FDA Unveils Voucher Program In Effort To Speed Up Drug Review Time
A new program will let drug developers who are "aligned with U.S. national priorities" submit a portion of their applications at least two months early, allowing the review process to be shaved from 12 months to possibly one or two. Plus, a push for psychedelics for mental health treatment.
Bloomberg:
FDA Announces New Vouchers To Cut Drug Reviews To Two Months
The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one to two months for companies it says are backing national interests. The Commissioner’s National Priority Voucher program is intended to slash review times from the current average of 10 to 12 months, the agency said in a statement on Tuesday. In the first year of the program, the FDA plans to give a limited number of vouchers to companies “aligned with U.S. national priorities,” it said. (Amponsah, 6/17)
On federal health funding cuts and DEI —
MedPage Today:
Patient Safety Network Papers Restored Amid Lawsuit From Doctors
Papers removed from a government patient safety website earlier this year have been restored. The reappearance of the papers comes amid a lawsuit challenging their removal from the Patient Safety Network (PSNet), which has existed as part of the Agency for Healthcare Research and Quality (AHRQ) under HHS. (Henderson, 6/17)
AP:
Judge Says Trump Administration Can't Cut Public Health Funding For Houston, Nashville, Other Cities
A federal court has temporarily blocked the Trump administration from clawing back millions in public health funding from four Democrat-led municipalities in GOP-governed states. It’s the second such federal ruling to reinstate public health funding for several states. U.S. District Judge Christopher Cooper in Washington, D.C., issued a preliminary injunction Tuesday sought by district attorneys in Harris County, Texas, home to Houston, and three cities: Columbus, Ohio, Nashville, Tennessee, and Kansas City, Missouri. The decision means the federal government must reinstate funding to the four municipalities until the case is fully litigated. (Shastri, 6/18)
The New York Times:
Trump Official Eyes Power Of Rescission To Override Congress On Spending
The White House is signaling it may soon invoke a little-known and legally untested power to try to cancel billions of dollars in federal spending, as President Trump’s top aides look for novel ways to reconfigure the budget without obtaining the explicit approval of Congress. Under the emerging plan, the Trump administration would wait until closer to Sept. 30, the end of the fiscal year, to formally ask lawmakers to claw back a set of funds it has targeted for cuts. Even if Congress fails to vote on the request, the president’s timing would trigger a law that freezes the money until it ultimately expires. (Romm, 6/17)
On RFK Jr. and MAHA —
Stat:
RFK Jr., FDA Eye Psychedelics For Mental Health Treatment
Eight months after Robert F. Kennedy Jr. declared that the Food and Drug Administration’s “aggressive suppression of psychedelics” was about to end, he and his newfound allies in the Trump administration are in a position to do something about it. (Goldhill and Keshavan, 6/18)
Bloomberg:
General Mills Is Latest Packaged-Food Company To Remove Dyes
Packaged-food maker General Mills Inc. is joining Kraft Heinz Co. in removing synthetic food dyes from its US products by the end of 2027 — a move that will eliminate ingredients such as Red 40 and Yellow 5 from its brightly colored cereals. The Minneapolis-based company said it will remove the colorants from US cereals and foods served in schools by the summer of next year. The company will also “work to remove certified colors from its full US retail portfolio by the end of 2027.” (Kubzansky, 6/17)
Other news from the Trump administration —
Stat:
CDC Leaders Rally Troops, Sidestep Controversy In All-Hands Meeting
In their first all-staff meeting since the start of the Trump administration, the interim leadership of the Centers for Disease Control and Prevention attempted to sidestep controversy and rally troops at the storied but demoralized agency on Tuesday. (Branswell, 6/17)
The New York Times:
Why A Vaccine Expert Left The C.D.C.: ‘Americans Are Going To Die’
Dr. Fiona Havers is influential among researchers who study immunizations. The wholesale dismissal of the agency’s scientific advisers crossed the line, she said. (Mandavilli, 6/18)
The Washington Post:
DHS Secretary Noem Taken To Hospital After Allergic Reaction
Homeland Security Secretary Kristi L. Noem was taken to a hospital on Tuesday after suffering an allergic reaction, a department spokesperson told The Washington Post. Tricia McLaughlin, an assistant secretary for DHS, said Noem was transported to the hospital by ambulance “out of an abundance of caution” and “is alert and recovering.” (Tucker and LeVine, 6/16)
