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# Cancer Activist Protests Trump Move on FDA Guidances
- URL: https://www.fdaweb.com/cancer-activist-protests-trump-move-on-fda-guidances/
- Published: 2019-04-18T12:00:00.000Z
- Updated: 2026-09-15T01:21:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143903

Friends of Cancer Research chairperson **Ellen Sigal** says a recent White House memo requiring Office of Management and Budget (OMB) review of all non-binding guidance documents from all federal agencies “potentially threatens the future of many scientific innovations that could save patients’ lives.” Writing in an [op-ed](https://thehill.com/opinion/healthcare/439342-we-are-cutting-government-regulation-at-the-expense-of-patients-lives?eType=EmailBlastContent&eId=c104ee4c-26c3-4592-8534-902979b45dd6&ref=fdaweb.com) in *The Hill*, Sigal says that after the OMB review, guidances would be subject to a congressional vote.

“Guidances are intended to convey an agency’s position on processes, policies, and emerging questions of the field in which a specific agency regulates,” Sigal says. “Their use and impact vary significantly agency-by-agency, a nuance that this memo ignores completely…. For decades, 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.”

She writes that with this delay, which involves 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,” Sigal writes, “now more than ever does FDA need \[to\] be able to effectively communicate with the biomedical research community regarding pressing development issues and future paradigms.”

Sigal says FDA plans to issue 111 drug and biologic guidances in 2019 and says the White House plan 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,” she says. “The agency currently has a robust process for issuing and reviewing potential guidance, including a robust public vetting of draft guidances that are noticed and open for public comments and input long before they are finalized. This process, along with other mechanisms that were recently instituted as part of the 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.”