On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the ever-expanding puzzle that is FDA’s regulatory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 Agency to unify its approach to digital health across all regulated categories (e.g., drugs, biologics, and devices).…

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 Guidance”).[1],[2] 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

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 focused on false and misleading promotional messaging.…

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] These enforcement actions indicate that FDA is keeping a close eye on the promotion of software-enabled medical devices, especially when that promotion suggests a function that has not been approved and/or cleared by FDA for the device.…

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 letter of 2023. As further discussed in our June blog post, in their letter to Xeris Pharmaceuticals, OPDP raised concerns regarding percentages that overstated the efficacy of the drug, Recorlev® (levoketoconazole) by omitting necessary context needed to understand the quantitative data.[2]…

Continue Reading FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements

The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to Xeris Pharmaceuticals, Inc. (“Xeris”).[1] The untitled letter involved promotional communications for Recorlev® (levoketoconazole) tablets for oral use (“Recorlev”) and focused on two of its consumer webpages.[2]…

Continue Reading FDA Issues First Untitled Letter of the Year to Xeris Pharmaceuticals

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

On May 31, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend its regulations regarding prescription drug product labeling regulations.[1] Under the new rule, each time a prescription drug products is used, dispensed, or administered in an outpatient setting, the patient would receive a one-page “Patient Medication Information” (PMI) Medication Guide that highlights essential information regarding the use of the drug. If implemented, FDA believes this rule will consolidate the various forms of prescription information that are dispensed to patients and consequently alleviate confusion for manufacturers deciding what forms are needed with particular prescriptions. Overall, it appears that the FDA’s goals are twofold: (1) standardization of patient-facing prescription drug product labeling, and (2) to expand accessibility of essential safety and efficacy information relevant to such medications.…

Continue Reading FDA Issues Proposed Rule for Standardized and Accessible Patient Medication Information

On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug development — “Regulatory Considerations Guidance”[1] and “Scientific Considerations Guidance,”[2] respectively. These guidance documents replace FDA’s previous draft guidance on the subject,[3] issued in 2005, and clarify requirements and recommendations for brining pediatric drugs to market. FDA will be accepting public comment on the Regulatory Considerations Guidance and Scientific Considerations Guidance through July 17 of this year.[4]…

Continue Reading FDA Clarifies Approach to Pediatric Drug Development

On May 22, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) issued an untitled letter to AT Venture Center for Global Techtrepeneurship, LLC dba Regenerelle, LLC (Regenerelle) for marketing human cells, tissues, or cellular or tissue-based products (HCT/Ps) and exosomes without FDA premarket review. The letter described Regenerelle’s marketing of products derived from umbilical cord as “biological solutions” or “biologic products” that are “intended for a ‘range of clinical applications’ and to treat various diseases or conditions, such as lupus, pain, inflammation, and ‘aging-associated diseases.’” This is CBER’s fourth untitled letter this year, illustrating FDA’s focus on this area of enforcement. This stands in contrast to FDA’s work on the CDER side, where the Office of Prescription Drug Promotion has not issued an untitled letter since June 2, 2022.[1]…

Continue Reading FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023