On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance provides valuable information about what steps the FDA will expect sponsors to take to promote adequate representation across demographic characteristics in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.
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.
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.
Recently, President Joe Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act, which provides a mechanism for industry and academia to access and research cannabis (including marijuana and other cannabis-derived products) without violating the Controlled Substances Act. This legislation creates a pathway for researchers to register with the US Department of Justice to legally conduct scientific research on such products subject to certain requirements. It also creates a system to allow drug manufacturers to legally produce products approved by the US Food and Drug Administration that contain cannabidiol or marijuana for commercial sale. The legislation also includes a doctor-patient relationship provision that permits state-licensed physicians to discuss the “currently known potential harms and benefits of marijuana and its derivatives, including cannabidiol, which may be derived from marijuana or other cannabis products such as hemp, as a treatment,” which may be of significant interest for healthcare providers.
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.
As companies consider whether or not to introduce vaccine mandates for employees, there is interest among some employers to increase health care premiums or impose financial penalties on employees who refuse vaccination. One major airline, for example, recently announced that unvaccinated employees enrolled in the company’s health plan would see a $200 monthly surcharge. However, according to McDermott Partner Judith Wethall in The Hill, financial penalties for the unvaccinated are legally complicated, and vaccine mandates likely pose less regulatory issues for employers to impose.
On August 26, 2021, Illinois Governor J.B. Pritzker issued Executive Order 2021-20 (the Order). The Order mandates that all individuals in Illinois who are at least two years old and who are medically able must wear face coverings indoors and in other specified settings.
In addition, the Order mandates COVID-19 vaccination for certain professionals in healthcare and education, as well as for students and state employees, subject to certain exemptions which require regular COVID-19 testing.
President Biden’s July 9, 2021, Executive Order—which seeks to increase competition throughout the American economy—takes aim at prescription drug prices. In this article, published in Law360, McDermott partner Emily Jane Cook says Biden’s focus on drug prices is unsurprising given the “significant public interest and frustration” with drug costs.
Subscribe
