West Virginia Office of Emergency Medical Services

Senate passes FDA Safety and Innovation Act

The information contained in this news article was current and accurate when we posted it, but may not necessarily represent current WVOEMS policy or procedure. If you have any questions, please contact our office at 304-558-3956.

Posted: Wednesday, May 30, 2012 12:37 PM

In recent months, the issue of shortages of medications administered by EMS personnel has risen to the forefront.

Update courtesy of Advocates for EMS:

On May 24, 2012, the U.S. Senate passed S. 3187, the Food and Drug Administration Safety and Innovation Act, by a vote of 96-1.

We're pleased to report that the bill includes revisions to the drug shortage notification process that Advocates for EMS supported in conjunction with 15 other EMS/Critical Care Transport organizations [including NASEMSO] during the bill's development at the Committee level.

As you will recall, the Health, Education, Labor and Pensions (HELP) Committee amended the statutory language in its bill to cover manufacturers of drugs used in the provision of emergency medical care and surgery and included all sterile injectable drugs as well. (The original draft included "life-supporting" and "life-sustaining" drugs, but did not make specific reference to drugs used in emergency situations.)

The House version of legislation to reauthorize the Prescription Drug User Fee Act will be voted on by the full House in the coming weeks, and then conferenced with the Senate-passed bill most likely before Congress adjourns for the summer. While the House bill as passed by the Energy & Commerce Committee does not make any statutory changes to the notification language, the Committee's report language to accompany the bill will clarify that drugs used for treatment in emergency care situations, including resuscitation are included in the drug notification process.

Furthermore, Rep. Burgess (R-TX) has secured an additional component of the GAO study in the legislation that will evaluate how providers are compensating for a lack of access to preferred drugs in caring for their patients and whether there are impediments to their ability to adjust accordingly that can be ameliorated.