Groups Urge Senate Fair Play as FDA Reform Bills Consolidated
The Senate Health, Education, Labor and Pensions (HELP) Committee should observe “regular order” and not tack on any new amendments as FDA reform and medical innovation bills recently approved by the committee are combined into one legislative package, according to a letter by 13 healthcare groups.
Last month, the HELP Committee completed its third hearing and voted out five bills (see story) that completed the Senate’s work on companion legislation to the House’s Cures Act that passed last year. As separate bills move forward and become counterpart to the House’s 21st Century Cures Act, which passed last year, the groups urge HELP members to not add any controversial provisions that were not discussed during the official mark-up hearings.
The healthcare groups’ letter said that adding any of the “dangerous provisions” in the Cures Act that were not discussed during the Senate mark-up “would constitute an unacceptable end-run around a normal legislative process, exactly the kind of cynical maneuvering feeding public distrust with the workings of the U.S. Congress. We are concerned that as the Senate counterpart moves through the legislative process, floor amendments and conference committee negotiations could include proposals that endanger the lives of patients and curb access to affordable treatments. This includes proposals that would dangerously require the FDA to recklessly speed the review of certain ‘breakthrough’ medical devices by restricting the FDA’s ability to request new evidence during clinical development, and lower drug approval standards by pressuring the FDA to rely more heavily on ‘evidence from clinical experience,’ meaning sources other than randomized, controlled clinical trials, the gold standard for medical research.”
Particularly troubling, according to the letter, is Section 2151 of the Cures Act that would “bar generic entry of certain medicines into the market for a longer period, denying patients access to affordable life-saving medicines. These and other dangerous proposals should be omitted from any final legislation. The threat of their inclusion is real, as worrying provisions from the 21st Century Cures Act are already making their way through Congress as proposed attachments to ‘must-pass’ appropriations legislation.”