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The U.S. government says it’s canceling a planned order of monoclonal antibody treatments for Covid-19 infections and warned that the country could eventually run short of vaccines because of a lack of funding.
The White House made the announcement Tuesday as it renews calls for lawmakers to authorize a fresh round of funding for the government’s Covid-19 response. Weeks of effort have fallen flat, leaving the administration to begin to claw back shipments and warn they may soon end. The funding is needed for new orders of treatments, to ensure fourth doses of vaccines are available to anyone if needed, and to continue to test and treat people here at home and abroad, officials said on a call Tuesday.
“Medical experts have been clear that in the next couple of months there could be increasing cases of Covid-19 here in the United States as well,” White House Press Secretary Jen Psaki said, citing rising caseloads abroad. “Waiting to provide funding until we’re in a worse spot with the virus will be too late,” she said. “We need funding now so we’re prepared for whatever comes.”
The administration’s warning comes as it presses for more money after its request for $22.5 billion failed to make it into a fiscal 2022 omnibus funding package that Biden signed into law Tuesday. Republicans were seeking offsets for around $15.6 billion in new Covid funding, and Democrats balked at those demands. The White House is still seeking $22.5 billion, the officials said.
Speaker Nancy Pelosi (D-Calif.) said Tuesday that House Democrats will seek to pass a Covid response bill “that can get votes in the Senate,” but she didn’t explain how that might be done, or whether it will be closer to the $22.5 billion sought by the administration. “I want more—I think we need to do more—but right now, we’ll take it one step at a time,” Pelosi said. “We’ll see what we are able to do.” Read more from Josh Wingrove and Jordan Fabian.
- But Senate Republicans rebuffed the White House claim that Covid response programs are going bankrupt, demanding details about the federal stockpile of drugs, countermeasures and unspent funds. “You can no longer just take somebody’s word they need more money,” Sen. Richard Burr (R-N.C.) said. Burr and other Republicans want an accounting of how many vaccines, tests, and therapeutics the government currently has in stock, and where previous Covid spending has gone. “I don’t know if they need more money,” Sen. Richard Shelby (Ala.) said. Read more from Alex Ruoff.
Also Happening on the Hill
Push for Drug Price Negotiations Renewed: Democrats on the Senate Finance Committee will make the case that this is the time to empower the government to negotiate with drug companies and to place caps on what millions of Americans pay for medicine. “What I’m going to do is lay out the case for urgency here,” Chairman Ron Wyden (D-Ore.) said ahead of today’s hearing examining drug pricing under Medicare, Alex Ruoff reports.
Wyden has led the Senate effort to pass sweeping changes to the pharmaceutical industry, such as demanding that drugmakers lower their prices and forcing companies to rebate the government if they raise the price of theirr revive that domestic agenda via public hearings where they’ll make the case for their policies, and acting without bipartisan support.
- Meanwhile, the Congressional Progressive Caucus Thursday plans to recommend several executive actions President Joe Biden can take to protect the environment and reduce rising costs for Americans, Chairwoman Pramila Jayapal (D-Wash.) and her office told reporters last night. The move, which will include health care priorities, seeks to inject new life into the moribund Build Back Better package, Kellie Lunney reports.
Senate Demands End to Mask Rules on Transit: The Senate backed legislation to end the federal mask mandate on trains and planes in a largely symbolic vote that highlights GOP opposition to White House’s pandemic policies. Senators on Tuesday voted 57-40 to pass the resolution (S. J. Res. 37) from Sen. Rand Paul (R-Ky.) to end the mask mandate on public transit. Republicans hope broad opposition will nudge the White House to rethink the requirement, which was set to expire on March 18 but last week was extended to April 18. Eight Democrats backed the measure. Read more from Lillianna Byington.
- BGOV Bill Summary: S. J. Res. 37, End CDC Travel Mask Mandate
FDA User Fee Bill to Include Diagnostics Changes: Legislation that would reform how diagnostic tests are regulated will be part of the FDA’s must-pass user fee bills, Sen. Patty Murray (D-Wash.) said Tuesday, a move that could settle a longstanding debate about the agency’s authority over laboratory-developed tests. She and Burr are “working on a bipartisan policy to try and improve the regulation of laboratory-developed tests,” Murray said while presiding over the Senate Health, Education, Labor, and Pension Committee. Lab-developed tests are those that are designed, manufactured, and used in a single laboratory. She said they aim to include the measure in the FDA user fee reauthorization package this spring. The current five-year authorization expires at the end of September. Read more from Jeannie Baumann.
Pandemic Preparedness Bill Advances in Committee: Legislation that seeks to beef up the nation’s pandemic response won a Senate panel’s approval Tuesday, setting up the long-awaited bipartisan legislation up for a full floor vote. The Health, Education, Labor, and Pensions Committee voted to 20-2 in favor of the PREVENT Pandemics Act (S. 3799). The legislation incorporates separate legislation (S. 3819) introduced last week authorizing the Advanced Research Projects Agency for Health, or ARPA-H, Biden’s proposed new agency to promote cutting-edge medical breakthroughs. Read more from Jeannie Baumann.
Public Workers’ Benefits/Black Lung Program: Several measures related to benefits of public sector employees are set to be marked up the Education and Labor Committee. One bill, the Longshore and Harbor Workers’ Covid-19 Compensation Act (H.R. 3114), would create a presumption that a Covid-19 diagnosis is work-related and authorize benefits for maritime workers; it would cover employees who contracted Covid-19 during a four-year period starting on Jan. 27, 2020. The panel also will act on legislation (H.R. 6102) dealing with the adjudication of claims under a Labor Department program that helps coal miners with black lung disease and a decade-long reauthorization (H.R. 5129) of the Health and Human Services Department’s Community Services Block Grant program.
What Else to Know Today
Pfizer Seek FDA Authorization for Fourth Dose: Pfizer said it has asked U.S. regulators for clearance of an additional booster shot for seniors in a bid to protect vulnerable adults as immunity provided by the first three doses wanes. The New York-based drugmaker and its German partner, BioNTech, said they have sought an emergency-use authorization from the Food and Drug Administration for a second booster of their vaccine, Comirnaty, for those 65 and older who have already received a booster of any of the authorized Covid-19 vaccines. Read more from Riley Griffin.
- Meanwhile, more vaccines are poised to reach poorer countries, thanks to a World Health Organization effort that some policy experts said dismantles an argument against waiving protections on pandemic-related innovations. Critics argue that the vaccines by Pfizer and Moderna are too complicated to produce without oversight, and that permitting poorer countries to try replicating them could do more harm than good. Such arguments are part of an ongoing push against a global waiver proposal on vaccine IP rights that’s been in talks for two years. Read more from Ian Lopez.
- Related: U.S. Says WTO Vaccine IP Talks Have Resulted in Compromise Outcome
Biden Opioid Plan Will Target Treatment, Trafficking: The White House is planning to roll out its drug control strategy in the next few months with a focus targeting opioid addiction treatment and the trafficking of illicit substances, the administration’s top drug policy official said in a Tuesday interview. Drug prevention programs based on research as well as policies that reduce the harmful consequences of drug usage will be front and center in the upcoming White House National Drug Control Strategy, said Rahul Gupta, director of the Office of National Drug Control Policy. Read more from Ian lopez.
Medicare Watchdog Warns of $12 Billion in Excess Payments: Medicare Advantage is leading the U.S. government to spend billions more on senior medical care than it should and needs a significant makeover, a nonpartisan watchdog said in a report sent to lawmakers. The program collected $12 billion in “excess payments” in 2020 over what the U.S. would have paid to cover people who used the private plans under standard Medicare, the analysis by the Medicare Payment Advisory Commission says. MedPAC said swelling costs could threaten the sustainability of Medicare. Read more from John Tozzi.
Louisiana Public Hospital Row Stays in Federal Court: A Louisiana public hospital’s fight against its insurer for $18 million to pay for Covid-19 related losses will stay in federal court because the district is subject to diversity jurisdiction, a federal court in the state decided. The St. Tammany Parish Hospital Service District No. 2, which operates Slidell Memorial Hospital, is a political subdivision, but not an “arm of the state,” the U.S. District Court for the Eastern District of Louisiana ruled. Thus, it’s a citizen of Louisiana for jurisdictional purposes, the court said. Read more from Mary Anne Pazanowski.
- Lilly Halts New Studies in Russia, Stops Sending Some Medicines
- Second Gentleman Doug Emhoff Tests Positive, V.P. Harris Negative
- Iovance Up After FDA Allows Cancer Therapy Drug Trials to Proceed
From the Courts:
- Gilead Loses Legal Bid to Keep BCBS Out of HIV Drug Antitrust Case
- J&J Unit Owes $20 Million Over Knee Surgery Patent, Jury Finds
- Texas Hospital Required to Face Negligence Suit on Leg Amputation
- Aerie Files Trio of Patent Lawsuits to Block Copies of Two Eye Drugs
- Lawsuit Claims Akebia Misled Investors on New Anemia Drug Safety
- Traveling Health-Care Workers Get $525,000 Overtime Deal Cleared
- Walgreen Medicaid Suit Advanced by U.S. Prosecutors in Tennessee
With assistance from Kellie Lunney