The senior Republican on the U.S. Senate health policy committee said Monday that a recall of tainted drugs by a Texas-based compounding facility confirms that “Congress must act soon to prevent another health crisis.” Senator Lamar Alexander has urged the Senate to vote “as soon as possible” on legislation to clarify oversight of businesses that compound drugs, after a deadly meningitis outbreak last year that has led to 15 deaths in Tennessee.
The Food and Drug Administration reports that 15 patients in two hospitals who received compounded drugs from the Texas compounder have developed bacterial bloodstream infections thought to be related to the drug infusions.
Senator Alexander said Monday: “It is deeply troubling to hear of more patients who may have been harmed by tainted compounding drugs. Senators on the health committee have worked carefully to put together the best possible legislation, because we knew that the lack of accountability over compounding businesses would lead to another crisis like last year’s meningitis outbreak. We know the problem, we have the solution, and it’s up to Congress to pass this bill as soon as it returns.”
Senator Alexander, with committee chairman Tom Harkin (D-Iowa) and Sens. Pat Roberts (R-Kan.) and Al Franken (D-Minn.), introduced the Pharmaceutical Quality, Security, and Accountability Act to help prevent another compounding crisis like the 2012 fungal meningitis outbreak that has led to 63 deaths and 749 illnesses.
The bill, which was passed unanimously by the Senate Health, Education, Labor and Pensions Committee, makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the U.S. Food and Drug Administration.
A recently released report from the nonpartisan Government Accountability Office confirmed that legislation is needed to clarify the U.S. Food and Drug Administration’s oversight of large-scale drug compounders. The report authors concluded that there are “gaps in oversight” and that “it is essential to have clear roles for FDA and states in regulation and oversight of drug compounding.”
Senator Alexander said about the report: “This nonpartisan compounding report recommends that Congress work on ‘clarifying FDA’s authority,’ and that’s exactly what we’ve done with our legislation. We’ve worked to put one agency clearly on the flagpole and in charge for each area of compounding or drug manufacturing, so that we don’t have another deadly outbreak for the same reason we did last year. I hope that this report will further encourage my colleagues to support and pass the bill as soon as possible.”