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
Justine Lei is an associate in the Corporate and Governmental Practice Groups in the firm's New York office and is a member of the firm’s healthcare industry team.
In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and radio format (CCN Final Rule Guidance). The CCN Final Rule Guidance was released to advise small entities seeking to understand and comply with the standards established in the final rule, “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” (CCN Final Rule).Continue Reading FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements
On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, Questions and Answers (the “2023 Draft Guidance”). The 2023 Draft Guidance is a revision to, and builds upon, FDA’s 2014 draft guidance on the same issue, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, which itself was a revision to FDA’s 2009 guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. Drug and device manufacturers (“firms”) will note that in the 2023 Draft Guidance, FDA introduces multiple new concepts. Addition of terms such as “SIUU Communications” and “Firm-Generated Presentations” appear to broaden the possibilities for firms’ communications with healthcare providers (“HCPs”) while inclusion of concepts such as “scientifically sound” and “clinically relevant” can be read as imposing certain limitations on what can be included in SIUU Communications. FDA’s inclusion of these new concepts provides both guidance and guardrails for firms to ensure SIUU Communications with HCPs stay in line with FDA regulatory requirements. With the 2023 Draft Guidance, FDA continues to be thoughtful and intentional with its views on communications between firms and HCPs, and demonstrates to industry that the agency will continue to evolve its thinking with the advent of new technologies, advancements in science, medicine, and the delivery of care, and in light of the ever-changing modes and methods of communication.Continue Reading From Good Reprint Practices to SIUU Communications: What Firms Need to Know
Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June, Governor Ned Lamont signed into law “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (the “Act”), which imposes new registration, reporting, and disclosure requirements on pharmaceutical representatives in the State of Connecticut. The Act builds on Governor Lamont’s policy initiatives, which aim to improve the delivery of care and reduce healthcare costs for Connecticut residents and includes the initiative to regulate pharmaceutical marketing practices. The Act sets forth certain requirements for pharmaceutical manufacturers and “pharmaceutical representative(s)” which remain subject to further clarification based on any forthcoming guidance and regulations from the Connecticut Department of Consumer Protection (“CT DCP”).Continue Reading Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives
On August 4, 2023, the Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to AstraZeneca which stated that the company made misleading claims in a promotional sales aid about the effectiveness of BREZTRI AEROSPHERE™ (“Breztri”). Given that it has been almost a year and half since OPDP issued a Warning Letter (the last Warning Letter was issued in February 2022), the takeaways here are significant for industry and provide insight into how FDA will examine efficacy claims that are so-called “consistent with label” and require compliance with FDA’s June 2018 guidance (the “CFL Guidance”)., Going forward, we expect the agency’s focus to remain on product communications to the public—to either a general consumer or professional audience—and whether those communications include essential contextual information to avoid the potential that such claims could be viewed as misleading.Continue Reading Context is Key: FDA Sends a Strong Message About Efficacy Claims
As the spring conference season winds down, there was one topic that remained top of mind. At the Food and Drug Law Institute (“FDLI”)’s Annual Conference on May 17-18, 2023, the U.S. Department of Justice (“DOJ”)’s Consumer Protection Branch (“CPB”), and the Food and Drug Administration (“FDA”) continued the discussion surrounding each agency’s approach to the CPB’s new Voluntary Self-Disclosure Policy for Business Organizations (“Voluntary Self-Disclosure Policy”). The Voluntary Self-Disclosure Policy responds to Deputy Attorney General Lisa Monaco’s September 2022 memorandum (the “Monaco Memo”), which directed all DOJ components that prosecute corporate crime to review or issue new written policies on corporate self-disclosure of criminal misconduct. The Monaco Memo, in turn, reflects the DOJ’s continued efforts to increase transparency and predictability for companies deciding whether to self-disclose misconduct. The DOJ’s continued efforts led the Criminal Division to announce its Corporate Enforcement and Voluntary Self-Disclosure Policy (“Criminal Division Policy”) in January 2023, and several other DOJ branches and divisions, including CPB, have followed suit, borrowing from the Criminal Division’s guidance while tailoring their policies to the specific matters within their jurisdiction. As part of the FDLI panel discussion, CPB and FDA provided their perspectives on the new CPB policy, discussed best practices to implement, and emphasized questions to ask and answer in the evaluation of a company’s compliance program.Continue Reading DOJ Continues to Discuss Updates to Compliance Program Guidance and Corporate Enforcement Policies
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