Lawmakers look beyond Change

Driving The Day

AN EYE ON CYBERSECURITY — Both chambers of Congress are back in session today — with a heightened focus on cybersecurity in the wake of the recent attack on Change Healthcare that disrupted provider payments nationwide.

Here’s what the health team will be watching this week:

Cybersecurity: While the consequences of the Change Healthcare attack have wound down, the House Energy and Commerce Health Subcommittee continues to probe the issue with a hearing planned for Tuesday.

Hospitals have pushed back against cybersecurity mandates that HHS plans to roll out in the coming years. Witnesses include the American Hospital Association’s adviser for cybersecurity and risk, John Riggi. Also testifying are experts in health care cybersecurity.

Andrew Witty, CEO of UnitedHealth, which owns Change, has also been summoned to the Hill to appear before the Senate Finance Committee, but no hearing has yet been scheduled. It comes after frustration from top Biden officials about how United handled the attack, with calls last month from HHS to United to be more transparent about the attack. Sen. Ron Wyden (R-Ore.), the committee’s top Democrat, has been an outspoken critic of United’s cybersecurity practices and the industry overall.

HHS’ budget talks: HHS Secretary Xavier Becerra will pitch his department’s budget for the next year, first at a Senate Appropriations hearing Tuesday and then at the House Energy and Commerce Health Subcommittee on Wednesday. Both hearings come after POLITICO reported that Becerra is eyeing a run for California governor after November’s election.

Covid-19 origins: The Select Subcommittee on the Coronavirus Pandemic will continue its probe into Covid’s origins — and federal officials’ oversight. A hearing scheduled for Tuesday invites the editors of three scientific research publications to testify. Holden Thorp, editor of the journals published by the American Association for the Advancement of Science, has agreed to testify. Editors of Nature and The Lancet declined.

Committee Chair Brad Wenstrup (R-Ohio) has focused on uncovering whether the Covid pandemic resulted from a lab leak and said this hearing would examine “any inappropriate influence” by federal officials to downplay research supporting that theory.

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Public Health

PREPARED FOR THE WORST — Should the threat of avian flu to humans in the U.S. grow, federal officials are prepared to roll out millions of vaccine doses for humans within months, POLITICO’s David Lim scooped.

Researchers are developing vaccines to target the avian flu strain that infected a Texas dairy worker confirmed by the CDC on April 1, according to Dawn O’Connell, HHS’ assistant secretary for preparedness and response. The government has just under 10 million doses that could be deployed in three to four months, she said.

What would happen: If health authorities saw additional sporadic human infections or a more severe case, it would trigger a heightened response level, CDC Director Mandy Cohen said.

That response would unfold in four stages:

1. The FDA would grant emergency use authorization for the vaccine.

2. ASPR could deploy vaccines in prefilled syringes. The shots could be distributed to priority populations — such as people who work with infected cattle or live near farms — based on what health officials see on the ground.

3. Bulk-stored vaccines could be filled into vials or syringes.

4. If the U.S. determined that an avian flu threat warrants a larger response, it could activate standing contracts with vaccine manufacturers to ramp up to a full-scale deployment.

“We would get to about 125 million doses in 130 days,” O’Connell told David.

There’s been one confirmed human avian flu infection. The risk the virus poses to the public remains low, but federal health officials are monitoring the situation closely.

Why it matters: That prep marks a critical difference from the chaotic early days of the Covid pandemic when vaccines targeting a novel pathogen had to be developed on the fly. And it bolsters the confidence of health officials who say the government is ready to respond if an avian threat to humans were to grow.

Global Health

DEAL OR NO DEAL — Countries are looking for a plan B after global negotiations over a new treaty that would protect the world from future pandemics have stalled, despite the World Health Organization’s insistence that the negotiations be wrapped up by the end of May, POLITICO’s Rory O’Neill reports.

Diplomats have bought themselves more time by scheduling an extra two weeks of talks beginning April 29, which will provide one last chance to reach an agreement.

POLITICO spoke to negotiators from both developing and wealthy countries granted anonymity to speak freely and experts such as Helen Clark, the former prime minister of New Zealand who co-chairs an independent panel of ex-politicians and diplomats calling for a new pandemic treaty, to find out what options countries are considering to break the impasse:

— Placeholder: The plan getting the most buzz among Geneva insiders is a high-level deal that would spell out some basic principles to govern the world’s response to the next pandemic.

Such a deal would go hand-in-hand with an extension of the May deadline to work out solutions to more difficult problems, such as whether pharmaceutical companies should enjoy customary intellectual property rights over new drugs and vaccines developed during a pandemic.

— Kicking the can: Countries could simply tell the WHO that they need more time to resolve their differences and extend the talks for a fixed period — negotiators have suggested a few potential timelines to POLITICO, ranging from six months to two years.

— Deal or no deal? The other two options are a deal — a substantive agreement on the issues that have proven impossible to resolve so far — or a collapse of the process. The first option is increasingly hard to imagine, while no one wants to contemplate the latter.

What’s next? There’s still a very narrow chance the parties could reach a deal by May, the anonymous negotiators from developing countries said, but it hinges on what the bureau — the committee of officials running the talks, who are due to provide compromise text on April 18.

WEIGHT-LOSS DRUGS

NO LINK TO SUICIDAL THOUGHTS — An evaluation by the EU’s top drug regulator of weight-loss drugs like Ozempic found no evidence to suggest a link between the drugs and suicidal thoughts, POLITICO’s Mari Eccles reports.

The European Medicines Agency’s drug safety committee evaluated the risk of possible side effects in people who have used a class of drugs known as GLP-1s after Iceland reported three cases of thoughts of self-harm and suicide in people taking either semaglutide or liraglutide.

The committee analyzed the findings of two studies, including its own, other clinical trials and postmarketing surveillance data.

“The results did not support a causal association between the use of GLP-1 receptor agonists and this risk,” the committee wrote in a statement.

Key context: The finding comes after a similar preliminary review by the FDA, which reported in January that it had found no link.

Names in the News

Amy Strope has joined Madison Services Group as a director of government relations. She previously worked at Ferring Pharmaceuticals.

WHAT WE'RE READING

The New York Times reports that the National Science Academies wants the Sackler name stripped from its endowment.

The Washington Post reports that hepatitis is now the second-leading infectious cause of death worldwide, according to the WHO.