U.S. Rep. Bob Latta (R-OH) on June 24 cosponsored a 96-page bipartisan bill aimed at making more over-the-counter (OTC) medications available to American consumers.
Rep. Latta introduced the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, H.R. 3443, with bill sponsor U.S. Rep. Diana DeGette (D-CO) to reform the OTC monograph system, which is used by the U.S. Food and Drug Administration (FDA) to review and approve new OTC drugs for sale on the commercial market.
“Our current process for approving over-the-counter products is unnecessarily inefficient, leading to higher prices and fewer choices,” Rep. Latta said on Monday. “A problem like this rightfully deserves bipartisan solutions and that’s what we have in the Over-the-Counter Monograph Safety, Innovation, and Reform Act.
“It’s time for the over-the-counter approval process to be as modern as the innovations being presented to the FDA,” added the congressman.
If enacted, H.R. 3443 would provide the FDA with additional funding to hire more staff for OTC-related work and to develop a new electronic infrastructure to speed its OTC review and approval process, among numerous provisions contained in the bill.
“From cold medicines to cures for your headaches, over-the-counter medicines are in nearly every household across our country,” Rep. Latta said. “That means when health care innovation is blocked by government regulations, it’s patients who lose.”
Additionally, H.R. 3443 would establish a new approval pathway to permit drug makers to update an existing OTC product and get them to market sooner, according to the bill’s text.
The proposal has been referred for consideration to the U.S. House Energy and Commerce Committee.