Craig Bleifer at Akin Gump Strauss Hauer & Feld LLP

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

Updates in Co-Pay Assistance and Accumulators Litigation

Key Points - A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more

12/3/2022 / Anti-Kickback Statute , Co-payments , Department of Health and Human Services (HHS) , Health Insurance , HIV , Insurance Industry , Medicare , OIG , Pfizer , Pharmaceutical Industry

Updates in Co-Pay Assistance and Accumulators Legal Developments

Key Points - Patient advocacy groups have filed suit challenging the legality of the 2020 HHS Final Rule permitting co-pay accumulator adjustment programs. The Second Circuit has upheld HHS’ prohibition of co-pay...more

10/17/2022 / Affordable Care Act , Anti-Kickback Statute , Co-payments , Department of Health and Human Services (HHS) , Final Rules , Health Care Providers , Pharmacy Benefit Manager (PBM)

The Impact of the Inflation Reduction Act of 2022 on Pharmaceutical Innovation, Patent Litigation and Market Entry

Key Points - The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data. New price setting provisions built into the IRA...more

10/11/2022 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Prescription Drugs

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 Changes Direction in Final CDS Guidance

FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more

10/5/2022 / Artificial Intelligence , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , GAO , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry

FDA Issues Draft Guidance on Equity, Diversity and Individual Sponsor Financial Ability Considerations in Charging for...

On August 23, 2022, the United States Food and Drug Administration (FDA or the “Agency”) published the revised draft guidance “Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry” (the...more

9/22/2022 / Draft Guidance , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

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

Co-Pay Assistance and Accumulators in the Legal Spotlight: A Changing Landscape

Key Points - Patient outcomes studies suggest a clinical benefit of co-pay programs, and a negative impact of co-pay accumulator programs. Co-pay programs remain unavailable to participants in federal...more

6/20/2022 / Anti-Kickback Statute , Beneficiary Inducement , Co-payments , Department of Health and Human Services (HHS) , Health Care Providers , Medicare Part D , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs

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

Craig Bleifer

Akin Gump Strauss Hauer & Feld LLP

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