FDA Law Update

Current Issues Affecting FDA-Regulated Companies

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On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation (Novartis) regarding a promotional, direct-to-consumer broadcast advertisement (TV Ad) for KISQALI® (ribociclib) tablets, for oral use, indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
Continue Reading FDA’s Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI®

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 that it would not impose sanctions under the Federal Anti-Kickback Statute (the “AKS”) or the Beneficiary Inducements Civil Monetary Penalty (the “CMP”) against the Requestor for paying cost-sharing subsidies to clinical trial participants to cover the participants’ share of costs for reimbursable, study-related items and
Continue Reading OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

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 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
Continue Reading From Good Reprint Practices to SIUU Communications: What Firms Need to Know

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
Continue Reading OIG General Compliance Program Guidance November 2023

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, the proposed rule would be promulgated by the Food and Drug Administration (FDA), which is expected to issue a Notice of Proposed Rulemaking in April 2024. The announcement is notable because it represents the first time that an administration has expressed its intent to ban the
Continue Reading Hair Products with Formaldehyde Are Going Out of Style: Is Your Organization Ready for the Change?

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 LDTs.
Continue Reading FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

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 regulations to software products that “supplement, explain, or otherwise textually relate to” the use of a prescription drug. As most of FDA’s recent regulatory activity with respect to medical software regulation has been in the device space, this Guidance represents a concerted focus by the
Continue Reading FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

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
Continue Reading Context is Key: FDA Sends a Strong Message About Efficacy Claims

On August 11, 2023, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Exeltis USA Inc. (Exeltis) regarding a promotional social media sponsored post for SLYND® (drospirenone) oral progestin tablets, indicated for use by females of reproductive potential to prevent pregnancy (Slynd).[1] The post appeared on Facebook,[2] and, in addition to being false and misleading, also was not submitted to OPDP at the time of publication as required by FDA regulations. This is only the second untitled letter from OPDP of the year, both of which have
Continue Reading FDA’s Office of Prescription Drug Promotion Issues Second Untitled Letter of the Year to Exeltis for Misleading Statements Relating to SLYND®

On July 13, 2023, the Food and Drug Administration (“FDA”) approved the first daily contraceptive for use without a prescription.[i] Opill® (norgestrel) tablet, .075 mg has been approved to prevent pregnancy in individuals of all ages and can be available for consumer purchase at pharmacies, grocery and convenience stores, and online.
Continue Reading FDA Approves First Over-the-Counter Daily Oral Contraceptive

On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) device and associated software for uses outside the scope of the device’s 510(k) clearance.[1] This warning letter is one of only a handful issued this year to medical-device manufacturers, and comes shortly after FDA issued a warning letter to iRhythm Technologies, which we wrote about, for touting uses for a remote monitoring device which were, in FDA’s opinion, outside the scope of the product’s 510(k) clearance.[2]
Continue Reading FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices

On June 27, 2023, the Food and Drug Administration (FDA) issued its final guidance for the presentation of “Quantitative Efficacy and Risk Information” in direct-to-consumer (DTC) promotional labeling and advertisements for prescription drug, biological products, prescription animal drugs, and OTC animal drugs (collectively, “Promotional Communications”).[1] As identified in both the 2018 Draft Guidance and this final guidance, the FDA has seen an increasing trend of quantitative presentations of efficacy and risk in Promotional Communications submitted to the Agency. OPDP has been taking a close look at these types of claims, focusing on quantitative data in in their only untitled
Continue Reading FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements

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
Continue Reading DOJ Continues to Discuss Updates to Compliance Program Guidance and Corporate Enforcement Policies