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animal drugs, and OTC animal drugs (collectively, “Promotional Communications”).[1] As identified in both the 2018 Draft Guidance and this final guidance, the FDA has seen an increasing trend of quantitative presentations of efficacy and risk in Promotional Communications submitted to the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

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

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

Sheppard Mullin litigators recently published an article in Food Manufacturing outlining USDA’s sweeping changes to its organic regulations. Entities that wish to continue utilizing the USDA Organic label must comply with USDA’s new regulations by March 19, 2024.
Continue Reading Implications of the USDA’s New Organic Rule

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

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. Although the Fifth Circuit did grant temporary, albeit limited, relief, the court maintained that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail.
Continue Reading Access to Abortion Pill in Limbo: Navigating the Intricacies of FDA Approval as well as Conflicting Federal Court Rulings

On March 24, 2023, FDA issued its draft guidance for industry regarding the use of “Dietary Guidance Statements” on food labeling. FDA defines “Dietary Guidance Statements” as voluntary labeling statements, images, or words used on food packaging that convey that the food item is part of, or contributes to, a “nutritious dietary pattern.” As noted by FDA, Dietary Guidance Statements provide manufacturers with an additional set of messages that can be used on-pack, beyond nutrient content claims or “healthy” claims. FDA has issued the guidance as part of its wider effort to create a healthier food supply for Americans and ensure consumers have…
Continue Reading “Dietary Guidance Statements” in Food Labeling: What You Need to Know About FDA’s Latest Draft Guidance for the Food Industry

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