Rachel Turow on Food and Drug Administration (FDA)

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

8/26/2025 / Capital Markets , Disclosure Requirements , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Publicly-Traded Companies , Regulatory Authority , Regulatory Oversight , Regulatory Requirements , Risk Management , Securities and Exchange Commission (SEC) , Securities Litigation

FDA Commissioner Launches Pilot Program To Speed Review of Certain Drugs

On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV). The program is intended...more

6/18/2025 / Drug Pricing , Food and Drug Administration (FDA) , National Security , New Regulations , Pharmaceutical Industry , Pilot Programs , Prescription Drugs , Public Health , Regulatory Oversight , Regulatory Reform

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

5/23/2025 / Biosimilars , Executive Orders , Food and Drug Administration (FDA) , Generic Drugs , Healthcare , Healthcare Reform , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Regulatory Requirements , Supply Chain , Technology

Mass Layoffs at FDA Could Have the Greatest Impact on Products in Development - The Trump Administration’s First 100 Days

Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more

5/1/2025 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Government Agencies , Layoffs , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Regulatory Requirements , Trump Administration

FDA Seeks To Remove Petroleum-Based Dyes From US Food Supply

On April 22, 2025, Secretary of Health and Human Services Robert F. Kennedy Jr. and Commissioner of the Food and Drug Administration (FDA) Dr. Martin Makary announced that FDA is taking actions to remove petroleum-based dyes...more

4/24/2025 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Government Agencies , Hazardous Substances , New Regulations , Proposed Rules , Regulatory Reform , Regulatory Requirements , Settlement , Toxic Chemicals

Regulatory Strategies To Combat Counterfeit Beauty Products

Increases in Counterfeit Beauty and Personal Care Products - The rise of e-commerce has led to increasing sales of counterfeit or noncompliant beauty and personal care products, including many that are knockoffs of...more

4/11/2025 / Counterfeiting , Customs and Border Protection , Enforcement Actions , Food and Drug Administration (FDA) , Popular , Regulatory Requirements , Retailers , Risk Management , Supply Chain , Trademarks

FDA at the Start of the Trump Administration: A Cheat Sheet

There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...more

4/10/2025 / Department of Health and Human Services (HHS) , Executive Orders , Food and Drug Administration (FDA) , Food Safety , Medical Devices , Prescription Drugs , Regulatory Agenda , Regulatory Reform , Regulatory Requirements , Trump Administration

FDA Contradicts Benzene Class Actions, Highlighting Risks of Third-Party Lab Testing

In March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results...more

3/28/2025 / Class Action , Cosmetics , Food and Drug Administration (FDA) , Healthcare , Insurance Industry , Life Sciences , Manufacturers , Personal Care Products , Regulatory Requirements , Risk Management , Third-Party , Toxic Chemicals

Makary Is Confirmed as Commissioner of an FDA in Transition

Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more

3/27/2025 / Department of Government Efficiency (DOGE) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Healthcare , Healthcare Reform , Pharmaceutical Industry , Prescription Drugs , Presidential Appointments , Public Health , Regulatory Agenda , Regulatory Reform , Trump Administration

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

3/13/2025 / Department of Health and Human Services (HHS) , Enforcement Actions , Executive Orders , Final Rules , Food and Drug Administration (FDA) , Food Safety , GRAS , Healthcare , Healthcare Reform , Life Sciences , Policy Updates , Regulatory Reform , Regulatory Requirements , Rulemaking Process , State and Local Government

Make America Healthy Again Commission Aims To Combat Chronic Disease and Reform Health Policies

On February 13, 2025, at the swearing-in of Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., President Donald Trump signed Executive Order “Establishing the President’s Make America Healthy Again...more

2/17/2025 / Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Environmental Protection Agency (EPA) , Executive Orders , Food and Drug Administration (FDA) , Healthcare Reform , Prescription Drugs , Public Health , US Foods , Vaccinations

Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts

Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more

2/13/2025 / Alternative Medicine , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Executive Orders , Federal Funding , Food and Drug Administration (FDA) , Food Labeling , Healthcare , Healthcare Reform , National Institute of Health (NIH) , Pharmaceutical Industry , Popular , Regulatory Agenda , Regulatory Reform , Research and Development , Trump Administration , Vaccinations

Gauging the Likelihood of Trump Administration FDA Reforms

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more

1/23/2025 / Department of Health and Human Services (HHS) , Drug Safety , Food and Drug Administration (FDA) , GRAS , Medical Devices , Pharmaceutical Industry , Public Health , Regulatory Reform , Regulatory Requirements , Trump Administration , User Fees

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

1/21/2025 / Affordable Care Act , Artificial Intelligence , Centers for Medicare & Medicaid Services (CMS) , Cybersecurity , Data Privacy , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Drug Pricing , Food and Drug Administration (FDA) , Healthcare , Healthcare Fraud , Healthcare Reform , Inflation Reduction Act (IRA) , Medical Devices , Pharmaceutical Industry , Regulatory Agenda , Regulatory Reform , Secretary of HHS , Trump Administration

The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’

The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more

1/14/2025 / Compliance , Final Rules , Food and Drug Administration (FDA) , Generic Drugs , Labeling , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements , Retail Market

Compounding and GLP-1s: What To Expect When GLP-1 Drugs Are Removed From FDA’s Drug Shortage List

What Are GLP-1s? Glucagon-like peptide-1 receptor agonists, also known as GLP-1 drugs, are a class of medications that mimic the action of the glucagon-like peptide-1 hormone, which is involved in the regulation of blood...more

12/9/2024 / DQSA , Drug Compounding , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Regulatory Agenda , Regulatory Reform , Regulatory Requirements

Rachel Turow

Skadden, Arps, Slate, Meagher & Flom LLP

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