The Justice Department Is Looking Into Gilead’s PrEP Profits

The Justice Department will investigate whether drug manufacturer Gilead violated the terms of the federal government's patent on Truvada as pre-exposure prophylaxis, according to the Washington Post. The news comes from Thomas Folks, a former Centers for Disease Control and Prevention scientist who performed trials for Truvada as PrEP during his time at the CDC.

Folks confirmed to the Post that a Justice Department lawyer visited the CDC in April to question scientists about the process that led to using Truvada as PrEP. The visit comes only a few weeks after the Washington Post reported that Gilead made $3 billion off Truvada in 2018 and had given no royalties to the United States despite the U.S. holding the patent for the drug and taxpayers having paid for its adoption as a preventative drug. Gilead has denied request to pay royalties on sales of the drug.

Spurred by a report on Gilead's profits off of the United States patent done by activist group PrEP4All, seven United States senators sent a letter to Health and Human Services secretary Alex Azar and CDC director Robert Redfield on Tuesday. The senators include Bernie Sanders (D-VT), Tammy Duckworth (D-IL), and out lesbian senator Tammy Baldwin (D-WI).

"The government should also be willing to enforce its patents and take legal action against companies that appear to be infringing on their patents,'' the senators wrote, "to prevent multinational companies from reaping billions of dollars in profits without properly compensating the government for its investments."

Pre-exposure prophylaxis is a cornerstone of Trump's plan to end the HIV/AIDS epidemic, but Gilead's sticker price could hinder those efforts. The drug currently costs between $1,600 and $2,000 per month out of pocket without insurance. In other countries, Truvada is available for as little as $6.50 a month.

"In order to end the HIV epidemic in the United States, we need to radically scale-up PrEP implementation and treatment as prevention for people living with HIV," Jason Rosenberg, co-founder of the PrEP4All Collaboration and member of ACT UP NY, said in a statement. "We can't do that if people cannot access these life-saving drugs."

Right now, there is no knowing what the government's ultimate aim in launching the investigation could be. In the past, the government has opted not to sue Gilead for patent infringement, but the investigation could be a means to gathering information for a lawsuit, the Post reports.

"The royalties that would be owed to the department would take years in the making to get to the department'' in a patent infringement lawsuit, said admiral Brett P. Giroir, assistant secretary of health and human services, according to the Post. "It wouldn't really make a difference on the pricing. We're really going down different avenues to make sure the pricing is lower moving forward. Those negotiations are ongoing."

Gilead said in a statement that it was in "discussions" with the government to improve access to PrEP for people in the United States.

However, activists are still looking for a seat at the table when it comes to these discussions.

"It is completely unacceptable that CDC and HHS continue to go through this process with zero input by the communities most impacted by HIV,'' James Krellenstein, a co-founder of PrEP4All, told the Post. "There has been no public transparency into this process at all."

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