Representative Edward Markey seeks action to regulate compounding pharmacies

WASHINGTON—Representative Edward Markey on Friday called on Congress to quickly establish cohesive oversight of compounding pharmacies following the deadly outbreak of meningitis linked to a Framingham pharmacy.

“Right now, compounding pharmacies are governed by patchwork regulations, with federal and state agencies engaging in piecemeal oversight,” said Markey, Democrat of Malden and the senior member of the House Energy and Commerce Committee.

“This is unacceptable. Congress must act immediately to address these gaps in the fragmented regulatory system over compounding pharmacies to ensure the safety and well-being of patients.”

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Congress is in recess until the end of the elections. Markey said he plans to introduce legislation intended to fill the regulatory gaps laid bare by the outbreak, which has killed at least 14 and exposed about 14,000 people to a tainted steroid injection that authorities contend was made by New England Compounding Center.

Markey said compounding pharmacies, which manufacture customized medicine, must comply with minimum safety standards and must provide warnings to patients that compounded pharmaceuticals have not been approved as “safe and effective” by the Food and Drug Administration, which regulates the drug industry.

Earlier this week, Markey sought answers from the FDA to ascertain what levels of oversight should be imposed on the facilities, which mostly operate outside the authority of federal regulators.

“Compounding pharmacies fall into a regulatory black hole,” Markey wrote in a letter addressed to FDA chief Margaret Hamburg. “State regulators have primary oversight responsibility over these pharmacies; however, limited state resources and varying standards and regulatory requirements affect the adequacy of state regulation.”

On Saturday, the Framingham pharmacy issued a recall of all of its drugs.

Specialized drugs from compounding pharmacies account for 37 million prescriptions every year, according to data compiled by Markey’s office. The resulting drug formulations are used by patients who cannot use traditional medications or have allergies to dyes and fillers used by traditional drug companies.

“If compounding is done on a large scale and is not done properly, compounders can expose large numbers of patients to health risks associated with unsafe or ineffective medications,” Markey wrote.

In his letter, the Malden Democrat asked the FDA to respond to questions about how much it knows about how compounding pharmacies operate—including how their products are sold and marketed, particularly online.

More importantly, Markey asked, “does FDA have the statutory authority it needs to ensure the safety of consumers with respect to drugs made by compounding pharmacies? Does FDA believe that new legislation is needed to strengthen federal oversight over compounding pharmacies?”