Agencies across the federal government continue to grapple with how to respond to the directives in President Biden’s October 2023 executive order on artificial intelligence, including the Food and Drug Administration (FDA) and its parent agency the Department of Health and Human Services (DHHS). As summarized in this handy Mintz/ML Strategies timeline of the actions set forth in President Biden’s AI executive order, DHHS has a mandate to “develop a strategy for regulating the use of AI in the drug development process” and a deadline of October 29, 2024 to meet that obligation. Notably, earlier this year DHHS announced a functional reorganization within the department that included creating the position of Chief AI Officer in response to the presidential order.

Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders. An announcement on August 7, 2024 by the Centers for Medicare and Medicaid Services (CMS) of a final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway was therefore a welcome development. However, digging under the surface of the TCET pathway uncovers some less than thrilling details. CMS’s failure to address stakeholder proposals to modify the TCET program has increased interest and advocacy around Congress’s consideration of the Ensuring Patient Access to Critical Breakthrough Products Act. We explore both the shortcomings of the TCET pathway and the possible legislative solutions to its perceived gaps below.

Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and breakthrough therapy/breakthrough device designation programs. These designation programs follow a typical paradigm – (1) a product developer demonstrates to FDA that its candidate meets certain qualifying criteria; (2) FDA grants the relevant designation to the product candidate in question; and (3) the product developer then benefits from an increased frequency of interactions with the agency during continued development of the product and/or a valuable advantage that’s secured upon the product’s future marketing authorization (e.g., orphan exclusivity or a priority review voucher). 

Read about the Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) joint workshop in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding down its historical enforcement discretion posture for LDTs. But FDA’s crusade is far from over. It will have much to do to implement the four-year phase-out period described in the final rule and those efforts may be delayed by litigation seeking to enjoin implementation of the rule altogether. While we wait for the litigation shoe to drop, let’s take a look at what the final rule says and the changes FDA made in these highly significant policy decisions since the Notice of Proposed Rulemaking was published on October 3, 2023 (see our previous posts on the NPRM here and here).

In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are classified as medical devices and include “reagents, instruments, and systems intended for use in diagnosis, including determining the state of health, through the collection, preparation, and examination of specimens taken from the human body.” Unlike human drug and non-IVD device products, which generally must be authorized for a specific medical use prior to commercialization, IVD products may be sold for certain scientific research studies without FDA authorization, but such IVD products may not be sold for clinical diagnostic use. 

In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs).

The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not know quite as well, however, is how many important regulatory programs the Food and Drug Administration (FDA) has tasked itself with completing sometime this year. Given the centrality of much of FDA’s work to the average American consumer and all users of health care services, not to mention the various business stakeholders whose operations can be shaped in part by policy decisions executed by the agency, this blog post will preview upcoming milestones that FDA is expected to meet in 2024.

An important new initiative focused on women’s health research – defined as “the study of health across a woman’s lifespan in order to preserve wellness and to prevent, diagnose, and treat disease” – was recently kicked off in the United States. On November 13, 2023 the White House announced the Initiative on Women’s Health Research, to be led by First Lady Jill Biden and the Gender Policy Council. The Initiative aims to recognize and address the historic and persisting gaps in women’s health research and, by extension, in our collective knowledge about women’s health as well as how women experience certain conditions or respond to certain treatments differently than men. 

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation efforts steadily increased throughout the calendar year, as the December 29, 2023 compliance date for most MoCRA provisions approached, FDA’s release of information and deployment of new systems for the industry came to a climax. Several recent MoCRA-related developments will influence how cosmetic industry stakeholders, consumers, and even the FDA will approach and navigate the law’s requirements over the next year. In this blog post, we will discuss each of these developments and forecast the law’s future as we move into 2024.