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4 January 20244 minute read

Life sciences policy: What we’re watching in 2024

The second session of the 118th Congress begins Monday in the Senate and Tuesday in the House. With razor-thin majorities in both houses, a presidential campaign entering primary season, and more budget deadlines looming, maintaining a watchful eye on health policy is more important than ever.

Here are five issues we believe deserve particular attention in 2024:

  1. Drug pricing. While drug pricing will likely remain a major issue for years to come, the dynamics of the presidential campaign will magnify the ongoing fight over the Inflation Reduction Act (IRA) in 2024. President Joe Biden is likely to celebrate securing the IRA’s drug price negotiation and insulin cost cap wins, as well as his recently released plan to utilize march-in rights to target pharmaceutical patents. If former President Donald Trump becomes the Republican nominee, he too may run on his Executive Orders designed to lower drug prices. Meanwhile, pharmaceutical manufacturers will be closely watching important negotiation program deadlines for drugs selected for initial price applicability in 2026, including projected due dates for manufacturers’ proposed counteroffers (March 2), the end of the negotiation period (August 1), and publication of the resulting negotiated prices (September 1).

  2. Antitrust. Both the Federal Trade Commission (FTC) and Department of Justice have made little secret of their intent to continue targeting life sciences mergers and acquisitions for heightened scrutiny and potential litigation. The FTC has been seeking to block vertical deals (mergers of non-competitors), despite decades of practice that encourage these kinds of transactions. New merger guidelines proposed by the agencies along with a redesign of the Hart-Scott-Rodino Act that governs merger law threaten to block and/or add substantial cost and uncertainty to deals.

  3. Government funding. Following an excruciating and ultimately fruitless attempt to pass FY 2024 appropriations, the White House and Congress agreed to a unique two-tiered continuing resolution (CR) that extends funding for some government programs through January 19 and a second set of government programs through February 2. To avoid a lapse of funding for federal agencies or a forced sequester imposed by the Fiscal Responsibility Act of 2023 due to go into effect on April 30, Congress will have to overcome intense intra- and interparty differences, among them how to fund a host of health programs that include user fees.

  4. Access to care. Medicare currently does not cover any medication for obesity indications by statute, but with more anti-obesity drugs coming to market and a surge in popular demand, there will be continued pressure to pass legislation to cover these medicines. Further, we expect to see more regulatory fights over drugs for rare or otherwise undertreated diseases that may require the Food and Drug Administration to exercise regulatory flexibility already granted above and beyond its traditional authorities.

  5. Artificial intelligence. The debate over how to regulate artificial intelligence (AI) affects every sector, and healthcare is no exception. Per President Biden’s sweeping October 30 Executive Order on AI, the Secretary of Health and Human Services (HHS), in consultation with the Secretaries of Defense and Veterans Affairs, must establish an HHS AI Task Force by the end of January 2024. That task force is required, within one year, to “develop a strategic plan that includes policies and frameworks – possibly including regulatory action, as appropriate – on responsible deployment and use of AI and AI-enabled technologies in the health and human services sector.”

Our lawyers and policy advisors practice in every corner of the healthcare industry, with a particular focus on the life sciences. We use that knowledge to secure positive outcomes for our clients.

Find out more about these evolving policy issues and how they affect your business by contacting any of the authors.