U.S. Senators Johnny Isakson, R-Ga., and Bob Casey, D-Pa., applauded the Senate passage of legislation they introduced to overhaul the way over-the-counter medications are regulated and brought to market.
 
The current system used by the Food and Drug Administration (FDA) to regulate these medications, called the “over-the-counter monograph system,” was implemented in 1972. While modern medicine is constantly improving and adapting as research offers new information, the regulatory system is outdated, putting consumer health at risk and hindering innovation that could benefit all Americans.
 
The Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2740, seeks to streamline and modernize the FDA’s regulatory system to better serve the American public. It passed in the Senate Health, Education, Labor and Pensions Committee by voice vote on Nov. 5. It passed the full Senate today by a vote of 91-2.
 
“The Over-the-Counter Monograph Safety, Innovation, and Reform Act will help ensure that Americans have effective, accessible health products in their medicine cabinets and on supermarket shelves. In addition, the legislation will ensure innovations can be made well into the future and that we are promoting competition to bring down costs for consumers,” said Isakson. “I thank my Senate colleagues for their overwhelming support in passing this legislation to modernize and overhaul our woefully outdated over-the-counter drug approval process, and I urge our colleagues in the House to quickly follow suit in passing this measure.”
 
“I am pleased that my Senate colleagues have passed the Over-the-Counter Monograph Safety, Innovation, and Reform Act, which will make long overdue updates to the regulation of over-the-counter drugs,” said Casey. “By modernizing regulation of over-the-counter drugs, we will provide confidence to American consumers that non-prescription medications 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.”
 
Isakson and Casey’s Over-the-Counter Drug Safety, Innovation, and Reform Act would also speed up the current years-long approval process for new over-the-counter medications.
 
The pharmaceutical industry would help cover much of the costs of the updated regulatory system through “user fees” to support medication review, new information technology (IT) infrastructure and new full-time employees for the FDA.