Califf Clears First Senate Hurdle, But FDA Abortion Pill Decision May Complicate Final Confirmation

Republican opposition to Califf over the agency’s recent move to relax its Mifeprex restrictions is ominous since in order be confirmed as FDA commissioner he’ll need enough GOP votes to make up for Democratic opposition over his opioid track record and connections to the drug industry.

Robert Califf testisified 14 Dec 2022 at the Senate HELP committee
Robert Califf testified on 14 December at the Senate HELP Committee • Source: Alamy

The Senate Health Committee voted 13-8 on 13 January to advance Robert Califf’s nomination to lead the US Food and Drug Administration. The positive but close vote sharply contrasted with his unanimous committee vote when he was confirmed to lead FDA under President Barack Obama and is indicative of a much tougher fight Califf is likely to face on the Senate floor this go round.

A key stumbling block appears to be FDA’s recent action to make it easier for people to access the abortion...

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New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

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Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

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The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.