Pathways’ Picks December 15: Califf on the Hill, HHS Agenda, and More

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ARTICLE SUMMARY:

In this week’s roundup: FDA Commissioner-nominee Robert Califf testifies in the Senate, CMS alternative to MCIT is one highlight of HHS’ latest regulatory agenda, FDA chips away at classification backlog, EU issues more implementation documents, and more updates from China, India, and US FDA.

DC Picks

Updates from the Hill and HHS:

Califf talks to Senate. FDA Commissioner-nominee Robert Califf testified before the Senate Health, Education, Labor, and Pensions Committee December 14, responding to questions on an array of FDA topics. The senators did not specifically focus much on medical devices, other than several lawmakers pushing for broader access to COVID tests. The opioid epidemic and FDA deliberations on whether to broaden access to an abortion pill (mifepristone) were two repeat topics at the hearing that could sway lawmaker’s ultimate votes on Califf’s confirmation. Near the end of the hearing, Sen. Richard Burr (R-NC), the leading Republican on the committee, urged his colleagues to support Califf. Republican votes will be necessary for the cardiologist and former FDA commissioner to be confirmed. Several Democrats oppose Califf because they don’t feel he’s been strong enough in response to opioid addiction issues or because of his financial relationships with industry that result from years as a leading clinical researcher.

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