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Friday, Jun 28 2019

Full Issue

House Democrats Question If Gilead's Decision To Donate Free Doses Of PrEP Had Anything To Do With Patents

Gilead has said it will donate 2.4 million bottles per year of Truvada for PrEP to the effort, and has previously denied accusations that the negotiations to do so have any connections to patents. But on Thursday Rep. Elijah E. Cummings (D-Md.) demanded details from Gilead's discussions with the U.S. government over the deal.

The chairman of the House Oversight Committee is expanding the committee鈥檚 review of Gilead Science鈥檚 patent claims relating to Truvada for PrEP, the company鈥檚 drug that prevents HIV infection. In a letter released Thursday, Rep. Elijah E. Cummings (D-Md.) demanded emails and other information from Gilead about negotiations that led to Gilead鈥檚 pledge to donate free doses of the drug for President Trump鈥檚 effort to eradicate HIV by 2030. (Rowland, 6/27)

At issue is an injectable medication called AmBisome that is used to combat cryptococcal meningitis, which is the second biggest killer of people living with HIV, after tuberculosis, according to the group. And the World Health Organization estimates the infection is responsible for 15% of HIV-related deaths globally. Last September, Gilead committed to widening access shortly after the WHO recommended AmBisome 鈥 when combined with another medicine 鈥 as the preferred treatment over side effect concerns caused by an older drug. As part of the effort, the company promised what it called 鈥渘o-profit pricing鈥 and also agreed to expedite registration in the 116 countries. (Silverman, 6/27)

"Gilead has taken the position that the government's patents are not valid," the lawmakers wrote. "We would like to understand whether these patents played any role in the negotiations between the company and (HHS), and whether Gilead has otherwise engaged in negotiations with the U.S. government regarding these patents." (Johnson, 6/27)

President Donald Trump touted the donation as a step towards ending the HIV epidemic. But some public health experts balked. They asked the CDC to enforce its own patents on the HIV prevention drug, which was discovered with the use of federal research dollars. They called for Gilead, the drugmaker that sells Truvada for PrEP, to pay royalties and lower the price. (Kopp, 6/27)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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