Health Law & Business News

Capsule: HIV Drug Spat Heats Up and IT Wonks Talk Health Gaps

Jan. 21, 2020, 11:00 AM

Welcome to Capsule, where we’ll give you your weekly dose of what to watch out for in the health-care space. Each week reporters Ayanna Alexander and Jacquie Lee get you prepped for the week’s hottest health-care topics.

Jacquie: Gilead has until Thursday to reply to a lawsuit alleging the company is ignoring the federal government’s patent rights for the HIV-prevention drugs Truvada and Descovy. The government claims the Centers for Disease Control and Prevention was instrumental in creating Truvada—the leading HIV-prevention drug—and Descovy, which the FDA recently approved to prevent HIV as well.

Here’s how the federal government sees it: “As its PrEP sales have skyrocketed, Gilead has exaggerated its role in developing PrEP. In so doing, Gilead has ignored CDC’s clear contributions and baselessly denied the validity of CDC’s patents.” That’s from the complaint the government filed in November.

Gilead says the government’s patents aren’t valid.

It’s unusual for the government to be suing Gilead right now because the drug company agreed last year to dispense Truvada for free as part of the Trump administration’s push to end the HIV epidemic in the U.S. Valerie Bauman has been watching this case closely, so keep an eye out for her coverage.

Ayanna: Coming up Friday, an IT committee advising the Department of Health and Human Services’ Office of the National Coordinator for Health Information will roadmap plans for filling gaps in the health technology landscape under the 21st Century Cures Act. Top issues include patient access to digital health information and seamless data sharing.

ONC’s health information technology committee discussed the report, which it submitted to HHS at a recent meeting. The committee hopes to address how health IT developers and health-care providers can use data from outside sources and offer ways that health IT can improve price transparency within health care, according to the update.

The group plans to listen to feedback and provide another update at the upcoming meeting. The plan is to send off the report by March.

Jacquie: Congress wrapped up the FDA’s fiscal 2020 funding Dec. 20, but that doesn’t mean it’s too early to talk about 2021. The nonprofit group and champion for the agency, Alliance for a Stronger FDA, is already setting up meetings with agency leaders to figure out what the FDA considers its biggest challenges. They’ll also discuss how the Alliance can persuade Congress to cough up more cash through the appropriations process.

The group’s members include drug companies like AbbVie and Pfizer along with trade associations, nonprofits, and consulting firms. The first meeting to kick off the 2021 funding process is Tuesday between Alliance members and Peter Marks, the director of the Center for Biologics Evaluation and Research.

As a reminder, the agency got a $91 million increase in FY 2020 compared to FY 2019. But Steven Grossman, the head of the Alliance, said he expects this next funding cycle to be “extremely tight for all non-defense agencies,” like the FDA. That’s thanks to some budget caps Congress set in December.

The president will lay out priorities for the country in the State of the Union in February, which will start the cycle of debate over which agencies get what, so anyone interested in getting a piece of the pie is setting up their strategy now.

What Else We’re Watching

The World Economic Forum is opening in Switzerland this week and there are plenty of health-care themes to keep an eye on. Some of the panels are about mental health in youth, creating sustainable health-care systems, and how climate change affects your body. But some of them are straight out of a sci-fi film, like a panel called When Your Doctor is a Robot. Some of the health panels will be livestreamed (lucky for you guys that includes the robotic doctor panel).

Lobbying disclosures are due on Tuesday and the folks at Bloomberg News will be putting together an overview of what the health-care industry has pushed for this year. Big Pharma fought and lost out on additional protections in NAFTA 2.0, and is fighting congressional actions to rein in drug prices. The vaping industry was able to carve out big exemptions in the FDA’s flavor policy announced this month. Surprise billing changes also are up in the air right now. We’ll all be watching to see if Congress can pull off any health-care legislation before the 2020 presidential election.

The National Science Advisory Board for Biosecurity on Thursday is set to discuss disease-causing viruses and bacteria that could spread uncontrollably, also known as potential pandemic pathogens. The panels will specifically look into security and public transparency when sharing research information on the pathogens. Follow our colleague, Jeannie Baumann, for the deets.

To contact the reporters on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com; Ayanna Alexander in Washington at aalexander@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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