FDA

Following up on Trump’s orders, the FDA wants to know: which regulations and paperwork requirements need to go?

As part of work under two executive orders, FDA centers on Thursday sought comments on which existing regulations and related paperwork requirements could be modified, repealed or replaced, to reduce the burden on industry while allowing the regulator to continue its public health mission while fulfilling statutory obligations.

Back in February, when President Donald Trump first announced his order to reduce regulatory burdens, several experts pointed Focus to some outdated regulations that could be removed with little impact on public health and the agency’s mission, though there are still questions as to what types of regulations will be targeted.

And as Anna Abram, FDA’s deputy commissioner for policy, planning, legislation and analysis, noted in a blog post on Thursday, there’s “a lot of ground to cover” as FDA’s regulations comprise more than 4,000 pages in the Code of Federal Regulations.

In general, though, the agency says it’s looking for comment and supporting technical, scientific, economic or other data from those significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and state, local and tribal governments.

“Some regulations may not adequately reflect advances in science, technology or changes in industry practice. Others may be geared toward products and practices that have largely ceased to exist,” Abram said, offering the example of how the manipulation of FDA’s rules on Risk Evaluation and Mitigation Strategies (REMS) can create obstacles to the timely entry of generic competition.

Featured in Thursday’s Federal Register notices are questions FDA says it is using to guide its initial review, including:

  • Is the regulation still current, or is it outdated or unnecessary in some way?
  • Have regulated entities had difficulties complying with the regulation?
  • Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (e.g., International Council for Harmonisation, International Organization for Standardization, Codex Alimentarius)?
  • Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records, e.g., reporting, recordkeeping, or labeling requirements?
  • Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection?
  • What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?

Links

Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration

Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements

Review of Existing Center for Biologics Evaluation and Research Regulatory and Information Collection Requirements

Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements


Image: Getty, Endpoints News, The White House

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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