House and Senate Pass Final Version of Legislation Addressing Emergency Care Drug Shortages
July 9, 2012
On June 26 the U.S. Senate voted 92-4 to agree to a version of S. 3187, the Food and Drug Administration Safety and Innovation Act, that passed the U.S. House of Representatives on June 20.
The bill, which the National Volunteer Fire Council (NVFC) supports, contains language requiring manufacturers of certain drugs, including those “used in emergency medical care,” to report to the Secretary of Health and Human Services (HHS) 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. On June 28, S. 3187 was presented to the President, who is expected to sign it into law.
Policy makers have only recently begun to focus on the problem of emergency care drug shortages, which have reached a crisis level for patients of pre-hospital EMS agencies across the country. In addition to requiring drug manufacturers to notify HHS of potential impending shortages, S. 3187 contains language that:
- 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.
- Directs the Secretary to establish and maintain “an up-to-date list of drugs that are determined… to be in shortage in the United States.”
- 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.”
- Directs the Attorney General to submit to Congress a report on drug shortages.
- Directs the Comptroller General to “conduct a study to examine the cause of drug shortages and formulate recommendations on how to prevent or alleviate such shortages.”
A final version of S. 3187 can be viewed online.