Read ML Strategies’ in-depth analysis of how the results of the November 2024 elections are likely to shape policy in many areas, including energy & sustainability, US-Canada cross-border issues, taxation, health care, international trade, infrastructure, consumer product safety, and financial services, and what to expect in the upcoming lame duck session of Congress.

In its August 2024 issue, the journal Environmental International published an article called Tampons as a Source of Exposure to Metal(loid)s. The article reports on the results of a recent study by researchers from Columbia, UC Berkeley, and Michigan State that evaluated the presence of metals in different tampons. The research team evaluated 60 samples of tampons, representing 30 unique products from 24 different brands, for the presence of 16 different metals. The researchers found that all the tampons evaluated contained measurable concentrations of each of the 16 metals, including toxic metals such as lead, arsenic, and zinc.

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.

On June 28, 2024, the Food and Drug Administration (FDA) released draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (the Draft Guidance), for public review and comment. The Draft Guidance was issued pursuant to a directive from Congress in the Food and Drug Omnibus Reform Act (FDORA), signed into law in December 2022, which required FDA to issue or update guidance on diversity action plans that sponsors submit for certain clinical studies of investigational drugs and medical devices. The Draft Guidance also serves to update guidance that FDA previously issued on the topic in April 2022.

Read about President Biden’s recent withdrawal from the 2024 presidential election and his endorsement of Vice President Kamala Harris as the Democratic nominee, including her stance on technology, climate change, health care, and tax policy.

On March 18, President Biden signed an executive order (EO) that contributes to the administration’s objective to create solutions to long-lasting women’s health issues that have been historically understudied and under-evaluated.

Read about Sprint for Women’s Health, a first-of-its-kind initiative to commit $100 million for research and development in women’s health, announced by the Advanced Research Projects Agency for Health.

On Friday, September 22, 2023, in the Rose Garden, President Biden announced the establishment of a White House Office of Gun Violence Prevention. This initiative builds on several actions President Biden spearheaded to advance gun violence prevention such as working with Congress to enact the Bipartisan Safer Communities Act and issuing executive orders to support communities impacted by gun violence.