Photo of Scott Liebman

Scott Liebman

Subscribe to Scott Liebman's Posts

Scott Liebman is leader of the firm's Life Sciences team and is based in the firm’s New York office.

Contact:Read more about Scott Liebman

Late yesterday, FDA issued a press release warning that it would be sending “thousands of letters warning pharmaceutical companies to remove misleading ads and issue approximately 100 cease-and-desist letters to companies with deceptive ads[,]” as well as initiating rulemaking to “close the ‘adequate provision’ loophole[.]” Concurrently, the White House issued its own memorandum, commanding the Secretary of Health and Human Services to take actions “to the extent permitted by applicable law.”Continue Reading FDA’s Vast Ad/Promo Warning – Enforcement Ramp-Up or PR Nothingburger?

In an interesting and somewhat unexpected turnabout over the last six months, FDA has pivoted its focus from regulating industry’s use of artificial intelligence (“AI”) to how the agency itself utilizes AI. This internal shift marks a departure from FDA’s development of AI guidance over the last few years.Continue Reading What to Watch: FDA Shifts Attention on Artificial Intelligence

Gathering topics and reviewing the articles for our annual Top-of-Mind publication is always one of my favorite yearly endeavors, allowing me to talk to clients, colleagues and industry experts about the overall state of the life sciences industry. The timing of this publication usually coincides with the J.P. Morgan Healthcare Conference, providing a key opportunity to vet our articles. The breath and scope of comments, concerns, predictions have been remarkable.Continue Reading 2025 Top-of-Mind Issues for Life Sciences Companies

This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration (“FDA” or the “Agency”) final rule in May, which established a staged plan that will phase out FDA’s previous policy of enforcement discretion for LDTs; second, the overturn of the Chevron Doctrine in Loper v. Raimondo in late June; and third, the recent election of Donald Trump as the forty-seventh president of the United States. And of course there are the legal challenges—difficult to predict with the maelstrom of news over the past few months. However, we now have the context necessary to assess these challenges and make some informed predictions about their future. While a host of legal theories have been lobbed at the rule, they each underscore a common sentiment—agencies should not be able to create their own authority, a position strengthened by the overturn of Chevron and election of Trump.Continue Reading LDT Final Rule Series: Part 3 – Legal Challenges

In this second installment of our nine-part deep-dive into the U.S. Food & Drug Administration (“FDA” or “the Agency”) final rule on Laboratory Developed Tests (“LDTs”) – which established a staged plan that will phase out the Agency’s previous policy of enforcement discretion for LDTs – we are taking a closer look at the response to the rule, not only from laboratories and other industry stakeholders but also from members of the legislature. The long and short of it is – people are not happy!Continue Reading LDT Final Rule Series: Part 2 – Response to the Rule

Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous policy of enforcement discretion for Laboratory-Developed Tests (“LDTs”). The final rule was issued at an astonishing speed compared to FDA’s usual rulemaking timeline,[1] coming not even six months after FDA issued the proposed rule.Continue Reading LDT Final Rule Series: Part 1 – Rule Overview

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although there was no single moment like the passage of the Affordable Care Act in 2010, there are numerous distinct events that will loom large in 2024 and beyond.Continue Reading 2024 Top-of-Mind Issues for Life Sciences Companies

In late April this year, the Office of Inspector General, Department of Health and Human Services (OIG) announced that it would make changes to its existing body of healthcare compliance program guidance (CPGs) as part of its current Modernization Initiative.[1] These CPGs were directed at various segments of the health care industry and provided specific guidance on risks posed by industry practices. To kick off the initiative, OIG indicated that it would first issue a new general compliance program guidance (GCPG) by year end applicable to individuals and entities in all segments of the health care industry that would address overarching compliance elements regarding federal fraud and abuse laws, compliance program basics, compliance program effectiveness and general process and procedures. Thereafter, OIG said it planned to update existing industry-specific compliance program guidance (ICPG), which would include tailoring each to address fraud and abuse risk areas specific to a particular industry and describing the compliance measures that industry could take to reduce these risks[2].Continue Reading OIG General Compliance Program Guidance November 2023

The Sheppard Mullin Life Sciences Team decided to take a different approach to our year-end review. We surveyed and considered issues most important to our clients, asking the experts across the various specialties in our Life Sciences Practice the following question: What do life sciences companies need to keep top of mind in 2023?Continue Reading 2023 Top-of-Mind Issues for Life Sciences Companies