Gilead Sciences' important HIV business has been under fire in recent weeks, with lawsuits and critics airing allegations about the company’s pricing, patents and more. On Thursday, the company’s new CEO Daniel O’Day took the congressional hot seat for a grilling about the drugmaker’s preventive option for the disease, Truvada for PrEP.  

After Dr. Robert Grant, who Public Citizen calls the father of PrEP, testified that Gilead "did not provide leadership, innovation or funding for PrEP research," O’Day told lawmakers that researchers at the company have helped transform HIV from a "death sentence to a manageable chronic condition." 

"To be clear, despite some media suggestions otherwise, Gilead invented Truvada," O’Day said. "No one else. Gilead developed the two drugs that are combined in Truvada, invented the combination that allowed these drugs to be taken as a single pill, and invented the drugs used to treat HIV in combination with other antiviral drugs." 

The four-hour House Committee on Oversight and Government Reform hearing at times devolved into shouting as lawmakers on either side of the aisle either sided with the company or pressed the drugmaker on its HIV drug pricing. After Rep. Jim Jordan defended Gilead’s research efforts, Rep. Elijah Cummings, the committee chair, told O’Day that "nobody has come here to beat you up." 

Still, Cummings said, "there’s nothing like holding the hand who is dying from AIDS. ... All we are trying to do is represent our constituents and help them stay alive." 

Some of the discussion surrounded Truvada’s prices outside of the U.S., where generics have launched. In Australia, Grant said, three states bought the drug for $8 per person per month, leading to the largest-ever PrEP scale-up. In the U.S., the drug costs $1,780 per person per month, and the scale-up has "failed."  

Cost is one barrier to access and one reason only 10% of people who can benefit from PrEP are currently receiving it, according to testimony. Other issues include a stigma and a lack of education about the preventive option.  

The meeting provided plenty of back-and-forth but little in the way of legislative progress, Bloomberg Law reports. Instead, lawmakers were able to get O’Day to offer some commitments. For one, the company’s recent announcement of Truvada donations will be in addition to existing financial aid, the publication reports. 

Further, the company won’t take tax deductions from the full list price on the donations, O’Day said. It’ll only deduct the cost of manufacturing.  

Thursday’s hearing followed a series of headlines for Gilead's HIV business in recent weeks. The company has faced scrutiny on its Truvada for PrEP patents, with activists saying the government provided the legwork for the approval and that the med should be publicly available. At the hearing, O’Day said Gilead believes the Centers for Disease Control and Prevention’s PrEP patent is invalid, but Gilead hasn’t sued because it values its relationship with the agency. 

After the hearing, Reps. Cummings and Alexandria Ocasio-Cortez wrote to Department of Health and Human Services Secretary Alex Azar requesting more information on the CDC’s patent. 

Aside from PrEP headlines, Gilead recently lost a motion to dismiss a case claiming the company delayed safer TAF-based HIV drugs to protect sales for its older generation of TDF-based medicines. And a set of plaintiffs recently sued the company for illegally monopolizing its suite of HIV meds with other pharmaceutical partners. 

O'Day isn't the only pharma exec to take a congressional grilling in recent months. A group of CEOs and an executive from top drugmakers in February accepted invites to testify on the industry's pricing in a much-watched hearing. The issue promises to remain a contentious topic as 2020 elections near, but it remains to be seen whether lawmakers can find common ground.

Register as Visitor to CPhI China 2019!

-----------------------------------------------------------------------
Editor's Note:

If you have any suggestion to the content, 

please email: Julia.Zhang@ubmsinoexpo.com.