Washington, D.C. – Yesterday, Rep. John Curtis (R-UT) and Rep. Angie Craigs (D-MN) introduced the bipartisan Modernizing Therapeutic Equivalence Rating Determination Act, a bill to reform the U.S. Food & Drug Administration (FDA) review and approval process for complex generics. Ultimately, this will increase availability and competition in the market and drive down prescription drug costs. Companion legislation in the Senate is sponsored by Sen. Cassidy (R-LA) and Sen. Smith (D-MN).
“I hear frequently from Utahns about the challenges that high out-of-pocket costs create to accessing lifesaving prescription drugs,” said Rep. Curtis. “This bill helps to address this problem. I am proud of this bipartisan effort to speed up the approval process for generic drugs.”
“Every year, millions of Americans all across the country struggle to fill prescriptions because they simply can’t afford the high prices of many name-brand drugs,” said Rep. Angie Craig. “The United States must take immediate action to remedy this challenge by ensuring that generics are readily available for hardworking Americans – which will help to lower drug costs and create competition in the pharmaceutical industry.”
The Modernizing Therapeutic Equivalence Rating Determination Act requires the FDA to assign therapeutic equivalence ratings for 505(b)(2) applications at the applicant’s request, as it does for ANDAs (Abbreviated New Drug Applications). The 505(b)(2) approval pathway is used to approve new drugs while leveraging certain data from an already approved drug. To the extent that the drug candidate differs from the already approved drug, the sponsor must generate sufficient data including clinical data to support the differences but does not automatically receive a therapeutic equivalence rating. A therapeutic equivalence rating is necessary to trigger automatic substitution at the pharmacy level and thus critical to driving competition. Because 505(b)(2) is technically a new drug pathway, the statute does not require FDA to assign a therapeutic equivalence rating. Sponsors can request it via the citizen petition process, but this can take significant time. Requiring FDA to assign a therapeutic equivalence rating for 505(b)(2) applications will level the playing field for 505(b)(2) products to compete with name brand drugs.