Non-binding Guidance

The Administration's Focus on Direct-to-Consumer Prescription Drug Advertising

Ropes & Gray LLP — Mon, 06 Oct 2025 14:34:01 -0400

In this episode of Non-binding Guidance, Greg Levine and Josh Oyster, partners in Ropes & Gray’s life sciences regulatory and compliance practice group discuss the Trump administration’s recent crackdown on direct-to-consumer (DTC) prescription drug advertising. The conversation explores the coordinated actions by HHS and FDA, aggressive enforcement measures, proposed rulemaking to reshape DTC broadcast ads, and the use of AI in regulatory oversight. The hosts examine the impact of recent FDA enforcement letters, challenges in digital and social media promotion, and the shifting compliance landscape for pharmaceutical companies. This episode offers practical guidance for life sciences companies navigating this rapidly changing regulatory environment.

Trends in False Advertising and Related Competitor Disputes Involving FDA-Regulated Products

Ropes & Gray LLP — Thu, 08 May 2025 10:14:22 -0400

On this episode of Ropes & Gray's Non-binding Guidance podcast , life sciences regulatory and compliance partner Josh Oyster discusses the complex world of false advertising and unfair competition disputes involving drugs, medical devices, and other FDA-regulated products. He explores recent developments in Lanham Act competitor lawsuits, ITC investigations, and the shifting regulatory landscape. Discover the nuances of private litigation, the powerful remedies available through Section 337 investigations, and the potential impact of recent changes at FDA.

Clinical Trial Diversity in Focus

Ropes & Gray LLP — Tue, 19 Nov 2024 14:46:15 -0500

On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on diversity action plans (DAPs) aimed at improving the enrollment of underrepresented populations in clinical studies. They examine the implications and challenges sponsors may face in setting and meeting enrollment goals, as well as the potential impact of the recent presidential election on the final guidance. They also address key open questions related to the draft guidance.

The Demise of Chevron and Implications for Future APA Challenges

Ropes & Gray LLP — Tue, 22 Oct 2024 14:37:00 -0400

On this episode of Ropes & Gray’s podcast series, Non-binding Guidance, life sciences regulatory and compliance partner Greg Levine and counsel Beth Weinman are joined by appellate and Supreme Court practice head Doug Hallward-Driemeier to explore the Supreme Court's recent landmark decision in Loper Bright, which ended the long-standing practice of Chevron deference. Learn how this ruling has reshaped the regulatory landscape for federal agencies like the FDA and what it means for companies navigating these changes, including implications for Administrative Procedure Act (APA) challenges going forward.

FDA Regulatory & Enforcement Risks Relevant to Academic Medical Centers, Health Systems and Research Institutions

Ropes & Gray LLP — Fri, 28 Jun 2024 14:38:24 -0400

On this episode of Ropes & Gray’s podcast series, Non-binding Guidance, counsel Steve Sencer moderates a discussion on how FDA regulatory issues may impact academic medical centers (AMCs), health systems, and universities/research institutions. Joined by partner David Peloquin, and counsel Sarah Blankstein and Beth Weinman, the episode explores the complexities of FDA regulation, the potential risks, and the best practices to mitigate them. The discussion also highlights the challenges and implications of using digital tools in research studies.

U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part IV): Digital Health

Ropes & Gray LLP — Wed, 31 Jan 2024 15:55:10 -0500

Join Ropes & Gray’s life sciences attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024. In this fourth and final episode, attorneys Greg Levine, Sarah Blankstein, and Beth Weinman discuss key areas to watch related to FDA regulation of digital health tools in 2024. These include digital health technologies used in product development, artificial intelligence and machine learning-enabled medical devices, clinical decision support software, and medical device cybersecurity.

U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part I): FDA Enforcement and Litigation

Ropes & Gray LLP — Wed, 17 Jan 2024 13:55:18 -0500

Join Ropes & Gray’s life sciences attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024. In this first episode, we focus on key issues to watch related to FDA enforcement and litigation in 2024. These include potential litigation over FDA’s planned final rule to regulate laboratory-developed tests (“LDTs”), the Supreme Court's review of FDA’s approval of mifepristone for medication abortion, litigation related to FDA discouraging the use of ivermectin in humans during the pandemic, and the potential effects of organizational changes in FDA’s Office of Regulatory Affairs (“ORA”) on inspections and enforcement.

FDA’s Proposed Rule on Laboratory Developed Tests

Ropes & Gray LLP — Mon, 30 Oct 2023 12:25:07 -0400

This installment of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA’s proposed rule that would affirm the Agency’s position that laboratory developed tests (“LDTs”) are in vitro diagnostic products regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”). In this episode, hear from Greg Levine, Josh Oyster, and Beth Weinman, industry-leading attorneys from Ropes & Gray’s life sciences regulatory and compliance team based in Washington, D.C., as they discuss FDA’s proposal to phase out the enforcement discretion policy it has historically applied to most LDTs.

Introducing the U.S. Medical Device Recalls Resource Manual

Ropes & Gray LLP — Mon, 17 Jul 2023 14:22:55 -0400

Join partners Greg Levine and Josh Oyster from Ropes & Gray’s life sciences regulatory and compliance practice group for a special edition of Non-binding Guidance, a podcast series which focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, Greg and Josh discuss the publication of Ropes & Gray’s U.S. Medical Device Recalls Resource Manual, a reference tool to guide medical device companies considering, planning, or executing product recalls and other field actions.

Recent Developments in Oncology Drug Development

Ropes & Gray LLP — Wed, 10 May 2023 09:30:01 -0400

This installment of Ropes & Gray’s podcast series Non-binding Guidance explores recent regulatory developments related to the development and approval of oncology drugs in the U.S. and Europe. On this episode, hear from Ropes & Gray FDA regulatory partner Josh Oyster and head of the European life sciences practice Lincoln Tsang as they compare approaches from FDA and E.U. legislation, and discuss what that means for companies researching and developing new oncology products for a global market.

The Regulatory Landscape for Drug Compounding—10 Years After the NECC Outbreak

Ropes & Gray LLP — Mon, 05 Dec 2022 09:51:54 -0500

This episode of Ropes & Gray’s podcast series Non-binding Guidance examines the regulatory landscape for drug compounding and how it has evolved over the last 10 years since a 2012 nationwide fungal meningitis outbreak caused by contaminated drugs from the New England Compounding Center (NECC) rocked the industry and led to a legislative overhaul. Listen to FDA regulatory partner Josh Oyster and associate Becca Williams as they discuss the continuing ramifications of the outbreak, the challenges faced by FDA and drug compounders, the opportunities presented to investors in the life sciences industry, and key areas of regulatory development to watch.

Continued Global Pressure on Drug Pricing & Reimbursement and the Next Frontiers for Effective Market Access

Ropes & Gray LLP — Thu, 13 Oct 2022 14:22:02 -0400

Following the recent publication relating to continued global pressure on drug pricing, this episode of Ropes & Gray’s podcast series Non-binding Guidance focuses on the significant changes to global business and legal environments for drug pricing brought about by the COVID-19 pandemic and the impacts on the pharmaceutical supply chain and patient access to innovative cutting-edge therapies. Hear from Ropes & Gray’s head of European life sciences practice Lincoln Tsang and health care partner Margaux Hall as they discuss the trend of rising health care drug costs in the U.S. and the UK, significant implications of the Inflation Reduction Act and similar drug pricing policy in the countries outside the U.S., the increasing role of real-world evidence in decision making, and impacts from these changes across the U.S., Europe and worldwide.

A Recall Readiness Rundown and Recent FDA Actions

Ropes & Gray LLP — Thu, 19 May 2022 10:53:15 -0400

This episode of Ropes & Gray’s podcast series Non-binding Guidance explores recent FDA guidance on recall readiness and other recall-related hot topics. In recent months, we have seen a trend of increased FDA inspection and enforcement activity as the impact from COVID-19 starts to lessen. Earlier this year, FDA also finalized guidance on the Initiation of Voluntary Recalls under 21 CFR Part 7, Subpart C, which explores FDA expectations regarding the process companies should already have in place ahead of a potential recall situation. Join Ropes & Gray FDA regulatory attorneys Josh Oyster and Beth Weinman as they provide a quick refresher on recalls and discuss the latest recall readiness suggestions from the Agency to help companies make decisions about how and when to recall their FDA-regulated products and how to involve FDA in that process. They also discuss FDA’s recent recall-related actions that invoked rarely-used legal authorities applicable to medical devices.

Recent Developments in FDA Inspection Policy and Implications for Drug and Device Manufacturers

Ropes & Gray LLP — Thu, 06 Jan 2022 12:37:57 -0500

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on recent developments in FDA inspection policy, including implications of the pandemic-related slowdown on product quality and approval delays as well as progress FDA has been making in clearing the inspection backlog. In March 2020, many routine inspections, such as foreign pre-approval and for-cause inspection assignments not deemed “mission-critical,” were temporarily postponed, but FDA has recently restarted some inspections. In this episode, Ropes & Gray life sciences regulatory & compliance practice group leader, Greg Levine, and Ropes & Gray counsel and former FDA Office of Chief Counsel attorney, Beth Weinman, discuss the significance of these developments and what FDA-regulated entities can expect when thinking about and preparing for FDA inspections in 2022.

Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule

Ropes & Gray LLP — Mon, 08 Nov 2021 14:16:42 -0500

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on the Biden administration's recent proposal to repeal the Medicare Coverage of Innovative Technology ("MCIT") final rule, which was published in January 2021 and initially scheduled to become effective on December 15, 2021. This proposed rule, although published by the Centers for Medicare and Medicaid Services ("CMS"), relates directly to FDA regulation of medical devices because it would provide automatic Medicare coverage to products that FDA approves or authorizes under its Breakthrough Device Program. In this episode, Ropes & Gray life sciences regulatory & compliance head, Greg Levine, and health care partner, Tom Bulleit, will discuss the significance of this development—a reversal of what would've been a significant innovation for Medicare coverage and payment of new device technology—and share some pathways manufacturers of breakthrough devices can use to obtain Medicare coverage after approval while FDA and CMS collect comments on a new program to replace the MCIT program.

COVID-19 Vaccine Mandate Litigation

Ropes & Gray LLP — Thu, 29 Jul 2021 11:26:20 -0400

This installment of Ropes & Gray’s podcast series Non-binding Guidance explores the current legal challenges relating to vaccine mandates for public and private sector employers and institutions of all types. Join Greg Levine, head of Ropes & Gray’s life sciences regulatory and compliance practice, Megan Bisk, a partner in the employment, executive compensation, and employee benefits practice and lead of the employment specialty group, and David Peloquin, a partner in the health care practice group, as they discuss ongoing lawsuits related to COVID-19 vaccine mandates, the context of approvals through Emergency Use Authorizations, the PREP Act and data privacy implications, and employment law considerations.

The Defense Production Act and the COVID-19 Pandemic

Ropes & Gray LLP — Thu, 27 May 2021 14:18:25 -0400

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on The Defense Production Act (DPA), a wartime production law that gives the president a broad set of powers to influence and mobilize domestic industry in the interest of national defense, and its implications for life sciences companies. Over time, Congress has expanded the DPA’s scope to include civil crises resulting from national disasters, terrorist attacks, and other national emergencies—most recently, the COVID-19 pandemic. In this episode, Ropes & Gray life sciences regulatory & compliance attorneys Beth Weinman and Jessica Band discuss the history of the DPA, how it has been used during the COVID-19 pandemic, and what use we can expect to see going forward. The discussion also addresses the specific authorities conveyed by the DPA, how to respond to issuance of a priority-rated contract and the scope of such contracts, and what opportunities may be provided by the DPA for life sciences companies.

European Life Sciences Regulatory Trends with Dr. Lincoln Tsang

Ropes & Gray LLP — Wed, 28 Apr 2021 12:00:00 -0400

This installation of Ropes & Gray’s podcast series Non-binding Guidance introduces Dr. Lincoln Tsang, a new Ropes & Gray lateral partner based in London, and head of the firm’s European life sciences practice. Join Greg Levine, partner and chair of the life sciences regulatory and compliance practice at Ropes & Gray, as he interviews and explores Lincoln’s unique career path as well as Lincoln’s thoughts on Brexit and other regulatory developments that may affect the life sciences industry in the UK and Europe in the coming years.

FDA Regulation of COVID-19 Diagnostic Tests and “Return to Work”

Ropes & Gray LLP — Tue, 21 Jul 2020 11:41:47 -0400

The tenth installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on FDA regulation of COVID-19 diagnostic tests, with a particular focus on employee testing. In this episode, chair of Ropes & Gray’s FDA regulatory practice, Greg Levine, interviews Lauren Silvis, a former FDA official and currently Senior Vice President of External Affairs for Tempus, a clinical molecular technology company, to hear her input on the role employee testing can play in maintaining a safe workplace. Topics covered include the role of antibody tests, testing of asymptomatic persons, pooled sample testing, and evolving technologies such as Next Generation Sequencing (NGS). Prior to joining Tempus, Lauren spent a number of years at the FDA, first as deputy center director for policy in the agency's Center for Devices and Radiological Health, and subsequently as the FDA chief of staff, where she was responsible for overseeing the daily management of the agency and leading the agency's activities on major initiatives. Additionally, Lauren co-authored several reports and articles on COVID-19 – most recently, “How Businesses Can Keep Employees Safe From Coronavirus.”

A Discussion of Kisor v. Wilkie

Ropes & Gray LLP — Tue, 12 Nov 2019 16:13:10 -0500

The seventh installment of Ropes & Gray’s podcast series, Non-binding Guidance, dives into the closely watched administrative law case, Kisor v. Wilkie. This Supreme Court case addresses the continued validity of the doctrine articulated in the 1997 Supreme Court case Auer v. Robbins, regarding judicial deference to federal administrative agency interpretations of their own regulations. In this episode, Ropes & Gray partner Greg Levine interviews his colleagues, Doug Hallward-Driemeier and Beth Weinman, about the factual background, opinions, and potential implications of Kisor, with particular emphasis on its significance for FDA-regulated life sciences companies seeking to challenge FDA or other federal agency regulatory interpretations. Among other things, Beth and Doug discuss the signals the Kisor case sends about the future of Chevron deference, which addresses the related question of judicial deference to agency interpretations of statutes. Tune in to this discussion to learn about key takeaways from the Supreme Court’s Kisor ruling and its potential impact on FDA-regulated companies.

Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders

Ropes & Gray LLP — Fri, 28 Jun 2019 09:06:55 -0400

The third installment of Ropes & Gray’s podcast series, Non-binding Guidance, highlights two recent federal district court decisions implicating enforcement efforts in the stem cell and compounding arenas. This episode, Ropes & Gray lawyers Greg Levine and Beth Weinman first explore the D.C. District Court’s decision to grant summary judgment to FDA in its efforts to enjoin a Florida clinic from administering unapproved adipose derived stem cell injections to patients to treat a number of serious diseases. Next they address a loss for the government in the decision by the Federal District Court for the District of Massachusetts to overturn the convictions of two former employees of the New England Compounding Center (NECC) for conspiracy to defraud FDA, on the basis of legal impossibility. Tune in to this discussion to learn more about these federal district court decisions, their impact on the industry, and how the Agency will move forward as a result of these findings.