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The First Amendment and Direct-to-Consumer (DTC) Prescription Drug Ads

Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more

Most-Favored-Nation Drug Pricing in the U.S.

On May 12, President Trump issued an Executive Order (EO) on drug pricing: “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” The EO requires a 30-day government negotiation with drug companies...more

Trump Administration Issues Wide-Ranging EO to Lower Drug Prices

On April 15, President Donald Trump signed an Executive Order (EO) titled “Lowering Drug Prices by Once Again Putting Americans First,” outlining a renewed policy agenda to reduce prescription drug costs. The EO is framed as...more

Trump Administration Takes First Steps Towards Tariffs on Pharmaceuticals

After months of signaling, the Department of Commerce disclosed on April 14 that it had begun an investigation into the national security impacts of importing pharmaceuticals, pharmaceutical ingredients and derivative...more

FDA Drug Review Threatened by a Government Shutdown

The Food and Drug Administration (FDA) is not likely to continue to review and approve human drugs or medical devices if the federal government shuts down in March....more

FDA Nominee Makary on the Orphan Drug Act

President-elect Trump’s nominee for commissioner of Food and Drugs, Martin A. Makary, MD, MPH, argued in 2016 that Congress should reform the Orphan Drug Act (ODA) because drug companies “are gaming the system to use the law...more

FDA’s Drug Review Gold Standard

Robert F. Kennedy Jr., President-elect Trump’s nominee for secretary of health and human services, has said one of his mandates from the president-elect is to return agencies to the gold standard of scientific review. This...more

Biden Reveals Health Care Priorities in FY 2024 Budget

Today, Thursday, March 9, President Biden unveiled his Fiscal Year (FY) 2024 budget request, the third of his presidency. The $6.1 trillion proposal calls for $1.9 trillion in discretionary spending and $4.2 trillion in...more

Summary of Health Care Provisions in Energy & Commerce Reconciliation Bill

This week, the House Energy and Commerce Committee approved sweeping health care legislation as part of the Democratic Congress’ plan to enact a $3.5 trillion legislative package through budget reconciliation. The committee...more

CMS Releases Long-Awaited Block Grant Guidance

On Thursday, Jan. 30, the Centers for Medicare and Medicaid Services (CMS) released the Healthy Adult Opportunity initiative, long-awaited guidance that would enable states to convert Medicaid funding into a block grant for...more

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