Key Takeaways: Federal and state agencies are actively proposing and enacting health technology-related legislation and regulations. Trending telehealth topics include federal changes for prescribing opioid treatments, challenges presented by shifting state laws and expansions in veterinary telemedicine. The Centers for Medicare & Medicaid Services (CMS) updated guidance on permitted text messaging of orders, the National Institute of Standards and Technology (NIST) updated its Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule guidance, and the Department o ..read more

BakerHostetler’s Healthcare Industry team is a Chambers-ranked full-service healthcare law firm with a national presence. We pride ourselves on our ability to strategically guide clients through the ever-changing challenges of the industry, enabling them to respond with agility and foresight. As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and dedication to staying at the forefront of developments allow us to provide a perspecti ..read more

Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). The Guidance provides recommendations and instructions for industry on how to submit facility registrations and product listings to the FDA. This Guidance follows draft guidance the FDA published in August 2023, including a new FAQ section, which the FDA seeks comments on by January 18, 2024. Along with publishing the Guidance, the ..read more

On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval.[1] Generally, there are three pathways to importing a prescription drug into the United States: personal importation, manufacturer imports of multi-market-approved products and the SIP pathway. Personal importation is when an individual imports prescription drugs for their own use and not for further sale or distribution. There is little enforcement by the FDA against personal importation. Practically, if individuals follow the FDA’s guidance on personal imp ..read more

On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,” often referred to as the SIUU Guidance. This much-awaited guidance seeks to address common questions and concerns associated with firms’ communications to healthcare providers (HCPs) regarding the scientific information on unapproved uses of FDA-approved/cleared medical products. While the guidance retains several principles from previous iterations focusing on the communicat ..read more

Key takeaways: FDA’s Commitment to Regulate Digital Health Technologies: The U.S. Food and Drug Administration (FDA) is establishing a Digital Health Advisory Committee to address the complexities of emerging digital health technologies (DHTs), such as AI/ML and augmented reality. Role of the Digital Health Advisory Committee: The committee will provide expert advice to the commissioner of the FDA on issues related to DHTs and FDA policies and regulations. It aims to enhance the FDA’s understanding of the benefits, risks and clinical outcomes associated with digital health technologies whil ..read more

Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials it sponsored, according to a 2022 Office of Inspector General report. Lack of transparency in clinical trials not only harms the integrity of the scientific process but also can result in civil or criminal penalties and impact grant funding. Universities and academic medical centers, which often conduct research as sponsor-investigators, are among the worst offenders in f ..read more

On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility registrations and product listings requirements. This forward-looking framework encompasses a wide array of products, as provided for by Section 604(2) of the Food, Drug, and Cosmetic Act, from makeup essentials and nail polishes to grooming products, perfumes, cleansers, haircare items and skincare solutions. Namandjé Bumpus, Ph.D., the FDA’s chief scientist, underscores the trans ..read more

On June 27 the Food and Drug Administration (FDA) published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, the FDA provides examples of activities prohibited by the wholesaling provision and not prohibited by the wholesaling provision. Congress created “outsourcing facilities” in Section 503B of the Drug Quality and Security Act of 2013, which was designed to protect the safety of compounded medications after deadly contamination at the New England Compounding Center (NECC). Previous ..read more

On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the FDA approval of the abortion drug mifepristone. The Texas decision blocks prescribing and dispensing of mifespristone nationwide, while the Washington decision enjoins the FDA from altering the status quo related to mifepristone. The discrepancy is likely to escalate to the Supreme Court of the United States for review. Read the full alert ..read more