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Oversight Democrats seek answers on potential HHS/Gilead deal

June 27, 2019
In The News

House Oversight Committee Chairman Elijah Cummings (D-Md.), Reps. Alexandria Ocasio Cortez (D-N.Y.) and Ro Khanna (D-Calif.) wrote a letter asking a drugmaker for information on its relationship with the Centers for Disease Control and Prevention Wednesday.

Last month, the CDC announced Gilead would donate an annual 2 million bottles of HIV-prevention drug Truvada for PrEP.

The CDC holds multiple patents on the drug, whose discovery was the result of federally-funded research. In May, Gilead CEO Daniel O’Day testified to the Committee that the amount of Gilead’s donation to the CDC was “requested and discussed with” the CDC and that the company would have donated more if asked.

The committee Democrats wrote that they are seeking to understand whether the donation was in any way tied to patents registered in the U.S., as Gilead has taken the position that the government’s patents are not valid.

“We would like to understand whether these patents played any role in negotiations between the company and the Department of Health and Human Services and whether Gilead has otherwise engaged in negotiations with the U.S. government regarding these patents,” they wrote.

The letter requests all documents and communications between HHS and CDC employees regarding any Truvada donations, as well as communications between Gilead and the agencies.

The three Democrats further request data on the cost of goods sold (COGS) of Gilead’s drugs Truvada and Descovy from 2004 through the present, and the total quantity of Truvada sold or distributed in the U.S. through commercial insurance, Medicare, Medicaid and the Department of Veterans Affairs.

The letter also asks for any communications relating to price increases for Truvada, including those on the reasons behind the increases and deliberations over whether to hike the price, and documents and communications regarding price increases for Truvada relating to the Food and Drug Administration’s 2012 approval of Truvada for PreEP.