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Friday, August 1, 20225, New York, NY– Today, PrEP4All filed suit against the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) in the Southern District of New York, asking the court to compel the agencies to comply with PrEP4All’s unfulfilled freedom of information act (FOIA) requests. For months, PrEP4All has sought access to the settlement agreement reached in United States v. Gilead, a document to which it is entitled by law. That settlement agreement was abruptly announced in January. Negotiated by the outgoing Biden administration, it apparently let the pharmaceutical company completely off the hook for infringing for many years on HHS’s  patents on PrEP. 

“Advocates have a right to see the terms of this settlement. For six years, community advocates supported the government’s case in hopes that royalties paid by Gilead would go toward a national PrEP access program and erase the disparities created through the company’s unethical business practices,” explains PrEP4All’s Executive Director Jeremiah Johnson. “But while seeking transparency into what seems to be a failure of the Biden administration, we appear to be running into the chaos of the Trump administration. It seems that even basic information requests are unmanageable for HHS and DOJ following DOGE cuts and reductions in force.”

Last year, advocates applauded the government’s appeal in the case after a surprising loss in a May 2023 jury trial. In December 2024—just days before a settlement was unexpectedly announced—PrEP4All and five other community organizations filed an amicus brief supporting the government’s appeal. The amicus brief informed the appeals court of the history of the invention of PrEP, which was led by the Centers for Disease Control and Prevention and National Institutes of Health, and the strength of the government’s patents on PrEP. The brief also emphasized  the harmful impact of Gilead’s actions. 

Following the unexpected settlement, Gilead put out a statement saying that “This resolution reflects the culmination of Gilead’s resounding success in these cases, and the government has withdrawn its appeal of the verdict.” In a recent interview, a lawyer for Gilead described the settlement as “extremely beneficial” for the company.

“This is a company that goes out of its way to use its money to get whatever it wants. We’ve heard estimates that Gilead threw many millions in legal fees at this case, far outpacing what DOJ could invest. Despite making some groundbreaking headway in the face of Gilead’s obscene wealth, it appears the prior administration sold us out.” Says Johnson. “We need to see exactly just how bad of a deal this was in order to know what to do next.”

Gilead’s bad behavior was on display in another recent case. DOJ recently secured a $202 million settlement with Gilead following the manufacturer’s admission of wrongdoing in violating the federal Anti-Kickback Statute by paying medical doctors to promote and, in effect, prescribe Gilead’s medications. Of this, nearly $177M will be provided to the federal government along with post-judgment interest of 12% per annum compounded annually, and over $25M will be provided to various undisclosed states. PrEP4All is inquiring into the possibility of investing these federal funds into expanding access to comprehensive HIV prevention and treatment in regions of the US that have been left out of key federal funding opportunities.

“Right now, advocates are fighting on all fronts to protect HIV funding and our progress toward finally ending this terrible epidemic. This is part of that same fight,” said Christopher Morten, Associate Professor of Law at New York University. “Gilead is the largest provider of HIV treatment and PrEP in America; we need to make sure that our government is holding the company accountable on all fronts– combatting any misinformation campaigns and leveraging any victories in order to benefit the communities most in need of PrEP and treatment access.”

The case is PrEP4All v. U.S. Department of Health & Human Services and U.S. Department of Justice, No. 1:25-cv-6335 (S.D.N.Y. Aug. 1, 2025).

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PrEP4All is represented in its FOIA litigation, pro bono, by the Science, Health & Information Clinic of Washington Square Legal Services, Inc., an affiliate of New York University School of Law. Clinic Director Christopher Morten is counsel of record in the litigation. Clinic student attorneys Angela Kang, Brooke Levy, and Sarika Ram supported the litigation and PrEP4All’s broader FOIA efforts.

PrEP4All is an organization of patients, healthcare professionals, lawyers, and academics all dedicated to increasing access to lifesaving HIV medication. We fight to put lifesaving medication into the hands of everyone who needs it. Everyone, everywhere should be able to access HIV prevention and treatment regardless of their race, gender, socioeconomic status, or geographic location. Universal access to HIV PrEP and treatment can help us end the HIV epidemic. prep4all.org