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U.S. lawmakers are asking Gilead whether there may have been strings attached to a recent donation involving millions of bottles of Truvada, a blockbuster drug used to treat and prevent HIV, which many suggest the government should actually hold partial ownership for developing.
In May, the manufacturer of Truvada announced that it was making an annual donation of 2.4 million bottles of the drug for use as a prophylactic to prevent the spread of HIV, also known as PrEP. However, some lawmakers are suspicious that the donation may have come with a secret agreement between the Trump administration and Gilead, involving patents the government may hold on the drug.
Elijah Cummings, chairman of the House Oversight Committee, and representatives Alexandria Ocasio-Cortez, Ro Khanna and Ayanna Pressley sent a letter (PDF) to Gilead on June 26, asking for clarification and all of the drug maker’s records involving negotiations with the government.
Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved in 2004 for the treatment of HIV. It is also used as a PrEP HIV drug to prevent the spread of the disease, and has generated billions in profits for Gilead. However, the government holds patents indicating it helped develop Truvada, and thus may be entitled to partial ownership of the product.
“Gilead has taken the position that the government’s patents are not valid,” the letter states. “We would like to understand whether these patents played any role in negotiations between the company and the Department of Health and Human Services (HHS) and whether Gilead has otherwise engaged in negotiations with the U.S. government regarding these patents.
The concern among Democratic House lawmakers is that Gilead may have struck a sweetheart deal behind Congress’s back with the Trump administration, which would lead to the government backing off its patent claims in return for the huge donations of pills.
Another issue is the drug’s high cost, which tops $1,780 per month in the U.S., meaning it is unaffordable for many who are at the highest risk of HIV infection. By comparison, Gilead only charges Australians $8 per month.
In addition to seeking documents of communications between HHS and Gilead, they are also seeking communications with any other federal agency, data on the costs and quantities of Truvada sold since 2004, and documents on the drug’s price increases, which have gone from $1,289.70 in January 2012, to a new average wholesale price of $2,190.48.
In addition, Gilead now faces a growing number of individual HIV drug lawsuits. The lawsuits claim Gilead knew enofovir alafenamide (‘TAF’) HIV drugs were less toxic than TDF drugs like Truvada because it could be administered at a lower dose with the same effectiveness. The company shelved TAF in 2004, and did not begin to sell TAF-designed drugs until 2015, plaintiffs point out, which gives them patent protection until 2032. TDF drug patents began expiring last year.
Several groups of plaintiffs have also filed class action lawsuits over Truvada and other HIV drugs, alleging that Gilead and some other drug makers purposefully price-fixed Truvada and similar tenofovir disoproxil fumarate (TDF) medications in the United States.