reshuffling priorities
Spotlighting and upstaging
By spotlighting the vaccine announcement, the administration stole attention from a nearly simultaneous one about increasing regulation of food additives, a major MAHA priority that, until recently, was the type of popular nutrition policy the White House wanted to shift to in the lead-up to the midterm elections.
Companies will need to notify the Food and Drug Administration before adding new substances to food, STAT’s Isabella Cueto and Elizabeth Cooney report. They’ll need to provide details on how they deemed the additive to be “generally recognized as safe.” Companies with GRAS substances already on the market would need to tell the FDA for the first time how the additives are used, and that information would be posted in a public database.
Read more about how the increased regulation still falls short of what MAHA had hoped for.
drug development
China tightens the reins on clinical trials
China’s rise in the field of biotechnology has been credited in large part to its relaxed clinical trial regulations. But as clinical trial deaths mount, China is mulling more oversight, STAT contributor Brian Yang reports.
China allows investigator-initiated trials, which let researchers launch clinical trials without approval, or review by, China’s equivalent of the Food and Drug Administration. But failed trials are not publicly reported, and at least two children have died in these types of trials in the past year.
Read more about the steps Chinese authorities are considering to rein in in those trials.
national security
WuXi AppTec gets reprieve from DOD blacklist
A federal district judge suspended the Defense Department’s designation of WuXi AppTec as a company with ties to the Chinese military.
Companies on the Defense Department’s blacklist, called a 1260H designation, are barred from contracting with the department and receiving certain federal funding, and the list is the predicate for treatment as a “biotechnology company of concern” under the BIOSECURE Act.
The preliminary injunction gives the major drug manufacturer temporary relief while the lawsuit (case no: 1:26-cv-02069) is heard by the U.S. District Court for the District of Columbia. Chief Judge James E. Boasberg wrote that the company “established a likelihood that the designation was arbitrary and capricious,” according to a court filing.
recess
Congressional odds and ends
Senators finished up their work over the weekend after passing a stopgap funding bill and confirming Todd Blanche as attorney general, both of which have implications for health care policy.
The government-funding bill, which runs until Dec. 11, includes a measure to block the White House’s proposal to give political appointees control over federal research grants. The House’s version of the bill doesn’t include that measure. The House could either pass the Senate bill when it returns on Aug. 31 or wait until the Senate returns on Sept. 14 to reconcile differences before current government funding runs out after Sept. 30.
Blanche, who has been the acting AG since April, recently told an anti-abortion group during a private meeting that the Justice Department is working with other federal health agencies and the White House “so that the Dobbs decision becomes permanent in every single state.” That statement refers to mail order abortion drugs, the DOJ told Politico.
medicaid
Brookings criticizes work requirement rule
The Brookings Center on Health Policy published a critical analysis of the administration’s regulation implementing Medicaid work requirements.
The central finding is that the administration assumes that work requirements will result in 29% of affected people in Medicaid getting jobs. That figure is more than six times higher than the largest estimate in any relevant research, the analysis states, including Arkansas's real-world experience with work requirements. In that case, work requirements caused major coverage losses with no measurable rise in employment.
They also flag an internal contradiction: the Centers for Medicare and Medicaid Services projects fewer people losing coverage than the nonpartisan Congressional Budget Office does, yet 10% more in federal savings.
