Alleged Price Gouging of PrEP Investigated by Justice Dept., Senate

The fact that Gilead Sciences is raking in billions from sales of the HIV drug Truvada even though the patent is owned by the federal government has caught the eye of U.S. senators, the Department of Justice, and HIV activists.

Truvada is the only drug approved for use in the HIV prevention method known as pre-exposure prophylaxis, or PrEP. It is also used in HIV treatment in combination with other drugs. But the research that led to Truvada's use as PrEP was conducted and almost entirely funded by the government, which patented this use in 2015 but has yet to receive any of the money earned by Gilead, which sold $3 billion worth of Truvada last year, according to a recent Washington Post investigation. Gilead argues that the government patent is invalid, and the company has turned down requests for royalty payments.

Seven senators sent a letter Tuesday to Health and Human Services Secretary Alex Azar and Centers for Disease Control and Prevention Director Robert Redfield expressing concern about patent infringement and the fact that Gilead is "selling it at a price that makes the drug unaffordable for many Americans." A month's supply of Truvada costs between $1,600 and $2,000.

The senators "would like to know what steps have been taken to ensure that any usages by private companies of government-held patents are properly licensed and that any infringements are acted upon," they wrote.

"When the government holds a patent, licenses should be granted on terms that make it economically viable for industry to develop drugs, but allow the government to recoup its investment and fund further research as well as ensure that drugs developed using government-owned patents are affordable," they continued.

The letter was signed by Debbie Stabenow of Michigan, Tammy Baldwin of Wisconsin, Tammy Duckworth of Illinois, Bernie Sanders of Vermont, Richard Blumenthal of Connecticut, and Ben Cardin and Chris Van Hollen, both of Maryland. All are Democrats except Sanders, an independent who caucuses with the Democrats.

Now the Justice Department has begun reviewing the patent issue, according to a Post story published today. A lawyer from the department visited the CDC, where the PrEP research was conducted, April 16, retired CDC scientist Thomas Folks told the Post. Folks joined in one of the meetings with the lawyer via phone and explained the PrEP research his team did.

The government has so far declined to sue Gilead for patent infringement. The lawyer did not make any promises that a suit was forthcoming, Folks said. The Justice Department review "could merely be intended to give officials greater leverage in ongoing negotiations with Gilead about cutting Truvada for PrEP prices and making the treatment more widely available," the Post notes. PrEP is expected to play a large role in Donald Trump's plan to eradicate HIV by 2030, but the cost is a barrier for many potential users.

PrEP4All, a coalition of activist groups, has sent its own letter to the CDC demanding action. Fewer than 10 percent of the people who need PrEP are using it, largely due to the cost, the coalition said.

"The CDC must license its patents protecting the use of Truvada as PrEP for maximum access and competition to benefit people living in the United States," the group wrote. "Any licensing agreement must require that Gilead dramatically reduce the price of Truvada, provide the drug at cost to public health programs, provide high quality data regarding PrEP utilization, and utilize royalty revenue for a National PrEP Access Program. This program must explicitly focus on increasing access in communities where PrEP is underutilized, including but not limited to communities of color and communities in the South, and fund existing community health centers providing HIV prevention services."

"The CDC should utilize these patents and other means at its disposal, including existing statutory licensing authorities, to lower the price of PrEP to a maximum price of $15 per month, whether through the entry of generic competitors or from an agreement with Gilead Sciences," the letter continued. Communities vulnerable to HIV should be included in any negotiations with Gilead, the activists added.