Alexander: Congress must act to prevent another tainted drug crisis

Alexander demanded that Congress pass legislation to clarify oversight of businesses that compound drugs, after new Food and Drug Administration reports (FDA) that 15 patients have contracted bacterial bloodstream infections from compounded drugs manufactured in Texas. 

ADVERTISEMENT
Alexander, along with Sen. Tom Harkin (D-Iowa), drafted the Pharmaceutical Quality, Security, and Accountability Act after compounded drugs caused a fungal meningitis outbreak in 2012. The outbreak caused the deaths of more than 60 people.

“It is deeply troubling to hear of more patients who may have been harmed by tainted compounding drugs,” Alexander said Monday. “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.”

His bill would allow the FDA to regulate compounding manufacturers and would distinguish between traditional compounding — which will continue to be regulated primarily by state pharmacy boards — and compounding manufacturers that make sterile products and sell them across state lines.

Alexander serves as ranking member of the Senate Health, Education, Labor and Pensions Committee.