Unified Agenda: A look at FDA’s upcoming rulemaking
Under the Biden administration’s first regulatory agenda, the US Food and Drug Administration (FDA) is preparing to promulgate three dozen proposed and final rules related to human drugs, biologics, medical devices and clinical trials.The proposed and final rules are detailed in the belated Spring 2021 unified agenda released by the Office of Management and Budget last week. Many of the rules are holdovers from previous biannual agendas, such as a final rule on the de novo classification process for medical devices and a proposed rule on modernizing the quality system regulation to harmonize with the international standard, ISO 13485:2016. Both rules, as well as proposed rules related to the classification of over-the-counter hearing aids and the classification of spinal spheres for use in intervertebral fusion procedures, are slated for publication this month, according to the latest agenda.
Other final rules slated for a notice of proposed rulemaking (NPRM) in the coming months include rules on “intended uses” and summary reporting under the Right to Try Act, as well as a rule that would allow the use of drug master files (DMFs) for so-called “deemed to be a license” biologics. (RELATED: FDA issues proposed rule clarifying stance on intended use, Regulatory Focus 23 September 2020; : FDA proposes reporting rule for Right to Try Act, Regulatory Focus 23 July 2020; FDA proposes new rule on allowing the Use of DMFs for Transitioning Biologics, Regulatory Focus 27 June 2019)
However, the agency’s deadline for one item that appears on the agenda, a final rule that would end FDA’s quarterly reporting of certain device decisions, has already come and gone. (RELATED: FDA wants to end quarterly reporting of device decisions, Regulatory Focus 16 December 2019)
“This Agenda presents the regulatory activities that the Department expects to undertake in the foreseeable future to advance this mission,” the Department of Health and Human Services wrote in its preamble to the agenda. “The regulatory actions forecasted in this Agenda reflect the priorities of the Biden-Harris Administration and HHS Secretary Xavier Becerra. Accordingly, this Agenda contains rulemakings aimed at advancing equity and ensuring nondiscrimination in health; ending the COVID-19 public health emergency; enhancing access to quality, affordable health care; addressing child welfare and maternal health; safeguarding the quality of medical products; protecting the public health by reducing tobacco use; revising prior actions that are inconsistent with the policy of this Administration; and supporting other priority areas.”
HHS also clarifies that the previous unified agenda and accompanying Statement of Regulatory Priorities issued in Fall 2020 by the Trump administration “no longer reflect views of the Department or this Administration.”
