Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the “Requestor”) and its proposed payment of cost-sharing subsidies. Maintaining its position from similar opinions issued in recent years, OIG said
FDA Law Update
Current Issues Affecting FDA-Regulated Companies
Latest from FDA Law Update - Page 5
2024 Top-of-Mind Issues for Life Sciences Companies
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…
FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements
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…
From Good Reprint Practices to SIUU Communications: What Firms Need to Know
On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, Questions and Answers (the “2023 Draft Guidance”). The 2023 Draft Guidance is a revision to, and builds upon, FDA’s 2014 draft guidance…
FDA Moves to End Use of Brominated Vegetable Oil in Food
By Abby Meyer
Within a month of California becoming the first state in the nation to ban manufacturing with, selling, or distributing food items that contain brominated vegetable oil (BVO), FDA has proposed to revoke the regulation authorizing the use of BVO in food as an additive. …
OIG General Compliance Program Guidance November 2023
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…
Hair Products with Formaldehyde Are Going Out of Style: Is Your Organization Ready for the Change?
On June 13, the Biden Administration released its Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions, which announced its plan to propose a rule that would ban the inclusion of formaldehyde and other formaldehyde-releasing chemicals in hair smoothing or hair straightening products that are marketed in the United States. According to the announcement,…
FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference
Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”).[1] The history of LDT regulatory status is long and meandering—and summarized below—but in short, FDA has for a long time exercised enforcement discretion over…
FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the ever-expanding puzzle that is FDA’s regulatory scheme for digital health products. The Guidance clarifies how FDA plans to apply its drug labeling…
Context is Key: FDA Sends a Strong Message About Efficacy Claims
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…