Democratic members of the House Oversight Committee want Gilead Sciences to reveal whether its decision to donate more than 2 million doses of its HIV-prevention medication Truvada was connected to an ongoing patent dispute.
In a letter sent Wednesday to Gilead CEO Daniel O'Day, House Oversight and Reform Committee Chair Rep. Elijah Cummings (D-Md.) asked whether the company's decision to donate Truvada was in some way connected to the company's dispute over its patent for the drug.
"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."
HHS announced in May that Gilead agreed to donate up to 2.4 million doses of its pre-exposure prophylaxis, or PrEP, medication that the agency estimated would cover up to 200,000 individuals a year for up to 11 years. HHS Secretary Alex Azar stated the agreement was the "result of discussions between the Trump administration and Gilead Sciences"
Azar called Gilead's donation a "major step" toward the Trump administration's effort to end the HIV epidemic in the U.S. by 2030.
Oversight committee Democrats asked Gilead to provide all documents and communications between the company and the federal government regarding the donation of Truvada, U.S. patents related to PrEP, and its series of annual price increases since 2012. Since 2012 the cost of Truvada has gone from an average list price of $1,391 per month to $2,100 a month. The deadline is July 26.
Gilead's patents for Truvada as a PrEP medication have been a hot topic for patient advocates. They argue the drugmaker reaped billions of dollars from years of market exclusivity due to lack of government enforcement. In 2018 alone, Truvada generated $3 billion in revenue, according to the company's financial statements.
Cummings and Sen. Debbie Stabenow (D-Mich.) on June 18 sent a letter requesting that the Government Accountability Office look into reports that Gilead may have infringed on government-owned patents involving Truvada for PrEP.
"If true, this would mean that a private entity has generated billions of dollars in revenue over several years while infringing on government-owned intellectual property, and that the government either failed to detect the infringement or was aware and failed to prevent it," lawmakers wrote.
Critics say Gilead's market exclusivity of Truvada for PrEP made the drug more cost prohibitive for individuals at greatest risk of HIV infection and limited their access to the treatment. Only 90,000 prescriptions for PrEP were filled in 2015 among the estimated 1.1 million Americans who would benefit from taking the medication, according to the Centers for Disease Control and Prevention's most recent figures. Among those who filled prescriptions, only 14,000 were filled by African-American and Latino adults, even though they make up 800,000 of the 1.1 million at risk.
The rising cost of Truvada was the subject of an oversight committee hearing in May, where O' Day argued the drug's price was tied to the costs of research and development, which totaled around $1 billion.
"Gilead bore the risk and the vast majority of the cost of research and clinical studies to demonstrate Truvada's efficacy and safety as part of combination HIV therapy," O'Day said. "Our well-supported view is that the U.S. government does not hold valid patents on the use of Truvada for pre-exposure prophylaxis ("PrEP"), nor does it hold any patent for Truvada itself."
Gilead initially marketed Truvada in 2004 as a treatment for HIV and eventually scored FDA approval in 2012 to sell it as PrEP.
But critics point out much of the research that led to the discovery of Truvada as a pre-exposure prophylactic was publicly funded and conducted by the CDC, which applied for a patent for that use in 2006 that was eventually awarded in 2015.
Patient advocates such as the PrEP4All Collaboration have called for the federal government to begin enforcing its patent on Truvada for PrEP, but so far it has not taken action.
"Members of Congress—the American people have invented a way to end the HIV epidemic, and today, we look to you, to ensure that every single person in this country can protect themselves from this plague," said Dr. Aaron Lord, co-founder of Prep4All, during the May committee hearing.
Gilead did not respond to requests for comment Thursday.