A coalition of 34 scientific and medical organizations led by the American Association of Immunologists and the American College of Physicians released the following statement.
AMCP Comment Letter on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
In AMCP's latest comments to the FDA, we emphasize the need for standardized public reporting of confirmatory trial progress, ensuring payers and health care providers have the necessary data to make informed coverage decisions. By supporting proactive communication and rigorous confirmatory trials, AMCP aims to balance early access to innovative treatments with patient safety and long-term therapeutic value.
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The Protecting Pharmacies in Medicaid Act would prohibit the use of spread pricing arrangements in Medicaid programs. Pharmacy benefit managers (PBMs) would be required to pass through to pharmacies the full amount of the money paid to the PBMs by Medicaid programs, except for a fixed administrative fee. The total reimbursement amount will be determined by a survey of national average drug acquisition costs administered by the Department of Health & Human Services.
Over the weekend, Congressional leadership released a continuing resolution (CR) that extends government funding at the same level as the previous fiscal year, through September 30. Congress must extend government funding by March 14 to avoid a government shutdown.
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