On September 9, 2025, the Department of Health and Human Services (“HHS”) and Food and Drug Administration (“FDA”) announced a series of measures to address “misleading” direct-to-consumer prescription drug (“DTC”) advertisements. The measures include (1) rulemaking to rescind the “adequate provision” requirement, which permits manufacturers to include a general statement of risk alongside a webpage or publication and 1-800 number to access the full product labeling, (2) enhanced enforcement of DTC violations, and (3) expanded oversight of prescription drug advertising on social media. Although these measures address DTC advertising broadly, they appear targeted at broadcast and social media advertisements.

Click here to read the full alert on cov.com.

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Photo of Stefanie Doebler Stefanie Doebler

Stefanie Doebler is co-chair of the firm’s Health Care Practice Group, and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising…

Stefanie Doebler is co-chair of the firm’s Health Care Practice Group, and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, transparency requirements, state law compliance and reporting regulations, interactions with health care professionals, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Stefanie also advises on the development and implementation of health care compliance programs.

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Photo of Michael Labson Michael Labson

Mike Labson has been a trusted advisor to pharmaceutical and biotechnology clients for 30 years. He draws on his wide range of regulatory expertise to provide strategic and compliance advice, and address FDA and other health care law issues in transactions, litigation, and…

Mike Labson has been a trusted advisor to pharmaceutical and biotechnology clients for 30 years. He draws on his wide range of regulatory expertise to provide strategic and compliance advice, and address FDA and other health care law issues in transactions, litigation, and investigations.

Mike is the managing partner of the Boston office and co-chairs the firm’s global Life Sciences practice. He previously served in a number of firm leadership positions, including as a member of the firm’s Management Committee and Executive Committee.

Mike provides creative and practical solutions to biopharmaceutical clients large and small across critical regulatory areas. He actively advises on:

Clinical trial programs, including study subject recruitment, informed consent, good clinical practice conduct issues, and expanded access.
Regulatory approval strategies, including FDA expedited approval programs, FDA advisory committee preparation, and drug/device and drug/diagnostic approvals.
FDA dispute resolution.
Orphan drug, pediatric, and Hatch-Waxman exclusivity, and generic drug and biosimilar product approval standards.
Product promotion, payer, and scientific exchange communications.
Company post-approval activities, including REMS, pharmacovigilance, required post-marketing studies, and NDA and BLA changes.
Rx-to-OTC drug switches and OTC drug claims.
DEA requirements for controlled substances.

Mike’s pro bono work focuses on criminal justice matters. He is on the Emeritus Board of the Children’s Law Center and previously served as the Vice Chair of the Children’s Dental Health Project. Mike has also been an Adjunct Professor of Law at the American University Washington College of Law, and is a Fellow of the American Bar Foundation.

Mike is Band 1 in Chambers Global and Chambers USA for Pharmaceutical/Medical Products Regulatory and Life Sciences Regulatory/Compliance. He is also recognized in The Best Lawyers in America, Washington DC Super Lawyers, and LMG Life Sciences, where he was the Life Sciences Attorney of the Year in 2016.

As one reviewer in Chambers stated, “Michael is the dean of the food and drug bar. He is really smart and understands the whole act. I take comfort knowing that I can call Michael for an enterprise-level ‘above the fray’ view.”

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Photo of Krista Carver Krista Carver

Krista Carver co-chairs Covington’s global Food, Drug, and Device Practice Group and the firm’s Life Sciences – Pharmaceutical and Biotechnology Industry Group. Drawing on her more than 18 years of experience at the firm, she provides strategic and practical advice to clients on…

Krista Carver co-chairs Covington’s global Food, Drug, and Device Practice Group and the firm’s Life Sciences – Pharmaceutical and Biotechnology Industry Group. Drawing on her more than 18 years of experience at the firm, she provides strategic and practical advice to clients on an array of FDA regulatory issues, including those that intersect with other areas such as healthcare. Ms. Carver also assists clients with advocacy before FDA, including formal dispute resolution and citizen petitions, and maintains an active policy practice addressing legislative issues surrounding amendments to the Federal Food, Drug, and Cosmetic Act and related laws. Chambers USA reports that Krista “is a brilliant lawyer with deep technical expertise that she is able to boil down clearly and succinctly,” and that she “is incredibly impressive in biosimilars issues and biologics,” per Chambers sources. Krista co-chairs Covington’s IRA Task Force.

Krista’s areas of focus include:

Inflation Reduction Act;
Biosimilars;
Hatch-Waxman regulatory issues;
Orphan-drug designation and exclusivity matters;
Pediatric Research Equity Act and Best Pharmaceuticals for Children Act;
Digital health;
Gene therapies and human cellular, tissue, and cellular- and tissue-based products;
Risk evaluation and mitigation strategies (REMS), pharmacovigilance, postmarketing study requirements; and the CREATES Act; and
Clinical trial and submission issues including real-world evidence, decentralized clinical trials, and diversity in clinical trials.

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Photo of Gerald Masoudi Gerald Masoudi

Gerald (Jerry) Masoudi has more than 20 years of broad experience in the life sciences industry. He served as Chief Counsel of the U.S. Food and Drug Administration (FDA) from 2007 to 2009. Jerry also has held positions in the Antitrust Division at…

Gerald (Jerry) Masoudi has more than 20 years of broad experience in the life sciences industry. He served as Chief Counsel of the U.S. Food and Drug Administration (FDA) from 2007 to 2009. Jerry also has held positions in the Antitrust Division at the US Department of Justice; as the general counsel of two large, highly regulated companies; and as a partner in private practice. He provides strategic legal, policy, and regulatory advice to life sciences clients, with a focus on FDA enforcement of manufacturing and promotional rules.

Jerry brings a unique profile and diverse set of experiences to enforcement and compliance work on behalf of clients. These matters are often high-profile and of critical importance to our food, drug, and device clients. He guides clients through significant corporate transactions, litigation, shifting regulatory expectations, and intensive crisis management activities.

From 2015 to 2018, Jerry was the Executive Vice President, General Counsel and Corporate Secretary of Celgene Corporation, a publicly traded biopharmaceutical company now owned by Bristol-Myers Squibb Company. While at Celgene, he was involved in numerous major legal and strategic matters, including IP strategy; two multibillion-dollar corporate acquisitions; a False Claims Act settlement resulting in no Corporate Integrity Agreement; antitrust litigation; congressional and public policy strategy relating to regulatory issues; and corporate governance.

Jerry was a partner and co-chair of Covington’s Food and Drug Practice Group from 2009 to 2015. Before joining Covington in 2009, he served as Chief Counsel of FDA, where he was responsible for supervising FDA’s involvement in civil and criminal litigation and investigations; providing legal review of warning letters, guidances and regulations; and providing advice to the FDA commissioner and senior leadership on matters relating to FDA regulated products. Before joining the FDA, Jerry served as Deputy Assistant Attorney General for international, policy, and appellate matters in the Antitrust Division at the DOJ.

Prior to entering government service, Jerry had a decade of experience in private practice in the areas of antitrust, telecommunications, patent law, and energy.

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Photo of Guillaume Julian Guillaume Julian

Guillaume Julian guides pharmaceutical manufacturers and other innovative life sciences companies through complex regulatory regimes related to drug approval, market access, pricing, and reimbursement.

A member of the firm’s leading Food, Drug, and Device and Health Care practice groups, Guillaume specializes in the…

Guillaume Julian guides pharmaceutical manufacturers and other innovative life sciences companies through complex regulatory regimes related to drug approval, market access, pricing, and reimbursement.

A member of the firm’s leading Food, Drug, and Device and Health Care practice groups, Guillaume specializes in the challenging legal and regulatory issues facing manufacturers of drugs and biological products. Guillaume frequently assists FDA-regulated entities with the following kinds of activities:

Preparing and submitting drug applications;
Navigating complex pre- and post-marketing legal and regulatory questions;
Developing innovative legal and policy strategies related to the regulation of drug and biological products;
Advising on FDA disclosure laws and regulations including the Freedom of Information Act; and
Counseling on matters related to FDA user fee programs including PDFUA and BsUFA.

Guillaume also assists clients with key market access, pricing, and reimbursement issues including:

Advising on government price reporting, payor communications, Pharmacy Benefit Manager (PBM) matters, most favored nation pricing, and other coverage, coding, and reimbursement matters.
Counseling pharmaceutical manufacturers on the drug pricing provisions of the Inflation Reduction Act (IRA) and the 340B Drug Pricing Program.

In particular, Guillaume has advised multiple manufacturers of drugs selected for the IRA’s Medicare “Drug Price Negotiation Program” on all aspects of the program—including preparing for selection, meeting with the Centers for Medicare and Medicaid Services (CMS), and implementing processes to effectuate the “Maximum Fair Price.” Guillaume also routinely advises pharmaceutical manufacturers on the 340B Drug Pricing Program including general compliance questions, state and federal contract pharmacy laws and regulations, the administrative dispute resolution process, and the intersection of the 340B program with the IRA and Medicaid Drug Rebate Program.

Guillaume maintains an active pro bono practice where he assists veterans and victims of violent crimes with immigration matters and advises non-profit health organizations on government advocacy and regulatory questions related to FDA and congressional matters.

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