On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance provides valuable information about what steps the FDA will expect sponsors to take to promote adequate representation across demographic characteristics in study populations.
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support hub for innovative approaches to clinical trials designed to improve the quality and efficiency of drug development and regulatory decision-making. Following a public solicitation of comments on the barriers of clinical trial designs, FDA determined that the establishment of C3TI would enhance CDER’s ability to address those barriers and foster innovation.
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from the US Food and Drug Administration (FDA) for importation programs under Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) to import prescription drugs from Canada. These “Section 804 Importation Programs” (SIPs), if approved, would enable states to import prescription drugs from Canada, often at significantly lower prices than those available in the United States.
After years of legal and other challenges to the rule, on January 5, 2024, the FDA authorized Florida’s SIP proposal. While eight other states have laws that permit drug importation, and six of them are seeking FDA approval, this is the first time that the FDA has approved a state entity to import drugs from another country. Following Florida’s example, Colorado and other states are moving forward with their own SIP plans.
The Centers for Medicare & Medicaid Services (CMS) announced in March that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they receive Food and Drug Administration (FDA) approval for an additional medically accepted indication.
In Wegovy’s case, the FDA recently approved an additional indication “to reduce the risk of major cardiovascular events (such as cardiovascular death, non-fatal myocardial infarction, or non-fatal strokes) in adults with established cardiovascular disease and either obesity or overweight” in combination with a reduced caloric diet and increased physical activity. As a result, Wegovy can be available for Medicare beneficiaries who have an established cardiovascular disease and are either overweight or obese. Part D coverage is still not available for weight-loss medications in beneficiaries who do not have the additional medically accepted indication.
During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies.
This chart displays health-related regulations that may be issued this year, organized by federal agency and date of potential release.
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA), which contains prescription drug pricing reform provisions. The three main Medicare prescription drug pricing reform provisions included are as follows:
Leveraging data from the Centers for Medicare and Medicaid Services’ (CMS’s) Medicare Drug Spending Dashboard and FDA databases, McDermott+Consulting has identified the potential list of drugs subject to negotiations.
This information is particularly valuable for pharmaceutical companies, health plans, patients, pharmacies and other stakeholders as they evaluate and consider the implications of this legislation. In less than one year, on September 1, 2023, the Health and Humans Services (HHS) Secretary will publish the first list of selected drugs subject to drug price negotiations. Understanding the statutorily mandated negotiations framework, timeline and potential drugs that may be included is critical to support stakeholders’ efforts to obtain optimal outcomes.
This report describes the drug price negotiation program, an implementation timeline for drug price reforms from the IRA and information on which drugs are likely to be first subject to price negotiation.
On July 12, 2022, the US Equal Employment Opportunity Commission (EEOC) revised its guidance on compliance with disability discrimination law during the COVID-19 pandemic. While previous guidance, initially published on December 14, 2021, provided that COVID-19 viral testing was permissible for on-site employees and did not run afoul of the Americans with Disability Act (ADA) due to health and safety priorities of the pandemic, the recent EEOC updates now only permit screening and viral testing measures when such measures are job-related and consistent with business necessity, holding COVID-19 testing to the same standard as other workplace medical tests. The July 12 update “makes clear that going forward employers will need to assess whether current pandemic circumstances and individual workplace circumstances justify viral screening of employees to prevent workplace transmission of COVID-19,” the EEOC said.
The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets national standards for the licensing of prescription drug wholesale distributors (WDDs) and third-party logistics providers (3PLs) with the goal of strengthening the security of the US drug supply chain. When finalized and effective, these licensing regulations will pre-empt state and local licensing standards, requirements and regulations that are different from these federal requirements.
Healthcare and life sciences lawyers will likely have plenty of work in 2022 thanks to pending legislative and regulatory actions throughout the healthcare, health insurance, and drug and device industries.
According to this Law360 article, surprise billing, abortion and drug pricing are some of the major issues facing lawmakers and regulators in the year ahead. McDermott Partner Michael Ryan noted that changes to the Medical Device User Fee Amendments (MDUFA) also could be in order.
As more employers mandate vaccines for their workforces, in-house legal departments are encountering a host of challenges, including understanding religious accommodations and minimizing litigation exposure. According to this article published in Law.com, employers should have the ability to navigate Americans with Disabilities Act (ADA) and Title VII-related accommodation requests. However, McDermott Partner Carole Spink said many employers have never encountered the current breadth of religious exemption requests from their workforces.
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