A congressional hearing May 16 over the price of Gilead’s HIV drug Truvada devolved at times to frustration and shouting, a signal that drug pricing legislation won’t be as bipartisan an issue as lawmakers and industry observers initially hoped.
There was a clear distinction between Republican and Democratic lines of questioning—with Democrats probing Gilead CEO Daniel O’Day about price increases, access issues, and tax deductions and Republicans focusing on research dollars spent by the company and the importance of innovation.
Multiple times throughout the hearing committee members across the aisle butted heads, including House Oversight Chairman Elijah Cummings (D-Md.) with Ranking Member Jim Jordan (R-Ohio) and an impassioned speech by Rep. Chip Roy (R-Texas). Roy said he is disappointed in what he called Democratic rants that were “preening and posturing for cameras.”
Cummings acknowledged there wasn’t much discussion of legislation during the hearing, but he told Bloomberg Law “many of the members made it clear there are some legislative things that need to be done here” and circled back to the need to negotiate drug prices directly. Not allowing direct negotiations with drugmakers by government funding agencies like Medicare and Medicaid is “the biggest mistake that Congress has made,” he said.
A direct negotiation requirement would likely not pass through the Republican-held Senate, making its chances of passing the finish line in this congressional session low.
Cummings said he wasn’t discouraged about Congress’ ability to move bipartisan drug price legislation, despite the tense atmosphere in the hearing room May 16.
“I am not discouraged because I can not afford to be discouraged,” he said. “There are people who are literally laying on their dying beds hoping that we can get this type of medication into their hands so they can be able to stay alive.”
Gilead Makes Commitments
In lieu of legislative suggestions, lawmakers mostly focused on getting O’Day to commit to ensuring Truvada is available to more people. O’Day said the free treatment for 200,000 people the company recently promised the Trump administration would be in addition to any financial aid it was giving patients already. Lawmakers also asked Gilead to advertise the program so people would be aware it existed.
O’Day promised Gilead would only take tax deductions from those donations to cover the cost of manufacturing the drug and not for the full list price, which is around $2,000 a month.
Rep. Mark Desaulnier (D-Calif.) was the only member to bring up potential legislation, citing his plan to offer an amendment to the fiscal year 2020 Labor-Health and Human Services appropriations bill. It would require the National Academy of Sciences to study how much drug research funding provided by the National Institutes of Health should factor into the price of a medication when a private company owns the rights to the drug.
The Trump administration has committed to nearly eradicate HIV in the U.S. by 2030, and a large part of that plan is making sure HIV drugs are accessible.
To ensure accessibility, the administration May 16 changed an earlier Medicare proposal that HIV groups said would block access to antiretroviral drugs, which are traditionally used to treat HIV. The final rule, released May 16, omitted the proposed language that could have excluded coverage of those drugs if the prices get too high.
Who Invented Truvada?
The crux of the hearing was over how big a role the NIH and Centers for Disease Control and Prevention played in discovering Truvada. Scientist Richard Grant, who was part of the initial team working on this type of HIV drug, said, “Gilead did not provide leadership, innovation, or funding for PrEP research,” referring to pre-exposure prophylaxis. PrEP is a type of drug such as Truvada that one can take to prevent getting HIV.
He also said CDC scientists were the ones who discovered the drug combination that was eventually approved by the Food and Drug Administration as Truvada in 2012. O’Day pushed back by saying any CDC patents are invalid and that Gilead was involved in initial research as well.
Rep. Alexandria Ocasio-Cortez (D-N.Y.) submitted for the record a Yale study showing the CDC patents are valid. However, a Republican lawmaker also submitted an article stating Gilead participated in research that led to Truvada’s creation.
Ocasio-Cortez and Cummings followed up on the patent issues after the hearing with a letter to HHS Secretary Alex Azar demanding documents about how much federal funding went into discovering Truvada and more information about Gilead’s future Truvada donations. The letter cc’d Rep. Jordan, who expressed skepticism about problems with Truvada access during the hearing.
This is the second drug price hearing the House Oversight Committee has held, according to Cummings, and one of many congressional probes into drug prices and the drug supply chain.
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(Updated to reflect the government's decision to continue Medicare coverage of antiretroviral drugs in the 11th paragraph. An earlier version corrected the first name of Rep. Chip Roy (R-Texas.)