ALEXANDRIA, Va. — Rep. Edward Markey, D-Mass., on Thursday announced plans to introduce legislation that would strengthen federal regulations of compounding pharmacies. The legislation is borne out of the recent meningitis outbreak linked to the New England Compounding Center, which is located in Markey's district, that has drawn much criticism on how regulators oversee compounding pharmacies. According to Markey, the Verifying Authority and Legality in Drug Compounding Act will give the Food and Drug Administration clear, new authority to oversee compounding pharmacy practices throughout the country.
“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” said Markey, a senior member on the Energy and Commerce Committee. “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies."
The industry expressed mixed feelings over the proposed legislation. “We appreciate and agree with Rep. Markey’s interest in wanting to achieve the proper balance to promote patient health and allow for traditional pharmacy compounding services to continue, while addressing any entities illicitly manufacturing pharmaceuticals under the guise of compounding, as highlighted by the tragic meningitis outbreak," stated John Coster, SVP government affairs for the National Community Pharmacists Association. "The New England Compounding Center appears to have been engaged in inappropriately manufacturing medications and doing so without valid prescriptions," he said. “However, the proposed legislation also appears to create new overly broad requirements on traditional pharmacy compounding that could negatively impact both patients’ access to essential medications and the community pharmacists who provide them. As currently drafted, the legislation would grant new powers to an already stretched FDA to regulate traditional pharmacy compounding, and create new roadblocks for patients by requiring waivers for pharmacists to make medications that they have been making safely and effectively for decades."
The NCPA is currently reviewing the legislation and will submit comments to Markey, Coster noted.
“This bill will save lives by ensuring that compounding pharmacies play by the rules that are essential to protect patients,” said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund. “This month’s tragic meningitis outbreak from contaminated steroid injections was absolutely preventable. We call on Congress to work in a bipartisan manner to pass congressman Markey’s legislation, which is necessary to protect our families from these predictable, preventable tragedies.”
The legislation has been endorsed by the Cancer Prevention and Treatment Fund, Jacobs Institute for Women’s Health, National Consumers League, National Research Center for Women & Families, Our Bodies Ourselves and Union of Concerned Scientists.
A copy of the VALID Compounding Act can be found here.