WASHINGTON, DC— Congresswoman Rosa DeLauro (D-CT) today outlined her concerns over accelerated drug approval in a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg. She also asked Hamburg for details on device safety to ensure that women and families can rely on safe and effective drugs and medical devices that improve health and wellness. DeLauro is a former chairwoman of the subcommittee responsible for funding the FDA.
“Last year, the FDA began discussing an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need,” DeLauro wrote. “Under these new guidelines, the FDA lowers the standard from two well-designed controlled clinical trials to one smaller study that may not necessarily measure a meaningful health outcome. In addition, if the FDA permits smaller sample sizes, it would not be feasible to conduct subgroup analyses for safety and efficacy in women and men, in different racial and ethnic groups, or across age. It would also not be possible to determine the appropriate dosages for these different groups. This information is essential for prescribers and patients.”
Concerns were raised after a tuberculosis drug, Situro, was approved through an accelerated approval pathway although patients are five times more likely to die while taking the drug. Accelerated drug approval often pushes drugs through short, limited clinical trials that do not measure overall patient health and wellness. Further, as DeLauro outlined in her letter, the small limited trials found in accelerated approval often fail to include women and minorities, leaving these subpopulations unrepresented and vulnerable.
“The FDA has a high level of regulatory authority and discretion over medical device classification and drug approval methods,” DeLauro said in a statement accompanying the letter. “The public trusts in FDA to ensure that drugs and medical devices are both safe and effective. Public health and wellness has been, and should continue to be, the primary focus of the FDA.”