HEALTH CARE BRIEFING: US Pressed to Declare Monkeypox Emergency

Just as the country has largely moved passed the threat of Covid-19, the Biden administration’s pandemic response team is facing a new concern—monkeypox—after the World Health Organization declared the virus a public health emergency this weekend and Democratic lawmakers urged the White House to do the same.

“We’re looking at that, looking at what are the ways in which the response could be enhanced by declaring a public health emergency,” Ashish Jha, the White House’s Covid response coordinator said on Friday as cases in the US hit more than 2,800.

• US Testing, Treatment Capacity: Jha said Sunday that the virus “can be contained” in the US, with the ultimate goal of eventually eliminating the disease as testing and vaccinations ramp up. He said the US is able now to test 80,000 people a week and has 300,000 vaccines available. The US should have “an additional 750,000 doses” of vaccine by the end of the month, Anthony Fauci, chief medical adviser to President Joe Biden, said Sunday. Read more from Ian Fisher.
• Warning From WHO Director: Jha’s Sunday remarks came a day after the WHO’s director declared the virus a public health emergency of international concern, overruling a divided expert panel to issue the group’s highest alert. Read more from Deirdre Hipwell and Bryce Baschuk.
• Lack of Urgency a Consideration: The lack of urgency and coordination in testing and treatment in many parts of the world was what prompted the WHO’s chief to sound the alarm. “This is an outbreak that can be stopped with the right strategies in the right groups,” Tedros said, referring to the fact that the outbreak is thus far concentrated among men who have sex with men and people with multiple sexual partners. Madison Muller, Riley Griffin, and Hipwell have more.
• Lawmakers Urge US Response: Fifty House lawmakers urged the White House to declare a public health emergency. “While the United States placed an order for almost 7 million monkeypox vaccines, the majority will not arrive for months,” according to the Democratic lawmakers—including Reps. Jerrold Nadler (N.Y.) and Mondaire Jones (N.Y.)—in a Friday letter. Read it here.

Meanwhile, health officials said they’re clarifying how to use Siga Technologies’ smallpox antiviral medication, Tpoxx, in young patients with monkeypox. Earlier Friday, the CDC said it’s streamlining the process health-care providers must go through in order to prescribe Tpoxx. The change occurred after clinicians expressed frustration with the amount of paperwork required to give patients the drug under what is called an expanded access protocol. The new process will allow for clinicians to prescribe Tpoxx virtually.

The government has also said its looking to deploy another antiviral called Tembexa made by Chimerix. It comes, however, with some serious side effects and has been little-studied in humans. Read more from Madison Muller and Jeannie Baumann.

Happening on the Hill

This Week’s Hill Hearings:

• The Senate Health, Education, Labor and Pensions Committee holds a Tuesday hearing on the nation’s fentanyl crisis. Assistant HHS Secretary Miriam Delphin-Rittmon is among those scheduled to testify.
• The House Oversight and Reform Environment Subcommittee holds a Thursday hearing on the negative health impacts of aviation-related air pollution on children.
• BGOV Calendar: Click here to see this week’s events.

Senate Vote on Burn Pits Bill: When the Senate returns Monday, lawmakers will consider legislation to expand health care eligibility to 3.5 million veterans exposed to toxic burn pits (S. 3373). The House has already passed the measure.

Fiscal 2023 Appropriations Update: Majority Leader Steny Hoyer (D-Md.) had said the House could take up the Labor-HHS-Education measure before the August recess, but those bills weren’t listed during a colloquy outlining next week’s business. Senate appropriators are set to release their spending bills before recess though there are no plans for committee markups. Read a BGOV OnPoint on the state of play here.

Medicare Telehealth, South Asian Health Bills: The House plans action this week on legislation on South Asian cardiovascular health under a structured amendment processes set on July 22 by the House Rules Committee. The panel is also scheduled to meet tomorrow to set the terms for floor debate on legislation H.R. 4040 that would extend Medicare telehealth services. A simple majority would be required for passage of these measures. In addition, the House will take several health-care-related measures under suspension of the rules, including:

• BGOV Bill Summary: H.R. 7180, Covid-19 Cognitive Research
• BGOV Bill Summary: H.R. 623, Pediatric Cancer Research Funds

For more on what the House will vote on this week, including on medical marijuana research H.R. 8454, see the House Agenda for the Week of July 25 by BGOV’s legislative analysts.

What Else to Know Today

Abortion Pill Maker Moves to Challenge Mississippi Law: Generic mifepristone maker GenBioPro seeks to challenge a Mississippi law set into motion by the US Supreme Court’s reversal of Roe v. Wade, claiming the anti-abortion law is keeping its product off local shelves. Mississippi’s trigger law bans the majority of abortions within the state, including those that rely on pills approved by the Food and Drug Administration like mifepristone, which is used to end pregnancies up to 10 weeks. Read more from Ian Lopez.

• In Georgia, state prosecutors said they stand by their commitments against criminalizing reproductive health decisions after a federal appeals court allowed the state’s six-week abortion ban to take effect. Democratic officials have been voicing opposition to efforts that threaten abortion rights following the US Supreme Court’s decision. Seven prosecutors in Georgia signed a nationwide statement last month declining to use their offices’ resources to criminalize abortion. Jalen Brown has more.

FDA to Enforce Generic Drug Deadlines: Generic drugmakers risk having their product applications withdrawn by the FDA if they don’t address application deficiencies within one year of notification, according to guidance issued Friday. The FDA’s recommendations apply to abbreviated new drug applications for generic versions of approved drugs. Celine Castronuovo has more.

HHS Pulls Rule for Civil Enforcement Standards: The Health and Human Services Department withdrew a rule that would prevent the agency from using standards solely from guidance documents when taking civil enforcement actions. The move by the HHS, in the form of a final rule, rescinds the regulation issued in the final weeks of the Trump administration. Read more from Shira Stein.

FDA Moves to Boost Safety With Remote Tools: The FDA plans to increase its use of remote assessments across all product areas to supplement in-person inspections and other regulatory activities beyond the Covid public health emergency. Read more from Celine Castronuovo.

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com