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Ed Markey to Seek Stronger FDA Oversight of Compounding Pharmacies

Massachusetts Democrat Ed Markey will announce today the first legislative plan to increase oversight of compounding pharmacies since the September outbreak of fungal meningitis. 

Markey, a member of the House Energy and Commerce Committee, plans to outline his legislation at a press conference outside the New England Compounding Center, the company that made a contaminated injectable steroid that caused the outbreak. The company’s headquarters are in Markey’s district. 

So far, the outbreak has caused 28 deaths and 377 cases of fungal meningitis in 19 states, according to the Centers for Disease Control and Prevention.

Markey has said his bill will address a “regulatory netherworld” of oversight by requiring pharmacies that sell compounded drugs across state lines to register with the Food and Drug Administration. He would also give the agency authority to thoroughly inspect pharmacy facilities and to tell patients that compounded drugs have not been approved by the FDA. 

The FDA generally leaves oversight of compounding pharmacies up to the states and does not require compounded drugs to meet the same safety and efficacy requirements as other new drugs. But Markey and other Democrats say that some compounding pharmacies act like traditional drug manufacturers, making large batches of drugs and essentially avoiding FDA oversight. 

Earlier this week, Markey released a report that said the compounding industry has resisted increased regulation from the FDA and that state regulators have not had a consistent role in ensuring compounded drug safety. 

Rep. Rosa DeLauro (D-Conn.) has said she plans to introduce legislation when Congress returns from recess that would give the FDA more authority over compounding pharmacies.

The Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee are conducting investigations into the NECC. Lawmakers also have sought information on the pharmacy and its oversight, and some have called for hearings. 

As the number of people who have contracted meningitis from the NECC’s injectable steroid continues to grow, the Center for Medicaid and CHIP Services is advising states to prepare for treating patients. On Wednesday, the center told states to prepare for a rush of prescription requests for voriconazole, an anti-fungal drug the CDC recommends to treat infections caused by the contaminated product. It also told states to expedite all decisions about covering that drug and all other appropriate antifungal medications. 

The center warned states that any delays could have “potentially life-threatening consequences” for patients with central nervous system or parameningeal infections and septic arthritis. 

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