Markey to FDA: Were Federal Regulators Misled by New England Compounding Center?

Lawmaker plans to introduce legislation to address loopholes in federal oversight of compounding pharmacies

WASHINGTON, D.C. – Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), today sent a letter to FDA asking when the agency became aware of the scope of the activities of the New England Compounding Center (NECC) and if the agency believes it was misled by the company. Massachusetts Governor Deval Patrick today stated that he believes the NECC “misled” both federal and state authorities and operated beyond the scope of its licensing authority by compounding, manufacturing and shipping large quantities of prescription medication that led to a meningitis outbreak that has already taken 12 lives. Earlier this week, Rep. Markey sent a letter to the FDA querying the agency about current federal regulations and oversight practices governing compounding pharmacies. Yesterday, Rep. Markey announced he plans to introduce legislation to address gaps in federal regulation and strengthen FDA’s authority to do oversight of compounding pharmacies.

“The New England Compounding Center was masquerading as a compounding pharmacy so it could escape federal regulation when it was actually operating as a drug manufacturer,” said Rep. Markey. “This company may have disregarded federal guidelines, and we need to know from the FDA whether the company misled regulatory authorities and if sanctions against the company are available or warranted. This regulatory netherworld is why I plan to introduce legislation to update and strengthen the rules that govern these compounding pharmacies and put in place strong safeguards for patients.”

A copy of Rep. Markey’s letter to the FDA can be found HERE.

Rep Markey’s legislation will require certain pharmacies that engage in interstate commerce to register with the FDA and comply with basic minimum safety standards, ban pharmacies from compounding drugs using ingredients that are not approved by the FDA, require explicit distinction between compounding pharmacies and drug manufacturers, require compounding pharmacies to provide adverse event reports to the FDA, and give the FDA authority to perform thorough inspections of pharmacy facilities. Finally, the legislation will require a warning to patients of any compounded pharmaceutical that it has not been approved safe and effective by the FDA.