September 23, 2026

Last Friday, the White House posted an announcement that all 50 state Medicaid programs are expected to participate in the drug price agreements made with biopharmaceutical manufacturers to match the lowest prices paid by other developed nations.

Specifically, under the GENEROUS Medicaid Payment Model, manufacturers are to provide State Medicaid programs with rebates on branded medications to ensure that Medicaid prices do not exceed MFN prices.

To read the full announcement, click here.

Tomorrow, the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP) will consider the nomination of Dr. Heidi Overton to lead the Food & Drug Administration (FDA). The hearing will begin at 10:30AM.

To watch the nomination hearing, click here.

Last week, the PDAC held their September meeting and discussed the details of their plans for the report that they are beginning to compose. The meeting provided an overview of the report’s key sections, which the PDAC will now begin examining and studying in greater detail.

Sections include studying hospitals (including 340B transparency), Medicaid (including GENEROUS, BALANCE and other MFN models), governance — noting that they do intend to begin recording their meetings — affordability topics including potential State PBM and PBM reforms, pharmacy deserts and access, and a variety of other topics. The PDAC members also discussed the struggles that Patients face when navigating prior authorization and step therapy, and intend to evaluate the potential justifications or lack thereof for the use of these practices.

BioNJ, in partnership with the Biotechnology Innovation Organization (BIO), submitted informational comments to the NJ PDAC ahead of this meeting. The PDAC intends to now develop a formalized and simplified means by which additional comments can be submitted, and intends for these comments to be publicly accessible.

The PDAC will next meet on October 15th at 9AM. Members conveyed that they intend for the meeting to be focused on receiving public comments.

For additional information or interest in connecting with BioNJ on the topic of the NJ PDAC, please contact BioNJ SVP of Government Affairs & Policy, Ian McLaughlin at IMcLaughlin@BioNJ.org.

In response to the increase in the prevalence of Medical Spas, the National Association of Boards of Pharmacy (NABP) has announced model legislation to provide boards of pharmacy with model language in the development of state laws or board rules. At the core of this effort is safeguarding the public interest in the context of regulating the practice of pharmacy and distribution of medications and medical devices.

This coincides with a warning letter issued by the Food & Drug Administration’s (FDA) Center for Drug Evaluation & Research (CDER) to a company offering peptide-based products.

To explore the NABP’s resources on Model Pharmacy Acts & Rules, click here.

To view the warning letter from the FDA to the peptide company, click here.

The Small business Education & Entrepreneurial Development (SEED) organization has released a searchable list to screen proposed partners, contractors, contract research or manufacturing organizations, vendors, collaborators and other project participants who might be listed among the eight U.S. Government restricted-party lists in the context of applications for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

If you visit the resource, you will see that the lists are rather extensive. Given the frequency with which some applications have received fairly brief rejection letters that note some kind of foreign entity of concern, anyone submitting an SBIR/STTR application should explore this resource prior to submission.

To visit the Restricted Entity Search Tool for SBIR/STTR Applicants, click here.

Last week, a coalition of organizations across academia, the private sector and public health sent a letter to congressional leadership to urge full reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA).

BioNJ, along with our partner organizations across the country in the Council of State Bioscience Associations (CSBA), joined the letter to encourage reauthorization of this program. We are hopeful that the full New Jersey congressional delegation will be supportive. This is the 20th anniversary of the passage of the original PAHPA — and the legislation has only grown more critical to the national security and health of the United States.

BioNJ released the following statement to urge PAHPA reauthorization:

To read the full coalition letter, click here.

This afternoon, the U.S. Senate Special Committee on Aging is holding a hearing entitled “Leveling the Playing Field: Restoring America’s Edge in Generic Drug Manufacturing.” Invited witnesses include the leaders of PAI Pharma based in Parsippany, NJ, Apotex USA & LATAM, and the Coalition for a Prosperous America.

To watch the hearing, click here.

Last week, the group at Yale University posted this resource that opens with an acknowledgement that the average premium for private health insurance has grown 78% since 2011 against a growth of prices economy wide of 39% over the same period.

The visualization then explores the impact that insurer markup, which covers insurers’ administrative costs and profit, have had in overall spending — noting that insurer markups, measured as a share of premiums, have actually decreased.

The tool also has a state-by-state comparison of premiums vs. inflation, premiums and health spend, and insurer markup.

To visit the Yale Health Care Affordability Lab resource, click here.

Last week, the Judiciary Committee held a hearing entitled “Examining Healthcare Markets: Fraud & Competition.” Invited witnesses included professors from Johns Hopkins University, the University of North Carolina system and the President of Paragon Health Institute.

The focus of the hearing was to explore the effect of mergers, vertical integration and fraudulent insurance practices on healthcare access and affordability nationwide.

To watch the hearing, click here.

In partnership with the IQVIA Institute, AAM’s annual report on Generics & Biosimilar Medicines Savings Report has been released. The report notes $496B in healthcare system savings in 2025, which is an increase of $30B relative to 2024.

To review AAM’s 2026 report, click here.

Yesterday, the Drug Channels Institute posted a preview of data from their upcoming 2026-2027 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. The post specifically explored how the biosimilars category has evolved over time.

One trend the group identifies is an increase in gross profit contributions from biosimilars by over triple between 2022 to 2026 while generic gross profit dollars were either flat or diminished.

To read the Drug Channels post, click here.

BioNJ is the voice of New Jersey’s life sciences sector in Trenton and Washington. BioNJ’s Public Policy Support Series sponsorship opportunities are now available for 2026. You can help to ensure that BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship.

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