WASHINGTON, D.C. – Congressman Neal Dunn, M.D. (Florida-02) recently introduced the Increasing Transparency in Generic Drug Applications Act (H.R. 3839) with Congresswoman Ann L. McLane Kuster (NH-02). This bill expedites and improves the U.S. Food and Drug Administration's (FDA) review process for complex generic medications by allowing the agency to inform generic drug sponsors about the differences between their application and the reference product.

“Americans deserve ample access to safe, generic medications. Branded drugs currently account for 82% of the total drug spend in the U.S., and Americans deserve options. With many households struggling with inflation, the more money we can help patients save, the better,” said Congressman Dunn. “There is more work to be done, but ensuring this bill is signed into law is a great first step in helping break down cost-prohibitive barriers to care.”

According to the Association for Accessible Medicines, generic and biosimilar drugs generated $373 billion in savings in 2021. The FDA should readily provide ingredient information to generic manufacturers seeking to bring lower-cost medications to market.

“Cost shouldn't be a barrier for families accessing medical care, especially when it comes to life-saving medications,” said Congresswoman Kuster. “Last year, 40% of Americans put off much-needed care because of costs—that’s unacceptable. This bipartisan legislation will simplify the FDA’s generic drug approval process and allow patients to access affordable generic medications faster. I’ll continue working to lower overall health care costs for Granite Staters and folks across the country.”

H.R. 3839 advanced favorably from the House Energy and Commerce Committee on May 17^th, 2023, as part of H.R. 3281, the Transparent PRICE Act.

Read H.R. 3839 bill here.

###