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WASHINGTON, D.C. – TUESDAY, APRIL 28, 2026 – PrEP4All, the national nonprofit organization focused on expanding access to HIV prevention and the creation of a national federally-funded PrEP program, today announced the filing of a federal lawsuit against the U.S. Department of Health and Human Services (HHS), Department of Justice (DOJ), Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH), seeking the release of a previously undisclosed agreement tied to HIV prevention research and policy.

READ THE FULL FILING HERE

The lawsuit aims to compel the government to produce a materials cooperative research and development agreement (M-CRADA) between federal agencies and Gilead Sciences, which has never been made public despite formal Freedom of Information Act (FOIA) requests.

The existence of the M-CRADA was revealed through a prior FOIA lawsuit filed by PrEP4All in 2025, which forced the government to release the settlement agreement resolving the landmark United States v. Gilead patent litigation. That case, which was first brought by HHS and DOJ in 2019, alleged that Gilead had infringed on government-owned PrEP patents, profited from publicly funded HIV prevention research, and sought more than $1 billion in damages.

The United States v. Gilead litigation was unexpectedly settled in January 2025 without public explanation. The settlement agreement disclosed that it was executed alongside a second, previously secret agreement — the M-CRADA — involving NIH, CDC, and Gilead. Despite subsequent FOIA requests submitted in October 2025 to four federal agencies, the government has failed to produce the M-CRADA.

Statement by PrEP4All Executive Director Jeremiah Johnson: “If government held patents and taxpayer-funded science leads to life-saving HIV prevention, then the public deserves full transparency on what happens next. Right now, that transparency is missing — and that’s why we’re taking action. People deserve to understand the agreements shaping access to care that can impact their lives.”

Advocates say the undisclosed agreement could contain critical information about future HIV prevention research, including work related to lenacapavir, as well as potential commitments between federal agencies and Gilead that may shape pricing, access, and public health strategy.

Statement by Christopher Morten, Director of the Science, Health & Information Clinic at NYU Law and pro bono attorney for PrEP4All: “PrEP4All is yet again taking the U.S. government to court to vindicate its right to information. The public has a right to know what public agencies are up to, and that right is of the utmost importance when those agencies’ decisions impact public health. This FOIA lawsuit is unfortunately a necessary step because the agencies are months late in complying with their legal obligation to share information with the public.”

PrEP4All previously filed a FOIA lawsuit in August 2025 after HHS and DOJ failed to comply with requests for the original settlement agreement. That lawsuit resulted in the settlement being released in September 2025, which ultimately exposed the existence of the M-CRADA. PrEP4All has stated that it would prefer to resolve the matter without litigation, but has been left with no alternative due to continued non-compliance from federal agencies. Once obtained, PrEP4All intends to analyze the M-CRADA and share its findings with the HIV/AIDS community and the public.

For more information, including access to the suit filing and background materials, visit https://storage.courtlistener.com/recap/gov.uscourts.nysd.662811/gov.uscourts.nysd.662811.1.0.pdf

FAST FACTS:

• PrEP4All has filed a federal lawsuit against HHS, DOJ, CDC, and NIH to compel the release of a previously undisclosed agreement related to HIV prevention research and policy
• The lawsuit seeks a materials cooperative research and development agreement (M-CRADA) between federal agencies and Gilead Sciences that has never been made public despite formal FOIA requests
• The existence of the M-CRADA was uncovered through a prior FOIA lawsuit filed by PrEP4All in 2025, which forced the government to release the settlement agreement in United States v. Gilead
• United States v. Gilead, first filed in 2019, alleged that Gilead infringed on government-owned PrEP patents and profited from HIV prevention research funded by taxpayers, with over $1 billion in damages at stake
• The case was unexpectedly settled in January 2025 without public explanation, despite years of litigation and an active appeal underway
• The settlement agreement revealed that a second agreement — the M-CRADA — was executed simultaneously between Gilead, NIH, and CDC, but its contents remain undisclosed
• In October 2025, PrEP4All submitted FOIA requests to four federal agencies seeking the M-CRADA, but none have produced the document despite statutory obligations to do so
• This marks the second time PrEP4All has had to sue the federal government after agencies failed to comply with FOIA requirements
• The undisclosed agreement may contain critical information about future HIV prevention research, including potential plans related to long-acting PrEP options like lenacapavir, as well as commitments that could impact access, pricing, and public health strategy
• PrEP4All intends to analyze and publicly share the M-CRADA once obtained, providing transparency to the HIV/AIDS community, policymakers, and the public about decisions shaping the future of HIV prevention
• The lawsuit underscores broader concerns about government transparency and accountability, particularly when it comes to decisions involving taxpayer-funded research and life-saving medical interventions

About PrEP4All: PrEP4All is a national advocacy organization founded in 2018 and led by patients, healthcare professionals, and policy experts working to expand access to lifesaving HIV prevention and treatment. Grounded in lived experience and inspired by the legacy of ACT UP, PrEP4All uses direct action, media, and policy advocacy to lower drug costs and advance a national strategy to end the HIV epidemic in the United States.