Every five years, the Food and Drug Administration (FDA) negotiates an agreement with the pharmaceutical industry over the fees companies pay to have their drug applications reviewed and the performance goals the agency promises in return. Those terms are set out in a commitment letter under the Prescription Drug User Fee Act (PDUFA), and Congress relies on that agreement when it reauthorizes the program. In August 2026, the FDA published its draft commitment letter for PDUFA VIII, held a public meeting on September 16, 2026, and invited stakeholders to file comments under docket FDA-2026-N-8163.

Influencers are increasingly advertising prescription medicines on social media, and the financial relationships behind these promotions are largely invisible to regulators and the public. This brief discusses how Congress and federal regulators can address this issue, including:

Section 3060 of the 21st Century Cures Act excluded certain software functions from the definition of a medical device. Every two years, the Food and Drug Administration (FDA) publishes a report on the risks and benefits to health of those software functions. To prepare each report, the agency gathers public input through docket FDA-2018-N-1910, which reopens for comment every reporting cycle.

Generation Patient is at a pivotal transition point as its founder moves out of the Executive Director role. The organization seeks its next Executive Director to bring it into a new phase of impact. The Executive Director will oversee all aspects of the organization, […]

Every five years, the Food and Drug Administration (FDA) negotiates an agreement with the medical device industry over the fees companies pay to have their products reviewed and the performance goals the agency promises in return. Those terms are set out in a commitment letter under the Medical Device User Fee Amendments (MDUFA), and Congress relies on that agreement when it reauthorizes the program.

At Generation Patient, our Peer Support Groups provide a welcoming space where young adults can connect with others who truly understand the challenges, questions, and emotions that come with living with a chronic illness.

Members of the Senate Committee on Health, Education, Labor and Pensions (HELP) voted 16–6 on June 17, 2026, to advance the Medication Affordability and Patent Integrity Act (S. 2658), a bipartisan bill introduced by Senators Maggie Hassan (D-NH) and Josh Hawley (R-MO). Generation Patient applauds this Senate HELP vote to advance S. 2658.

Patent thickets are rarely the focus of congressional hearings. On June 4, 2026, however, patent thickets and skinny labels took center stage at a hearing held by the U.S. House Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet.

Drug patent policy must strike a balance between incentivizing genuine biomedical innovation and enabling competition after limited exclusive rights expire. Achieving this balance is crucial for ensuring affordable access to medicines for young adults with chronic conditions, many of whom rely on high-cost therapeutics. However, brand companies typically exploit gaps in the patent system to disrupt […]

Generation Patient is seeking a Monitoring, Evaluation, and Learning (MEL) Consultant to support a 15-month initiative focused on AI companion tools and their impact on young adults with chronic conditions.

This role is primarily a research and landscape analysis position (approx. 80%), focused on understanding how young adults with […]

Washington, D.C., May 6, 2026. Generation Patient today published a new report, "Patent thickets increase costs and delay access to medicines for young adult patients," documenting how drug companies use terminal disclaimers to build patent thickets that delay generic competition and keep American drug prices high.

Generation Patient is seeking a Consultant Coordinator to support a 15‑month initiative focused on increasing oversight of AI companion tools through a health regulatory lens. The consultant will work closely with the Generation Patient team and serve as a project coordinator and strategist, owning schedules, logistics, and partner engagement, while bringing an entrepreneurial, […]

Last week, the House Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet held an oversight hearing with U.S. Patent and Trademark Office (USPTO) Director John Squires. Chairman Darrell Issa (R-CA) raised several concerns about ongoing USPTO policies that are restricting public access to patent challenges. Generation Patient shares many of the concerns raised by Chairman Issa.

Generation Patient (GP) is at a defining moment of organizational growth and leadership transition. Building on its nationally recognized work advancing young adult-driven health policy, peer support, and independent patient leadership, GP is hiring a Policy Director to carry the organization into its next phase. This role offers a unique opportunity to lead a respected policy program at the forefront of young adult patient-led health reform.

The next leader will guide Generation Patient through its transition from being founder-led to grow in its next chapter. They will oversee all aspects of the organization, sustain and scale impact, and remain committed to the young adult patient community that Generation Patient proudly serves. Leveraging Generation Patient’s deep-rooted partnerships with peer organizations and its strong […]