Health Law Advisor

On Monday, February 26, 2024, BioMarin Pharmaceutical, Inc. (“BioMarin”) disclosed in its annual filing that the company recently received a subpoena from the U.S. Department of Justice (DOJ) requesting certain documents regarding BioMarin’s sponsored testing programs relating to two of its products, VIMIZIM and NAGLAZYME.[1] BioMarin also stated that the company “produced documents in response to the subpoena and are cooperating fully, but there is no assurance that such sponsored testing programs, or [BioMarin’s] other operations or programs, will not be ...

A federal appeals court panel in New Orleans is poised to uphold a lower court ruling enjoining the enforcement of the Affordable Care Act's (ACA) requirement that most private health insurance cover recommendations of the United States Preventive Services Task Force (Task Force).

On March 4, 2024, the U.S. Court of Appeals for the Fifth Circuit heard oral arguments in Braidwood v Becerra, a case challenging the constitutionality of the ACA requirement that most forms of private health coverage include certain recommended preventive services. The panel of three judges ...

In our upcoming series of blog posts, we will look at several key negotiating points for tenants in triple net healthcare leases. We will also offer suggestions for certain lease provisions that will protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. The first blog post in our series focuses on negotiation of initial terms and ...

As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of Information and Regulatory Affairs (“OIRA”) within the Office of Management and Budget (“OMB”). While review by OIRA is capped at 90 days by Executive Order 12866, there is no minimum period required, and therefore action can be taken any time between now and June.

During this election year, FDA’s efforts to push the rule forward fairly quickly is ...

On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to the OTP regulations in over 20 years, and significantly increases access to lifesaving medication while easing operational restrictions.

The agency eased admission requirements and cemented some of the telehealth and take-home dose flexibilities put in place during the COVID-19 pandemic. Other changes streamline OTP operations, reduce restrictions on ...

FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking.  What do the data show regarding FDA’s performance in moving proposed guidance to final?

If you haven’t read it, the Federal Register notice explains that the Consolidated Appropriations Act of 2023 directs FDA to issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementing those practices. The comment period on ...

From our Thought Leaders in Health Law video series: Braidwood v. Becerra represents a significant legal challenge to the Affordable Care Act’s (ACA’s) preventive services coverage provision, which requires private health insurance to cover various clinical preventive services, including immunizations; services rated A or B by the U.S. Preventive Services Task Force; and women's preventive services, such as contraceptives.

Employer plaintiffs have contested the law on moral and religious grounds, particularly objecting to coverage for HIV prevention medication ...

On February 22, 2024, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2023, which ended on September 30, 2023. While the $2.68 billion in total recoveries continues an upward trend from the $2.24 billion reported in FY 2022, a primary takeaway is the focus on DOJ-driven investigations.

During remarks on February 22 at the Federal Bar Association’s Qui Tam Conference, DOJ Principal Deputy Assistant Attorney General Brian M. Boynton reported that in FY 2023, the United  States was a party to 543 FCA ...

Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and effectiveness. So how do consumers know if a product is safe, and how can manufacturers protect themselves in the case of a problem?

In response to stakeholder feedback, the FDA on February 21, 2024, released its updated directory of FDA actions and communications with respect to “Information on Select Dietary Supplement Ingredients and Other Substances.”

Background

On February 16, 2024, the Alabama Supreme Court issued an opinion in the consolidated cases LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al., SC-2022-0579, in which the Court reversed a trial court’s dismissal of the plaintiffs’ civil wrongful-death claims and allowed the plaintiffs to move forward with a cause of action under the Alabama Wrongful Death of a Minor Act (the “Act”).[1] In so holding, the Alabama Supreme Court found that fertilized pre-embryos stored outside of ...