Trials and tribulations

The FDA plans to require just one clinical trial, instead of two, for medical product approvals, according to Commissioner Marty Makary, who spoke exclusively with my colleague Lizzy Lawrence about the plan.

Makary has said the longtime two-trial standard is overly bureaucratic. But career agency scientists believe a one-trial standard would tarnish the agency's vaunted gold standard. Read more about the debate.

The change, intended to speed product reviews, is believed to have contributed to drug center head Richard Pazdur's decision to leave the agency, two sources told Lizzy, who was the first to report on Pazdur's departure.

Pazdur agreed to head the FDA's drug center based on the promise that he would be shielded from politics in an administration rife with political interference. He lasted about a month, and is being replaced by Tracy Beth Høeg, a Makary aide who investigated Covid vaccines.

Pazdur joins a long list of FDA officials leaving the agency — or being reassigned — during the Trump administration. In fact, a day after Pazdur's retirement announcement, Lizzy wrote that the FDA removed the longtime director of the Office of Nonprescription Drugs. Theresa Michele told staff at an internal meeting on Wednesday afternoon that she is being transferred to the FDA's medical devices center, effective today.

This upheaval has experts worried. Even the drug industry, which has taken pains to appease the Trump administration, is starting to speak out about the destabilization.

Read more for a rundown of the turnover at the drug center, along with the policy debates and drama. And click here for a running list of officials who have left the agency this year.

vaccines

12

That's how many former FDA commissioners signed onto a paper in the New England Journal of Medicine warning that planned changes to vaccine regulation would hurt public health, Matthew Herper wrote.

The changes, as described in a leaked memo by Vinay Prasad, the FDA's top regulator of biologics, "will upend core policies governing vaccine development and updates," the former commissioners wrote in their piece.

The article, written by almost every head of the agency for the past 35 years, is a striking show of unanimity among those who have served in both Republican and Democratic administrations.

acip

Shut out

Today, the CDC's Advisory Committee on Immunization Practices is scheduled to review the hepatitis B vaccine, and STAT will be following the meeting closely.

Experts on the shot — both in and outside of the government — told Daniel Payne and Chelsea Cirruzzo that they were shut out of the process.

CDC subject matter specialists, who usually present agency data and answer questions from committee members, are also not expected to speak at the meeting. Read more.

aca

Still no Democratic ACA bill

Democratic minority leaders Sen. Chuck Schumer (N.Y.) and Rep. Hakeem Jeffries (N.Y.) held a press conference on Wednesday to say they are united on a plan to extend enhanced the ACA tax credits. But they didn't say for how long.

Democrats say there isn't enough time to negotiate a different approach to the current system, so they're asking for an extension of the credits. House Democrats have all signed a discharge petition seeking to force a vote on a bill for a three-year extension, while some moderate Senate Democrats want to request a one-year extension, which would be more palatable to some moderate Republicans.

It's not clear why Democrats haven't decided on the length of their extension request. The Senate is supposed to vote on a bill of Democrats' choosing by Dec. 15.

Republicans are much further apart on their approach. Senate Health Committee Chair Bill Cassidy (R-La.) on Wednesday held a hearing aimed at discussing a potential compromise, but the two parties didn't seem to make any progress. President Trump hasn't outlined his preferred approach, either.

Most Republicans would prefer to pivot away from health care next year, because it's a topic on which they don't poll well. Others, like Cassidy, would like to work on bipartisan health care reform. The conservative wing wants to use budget reconciliation, which would cut out Democrats, to move conservative reforms that echo the GOP's 2017 repeal-and-replace efforts.

There are 11 days left to enroll in ACA marketplace plans for next year.

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