Meningitis Outbreak Sparks Federal Investigations, Potential Legislation
From the American Academy of Ophthalmology
The deadly multi-state outbreak of fungal meningitis linked to New England Compounding Center has drawn scrutiny from Capitol Hill, with the potential for new regulatory legislation. The U.S. House Committee on Energy and Commerce is conducting an investigation that will include bipartisan briefings on the outbreak by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, as well as the owners of NECC. Sen. Richard Blumenthal, D-Conn., has also called on the U.S. Department of Justice to open a criminal investigation into how NECC distributed the potentially contaminated drugs.
Several Democratic members of Congress intend to introduce legislation to strengthen the FDA’s oversight of compounding pharmacies, citing a current lack of effective state and federal regulations. Because these pharmacies create modified drugs for individual patients, they are not currently subject to the same regulations as other new drugs.