Last week the White House released a memo, which put forth a directive that potentially threatens the future of many scientific innovations that could save patients’ lives. The memo outlined that the Office of Management and Budget (OMB) would now need to review all non-binding guidance documents from all federal agencies. These guidance documents would then be subject to a congressional vote. Guidances are intended to convey an agencies position on processes, policies and emerging questions of the field in which a specific agency regulates. Their use and impact vary significantly agency-by-agency; a nuance that this memo ignores completely.
Now this may seem like just another step in the usual slog of government bureaucracy — or part of the administrations agenda to cut government regulation. However, a delay in guidance from an institution like the U.S. Food and Drug Administration (FDA) — which regulates a quarter of the United States economy — carries significant weight and consequence.
For decades the FDA has put forth some of its most innovative and important paths for how new therapies will be reviewed and how they can most efficiently, effectively and safely get to patients. This includes instruction to industry on how clinical trials can be better constructed to be more efficient, accessible and patient-focused.
By creating this delay — with an unnecessary extra review step — all future cancer guidance documents that are helping to promote innovation and access could be significantly delayed and may be halted. With the current pace of scientific discovery unfolding at an unprecedented pace, now more than ever does the FDA need be able to effectively communicate with the biomedical research community regarding pressing development issues and future paradigms.
In 2019 alone, the FDA plans to issue 111 guidances (Center for Drug Evaluation and Research: 93, Center for Biologics Evaluation and Research: 18). This covers a range of issue areas, such as the development of therapies for rare diseases and addressing an issue this very White House deemed a national emergency and a public health crisis through the assessment of opioid benefits and risks.
If enacted, this memo could impact public safety, impede access to clinical trials, or even delay entire new fields of drug development from efficiently moving forward.
FDA is unique from most all other agencies in this process. The agency currently has a robust process for issuing and reviewing potential guidance — including a robust public vetting of draft guidance that are noticed and open for public comment and input long before they are finalized.
This process — along with other mechanisms that were recently instituted as part of the bipartisan 21st Century Cures Act — (such as the ability for professional societies and patient groups to provide direct input on needed guidance) should serve as a model for transparency and efficiency — not a target of a sweeping memorandum.
The FDA is at its core a public health agency and should not be bucketed with those institutions that regulate commerce and business practice. Yes, the FDA does regulate multi-billion-dollar companies in how they are able to commercialize their products. However, their products impact is less counted by financial gain and more by lives saved. All of this necessitates that FDA should and must be exempt from the directive in this memo. Because advancing science, protecting consumers, and bettering patients’ lives are too important to fall victim to a policy misstep.