Legislation & Regulation

President Donald Trump announced a series of agreements with Eli Lilly and Company and Novo Nordisk to offer Most-Favored-Nation (MFN) prices on two GLP-1 therapies, semaglutide (brand names Ozempic and Wegovy) and tirzepatide (brand names Mounjaro and Zepbound). This marks the fourth and fifth publicly announced agreements between the Trump administration and pharmaceutical manufacturers, joining earlier announcements with Pfizer, AstraZeneca, and EMD Serono. The manufacturers also agreed to cap prices for insulin products and other commonly prescribed diabetes medications.

On Saturday, October 11, Governor Gavin Newsom signed SB 41, a bill that limits certain business practices employed by pharmacy benefit managers (PBMs) in California. This bill follows previous attempts by the governor to regulate PBMs, including changes implemented in the budget that require PBMs to obtain a license, submit detailed operational and financial statements annually to the Department of Managed Health Care, and act in the best interests of health plans and covered individuals.

Under the current Continuing Resolution passed on March 15, government funding will expire at 12:01 AM ET on the morning of Oct. 1. A Continuing Resolution (CR) extends government funding at existing levels in lieu of passage of a regular appropriations bill—occasionally with minor fiscal changes or additional policy “rider” amendments included—for a predetermined amount of time. Unless Congress reaches a deal on an additional funding package, federal government activities and operations deemed “nonessential” will temporarily cease, while “essential” functions and mandatory spending such as Social Security and Medicare payments will continue under contingency plans determined by federal agencies and the Office of Management and Budget (OMB). Since 1980, there have been 14 government shutdowns, with the longest and most recent shutdown to date occurring from Dec. 22, 2018 – Jan. 25, 2019 under the first Trump administration.

Last month, the Department of Health and Human Services (HHS) abruptly announced the firing of former CDC Director Dr. Susan Monarez, which was followed by the resignation of several CDC officials including former CDC Chief Medical Office Dr. Debra Houry.

As organizations representing public health, patients, family caregivers, and healthcare professionals, we have a clear stake in the availability of vaccines. Vaccines represent one of our most effective tools in preventing disease and improving quality of life, throughout the lifespan. The proceedings and recommendations of the CDC’s ACIP have a huge impact on trust and confidence in vaccines, and in Americans’ ability to access those life-saving vaccines. Recognizing the critical importance of this meeting, we respectfully submit the following recommendations.