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 The final guidance, issued over three years after the draft guidance, provides FDA’s expectations for the content and format of IFUs so that they are consistent across drug and biological products. The FDA’s final guidance does not modify its draft guidance in any major substantive way. Rather, as stated by the FDA, the final guidance merely includes “editorial changes to improve clarity.”…

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 Companies for misleading statements for DUOBRII™ conveyed in a promotional video and healthcare professional website.…

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 be a welcome shift towards a more holistic, metric-based review of manufacturers with mature quality systems.…

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.  This set of warning letters marks the first time FDA has publicly taken enforcement action against products containing Delta-8 THC, and it will likely not be the last.
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 AOs, OIG found that while the Proposed Arrangement could generate fraud and abuse risks under both the Federal anti-kickback statute (i.e., Section 1128A(a)(7) and 1128B(b) of the Social Security Act (“Act”)) and the Beneficiary Inducements CMP (i.e., Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented. Medical device manufacturers should pay close attention to this trend when considering trial designs and patient populations.
Continue Reading OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

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 stakeholders to avoid supply disruptions and product shortages. Following the transition period, manufacturers who want to continue selling covered devices would be expected to comply with all the usual regulatory requirements. Manufacturers who do not wish to continue distribution post-PHE could keep business as usual through the end of the 180-day transition period. Comments on the draft guidance are due on March 23, 2022.  The guidance for EUA devices can be found here, and for devices marketed under COVID-19 enforcement policies, here.
Continue Reading FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies During COVID-19

On December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from participants in clinical investigations. DHTs (such as wearables and sensors) are playing a growing role in clinical research, accelerated by the need for decentralized clinical trials and remote patient monitoring during the COVID-19 pandemic. Though largely directed to study sponsors using DHTs, the guidance raises issues that developers and manufacturers of these technologies will want to be mindful of given the ways in which their products might be used in a broader clinical use case than originally anticipated. Comments on the draft guidance are due March 23, 2022. The full text of the guidance can be accessed here.
Continue Reading FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations