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Audrey Mercer is an associate who specializes in the life sciences and healthcare industries and works out of the firm’s Dallas office.

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the “Requestor”) and its proposed payment of cost-sharing subsidies. Maintaining its position from similar opinions issued in recent years, OIG said that it would not impose sanctions under the Federal Anti-Kickback Statute (the “AKS”) or the Beneficiary Inducements Civil Monetary Penalty (the “CMP”) against the Requestor for paying cost-sharing subsidies to clinical trial participants to cover the participants’ share of costs for reimbursable, study-related items and services that the participants would otherwise be required to pay out of pocket.[1] This Opinion illustrates that OIG appears to remain willing to permit arrangements that do not fall squarely within an AKS safe harbor in order to incentivize participation, especially diverse participation, in clinical trials for medical devices.Continue Reading OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although there was no single moment like the passage of the Affordable Care Act in 2010, there are numerous distinct events that will loom large in 2024 and beyond.Continue Reading 2024 Top-of-Mind Issues for Life Sciences Companies

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”).[1] The history of LDT regulatory status is long and meandering—and summarized below—but in short, FDA has for a long time exercised enforcement discretion over LDTs.Continue Reading FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the ever-expanding puzzle that is FDA’s regulatory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 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 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 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

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

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