Congress calls for gender equity in clinical trials
- RAPS' Alec Gaffney notes that a bipartisan clinical trial gender equity bill, The Research for All Act, was reintroduced in the House of Representatives on April 29, .
- The bill was originally introduced in 2014 by the same legislators—Reps. Jim Cooper (D-TN) and Cynthia Loomis (R-WO).
- This bill aims not only to address the longstanding problem of representation of women in clinical trials, but also to make sure that when drugs are being approved through an expedited pathway, specific sub-group analysis confirms safety and effectiveness in women.
Efforts to increase female participation trials have been ongoing for years. While there still is not complete equity in terms of numbers, the FDA often require individual companies to provide additional sex-specific data attesting to the effectiveness or safety of a particular product in women. For example, in 2013, the FDA announced that it would require companies that manufacture sleep drugs containing zolpidem to lower recommended doses, in light of the intensified effect in female patients.
While this bill addresses important safety concerns, it also conflicts with certain key aspects of the expedited approval process. The major concerns are that this bill could lead to longer, more expensive clinical trials.
This is the second time the bill has been introduced, which signals a determination to bring the goals of this initiative to fruition. And who knows? Given Congress' interest in pursuing wide-ranging FDA and NIH reforms this year, 2015 might finally be the year this breakthrough legislation passes.
- Regulatory Affairs Professional Society Legislation Calls for FDA to Ensure Expedited Drugs are Safe for Women