Anna Abram on Food and Drug Administration (FDA)

FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In over Four Years

On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more

5/2/2024 / CLIA , Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Regulatory Oversight

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Congress and White House Press Ahead on AI in Health Care & Life Sciences

Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more

1/5/2024 / AHRQ , Algorithms , Artificial Intelligence , Biden Administration , Department of Health and Human Services (HHS) , Executive Orders , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Machine Learning , Transparency

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

FDA Serves Up More Food for Thought: 2024 Will Be a Pivotal Year for the Agency’s Reorganization Efforts

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more

12/27/2023 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Imports , Inspections , Investigations , Office of Regulatory Affairs (ORA) , OMB , Reorganizations , Whistleblowers

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

11/13/2023 / Abbreviated New Drug Application (ANDA) , Artificial Intelligence , Critical Infrastructure Sectors , Cybersecurity , Department of Health and Human Services (HHS) , Executive Orders , Food and Drug Administration (FDA) , FTC Act , Health Insurance Portability and Accountability Act (HIPAA) , Healthcare , HITECH Act , Joe Biden , Life Sciences , Machine Learning , ONC , Popular

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

10/6/2023 / CLIA , Emergency Use Authorization (EUA) , Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Proposed Rules , Public Health , Rulemaking Process

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

Software and Digital Health Policies Issued by FDA

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more

4/6/2023 / Artificial Intelligence , Cybersecurity , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices

FDA Gets Digital, Agency Issues Digital Health Policies on PCCP, Cybersecurity and Drug Development

In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more

4/4/2023 / De Novo Standard of Review , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry

Drug Pricing Déjà Vu: The Biden-Harris Administration’s Fiscal Year 2024 Budget Doubles Down on Inflation Reduction Act Reforms;...

Are Accelerated Approval Drugs a New Target for Cost Reductions? As outlined in our prior analysis, the Inflation Reduction Act (IRA) included sweeping drug pricing reforms for the Medicare program and the Biden-Harris...more

3/14/2023 / CMMI , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , MedPAC

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

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

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

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