The FDA recently provided its opinion on a pharmaceutical television ad that should help other pharmaceutical companies in their own advertisements.  The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) informed pharmaceutical company AbbVie that their television ad for migraine medication, Ubrelvy, featuring Serena Williams “…makes false or misleading representations and suggestions about the efficacy of Ubrelvy.” The letter focused on efficacy claims made in the advertisement.  The 30-second ad shows Serena Williams experiencing symptoms of a migraine while getting ready to go on stage. The ad then goes on to show how one dose of Ubrelvy helped Serena feel better, and she is later shown smiling and laughing as she walks onto a talk show stage. The FDA’s letter explains that in the original storyboard for the ad, Serena experiences migraine pain in the afternoon and feels better before her talk show appearance in the evening. The FDA contends that the televised ad does not accurately portray the time lapse that was in the storyboard version. The FDA stated that, “This compelling before-and-after presentation in conjunction with claims such as, “One dose works fast to eliminate migraine pain” and “UBRELVY QUICKLY ELIMINATES MIGRAINE PAIN” (emphasis added) misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials.” The letter also claims that the ad “…misleadingly suggests that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated.” Continue Reading FDA Calls Out a Migraine TV Ad for Misleading Viewers

Linda Malek and Jason Johnson are partners in Crowell’s Health Care and Privacy & Cybersecurity Groups, and have a particular focus on advising clients on compliance issues related to clinical research and clinical trials. Stephen Holland is Senior Counsel in Crowell’s Government Affairs Group and previously served as Senior Health Counsel to the U.S. House Committee on Energy and Commerce, where he advised on FDA policy, including legislation related to medical devices and laboratory developed tests.

The FDA has provided answers to the most common questions it has received regarding its final rule on laboratory developed tests (LDTs) (the “Final Rule”).  The answers are styled as FAQs that are organized by topic areas.  The FAQs can be found here.  If there is a question that is not answered, the FDA encourages individuals to submit questions to the FDA through the mailbox at ldtfinalrule@fda.hhs.gov.  The FDA notes that it intends to update the FAQs periodically so entities should check the webpage often for additional answers. Continue Reading FDA Publishes FAQs Around Its Recent Laboratory Developed Tests Final Rule

Linda Malek and Jason Johnson are partners in Crowell’s Health Care and Privacy & Cybersecurity Groups, and have a particular focus on advising clients on compliance issues related to clinical research and clinical trials. Stephen Holland is Senior Counsel in Crowell’s Government Affairs Group and previously served as Senior Health Counsel to the U.S. House Committee on Energy and Commerce, where he advised Members of Congress and their staffs on FDA policy.

On July 25, the Food and Drug Administration (FDA) issued final guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. The guidance aims to provide drug sponsors with considerations should they wish to use real-world data (RWD) drawn from electronic health records (EHRs) or medical claims data in their clinical studies to support regulatory decisions related to the safety and efficacy of a drug.Continue Reading FDA Issues Guidance on Using Electronic Health Records and Medical Claims Data in Clinical Studies

The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen significant policy activity in recent years and that are relevant to healthcare stakeholders, including providers, plans, electronic health record (EHR) vendors and health technology companies.

Stakeholders should use this summary to examine existing regulatory and compliance gaps, prepare their organizations to comply with forthcoming federal regulations, and keep apprised of federal funding opportunities. For more information on these policy developments, please contact the professionals listed below, or your regular Crowell contact.Continue Reading Healthcare Policy Developments to Watch in 2024

On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled medical devices (“MLMD Guiding Principles”).Continue Reading FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles

On May 2, FDA published a draft guidance on decentralized clinical trials (DCTs) to provide recommendations for sponsors, investigators and others on implementation of DCTs, as required by the Food and Drug Omnibus Reform Act (FDORA).

Background

DCTs include both fully decentralized trials – where all trial activities take place at locations other than trial