HEALTH CARE BRIEFING: Biden Plan Seeks Wider Access to Paxlovid

The U.S. government is finishing plans to make Pfizer’s Covid-19 pill available at any pharmacy across the country, with supply increasing as the BA.2 sub-variant drives an uptick in cases and hospitalizations.

The administration will outline a plan this week aimed at getting the pill, called “Paxlovid,” to additional people who otherwise could face a more serious Covid illness, an administration official said. Use of oral antiviral pills in the U.S. jumped 103% between March 27 and April 10, the official said. The White House wants to drive that number higher, and signal to health providers to err on the side of prescribing the pills, rather than worrying about scarcity.

“We’re working to make sure doctors and patients know about Paxlovid,” White House spokeswoman Karine Jean-Pierre said last Thursday. It was in limited supply after its FDA approval in December, she said. “That’s not the case anymore. It’s widely available, and the eligibility criteria are pretty expansive,” she said.

The administration announced a test-to-treat system in Biden’s State of the Union remarks, in which people could immediately get Paxlovid at certain pharmacies after testing positive. About 2,000 of those locations are available so far, with more to come, the official said. In total Paxlovid is available now at roughly 20,000 locations nationally. The administration plans to allow every pharmacy that wants the pill to order Paxlovid directly from the U.S. government, the official said. Josh Wingrove and Fiona Rutherford have more.

Biden Faces Bipartisan Angst as Migrant Cases Unfold

Biden faces political peril as a showdown at the Supreme Court on immigration coincides with widespread criticism of his plan to end pandemic-related border controls. Justices on Tuesday will weigh whether Biden can end former President Donald Trump’s “remain in Mexico” policy, which has forced tens of thousands of asylum-seekers to stay south of the border while their applications are processed.

A federal trial judge ordered the Biden administration to restart the program. A ruling against the administration would further complicate Biden’s handling of immigration. Republicans are preparing to highlight the migrant surge at the border in the November midterms, while a growing number of Democratic lawmakers are distancing themselves from the White House’s plan to pull the separate, pandemic-driven Title 42 border controls, fearing the influx will only worsen.

GOP Texas Attorney General Ken Paxton on Friday filed his 10th lawsuit against Biden’s administration over the border situation, alleging the Title 42 measures are “the only rules holding back a devastating flood of illegal immigration.” Greg Stohr and Jordan Fabian have more.

• Concerns that the White House lacks adequate plans to manage an influx in migrant arrivals when Title 42 ends has emerged as both a political cudgel and a source of anxiety for charities on the ground. The U.S. relies on scores of faith-based and humanitarian organizations to do relief work at the border. Many support ending Title 42 but say they need the White House to provide more information on logistics to ensure their teams are up to the task. Read more from Ellen M. Gilmer.

Budget Hearings This Week:

• Health and Human Services Secretary Xavier Becerra testifies Wednesday to the House Energy and Commerce Health Subcommittee on the Biden administration’s fiscal year 2023 budget request.
• A House Appropriations subcommittee holds a Wednesday hearing on the Food and Drug Administration’s budget request with Commissioner Robert Califf testifying.
• On Thursday, Califf is also scheduled to testify to the Senate Appropriations Agriculture, Rural Development, Food and Drug Administration Subcommittee on the agency’s fiscal request.

BGOV Calendar: See all hearings happening this week.

Industry & Regulation

PhRMA Hires Brother of White House Adviser: The pharmaceutical industry’s top lobbying organization hired Jeff Ricchetti, bother of key White House advisor Steve Ricchetti, earlier this year, according to recently released federal disclosures. Ricchetti was hired at the beginning of the year by the Pharmaceutical Research and Manufacturers of America and paid $60,000 to lobby on behalf of the group for the first three months of the year, the disclosure says. He isn’t lobbying the White House or Congress, according to the paperwork filed.

The move comes as Biden seeks to renew efforts to get a drug pricing measure through Congress. Ricchetti was hired in 2020 to lobby for drugmakers GlaxoSmithKline and Horizon Therapeutics, companies that still retain his services and for which he lobbies Congress, according to federal disclosures. Ricchetti was also hired this year to lobby for Pardes Biosciences, a California-based company that is developing Covid-19 drugs, Alex Ruoff reports.

Tobacco-Free Vapes to Linger on Shelves: Many unauthorized, tobacco-free nicotine products may remain on the market past a summer deadline as the FDA grapples with its authority to regulate them and an influx of marketing applications. A government spending package for fiscal 2022 gave the Food and Drug Administration the authority to regulate synthetic nicotine, closing a loophole that e-cigarette manufacturers had used to skirt federal oversight.

Attorneys who counsel tobacco and vaping companies say Congress set unrealistic deadlines for companies to submit premarket applications and for federal regulators to review them. Companies have until May 14 to apply—and all existing products that haven’t won authorization must be pulled from the market by July 13 under the law. Read more from Celine Castronuovo.

• Meanwhile, long-awaited proposals to ban menthol in cigarettes and cigars have cleared White House review and can be published at any time. The first rule from the FDA would prohibit tobacco manufacturers and retailers from making, distributing, and selling cigarettes containing menthol as a flavor. A second rule proposes a ban on all characterizing flavors, including menthol, in cigars. Celine Castronuovo has more.

Medicare Proposal Revises Enrollment Dates, Kidney Coverage: The Biden administration issued a proposed rule on Friday that would provide for Medicare coverage the month after enrollment, which would reduce the uninsured period for new beneficiaries. In addition, the plan from the Centers for Medicare & Medicaid Services would expand access to Medicare coverage through special enrollment periods for the first time, and allow eligible beneficiaries to get Medicare outpatient “Part B” coverage without a late enrollment penalty. Read more from Tony Pugh.

Texas Medicaid Plan Lives After Agency Drops Bid: The Biden administration has ended its attempt to roll back a 10-year extension of Texas’s Medicaid proposal that was approved in the last days of the Trump administration. The Centers for Medicare & Medicaid Services told Texas officials it is withdrawing an April 2021 letter in which it walked back approval of Texas’s request to amend and extend its Medicaid waiver under Section 1115 of the Social Security Act. Christopher Brown has more.

Abortion Provider’s Bid to Expand Kentucky Fight Denied: A federal judge in Kentucky Friday denied an abortion provider’s bid to add a challenge to the state’s new 15-week abortion to an already-existing case fighting a six-week abortion ban. Federal courts have a liberal policy of allowing complaints to be amended to bring courts up to speed on the claims as they evolve, a judge on the U.S. District Court for the Western District of Kentucky ruled. But it’s not apparent the law will affect the issues sought in the pre-existing case, he said. Mary Anne Pazanowski has more.

More Headlines:

• HHS Requests Health Industry to Pledge to Cut Down Emissions
• LA Sees ‘Steep’ 56% Spike in Homeless Deaths During Pandemic
• Aetna Defeats Appeal on Denial of Brand-Name Drug Payments
• Pennsylvania Home Health Office Faces Covid-Based Firing Suit
• Florida Supreme Court Clarifies Time Limit for Health-Care Suits
• Congo Declares a New Ebola Outbreak After Man Dies, WHO Says

With assistance from Alex Ruoff

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