FDA Reforms Included in Year-end Omnibus Bill
The recent signing of the year-end omnibus legislation (HR 2617, Consolidated Appropriations Act, 2023) not only provided FDA with a $226 million bump in its spending level (see story), but it also included notable agency reforms that were part of the user fee reauthorization legislation last summer but eventually were abandoned when legislators ran out of time trying to reach a compromise.
The reforms are included under the Food and Drug Omnibus Reform Act (FDORA) as part of the omnibus bill. For example, highly anticipated accelerated-approval modifications are included in Sec. 3210 Modernizing Accelerated Approval, such as giving the agency authority to require a confirmatory study to be underway prior to approval, or within a specified time period after approval. The section also spells out “expedited procedures” FDA can take to force an accelerated-approval product from the market when a drug sponsor’s confirmatory data fail to demonstrate a clinical benefit.
Another accelerated approval modification requires drug sponsors to submit twice per year a progress report on any required study, including progress toward enrollment targets and milestones. And FDORA requires FDA to issue a guidance describing how sponsor questions related to the identification of novel surrogate or intermediate clinical endpoints may be addressed in early-stage development meetings with the agency. The guidance should also describe the use of novel clinical trial designs that may be used to conduct appropriate post-approval studies, and considerations related to the use of surrogate or intermediate clinical endpoints that may support an accelerated approval.
One provision missing from the legislation is the Verifying Accurate Leading-edge IVCT Development (VALID) Act that would have clarified FDA’s authority over lab-developed test but were omitted due to “opposition from stakeholders (including academic medical centers) as well as a reluctance by certain members to increase FDA’s authority,” according to a summary by the law firm Arnold & Porter. The attorneys say it will be important to monitor FDA’s response because “commissioner Robert Califf has indicated that the agency will lean harder on its existing authorities, which could include rulemaking. In addition, another top FDA Center for Devices and Radiological Health official has stated that ‘FDA believes that enforcement discretion policy no longer makes sense here, suggesting a major shift in the way the agency regulates laboratory developed tests.’”
Other absent provisions that stakeholders sought are dietary supplement listing requirements, proposals related to drug importation, and a proposal intended to reverse the Eleventh Circuit’s decision in Catalyst Pharmaceuticals, Inc. v. FDA that is about the scope of orphan drug exclusivity (see earlier story). But FDORA does include language that is intended to “partially reverse the DC Court of Appeals decision in Genus Medical Technologies v. FDA (which held that FDA could not classify any product, including the contrast agent at issue in the case, as a drug when it also meets the definition of a device) for most affected products” (see story), the summary notes.
Additionally, FDORA includes language describing the circumstances under which the agency will undergo a therapeutic equivalence evaluation for drugs approved under the 505(b)(2) pathway. And the legislation directs FDA to establish an advanced manufacturing technologies designation program and to expedite the development and review of NDAs/BLAs products manufactured using such technologies.