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Six former FDA commissioners are urging President Biden to quickly nominate an FDA commissioner. The FDA, which plays a central role in the coronavirus pandemic, has been without a permanent commissioner since January and there’s no telling when that will change. Biden is already on track to nominate an FDA commissioner later in his tenure as president than his two most immediate predecessors. (Florko, 3/9)

Seemingly overnight, the Food and Drug Administration appears to be taking a more risk-averse stance on drug reviews, leaving drug makers confused and their stock prices battered. Acadia Pharmaceuticals said Monday evening that it was notified by the FDA about “deficiencies” in its application for an expanded use for its anti-psychosis drug Nuplazid. The company said the letter from the agency arrived on March 3 without any warning, exactly one month before Acadia was expecting a decision on Nuplazid’s approval. (Feuerstein, 3/9)

The Department of Health and Human Services’ watchdog is examining how the Centers for Disease Control and Prevention can improve the accuracy of its data on Covid-19’s toll by race and ethnicity, according to two senior administration officials with direct knowledge of the investigation. The HHS inspector general has interviewed several officials who deal with Covid-19 data over the past week and plans to continue meeting with the agency over the coming days, those sources said. Those initial conversations suggest the inspector general is focused on finding ways to get a more complete picture, particularly around vaccinations, and how the agency can more closely coordinate with states on the collection of the data, officials said. (Banco and Tahir, 3/9)

In the decade-plus since it became law, the Affordable Care Act has helped slow the explosive growth in health spending. But the United States still spends about twice as much per capita as other wealthy nations. That leaves President Joe Biden with an enormous health care challenge, beyond leading the country out of the pandemic: curbing health care cost increases that, economists warn, are unsustainable. The political obstacles will be enormous. Biden faces a Republican Party that has spent the past decade trying to destroy the ACA. There also is a remote possibility that the U.S. Supreme Court will scrap Obamacare when it rules on a challenge to the law mounted by GOP state attorneys general, many legal experts say. And Biden will have to overcome the resistance of powerful medical and pharmaceutical interests that oppose price constraints. (Ollove, 3/8)