Legislation Addressing Emergency Care Drug Shortage Passes Senate and House

June 13, 2012

The U.S. Senate and House have both passed legislation within the past month that would begin to address the national shortage of drugs, including those used in emergency medical care. This issue of drug shortages, which  policy-makers have only recently begun to focus on, has reached a crisis level for patients of pre-hospital emergency medical services agencies across the country.

On May 24, the Senate passed S. 3187, the Food and Drug Administration Safety and Innovation Act, which contained language requiring manufacturers of drugs that meet various qualifications, including being “used in emergency medical care or during surgery,” to report to the Secretary of Health and Human Services any plan to discontinue or interrupt the manufacture of a drug that could lead to a meaningful disruption in the supply of that drug in the United States. The bill gives the Secretary the authority to expedite review of a supplement to a new drug application and/or expedite an inspection or re-inspection of an establishment that could mitigate or prevent a drug shortage from occurring. S. 3187 also directs the Secretary to “establish a Task Force to develop and implement a strategic plan for enhancing the Secretary’s response to preventing and mitigating drug shortages.”

On May 30, the House passed H.R. 5651, the Food and Drug Administration Reform Act, which included language similar to S. 3187 addressing the problem of drug shortages. However, rather than specifically referencing drugs “used in emergency medical care or during surgery,” the House included language in the non-statutory Committee Report accompanying H.R. 5651 clarifying that “any drug that is required during emergency or critical situations” should be considered a “life-supporting” drug and therefore covered under the bill.

You can download the language dealing with drug shortages in both bills (S. 3187 and H.R. 5651) as well as the House Committee Report. S. 3187 and H.R. 5651 are now expected to be referred to a conference committee where differences between the two versions of the bill can be worked out.