FDA Law Update

Current Issues Affecting FDA-Regulated Companies

Latest from FDA Law Update - Page 2

FDA issued a proposed rule on September 28, 2022, to update the definition of “healthy” by specifying new criteria by which the term can be used in food labeling. As a result of the proposed changes, FDA expects more food in the marketplace will be able to make use of the “healthy” claim.
Continue Reading FDA Proposes Updated Rule for “Healthy” Foods

Effective January 1, 2023, the recently enacted California Assembly Bill 1278,[1] requires a physician and surgeon (defined as a physician and surgeon licensed pursuant to the Medical Practice Act or an osteopathic physician and surgeon licensed by the Osteopathic Medical Board of California under the Osteopathic Act, but not a physician or surgeon working in a hospital emergency room) to provide a written or electronic notice of the Open Payments database to a patient at the initial office visit. The written or electronic notice shall contain the following text:
Continue Reading California Passes First State Law Requiring Physicians to Disclose Open Payments Database to Patients

On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries via 501(c)(3) charities without running afoul of the Federal Anti-Kickback Statute (the “AKS”).
Continue Reading OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies

The United States’ recent False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. In Prometheus Group, the government alleges that the defendant medical device manufacturer trained providers to re-use disposable rectal probes against U.S. Food and Drug Administration (“FDA”) recommendations, causing the providers to submit false claims for payment to Medicare for the services mis-using the probes. The complaint alleges that Prometheus put vulnerable Medicare
Continue Reading The Government Seeks FCA Liability for Off-Label Use of Medical Devices

With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data for low-risk consumer health products. Consumer health products, as described in the FDA guidance, include class 1 devices that are typically sold directly to consumers, such as digital health products and consumables. The FDA guidance extends the compliance date for data submission from September 24, 2022 to December 8, 2022, giving manufacturers of consumer health products more time to prepare their submissions.
Continue Reading FDA Delays Enforcement of UDI Reporting Requirements for Consumer Health Products

On July 15, 2022, the Food and Drug Administration (FDA) issued its final guidance on developing the content and format of patient Instructions for Use (IFU) for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The final guidance, issued over three years after the draft guidance, provides FDA’s expectations for the content and format of IFUs so that they are consistent across drug and biological products. The FDA’s final guidance does not modify its draft guidance in any major substantive way.
Continue Reading FDA Issues Final Guidance on Drug and Biological Instructions for Use (IFU)

On June 2, 2022, the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter [1] to Althera Pharmaceuticals, LLC (Althera) relating to promotional communication for ROSZET® (rosuvastatin and ezetimibe) tablets for oral use (Roszet). The promotional communication was a professional “Roszet Doctor Info Letter Size”. [2] This is the third untitled letter from OPDP this year. In January, OPDP sent an untitled letter to Eli Lilly & Company regarding promotional claims for TRULICITY® on social media. In March, OPDP sent an untitled letter—which we covered in our blog post here —to Bausch Health
Continue Reading FDA Issues Untitled Letter to Althera Pharmaceuticals for Statements Relating to ROSZET®

The metaverse has been described as the “next frontier” and the “new era” of healthcare. Although still a loosely defined and relatively broad term, the “metaverse” generally refers to a shared virtual environment accessed by individuals via the Internet. Individuals generally enter the metaverse through the following four technologies: virtual reality, augmented reality, mixed reality and extended reality.  
Continue Reading Digital Health in the Metaverse: Three Legal Considerations

The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework to evaluate the Quality Management Maturity (QMM) of pharmaceutical manufacturing sites. The White Paper supports CDER’s long-held vision for pharmaceutical quality in the 21st century, described as a “maximally efficient, agile, flexible manufacturing sector” that is able to reliably produce high-quality drug products without extensive regulatory oversight.[1] The Agency is hosting a two-day workshop on May 24 and 25 for stakeholders to provide feedback on the proposed QMM, which may
Continue Reading FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems

On May 4, 2022, the Food and Drug Administration (FDA) issued warning letters to five companies it asserts are illegally marketing products labeled as containing delta-8 tetrahydrocannabinol (Delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FDCA). Simultaneously, FDA issued a new consumer update “5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC.”  The consumer update and warning letters are a continuation and expansion of FDA’s efforts to warn the public about products that are not approved under the FDCA and to rein in the rapidly expanding market of products containing hemp-derived cannabinoids. 
Continue Reading Warning! FDA Issues Warning Letters for Products Containing Delta-8 THC

On March 31, 2022, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Bausch Health Companies Inc. regarding a promotional video and healthcare professional website for DUOBRII™ (halobetasol proprionate and tazarotene) lotion, indicated for topical treatment of plaque psoriasis in adults (DUOBRII). The video[1] content aired on a popular television network and the website[2] content was directed at healthcare professionals.  This is only the second untitled letter from OPDP this year, both of which were focused on false and misleading promotional messaging.
Continue Reading FDA Issues Untitled Letter to Bausch Health Companies for Misleading Statements Relating to DUOBRII™

On Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. 22-05, relating to subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial involving medical devices (the “Proposed Arrangement”). This is the third AO in a recent series of AOs (see AO 21-17 on November 19, 2021 and AO 21-13 on October 4, 2021) focused on Medicare cost subsidies in a clinical trial setting for serious conditions that affect large portions of the population in the US. Like these other
Continue Reading OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

The digital health sector has seen tremendous growth and innovation over the past few years. This momentum introduces new complexities within the legal and regulatory landscape that is trying to keep pace. In the attached article, we highlight some of the key legal considerations that the digital health industry can expect in the coming year from the perspective of: (1) telehealth related laws and regulations, (2) FDA, (3) privacy and cybersecurity, (4) fraud and abuse, and (5) antitrust issues.
Continue Reading Top 5 Legal Issues in Digital Health to Watch for in 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Acknowledging that the COVID-19 emergency will not last forever, the FDA’s recent draft guidances propose a 180-day transition path back to “normal operations,” i.e., compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and regulatory requirements. The transition periods, which would begin (in most cases) 180 days after the end of the public health emergency (PHE), would allow manufacturers, healthcare facilities, and other
Continue Reading FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies During COVID-19