Sean Feely on Food and Drug Administration (FDA)

Happy Birthday Two You, IRA: Drug Pricing Dynamics to Watch as Maximum Fair Price Announcements Loom

This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more

8/14/2024 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Due Process , Fair Price , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Negotiations , Pharmacy Benefit Manager (PBM) , PHRMA

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

1/2/2024 / Appropriation , Artificial Intelligence , Clinical Laboratories , Congressional Oversight , Department of Health and Human Services (HHS) , Diagnostic Tests , Drug Pricing , Fiscal Year , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Inflation Reduction Act (IRA) , Medicare , Mental Health , Pharmaceutical Industry , Price Transparency , Proposed Rules , Supply Shortages

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

9/1/2023 / Animal Drugs , Coronavirus/COVID-19 , DEA , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Healthcare , Inflation Reduction Act (IRA) , Opioid , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Supply Shortages , Telehealth , Transparency

FDA Harshes the CBD Buzz; is it High Time for Congress to Step In?

The U.S. Food and Drug Administration (FDA) announced the conclusion of an internal working group that cannabidiol (CBD) will require a new regulatory pathway. The FDA explicitly denied three citizen petitions urging the...more

1/30/2023 / Cannabidiol (CBD) oil , Decriminalization of Marijuana , Dietary Supplements , Food and Drug Administration (FDA) , Marijuana , Regulatory Agenda , Regulatory Oversight , Working Groups

As “Skinny” FDA User Fee Reauthorizations Cross Finish Line, Congress Prepares to Revisit FDA Policy Riders in Lame Duck Session

On September 30, 2022, Congress enacted legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and biologics, medical devices, generic drugs and biosimilars (PDUFA,...more

10/6/2022 / Continuing Resolution , Food and Drug Administration (FDA) , Lame Duck Session , Legislative Agendas , Telehealth , User Fees

FDA User Fee Reauthorization Legislation Continues to Simmer in Congress: What’s at Stake and What it Means for September

Update on UFA Reauthorization Legislation - As outlined in Akin Gump’s previous analysis, the current five-year authorization of the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and...more

8/15/2022 / BsUFA , Food and Drug Administration (FDA) , GDUFA , Medical Device User Fee Program (MDUFA IV) , Medical Devices , PDUFA , User Fees

FDA User Fee Reauthorization Gains Momentum with Senate HELP Committee Approval

There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more

6/27/2022 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , HELP , Imports , Medical Devices , Prescription Drugs , User Fees

Senate HELP Committee Unveils Draft FDA User Fee Reauthorization Legislation, with Major Reforms to In Vitro Diagnostics,...

On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more

5/24/2022 / Biologics , Biosimilars , Food and Drug Administration (FDA) , GDUFA , Generic Drugs , Medical Devices , PDUFA , Prescription Drugs , User Fees

FDA Preparedness Reforms Come into Focus as the PREVENT Pandemics Act Advances in the Senate HELP Committee

Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more

4/20/2022 / Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , HELP , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Supply Chain

Five Health Care Areas Worth Watching in 2022

With the second session of the 117th Congress underway, stakeholders are poised for another busy legislative session set against the dynamic backdrop of an ongoing global pandemic and midterm election year. Numerous...more

2/4/2022 / Biosimilars , BsUFA , Food and Drug Administration (FDA) , GDUFA , Medical Devices , PDUFA , Prescription Drugs , User Fees

America’s Pharmaceutical Supply Chain: An Overview of the Policy Landscape and Potential Path Forward

For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more

10/8/2021 / Biden Administration , Biomedical Advanced Research and Development Authority (BARDA) , China , Competition , Coronavirus/COVID-19 , Defense Production Act , Department of Defense (DOD) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , NDAA , Pharmaceutical Industry , Supply Chain

Cures 2.0, A Deeper Dive on ARPA-H and MCIT as Congress Considers Accelerating Innovation from Bench to Bedside

Background on Cures 2.0 - The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...more

7/12/2021 / 21st Century Cures Act , Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Healthcare Reform , Medicare

Sean Feely

Akin Gump Strauss Hauer & Feld LLP

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