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

The Food and Drug Administration (FDA) has released draft guidance for the labeling of plant-based milk alternatives, which could have a significant impact on the way these products are marketed and sold. The proposed guidance suggests that manufacturers and distributors of increasingly popular oat, almond, cashew, soy and other milk alternatives should be allowed to use the term “milk” to describe their products despite the fact these products have no actual dairy content. …

Continue Reading FDA Draft Guidance Signifies Acceptance of the Term “Milk” to Describe Plant-Based Alternatives

On Thursday, February 23, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued its first Advisory Opinion (“AO”) of the new year – OIG AO No. 23-01 – permitting a drug manufacturer to provide financial assistance for transportation, lodging, meals, and other out-of-pocket expenses to eligible patients receiving the manufacturer’s drug (the “Arrangement”). Overall, OIG concluded that: (1) the risk of fraud and abuse presented by the manufacturer’s Arrangement was sufficiently low under the Federal anti-kickback statute; and (2) the remuneration offered under the Arrangement was not likely to influence a beneficiary to order the manufacturer’s drug (the “Drug”) from a particular provider and therefore did not constitute grounds for the imposition of sanctions under the Beneficiary Inducements CMP. Ultimately, the crux of this decision came down to the unique manufacturing and distribution of the Drug, which (i) is the only available potentially curative treatment for an ultra-rare disorder; (ii) pursuant to its FDA approval, can only be manufactured at a single facility, located on the campus of a treatment center (the “Treatment Center”); (iii) can only be administered within 3 hours after being manufactured; and thus, can only be administered at the single Treatment Center site.…

Continue Reading OIG Advisory Opinion Alert: Medical Flights for Patient Access

On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter[1] to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding and adulteration. The RightEye Vision System is a Class II Nystagmograph medical device which is cleared under its 510(k) notification for the following indication: “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.”[2] …

Continue Reading FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration

The Sheppard Mullin Life Sciences Team decided to take a different approach to our year-end review. We surveyed and considered issues most important to our clients, asking the experts across the various specialties in our Life Sciences Practice the following question: What do life sciences companies need to keep top of mind in 2023?…

Continue Reading 2023 Top-of-Mind Issues for Life Sciences Companies

On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” (the “Inspection Draft Guidance”), which clarifies the types of behaviors that FDA considers to be inappropriately delaying, denying, limiting, or refusing access to an inspection, each of which constitutes adulteration of a drug or device under the Federal Food, Drug, and Cosmetic Act (FDCA).[1] The Inspection Draft Guidance clarifies certain behaviors described in FDA’s previous guidance on the subject (the “2014 Guidance”) and, most significantly, expands the previous guidance to apply to medical device manufacturers.…

Continue Reading FDA Expands Inspection Guidance to Apply to Device Manufacturers

The U.S. Food and Drug Administration (FDA) has extended the comment period for its proposed new “healthy” regulations for food packaging. The new deadline for comments is February 16, 2023. The 50-day extension follows requests from stakeholders to allow additional time for interested persons to submit comments to the proposed regulations. …

Continue Reading Comment Period for “Healthy” Regulations Extended; But Consumer Class Actions Targeting “Health Halos” May Continue

As we take a breather during the holiday whirlwind, we wanted to flag for readers a recent development in advertising and promotion regulation that FDA quietly released nearly a month ago. In a Memorandum issued on October 27 (the “Memorandum”), the Food and Drug Administration (“FDA” or the “Agency”) indicated that it will now permit certain COVID-19 drugs that have been granted Emergency Use Authorization (“EUA”) to make claims of safety and efficacy in print, advertising, and promotional materials, pursuant to certain limitations.…

Continue Reading FDA Lightens Promotional Restrictions for Certain COVID-19 Drugs with Emergency Use Authorization

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting cost-sharing subsidies for life-saving oncology drugs. In October, we discussed the Office of Inspector General’s (“OIG”) Advisory Opinion No. 22-19 (the “Advisory Opinion”), which declared that a charitable organization funded by manufacturers would violate the AKS if it offered certain cost-sharing subsidies under Medicare Part D (“Part D”), even if the organization was independently run and patients had equal access to discounts for 90% of drugs on the market. On November 9, 2022, the Pharmaceutical Coalition for Patient Access (“PCPA”), presumably the organization behind the Advisory Opinion, filed a lawsuit against OIG, seeking declaratory judgment that its cost-sharing program is legal under the AKS and that the Advisory Opinion violates the Administrative Procedure Act (“APA”) and the First Amendment.[1]…

Continue Reading Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

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