21st Century Cures Bill ‘a Disaster Still’: Yale Critic
Yale University’s Collaboration for Research Integrity and Transparency renews its sharp criticism of the pending 21st Century Cures Act as “a disaster still,” despite changes, for its likely weakening effects on FDA regulation of medical products.
Despite some changes since it was introduced, the pending 21st Century Cures Act “is a disaster still” for its likely weakening of FDA regulation of medical products, according to Gregg Gonsalves of Yale University’s Collaboration for Research Integrity and Transparency (CRIT). In a four-page critique requested by staff of Senator Chris Murphy (D-CT), CRIT says the latest version of the legislation, which is a high Republican leadership priority for early passage, has the following liabilities:
- It “weakens the FDA’s regulation of medical devices” by expanding the expedited pathways program for vaguely defined “breakthrough” devices, permitting the agency “to approve more devices through a less stringent review process.” The same section “permits the FDA to approve high-risk devices on the basis of less rigorous evidence, such as case studies (i.e., anecdotal evidence), registries, and medical journal articles.” Another section “allows devices makers to select and pay a nongovernmental third-party to certify that changes to devices are safe and effective, in lieu of submitting an application to the FDA.”
- It “encourages the use of less rigorous evidence to approve new drugs and new uses for drugs [by] requiring FDA to establish a process for using “patient experience data” in the risk-benefit assessment for new drug approvals.” Another section requires FDA to develop criteria for relying on “evidence clinical experience” rather than randomized clinical trials for the approval of new uses or satisfying post-market study requirements. Two other sections “encourage the FDA rely more on biomarkers and other surrogate measures, rather than actual clinical endpoints, in assessing the efficacy of drugs and devices …”
- It “weakens the FDA’s approval standards for antibiotics while increasing financial incentives for hospitals to use costly new antibiotics.
CRIT’s critique includes a nine-item bibliography, among which is a New York Times op-ed Gonsalves co-authored last year with former FDA commissioner David A. Kessler, describing similar concerns with the 21st Century Cures Act. CRIT describes itself as “a joint initiative of Yale Law School, Yale School of Public Health, and Yale School of Medicine.”