Health Law Advisor

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 ...

As of September 25, 2023, Bill A4151 was approved by the New Jersey Senate and is now law in New Jersey. This approved bill amends the existing New Jersey recreational cannabis regulatory landscape. Bill A4151, or P.L. 2023, c.162, (the “Amendment”) revises and waives certain restrictions currently imposed on owners of cannabis establishments. Prior to the enactment of the Amendment, Class 5 retail license holders and their owners, were prohibited from holding interest in other Class 5 retail licenses because horizontal expansion is otherwise prohibited under the state’s ...

This post was co-authored by David Schwartz, CEO and Co-Founder at Ethics Through Analytics, and Michael Shumpert, Data Science Executive at Mosaic Data Science.

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted[1] our April FOIA request in which we asked the agency to add back demographic data fields that it had previously removed from its public Medical Device Report (“MDRs”) databases. To find potential bias, we encourage manufacturers to use this data to look for any disproportionate impact its ...

CMS’s New Actions Related to EMTALA

On January 22, 2024, the Department of Health and Human Services (HHS) announced that, through the Centers for Medicare & Medicaid Services (CMS), it will launch a comprehensive plan related to the Emergency Medical Treatment and Labor Act (EMTALA). The goals of this comprehensive plan are reportedly: (1) to educate the public about their rights related to emergency medical care, and (2) support hospitals that are subject to EMTALA in meeting their obligations. Specifically, this comprehensive plan will:

• Add new informational resources on ...

Use of telehealth services has surged since the COVID-19 pandemic; however, this increase in use does not come without limitations. Telehealth providers are subject to regulations, which differ by state, that govern various aspects of providing services via telemedicine, including what types of health care providers can provide telehealth services, what services can be provided via telehealth, and where providers must be located in order to provide telehealth services to a patient. A requirement consistent across most states is that providers engaging in telehealth services ...

On January 18^th, the Centers for Medicare & Medicaid Services (CMS) announced a new demonstration model called the Innovation in Behavioral Health (IBH) Model, which is designed to improve outcomes for adults with mental health and substance use disorders (MH/SUD) by enhancing behavioral health provider capacity to integrate physical health care into their practice settings and services. The new demonstration model will be run out of the Centers for Medicare and Medicaid Innovation (CMMI) under the funding authority of Section 3021 of the Affordable Care Act and demonstration ...

On January 16, 2024, New Jersey Governor Phil Murphy signed into law Senate Bill No. 332, “An Act concerning online services, consumers, and personal data” (“SB 332”).  New Jersey is the fourteenth state to pass a comprehensive consumer privacy bill, and the obligations and rights created by SB 332 follow the format used in a growing number of states that have passed comprehensive consumer privacy laws.

Scope and Exemptions

SB 332 imposes obligations on “controllers”  – entities or individuals that determine the purpose and means of processing personal data – that ...

On January 9, 2024, the Center for Medicare and Medicaid Services (CMS) sent a letter to New York’s Medicaid director approving New York’s Section 1115 Waiver amendment, which the state submitted for approval on September 2, 2022. During the term of the amendment (January 9, 2024 through March 31, 2027), New York aims to fundamentally reform the way health care services are delivered through its Medicaid program by:   

1. Investing in Health Related Social Needs (HRSN) via providers working with Social Care Networks (SCNs) which in turn contract with existing Medicaid managed care ...

Introduction

Frequently, I am asked by clients to predict how long it will take for FDA to review and clear a 510(k).  At a high level, I observe that on average clearance can take 160 days according to the data.  Then, beyond that, I observe that review times are highly variable among differing product codes, and the very first Unpacking Averages post I wrote in October 2021 provided a graphic to show just how much variation there was depending on the technology.  Here, though, I want to dive into yet another separate factor that should be taken into account, the seasonality of FDA ...