In the wake of a recent deadly meningitis outbreak, the Senate Health, Education, Labor and Pensions (HELP) Committee will consider ways to strengthen regulation of drug compounding.
The issue is on Congress’s radar as a result of the meningitis outbreak that has killed 53 people and sickened more than 700 since September. It has become clear to Congress that regulation has not kept pace with the fast-growing sector of the drug industry that makes batches of commonly used combination drugs for clinics and hospitals nationwide. The outbreak was caused by a negligent drug compounder, the now-shuttered New England Compounding Center (NECC), which created and shipped custom medications in large quantities.
The Food and Drug Administration (FDA) has called on Congress to clarify its authority to regulate non-traditional drug compounders like the NECC, and lawmakers in both chambers are debating paths forward.
The Senate HELP Committee, which will hold a hearing Thursday, released a draft bill last month that would create a new category of large sterile compounding facilities which would have to register with the Food and Drug Administration and be subject to agency inspection and oversight.
That oversight would be slightly less stringent than the type faced by full-scale drug manufacturers, which have to meet the highest FDA standards, but more stringent than those governing traditional community compounders, which are regulated by state boards of pharmacy.