Recently, the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee and the House Energy and Commerce Committee approved legislation with overwhelming bipartisan support that will accelerate complex generic approval timelines by removing a key barrier to approvals. The bipartisan Increasing Transparency in Generic Drug Applications Act of 2023 is championed by Sens. Maggie Hassan (D-NH), Rand Paul (R-KY), John Hickenlooper (D-CO), and Mike Braun (R-IN), and Reps. Annie Kuster (D-NH) and Neal Dunn (R-FL).
This legislation, which is estimated to save the Medicare program nearly $1 billion, will increase patient access to lower-cost medications by improving transparency in the generic drug approval process. Known as Q1/Q2 assessments, this part of FDA’s review of a generic drug application ensures the generic formulation is quantitatively and qualitatively the same as its reference listed drug. This legislation will expedite generic drug approvals by allowing the FDA to disclose critical information about any deficiencies identified during the assessment to generic drug manufacturers, thereby allowing manufacturers to reformulate their proposed drugs to meet the regulatory requirements in a timely manner.
In a statement, Sen. Hassan referred to the legislation as “a commonsense way to help families save money” that “will cut unnecessary red tape to help get low-cost generic medications onto the market and into the hands of patients more quickly.” Echoing that sentiment, Sen. Paul added, “No one should have to play a complicated guessing game with the FDA simply to bring a safe, effective, and affordable drug to market.”
Now that the Increasing Transparency in Generic Applications Act has passed both the HELP and Energy and Commerce Committees, congressional supporters will work to ensure it is included in a larger legislative package slated to pass both chambers of Congress and be enacted into law later this year.