HEALTH CARE BRIEFING: Biden Declares Success in Beating Pandemic

A triumphant President Joe Biden all but announced an end to the pandemic in the U.S. on Sunday, celebrating what he called a “heroic” vaccination campaign on the country’s Independence Day holiday.

Speaking at a party on the White House’s South Lawn with more than 1,000 people in attendance, Biden declared that the U.S. had achieved “independence” from the coronavirus, though he cautioned against complacency with more transmissible variants circulating in the country.

“Today, all across this nation, we can say with confidence: America is coming back together,” Biden said to a cheer from the invited guests. “Today, while the virus hasn’t been vanquished, we know this: It no longer controls our lives, it no longer paralyzes our nation and it’s within our power to make sure it never does so again.”

He appealed for Americans who have not yet been vaccinated to get their shots, noting that the country’s battle against the virus had been costly, with more than 603,000 Americans dead. “It’s the most patriotic thing you can do,” Biden said.

Biden’s optimistic mood reflects the plunge in coronavirus infections, hospitalizations and deaths since he took office and a rebound that has made the U.S. economy one of the strongest in the world. The Bureau of Labor Statistics said Friday that more than 850,000 jobs were created in June. And Biden’s White House party followed a trip to Michigan on Saturday where he sought to give a political shot in the arm to Democratic allies ahead of 2022 midterm elections.

Biden plans to speak today on the Covid-9 and vaccination response, according to his schedule. Read more from Jennifer Jacobs and Sophia Cai.

Delta’s Rapid Spread Clouds Summer: Still, the fast-spreading delta variant is clouding Americans’ hopes for a carefree summer and casting a shadow of doubt over plans to get back to business as usual in the fall. The shift in sentiment marks a reversal from the spring, when it looked like the U.S. vaccine campaign would turn the tide definitively against the coronavirus. But lingering vaccine hesitancy in some areas has converged with the arrival of the more contagious strain and darkened the mood across the country.

“The delta variant recreates this anxiety that many of us had prior to being vaccinated,” said Megan Ranney, an associate professor of health services, policy and practice at Brown University. “‘Are we safe? Are our kids safe? Is it OK for me to go to a restaurant?’ The things that we had started to accept were normal again.”

While U.S. health officials say delta is on its way to becoming the country’s dominant strain, an analysis by genomic testing firm Helix suggests it’s already there, accounting for about 40% of new infections. As hospitalizations rise in some states, the administration is sending response teams to less-vaccinated areas to try to combat its spread. Read more from Elaine Chen and Rebecca Torrence.

Happening on the Hill

Small Biotech Carve-Out in Drug Pricing: A lawmaker central to the debate on Capitol Hill over drug pricing reform has a major challenge ahead of him: how to promote research for new drugs, while tamping down unnecessarily high prices. Lowering drug prices is theoretically a bipartisan goal. Eight in ten Americans say current drug prices are “unreasonable,” the Kaiser Family Foundation has found.

But a politically palatable drug plan must also encourage the drugmaking industry to pump out novel products. Squashing innovation is the leading complaint among Republicans over a Democrat-led push for direct government pricing negotiations.

Senate Finance Chairman Ron Wyden (D-Ore.) acknowledged the need to “reward scientific innovation” in a drug-pricing policy outline released in June. His outline includes proposals generally hostile to the pharmaceutical industry such as Medicare price negotiation and patient rebate requirements on drugs whose costs accelerate faster than inflation. Read more from Jacquie Lee.

Rush Bill Would Kill Cost-Sharing for Insulin: Rep. Bobby Rush (D-Ill.) on Friday unveiled a bill (H.R. 4158), cosponsored by more than three dozen House Democrats, to eliminate the cost-sharing requirement for insulin under the Medicare and Medicaid programs. The cost-sharing requirements Rush is seeking to eliminate include deductibles, according to a statement. Read the bill text here.

E&C Panel Hires New Staff Director: The House Energy and Commerce Committee is hiring a new staff director after its long-time incumbent plans to step down. Chair Frank Pallone Jr. (D-N.J.) announced Friday that Staff Director Jeff Carroll will depart Capitol Hill and his deputy, Tiffany Guarascio, will succeed him. General Counsel Waverly Gordon will take Guarascio’s role, the committee statement says.

More on the Pandemic

U.S. Ready to Deploy Booster Shots, Zients Says: The U.S. government is ready to deploy booster shots if scientists and health officials determine they’re needed in the fight against Covid-19, White House pandemic response coordinator Jeff Zients said. With increases in cases in parts of the U.S. linked to low vaccination rates and the delta variant, Zients said the U.S. will push ahead with encouraging young people and others to get shots. Read more from Yueqi Yang.

J&J Covid-19 Vaccine Batch Is Cleared by FDA: The Food and Drug Administration authorized another batch of the main ingredient for Johnson & Johnson’s vaccines for use after a safety review, the drug regulator said on Friday. The drug substance was produced at an Emergent BioSolutions plant in Baltimore. A past mix-up at the facility triggered a sprawling safety review.

The substance is enough for up to 15 million doses of J&J’s single-shot vaccine, but it must still go through a “fill-finish” process where it is placed into vials, according to a person familiar with the matter. Once finished, the shots could further fuel the Biden administration’s push to send shots abroad. Read more from Josh Wingrove and Riley Griffin.

• Meanwhile, some people who received the Johnson & Johnson Covid-19 shot in the U.S. are seeking out booster doses of an mRNA vaccine, worried their initial inoculation won’t protect them from the coronavirus. Demand for the J&J shot has suffered partly due to the perception that it’s inferior to the two-dose mRNA vaccines that showed higher efficacy in clinical trials. Read more from Riley Griffin.
• Still, Johnson & Johnson last week said that its single-dose vaccine neutralizes the fast-spreading delta variant and offers strong protection against infection more broadly. The company said in a statement that recipients of its vaccine produced durable neutralizing antibodies over eight months against all virus strains, including delta. Read more from Griffin.

When Lifesaving Vaccines Become Profit Machines for Drugmakers: As Covid-19 spread last year, rich countries spent billions of dollars to speed development of vaccines and purchase early supplies. Now, 18 months into the crisis, vaccines are saving lives and helping to avert further economic losses, at least in the nations that can afford them. Yet, as drug companies ride a wave of support following years of criticism over high prices, they face a tricky question: How much should they charge governments desperate to protect their populations from a disease that has killed about 4 million people, crippled economies, and created turmoil across the globe? Read more from James Paton and John Lauerman.

More on the Delta Strain:

• Pfizer Shot Halts Severe Illness in Israel as Delta Spread
• Fortress Australia Slashes Arrivals 50% to Curtail Delta Strain
• South Africa Sees Record 24,270 Daily Cases Amid New Wave
• Covid Strain Weighs on Travel Rebound, Airports CEO Warns

More Global Headlines:

• Olympics’ Organizers Weigh No Fans for Opening Ceremony
• U.S. Steps Up, Europe Holds Back, Africa’s Vaccine Chief Says
• Singapore’s Covid Cases Drop to 3-Week Low as Shots Surge
• Face Masks in England Become a ‘Matter of Personal Choice’
• U.K., EU Seek to Ease Travel Fears Over India’s Astra Vaccine
• Putin ‘Lockdown Lite’ as Moscow Stops Millions From Dining
• Argentina Signs Degree to Change Rule to Up Vaccine Access
• Israel, Pfizer Talk Swap of Expiring Vaccines, Haaretz Reports

What Else to Know

SCOTUS to Hear Medicare Drug Payment Case: The U.S. Supreme Court agreed to hear a case challenging cuts the Health and Human Services Department made to Medicare prescription-drug reimbursements for hospitals that serve low-income and underserved communities. Hospital groups filed the petition to the high court with various hospital and health systems. Read more from Lydia Wheeler.

• Also from the courts, justices said they’ll review a decision that clears a way for people with disabilities to sue drug benefit plan administrators for bias based on how their plans operate. CVS Pharmacy called on the top court to review a Ninth Circuit ruling that allowed HIV/AIDS patients to sue the company under Obamacare’s discrimination provisions. Mary Anne Pazanowski has more.

Employers Get Upper Hand in Surprise Billing Rule: Employer groups are happy with the first rule implementing a law aimed at protecting patients from large “surprise” bills from emergencies and hospital procedures. It appears to keep payment rates lower than what medical providers wanted. The interim rule lays out how payments from health plans to providers will be determined in emergencies and for care at facilities in patients’ insurance networks from clinicians who aren’t. Sara Hansard has more.

More Headlines:

• NFL Defeats Appeal Over Health Insurance for Retired Athletes
• Pfizer-Sanofi’s Pharmaceutical Rebate Suits Get on FTC’s Radar
• GSK Zofran Birth Defect Plaintiffs Appeal Preemption Dismissal

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

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