CHAIRMAN CUMMINGS' OPENING STATEMENT

PURPOSE

The hearing will examine Gilead’s pricing for an HIV prevention drug known as Truvada for pre-exposure prophylaxis (PrEP).  The hearing also will examine taxpayer funding that led to approval by the Food and Drug Administration (FDA) and whether the public is receiving an appropriate return on its investment.

In 2012, the FDA approved the use of Truvada for PrEP, a daily pill that prevents the transmission of HIV.  In the United States, Truvada is currently sold at a list price of approximately $2,100 per month, generating $3 billion in revenue for Gilead in 2018 alone. Generic Truvada is available in other countries at a fraction of the cost, but no generic version is offered in the United States.

During the State of the Union, President Trump unveiled his “Ending the HIV Epidemic” initiative, which seeks to reduce new HIV infections by 90 percent in the next ten years.  A critical component of his plan is to expand the use of PrEP among at-risk populations. However, the high price of Truvada may hamper the government’s ability to achieve this objective.

On May 9, 2019, Health and Human Services Secretary Alex Azar announced that Gilead agreed to donate up to 2.4 million vials of PrEP each year for up to 11 years.  The medication will be distributed to approximately 200,000 individuals who are uninsured and at high risk of HIV transmission.  However, there are approximately 1.1 million Americans who are “at substantial risk for HIV and should be offered PrEP,” according to the Centers for Disease Control and Prevention.  It remains unclear how the Administration will make up this shortfall, and at what cost.