Anna Abram at Akin Gump Strauss Hauer & Feld LLP

Food for Thought: FDA Proposes New Vision for the Human Foods Program

On January 31, 2023, the U.S. Food and Drug Administration (FDA) announced a proposal to restructure the agency’s human foods program. FDA regulates almost 80 percent of the nation’s food supply and this work is a cornerstone...more

2/2/2023 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Public Health , Regulatory Oversight

The Drug Pricing Drumbeat Continues: IRA Update and Key Areas to Watch in 2023

The Biden-Harris administration and Congress appear poised to continue focusing on drug pricing issues this year, most notably with the Centers for Medicare & Medicaid Services moving forward with implementation of the drug...more

1/18/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Health Care Providers , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs

Congressional Health Policy Outlook for 2023

The House and Senate convened this week to kick off the 118th Congress. Republicans control the House after four years of a Democratic majority. House Republicans have a very slim majority, with only 222 seats to the...more

1/12/2023 / Biden Administration , Centers for Disease Control and Prevention (CDC) , Congressional Budget Resolution , Health Care Providers , Health Insurance Portability and Accountability Act (HIPAA) , Healthcare Reform , Inflation Reduction Act (IRA) , Legislative Agendas , Medicare , Medicare Part B , Regulatory Agenda

Congress’ Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues

In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more

1/11/2023 / Biosimilars , Consolidated Appropriations Act (CAA) , Cosmetics , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Popular

Preparedness Policy Takes Shape: PREVENT Pandemics Act Enacted Ahead of PAHPA Reauthorization

On December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....more

1/10/2023 / Biden Administration , Centers for Disease Control and Prevention (CDC) , Federal Food Drug and Cosmetic Act (FFDCA) , Health and Safety , Infectious Diseases , New Legislation , Public Health , Public Health Service Act

Here are the Key Health Care Reform Effective Dates

The Inflation Reduction Act (IRA), P.L. 117-169, which became law on August 16th, included some of the most consequential prescription drug pricing reforms ever passed by Congress. This week marked a pivotal milestone in the...more

10/10/2022 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Healthcare Reform , Inflation Reduction Act (IRA) , Medicare , Prescription Drugs

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

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

Anna Abram

Akin Gump Strauss Hauer & Feld LLP

Popular Topics by This Author

Latest Publications