FDA is smashing the status quo for regulatory science

  • STAT | by: Peter J. Pitts |
  • 10/14/2019 12:00 AM
A recent press release from the Food and Drug Administration titled “Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality,” may have sounded like another bland and boring exercise in regulatory rhetoric. But it actually signals a revolutionary shift in regulatory velocity.

Changes in the FDA’s Office of New Drugs (OND) will create enhanced review zones that cross disease areas and divisions to maximize access to more focused and innovative areas of regulatory expertise. These changes will, among other things, increase the number of OND offices overseeing product reviews from six to eight and increase the number of specific clinical review divisions from 19 to 27. The rationale is to make the FDA more efficient and help it better understand the diseases that are the aim of treatment by the drugs being evaluated for approval.
These changes represent the FDA’s admission that it must be a leader in regulatory science — the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products — by dint of true expertise rather than for simply “being the FDA.” It recognizes that laying claim to the regulatory gold standard is a moving target.

The devil may be in the details but, as Admiral Hyman Rickover once said, “so is salvation.”

Increasing regulatory velocity

The hidden gem within the FDA’s announcement is a reorganized Office of New Drug Policy. As a former FDA associate commissioner, I see this as one of the most exciting elements of the reorganization effort.

The most potent way the FDA can enable innovation is by being a partner in advancing new approaches to both drug development and regulatory science. This begins at the conceptual policy level. Historically, there have been heterogeneous approaches to policy within the Office of New Drugs. Alas, regulatory ambiguity doesn’t instill confidence in an already high-risk developmental environment.

Under the FDA’s new plan, the new drug policy function is largely centralized in the reorganized Office of New Drug Policy. (Clinical expertise and decision rights remain firmly in the review divisions.) The policy staff — which includes clinicians, regulatory affairs experts, and lawyers — distills and aligns OND’s thinking across therapeutic areas in close coordination with clinical leadership and specialized partner offices throughout the FDA. The intent is to provide greater consistency and nimbleness regarding, for example, the appropriate use of new tools and techniques for drug development. This is as much a scientific issue as it is one of social and cultural calibration across therapeutic review divisions. Sometimes even brilliant scientists have a hard time viewing new ideas without being threatened by them.

To foster a more robust conversation about a more efficient and empowered Office of New Drugs, the FDA is holding a public meeting in November to solicit input on clinical policy priorities.

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