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Dominick DiSabatino is a partner on the Life Sciences team in the firm's Washington, D.C. office.

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

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

On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved in 2011 to reduce the risk of preterm birth in certain pregnant women.[1] The final decision followed a hearing and appeal process that took nearly three years, and cited the failure of post-approval studies to prove the drug’s effectiveness as the reason for the withdrawal.[2] Continue Reading Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs[1] and a guidance document[2] clarifying the agency’s intended implementation of the Consolidated Appropriations Act of 2023 (the “Omnibus”), which amended Section 524B of the Food, Drug & Cosmetics Act (the “FD&C Act”) to require the demonstration of cybersecurity safeguards in pre-market submissions for certain medical devices.[3] Continue Reading FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices

On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas)[1] for marketing human cells, tissues, or cellular or tissue-based products (HCT/Ps)[2] without FDA premarket review. The letter described Thomas’ marketing of products derived from human umbilical cord, umbilical cord blood and amniotic tissue as “regenerative therapy solutions” or “stem cell derived biological product” to treat various diseases and conditions including cardiac disease, Alzheimer’s, Parkinson’s, lung disease, diabetes and COVID-19.Continue Reading FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer