Insights^

White House Proposes Using March-In Rights to Lower Drug Costs 

The Biden administration proposed guidance on Thursday outlining factors that federal agencies should consider in determining whether to use march-in rights to seize the patents of certain expensive drugs.  Codified in the Bayh-Dole Act of 1980, march-in authority allows the government to take over patents for drugs developed with taxpayer funds and share them with other drug companies if the public cannot reasonably access the drug.  However, no federal agency to date has ever invoked march-in rights to break a patent over a drug’s high price.  The announcement comes as President Biden plans to make lowering drug costs a key pillar of his health care platform for his 2024 reelection campaign.   

Biden Administration Delays Ban on Menthol Cigarettes to 2024 

A ban on menthol cigarettes that was originally schedule to take effect in December 2023 won’t happen until at least March 2024, according to the White House Office of Information and Regulatory Affairs (OIRA).  While the Biden administration has so far declined to comment on the delay, the decision is likely due to lobbying from the tobacco industry, which has been fighting a similar ban in California.  News of the delay has left anti-tobacco advocates devastated due to the public health impact of menthol cigarettes.  The Food and Drug Administration (FDA) estimates that a ban on menthol cigarettes could prevent 300,000 to 650,000 smoking deaths over 40 years.  Most of these preventable deaths are attributed to Black Americans, who smoke menthol cigarettes at higher rates. 

Bipartisan Senators Seek Answers on Impact of Private Equity 

Senate Budget Committee Chairman Sheldon Whitehouse (D-RI) and Ranking Member Chuck Grassley (R-IA) sent letters on Thursday to seven companies in an effort to learn more about the impact of private equity on the health care industry.  The letters include questions on financial relationships and whether private equity companies can determine business practices like staffing ratios, billing, and key personnel decisions.   The senators’ inquiry reflects a growing scrutiny over the role of private equity in medicine, which critics say has been attributed to higher health care costs and utilization as well as lower-quality care.  However, proponents of private equity contend that these firms play an important role in the health care industry by enabling growth and increasing the market power of smaller health care entities. 

McCarthy, McHenry Announce Exits from Congress 

This week, former Speaker Kevin McCarthy (R-CA) and former Speaker Pro Tempore Patrick McHenry (R-NC) announced that they will not seek reelection to Congress in 2024.  The announcements cap off a chaotic year in the House, where McHenry served as acting speaker for most of October 2023 following his close ally McCarthy’s historic ouster from the speakership.  Known for his fundraising prowess, McCarthy will officially leave Congress at the end of 2023, although he has vowed to remain active in politics by working to recruit the next generation of Republican leaders.  In contrast, McHenry will stay on until his term ends in January 3, 2025, which will surely be followed by a competitive race to determine who will be the next top Republican on the House Financial Services Committee.   

ICYMI: Holiday Decorating Contest in Congress Draws Controversy 

Launched in 2019, an annual holiday decorating contest for lawmakers’ offices on Capitol Hill has been largely a friendly affair.  However, this year’s contest has ruffled a few feathers for being overly political.  Rep. Eli Crane (R-AZ) has faced criticism from Democrats for his border security-themed decorations that feature a “Border Patrol Elves Only” sign on an office door, while the office of Mike Collins (R-GA) has a cardboard cutout that references Hunter Biden’s drug use.  Fortunately, the majority of other members of Congress has taken a less political approach by choosing themes like local sports teams and Star Wars for their decorations. 

Biden Invokes DPA to Address Drug Shortages

On Monday, President Joe Biden invoked the Defense Production Act (DPA) during an inaugural meeting of the Council on Supply Chain Resilience to ease drug shortages.  The announcement comes amid shortages of penicillin, Adderall, and certain cancer drugs that have affected doctors and patients across the nation.  The administration plans to use the DPA to invest $35 million to support domestic manufacturing of essential medicines and key ingredients.  Additionally, the White House will appoint a new Supply Chain Resilience and Shortage Coordinator to focus on long-term supply chain issues, and the Defense of Defense (DOD) will release a report on pharmaceutical supply chain resilience.

US Life Expectancy Sees Post-COVID Bump

The US life expectancy rate rose for the first time since the COVID-19 pandemic began, according to data from the Center for Disease Control and Prevention (CDC).  Researchers found a 1.1-year increase in 2022, bringing the overall life expectancy to 77.5 years.  This marks a reversal of the 2.4-year life expectancy drop that occurred over 2020-2021, which was largely driven by COVID-19 deaths.  Native Americans saw the largest life expectancy increase of 2.6 years, while the life expectancy gap between White and Black Americans narrowed slightly in 2022.  However, CDC researchers did note a rise in deaths from flu, pneumonia, kidney disease, and fetal and infant conditions in 2022.  The CDC also found that deaths from suicide reached a record high of nearly 50,000 in 2022.

Lawmakers Explore Use of AI in Health Care

Members of the House Energy and Commerce Health Subcommittee heard from health care industry stakeholders in a hearing on Wednesday about the potential for artificial intelligence (AI) to decrease administrative burden and improve care delivery.  However, witnesses warned that regulations will be needed to protect patients’ privacy and ensure that AI does not discriminate against patients.  While subcommittee members were particularly interested in the ways AI could address clinician burnout as well as workforce shortages, there has yet to be any significant momentum on legislation to address AI in health care settings.

Califf Taps New Principal Deputy Director for FDA

FDA Chief Scientist Namandjé Bumpus will succeed Janet Woodcock as the agency’s Principal Deputy Director, according to an announcement from FDA Commissioner Robert Califf.  Earlier this month, Woodcock announced that she will be stepping down from her role in early 2024, marking the end of a 37-year career at FDA that included stints as action commissioner as well as head of the agency’s Center for Biologics Evaluation and Research (CBER).  Bumpus’ priorities in her new role include the creation of a new model for the office charge of inspecting facilities that manufacture drugs and medical devices.  Prior to joining the FDA in August 2022, Bumpus chaired the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine, where she conducted research on drug metabolism and the effects of antivirals on humans and pathogens.

ICYMI: High Winds Take Down White House Christmas Tree

The White House Christmas Tree was a casualty to 46 mph winds that befell the National Capital Region on Tuesday, just two weeks after the tree had been planted at the White House Ellipse.  The incident caused 20 ornaments to fall from the tree, although none of the ornaments were damaged.  Fortunately, the tree was raised just hours later, allowing the White House Christmas Tree lighting ceremony to continue as planned.