Legal questions swirl around FDA’s new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...
JD Supra

Medicare Drug Price Negotiation Program: The Inflation Reduction Act “Pill Penalty” and Other IRA Reforms on the Horizon for 2026

When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators. In ...
Washington Examiner

Controversial changes to drug pricing program are progressing through state legislatures

A bill bolstering a federal drug discount program that conservative critics have warned is a backdoor effort to subsidize transgender treatments for minors passed in the Oklahoma Senate last week, ...

Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times.
JD Supra

OIG Deems Free Drug Patient Assistance Program Low-Risk in Advisory Opinion 25-01

On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s ...