May 18, 2016
Groups Warn Against Senate HELP Committee Members’ Legislative Sleight of Hand on Cures Act
Without ‘Regular Order,’ Provisions Are Likely to Be Added That Could Harm Patients
WASHINGTON, D.C. – Thirteen consumer, patient advocacy, access to medicines and veterans’ health organizations warned members of the U.S. Senate Health, Education, Labor and Pensions (HELP) committee not to insert proposals that would undermine patient safety and curb access to lifesaving treatments in their version of the 21st Century Cures Act.
As the HELP Committee introduces its counterpart legislation to the House-passed 21st Century Cures Act, patient advocates and health experts told Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) to observe “regular order” during the bill’s remaining stages of the legislative process. They requested the committee not insert far more sweeping U.S. Food and Drug Administration (FDA) reforms found in the flawed U.S. House of Representatives-passed bill. Many of these proposals were never heard in committee and have no place for inclusion elsewhere in the legislative process, the advocates said.
The organizations cited proposals found in the House version that would endanger the lives of patients. They warned against including these reforms in floor amendments or conference negotiation proposals that would make up the final version of the bill.
Damaging proposals could include efforts to require the FDA to speed the review of certain “breakthrough” medical devices by restricting the agency’s ability to request new evidence during clinical development. Advocates also are concerned about reforms that would lower drug approval standards by pressuring the FDA to rely more heavily on “evidence from clinical experience” rather than the more widely accepted randomized, controlled clinical trials, which are the long-held gold standard for medical research.
The organizations further cautioned against the inclusion of Section 2151 in the Senate version of the 21st Century Cures Act. This section would bar generic entry of certain medicines into the market for a longer period, denying patients access to affordable lifesaving medicines.
The 13 organizations that submitted the letter to the HELP Committee include The Annie Appleseed Project, Article 25, Breast Cancer Action, Center for Medical Consumers, Knowledge Ecology International, Health GAP, Public Citizen, National Physicians Alliance, Treatment Action Group, Universities Allied for Essential Medicines, The Veterans Health Council, Vietnam Veterans of America and the Young Professionals Chronic Disease Network.