Last week, U.S. Rep. Neal Dunn, R-Fla., introduced the “Increasing Transparency in Generic Drug Applications Act.”
The 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.”
Dunn offered his reasons for introducing the bill.
“Americans deserve ample access to safe, generic medications. Branded drugs currently account for 82 percent of the total drug spent 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 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,” Dunn’s office noted.
U.S. Rep. Ann Kuster, D-NH, is co-sponsoring the bill.
“Cost shouldn’t be a barrier for families accessing medical care, especially when it comes to life-saving medications,” said Kuster. “Last year, 40 percent 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.”
The bill was sent to the U.S. House Energy and Commerce Committee. So far, there is no companion measure over in the U.S. Senate.
