Anti-abortion groups created a firestorm after FDA was statutorily obligated to approve a new generic mifepristone, citing mixed signals from the agency that has been reviewing whether it is safe to continue the abortion medication to be prescribed via telehealth.
Consumer advocates and health care experts are questioning the Trump administration’s claim last week that standalone Medicare Part D premiums will decrease for 2026 and worry that CMS’ unprecedented move to reject plan bids may limit options and potentially drive more people to Medicare Advantage.
Stakeholders are reeling from a roller coaster week in drug pricing -- from the Trump administration’s landmark drug pricing deal with Pfizer to CMS’ final Medicare guidance, and a surprise demo landing at the White House -- and Inside Drug Pricing has the latest:
The Third Circuit Court of Appeals on Monday (Oct. 6) unanimously rejected Novo Nordisk’s claims the Medicare drug price negotiation program violates of the First and Fifth Amendments, as well as the nondelegation doctrine of the Constitution's separation of powers -- marking the 15th rejection or dismissal by a court of the drug industry’s effort to block the Inflation Reduction Act’s (IRA) price negotiation program.
Amgen became the latest company to launch a new direct-to-patient program, announcing Monday (Oct. 6) it will make its blockbuster cholesterol drug Repatha available at nearly a 60% discount to U.S. patients in response to the Trump administration’s push to lower drug prices.
Deputy HHS Secretary Jim O’Neill, currently serving as the acting CDC director, has called on vaccine manufacturers to break the measles, mumps and rubella (MMR) vaccine into three separate shots, a demand virologists say has no public health justification and would make immunization more expensive and less accessible.
As the government shutdown that began Oct. 1 continues, unions representing government employees are seeking emergency relief from two California judges to prevent the Trump administration from conducting layoffs during the lapse in appropriations, while many other court cases on the administration’s heath policy have been postponed during the interruption in funding for the Department of Justice.
FDA is asking stakeholders to comment on practical postmarket surveillance strategies for artificial intelligence-enabled medical devices, but the Trump administration is signaling that the prominent Coalition for Health AI (CHAI) won't be central to its emerging strategy for postmarket vetting.
CMS told state Medicaid agencies that emergency services provided for undocumented residents ineligible for full benefits can no longer be included in capitated payments to Medicaid managed care due to program integrity concerns and must be paid either through fee for service or other no-risk contracts.
Facing pressure from the Trump administration, the Pan American Health Organization tabled a proposed policy that called for countries to ensure continuity of care for migrants being returned to their home countries, and also removed references to abortion and transgender care from its separate strategic plan that advanced last week.
