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 released the following statement after Massachusetts Governor Deval Patrick and state public health officials announced they are taking steps to address the regulation of compounding pharmacies in the wake of the meningitis outbreak caused by contaminated drugs from the New England Compounding Center (NECC). The state announced the preliminary results of its NECC investigation, which found numerous violations of good sterile compounding practices and other problems, said that it will begin making periodic unannounced inspections of compounding pharmacies that prepare sterile injectable medications; require compounding pharmacies in Massachusetts to submit annual reports of production, volume and distribution of medications; require compounding pharmacies to report to the Board of Pharmacies all interactions with federal regulatory authorities; and form a special commission to examine best practices and advise the state on what changes should make in state law to further assure the public's safety.
"It is now clear that the New England Compounding Center violated state law and endangered the health of countless patients. I commend Governor Patrick and state and federal officials for their ongoing investigation and for taking immediate and decisive action to update state practices. This is a deadly serious situation involving highly sensitive drugs and vulnerable patients, demanding the strongest response from state and federal authorities and Congress. The longer these compounding pharmacy loopholes are allowed to remain on the books, the longer patients are at risk. That's why I plan to introduce legislation addressing the regulatory gaps identified by this investigation and strengthening oversight of compounding pharmacies. I look forward to working with my congressional colleagues in a bipartisan manner to move this legislation forward and ensure the safety of patients in the future."
Rep. Markey plans to introduce legislation that will:
Require compounding pharmacies to 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
Require a warning to patients using any compounded pharmaceutical that it has not been approved safe and effective by the FDA