Reps. Scott Peters, D-Calif., Eliot Engel, D-N.Y., Brett Guthrie, R-KY, Anna Eshoo, D-Calif., Richard Hudson, R-N.C., Michael McCaul, R-Texas, Kurt Schrader, D-Ore., and Gus Bilirakis, D-Fla., yesterday introduced the Preventing Drug Shortages Act (H.R. 6080).
The AHA-supported bill would strengthen drug shortage reporting requirements under the Food and Drug Administration Safety and Innovation Act of 2012 to include manufacturers of active pharmaceutical ingredients and information such as the cause, extent and expected duration of shortages. It also would require manufacturers to implement risk management plans.
“The Preventing Drug Shortages Act builds upon the prior work of Congress to provide additional authority to the FDA to help mitigate drug shortages to ensure a stable supply of medications critical for patient care,” AHA and other 12 national organizations said in a letter of support for the bill.
Last week, AHA and others urged the Senate Health, Education, Labor and Pensions Committee to quickly advance the Mitigating Emergency Drug Shortages (MEDS) Act (S.2723), bipartisan legislation that also would strengthen drug shortage reporting requirements and include manufacturers of active pharmaceutical ingredients, among other provisions.