Capitol Correspondence - 09.22.20

HHS Issues Memo Asserting Secretary Azar’s Authority Over Regulatory Process

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Politico Pulse shared reporting by the New York Times on changes to the regulatory process within the Department of Health and Human Services (HHS). While it is unclear what effect this process will have on the timing of new regulations, we are sharing this item with our readers for their general awareness because many changes to the Medicaid program are done through the regulatory process.

“The health secretary wrote in a Sept. 15 memo that he would need to sign any new rules that his department’s agencies are posting, the New York Times first reported . It’s not clear why HHS is pursuing this path now, so close to an election, but it’s raised hackles among the FDA and public health community, including some who have suggested that HHS is seeking to control any coronavirus-related developments.

Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner, told the NYT that the new policy was ‘a power grab’ that would slow the regulatory process.

— HHS moved to knock the story down, issuing a statement on its regulatory process and an accompanying question-and-answer document.

‘Any speculation about this memo being motivated by policy considerations is utterly misinformed,’ the department said in a statement. ‘The memo should have no effect on operational work and does not pertain in any way to guidance or any vaccine or drug approval or authorization.’”