Member Action: HAP members are encouraged to sign Senators Klobuchar (D-MN) and Casey (D-PA) petition urging Congress to pass the Preserving Access to Life-Saving Medications Act, which would require drug manufacturers to notify the FDA of any incident that would likely cause a drug shortage and require the FDA to provide up-to-date public notification of actual shortages.
The Latest: The U.S. House Energy and Commerce Committee approved the “Food and Drug Administration (FDA) Reform Act,” H.R. 5651, by a vote of 46–0. The legislation, similar to the previously passed Senate Health, Education, Labor, and Pensions Committee legislation supported by HAP, requires drug manufacturers to report to the FDA when they anticipate a meaningful disruption in the supply of a drug they manufacture. HAP sent a letter of support to Energy and Commerce Subcommittee Chairman Joe Pitts (R-PA) earlier in the week during subcommittee consideration of H.R. 5651. Legislation is slated to be considered by both the full House and Senate during the coming weeks in order to avoid FDA disruptions that would occur beginning during July.
Background: During the last year, the FDA has reported a record number of drug shortages across all classes of medications. This issue is of significant concern to hospitals and health systems because drug shortages have had serious consequences for patient safety, quality of care, and access to therapies, as well as costly implications in terms of staff time and other resources needed to manage the shortages and buy off-contract and alternative drugs. HAP has been working with the American Hospital Association (AHA) and the Pennsylvania Congressional delegation to find a solution to the drug shortages that are impacting patient care.
AHA Testimonybefore the U.S. Senate Committee on Health, Education, Labor, and Pensions Committee on Securing the Pharmaceutical Supply Chain (September 2011)
