Explore every episode of the podcast Non-binding Guidance

In this episode of Non-binding Guidance, Greg Levine and Josh Oyster, partners in Ropes & Gray’s life sciences regulatory and compliance practice group, are joined by Kellie Combs, partner and chair of Ropes & Gray’s life sciences regulatory and compliance practice group, to 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.

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. 

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partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on diversity action plans (DAPs) aimed at improving the enrollment of underrepresented populations in clinical studies.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 They also address key open questions related to the draft guidance.

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. 

On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray’s life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA’s revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." They address key changes from the FDA’s prior draft guidance, potential challenges in implementing the FDA’s recommendations, and how the new guidance fits within the FDA’s overall framework for medical product manufacturer communications. 

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. 

In honor of Rare Disease Day, join Ropes & Gray attorneys Kellie Combs, Josh Oyster, and Sarah Blankstein for a special edition of Non-binding Guidance, a podcast series that focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, they provide a preview of the Second Annual Ropes & Gray Rare Disease Forum, which will be held in Cambridge, Massachusetts on May 7, 2024. 

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.

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 third episode, life sciences regulatory and compliance partners Kellie Combs and Josh Oyster discuss key developments and trends related to medical product advertising and promotion. They cover the latest enforcement trends, revisit FDA’s most recent guidance on the communication of off-label scientific information, and also discuss the implications of a long-awaited First Circuit decision. 

Join Ropes & Gray’s life sciences and health care 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 second episode, we focus on key issues to watch related to product development, approval, and drug pricing in 2024. These include FDA activities aimed at expediting the development of drugs to treat rare diseases, changes to FDA’s accelerated approval program, clinical trial diversity initiatives, actions to support use of real-world evidence, and developments in drug pricing and market access as CMS works to implement the Medicare Price Negotiation Program and prepares for the Medicare Part D redesign.

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.

This installment of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA’s recently issued draft guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products – Questions and Answers.” In this episode, hear from Kellie Combs, Josh Oyster, and Sarah Blankstein, industry-leading attorneys from Ropes & Gray’s life sciences regulatory and compliance team, as they delve into FDA’s new draft guidance to discuss key changes, constitutional considerations, and practical implications for the medical products industry.

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. 

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. 

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.

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.

This episode of Ropes & Gray’s podcast series Non-binding Guidance examines FDA’s final guidance on Clinical Decision Support (“CDS”) software, released in September, and its implications for the life sciences and health care industries. The final guidance represents a substantial change in FDA’s approach to CDS software regulation from the agency’s 2019 draft guidance and may prompt many software developers to reassess their CDS products in light of the new guidance. Join Ropes & Gray FDA regulatory partners Greg Levine and Kellie Combs and counsel Sarah Blankstein as they discuss FDA’s new CDS guidance and provide an overview of key changes, practical implications, and some of the challenges posed by the guidance.

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.

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.

This episode of Ropes & Gray’s podcast series Non-binding Guidance continues our exploration of recent trends and updates on the use of real-world evidence in drug development. Join Ropes & Gray FDA regulatory attorneys, Kellie Combs and Sarah Blankstein, as they discuss four new draft guidance documents released by FDA in 2021 addressing the use of real-world evidence to support FDA decision-making on safety and effectiveness. Tune in to this episode to learn more about FDA’s current approach to real-world evidence, these recent draft guidances, and what we can expect from FDA looking ahead in 2022 and beyond.

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.

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.

This edition of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on one of the most fundamental concepts in FDA regulatory law: intended use. On August 2, FDA issued a final rule amending its drug and medical device regulations describing the types of evidence the Agency considers relevant to determining a product’s “intended use.” The new regulations just took effect on September 1. Join Kellie Combs, a partner in Ropes & Gray’s life sciences regulatory and compliance practice, Doug Hallward-Driemeier, a partner in the litigation & enforcement practice and head of the firm’s appellate & Supreme Court practice, and Josh Oyster, a senior associate in the life sciences regulatory and compliance practice group, as they discuss this final rule and what its implementation means for the drug and medical device industry.

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.

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.

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.

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA regulatory developments in the area of artificial intelligence (“AI”) and machine learning. AI and machine learning represent a rapidly growing frontier in digital health, with applications ranging from medical device software used for diagnostic and triaging applications to drug candidate selection to clinical trial design and interpretation. In this episode, FDA regulatory attorneys Kellie Combs, Greg Levine, and Sarah Blankstein explore the development and uptake of these technologies in response to the ongoing COVID-19 pandemic, FDA’s current regulatory landscape for these technologies, recent steps FDA has taken to update its regulatory approach to these tools in coordination with industry, and continuing trends in this area they expect to see through 2021.

The eleventh installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on the current regulatory landscape surrounding the use of real-world evidence in drug development and the impact of the COVID -19 pandemic. Over the course of the COVID-19 pandemic, there has been an increase in reliance on real-world data and real-world evidence by FDA and other regulatory authorities, as well as industry. Innovative approaches and flexibility from the FDA during the pandemic ultimately may serve to accelerate the uptake of real-world evidence approaches post-pandemic. In this episode, FDA regulatory attorneys Kellie Combs and Sarah Blankstein discuss these recent developments and explore remaining impediments facing the use of real-world evidence and real-world data by regulators and industry stakeholders.

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.”

The eighth installment of Ropes & Gray’s podcast series Non-binding Guidance looks at SEC disclosure issues for life sciences companies. In this episode, Ropes & Gray partners Kellie Combs and Emily Oldshue discuss when to disclose, how to frame the disclosure, and how the responses to both of these questions are informed by SEC enforcement actions and securities litigation, as well as their experience working with life sciences companies in various stages of development. Emily and Kellie will dive into how to craft SEC disclosures involving a variety of FDA regulatory issues, such as clinical trial results, adverse findings from regulatory audits and inspections, and FDA interactions that occur during review of a pending application or post-market.

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.

The sixth installment of Ropes & Gray’s podcast series, Non-binding Guidance, continues our two-part discussion on FDA expedited review programs. In this episode, Ropes & Gray lawyer Kellie Combs interviews her partner Greg Levine, who provides an overview of FDA’s new Breakthrough Devices Program. This program, which was finalized in late 2018, aims to expedite the development and FDA premarket review of devices used in the treatment or diagnosis of serious or life-threatening conditions. The Breakthrough Devices Program provides a variety of benefits to manufacturers, including priority review and more frequent and efficient feedback from FDA during the submission and review process, so that devices receiving breakthrough designation can reach the patients who need them quickly and efficiently. In this episode, Greg dives into the program’s eligibility criteria, benefits, when to apply, and some of the practical considerations associated with the program. Additionally, Kellie and Greg discuss recent trends and developments affecting breakthrough devices and provide examples of devices that have recently received breakthrough device designation or that were approved or cleared as breakthrough devices. Tune in to this discussion to learn more about the program and its impact on the medical device industry.

The fifth installment of Ropes & Gray’s podcast series, Non-binding Guidance, is the first part of a two-episode discussion of FDA expedited review programs. In this episode, Ropes & Gray lawyer Greg Levine interviews his partner Kellie Combs, who provides an overview of the four expedited review programs for drugs and biologics: the Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval programs. These programs, which are broadly intended to address unmet needs in the treatment of serious or life-threatening conditions for which existing therapies are insufficient, are associated with significant benefits for manufacturers, such as earlier and more frequent FDA interactions, streamlined clinical development requirements, and a shorter FDA review clock—all of which may accelerate time to market and improve the bottom line. In this episode, Kellie discusses the eligibility criteria and benefits associated with each program, and describes timing and other practical issues for product manufacturers to consider. Tune in to this discussion to learn more about the expedited review programs and how to secure the benefits. Next week, we’ll release the second episode of this two-part series, which will focus on the Breakthrough Devices Program. Please stay tuned.

The fourth installment of Ropes & Gray’s podcast series, Non-binding Guidance, dives into the use of real-world evidence in drug development. In this episode, Ropes & Gray lawyers Kellie Combs and Sarah Blankstein discuss FDA’s current thinking on real-world evidence and how industry has been using real-world evidence studies in FDA submissions, as well as with payors and in product promotion. The speakers highlight key takeaways from FDA’s framework for real-world evidence, issued in December 2018, including the types of data sources and study designs that FDA considers to be “real-world,” and the Agency’s approach to assessing real-world evidence intended to support a determination of effectiveness. Additionally, our presenters discuss highlights from FDA and the Duke-Margolis Center’s public workshop on real-world evidence, which took place on July 11-12. Tune in to this discussion to learn more about FDA’s approach to real-world evidence, the impact on industry, and what companies should be thinking about in this space.

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.

The second installment of Ropes & Gray’s new podcast series, Non-binding Guidance, addresses the departure of former FDA Commissioner Scott Gottlieb, who resigned from his position last month. During his time at FDA, Commissioner Gottlieb employed an ambitious policy agenda, taking significant steps to combat the opioid crisis, improve access to generic drugs and biosimilars, confront the use of e-cigarettes by minors, and more. In this episode, Ropes & Gray lawyers Greg Levine, Kellie Combs, and Beth Weinman explore several areas of uncertainty that remain in the wake of Dr. Gottlieb’s resignation: the regulation of laboratory developed tests, dietary supplements, and off-label communications. Tune in to this discussion to learn more about the unfinished business of the Gottlieb administration, the impact of his resignation, and how the agency will move forward under Acting Commissioner Ned Sharpless.

Ropes & Gray’s new podcast series, Non-binding Guidance, highlights FDA regulatory developments and trends affecting the life sciences industry. In this inaugural episode, Ropes & Gray lawyers Al Cacozza, Sarah Blankstein and Joshua Oyster discuss how the FDA is currently regulating products containing cannabidiol, or CBD, and what to expect from FDA and Congress in the wake of FDA Commissioner Scott Gottlieb’s surprise resignation this month. The 2018 Farm Bill, signed into law last December, legalized hemp and its non-psychoactive ingredient CBD and distinguished both from marijuana, which is still considered by the federal government to be an illegal narcotic. But the Farm Bill left a cloud of uncertainty hanging over the emerging CBD industry because it expressly allowed FDA to continue unchanged its oversight and regulation of CBD products. Tune in to this lively discussion of the repercussions of the Farm Bill, how the FDA and state agencies are responding, and what investors and other stakeholders should know.