Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations
BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

After three weeks of brutal combat, Richard Pazdur decided that he has had enough.

December 05, 2025

Vinay Prasad to CBER employees: “It is not wise for FDA to further pollute the scientific literature with papers we cannot defend”

Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”

FDA releases draft guidance on reducing testing on non-human primates for monoclonal antibodies

FDA issued a draft guidance on Dec. 2, outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.

Vaccine skeptic installed as CDC’s new second-in-command

Ralph Lee Abraham, a Louisiana surgeon general who implemented controversial policies and held views that have drawn significant criticism from public health experts, has quietly been installed as the second-highest official at the Centers for Disease Control and Prevention.

December 05, 2025

Vol.51 No.44

By Claire Marie Porter

Cancer Policy

CMS cuts deal on four oncology drugs under Medicare

The Center for Medicare and Medicaid Services said it has negotiated down the price of 15 drugs, including significant discounts to four costly cancer treatment drugs, according to an announcement from Nov. 25.

Medicare Part B premiums expected to rise almost 10% in 2026

Centers for Medicare and Medicaid Services has announced that monthly premiums for Medicare Part B will begin costing patients $202.09 per month next year—a 9.7% rise up from $185 in 2025—for individuals making an annual income of $109,000 or less.

December 05, 2025

Vol.51 No.44

By Sara Willa Ernst

Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

YOU MAY BE INTERESTED IN

Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations
BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

Vinay Prasad to CBER employees: “It is not wise for FDA to further pollute the scientific literature with papers we cannot defend”

FDA releases draft guidance on reducing testing on non-human primates for monoclonal antibodies

Vaccine skeptic installed as CDC’s new second-in-command

CMS cuts deal on four oncology drugs under Medicare

Medicare Part B premiums expected to rise almost 10% in 2026

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Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

YOU MAY BE INTERESTED IN

Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulationsBIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

Vinay Prasad to CBER employees: “It is not wise for FDA to further pollute the scientific literature with papers we cannot defend”

FDA releases draft guidance on reducing testing on non-human primates for monoclonal antibodies

Vaccine skeptic installed as CDC’s new second-in-command

CMS cuts deal on four oncology drugs under Medicare

Medicare Part B premiums expected to rise almost 10% in 2026

Never miss an issue!

Login

Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations
BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”