News Releases

Thursday, October 31, 2019

Isakson, Casey Applaud Committee Passage of Bipartisan Health Measures

Over-the-counter drug reform; infant, childhood death awareness measures advance to full Senate

WASHINGTON – U.S. Senators Johnny Isakson, R-Ga., and Bob Casey, D-Pa., today applauded the Senate health committee’s passage of two measures they introduced to improve public health and help consumers and families.

The Over-the-Counter Monograph Safety, Innovation, and Reform Act would streamline and modernize the Food and Drug Administration’s (FDA) process regulating how over-the-counter medications are brought to market and monitored for safety and effectiveness. It would also speed up the current years-long approval process for new over-the-counter medications. It passed in committee by voice vote.

The Scarlett’s Sunshine on Sudden Unexpected Death Act would strengthen existing efforts to understand Sudden Unexpected Infant Death and Sudden Unexpected Death in Childhood. Currently, data about these unexpected infant and child deaths is not consistently or comprehensively collected, which limits the ability to conduct research that can lead to explanations and prevention. This measure would supply grants to help states improve data collection, improve death scene investigations related to unexpected infant and child deaths, promote safe sleep practices, and conduct death reviews for unexpected infant and child fatalities. It passed unanimously by voice vote.

“Senator Casey and I have been working for a long time on overhauling our woefully outdated over-the-counter drug approval process to help innovative products get to the pharmacy shelf and to give consumers the most up-to-date safety information on these medications. I have also been honored to work with Senator Casey on ensuring we are employing every resource available to combat infant mortality and protect our youngest and most innocent lives,” said Isakson. “I’m so glad to see each of these bills pass in committee, and Senator Casey and I will continue working with our colleagues to move them through the Senate.”

“I am pleased that the HELP Committee has passed both bills that Senator Isakson and I have been working on. The Over-the-Counter Monograph Safety, Innovation, and Reform Act will update and modernize the regulation of over-the-counter drugs to provide confidence to American consumers that non-prescription drugs have appropriate oversight from the FDA, and that the FDA has the authority to take swift action to protect public health should a safety problem occur. I am also glad that we passed Scarlett’s Sunshine on Sudden Unexpected Death Act, which will strengthen state and federal efforts to investigate and collect information when an infant or young child dies. The data we gain from these critical efforts will help us to learn more about the causes of unexplained deaths and develop new tools to prevent and reduce infant deaths,” said Casey.

About the Over-the-Counter Monograph Safety, Innovation, and Reform Act:
The FDA’s “over-the-counter monograph system” to regulate these medications was implemented in 1972. While modern medicine is constantly improving and adapting as research offers new information, the regulatory system remains outdated, putting consumer health at risk and hindering innovation that could benefit all Americans.

A version of this legislation was originally introduced by Isakson and Casey in January 2018 and it was previously approved 22-1 by the Senate Health, Education, Labor and Pensions Committee on April 24, 2018. Additional information on the bill can be found here.

About the Scarlett’s Sunshine on Sudden Unexpected Death Act:
The Scarlett’s Sunshine on Sudden Unexpected Death Act coordinates efforts between the Centers for Disease Control and Prevention (CDC) in Atlanta and state and local agencies to improve reporting for Sudden Unexpected Infant Death and Sudden Unexpected Death in Childhood through grant funding, and it encourages states to use standardized infant and child death reporting forms developed by, or in conjunction with, the CDC.

This bill has been endorsed by the American Academy of Pediatrics, Children’s Hospital Association, Cribs for Kids, First Candle, March of Dimes, Kids in Danger, SUDC Foundation, Within our Reach, Aaron Matthew SIDS Guild of Seattle Children’s Hospital, and Child Care Aware. Additional information on the bill can be found here.

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