lowey’s bill “would establish an FDA database on the pharmacies for use by the FDA and states in oversight of drug compounders.”
It also “would require the FDA to set minimum production standards and direct the FDA to offer training to state regulators.”
“There is really a regulatory morass out there with outrageous gaps in the system and the SAFE Compounding Drugs Act seeks to close those gaps, taking common-sense steps like improving standards and enhancing communication,” DeLauro told TheDC in a statement.
“The language of the bill is fairly rudimentary, but it doesn’t give any direction to the FDA,” Conko said. “It essentially writes a blank check for a regulatory authority that we know has a history of wanting to shut down pharmacies. It could result in rule-making that could destroy the industry.”