HEALTH CARE BRIEFING: Bill Sets Stage for Health Research Agency

Lawmakers are hewing closely to President Joe Biden’s proposal for a new $6.5 billion science agency as part of a sweeping measure to deliver medical breakthroughs.

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) yesterday released a draft bill—dubbed “Cures 2.0″— the follow-up to the landmark 21st Century Cures Act biomedical innovation law (Public Law 114-255). The bill’s release coincides with a commentary in Science magazine setting forth the vision of the White House’s science office and National Institutes of Health officials for the Advanced Research Projects Agency for Health, and why it would be different from existing programs and centers.

“The federal government has amazing resources at its disposal,” DeGette and Upton said in a joint statement yesterday. “Now is the time to put the full weight of those resources to use to cure some of the world’s most devastating diseases—such as cancer, diabetes, Alzheimer’s and more.”

Enactment of the legislation would achieve a personal priority for Biden, whose son died of cancer in 2015. Biden has championed biomedical research, and led the Cancer Moonshot initiative as vice president. He began meeting with DeGette, Upton, and other lawmakers to discuss health research initiatives soon after taking office.

Cures 2.0 would authorize ARPA-H and also touch on nearly every aspect of the health-care system—from the authorization of medical research, to the Food and Drug Administration’s regulation of medical products and Medicare’s payments for cutting-edge treatments.

DeGette and Upton plan to hold roundtables about their proposal in June and July with the aim of releasing a final bill after Congress returns from its August break, DeGette said in an interview. The goal is to get the legislation onto Biden’s desk before the end of the year, she said.

The legislation “picks up important areas to advance science and innovation,” Esther Krofah, the executive director of FasterCures, a center of the nonprofit Milken Institute, said in an email. Read more from Alex Ruoff and Jeannie Baumann.

Happening on the Hill

Youth Vaping: The House Oversight and Reform Subcommittee on Economic and Consumer Policy plans a hearing today on youth vaping. Food and Drug Administration acting chief Janet Woodcock and Sen. Dick Durbin (D-Ill.) will testify.

Wyden Unveils Principles on Drug Pricing: Senate Finance Chairman Ron Wyden (D-Ore.) yesterday laid out what he wants to see in a major drug pricing reform package, hewing closely to what Democratic leaders have already proposed. Wyden told reporters yesterday he’s working on a drug pricing package “in parallel” with discussions around a bipartisan infrastructure deal led by the White House, which so far hasn’t included any drug pricing provisions.

“The president is a very patient guy but patience is not eternity,” Wyden said. “So, we’re blasting ahead with proposals here.”

Wyden unveiled a document yesterday that showed he wants to empower the federal government to negotiate with drugmakers and roll back a Trump-era push to eliminate drug rebates for parts of Medicare, both policies that Democrats widely support. Like H.R. 3, the main drug pricing proposal backed by House leaders, Wyden’s proposal would allow commercial insurers to pay the prices negotiated by the government.

Wyden’s document said he wants to protect smaller biotech firms from price controls, potentially giving some companies a carve-out in the legislation. “To protect their ability to innovate, policies developed in the Finance Committee can be tailored to the scale of these companies, as well as other factors that affect their access to capital,” he said, Alex Ruoff reports.

• Meanwhile, Senate Finance ranking member Mike Crapo (R-Idaho) and Health, Education, Labor and Pensions ranking member Richard Burr (R-N.C.) reintroduced the Lower Costs, More Cures Act (LCMCA) which also aims to lower prescription drug prices. The bill would set annual out-of-pocket $3,100 caps for Medicare Part D enrollees as well as reduce cost sharing for beneficiaries from 25% to 15% before the out-of-pocket cap is reached, among other provisions, Alex Ruoff reports. Read the section-by-section breakdown here.

Senator Taps Doctor’s Lobby to Fight Vaccine Misinformation: The U.S. doctor’s lobby is being employed by senators to fight misinformation about Covid-19 vaccines on social media, as lawmakers eye ways to get more people vaccinated. Sen. Chris Murphy (D-Conn.) told Bloomberg Government he’s working with the American Medical Association on designing legislation to get the Department of Health and Human Services to track and evaluate medical misinformation online.

Murphy said the government could be doing more to counter this information directly. “The idea is HHS would sift through some of this information and send out information from physicians to people’s network,” he said.

Physicians groups say social media networks are rife with bad information about the coronavirus and vaccines. Susan Baily, the immediate past president of the AMA, told senators yesterday that misinformation has increased vaccine hesitancy among some Americans and needs to be checked, Alex Ruoff reports.

• The campaign comes as three Democratic senators asked Facebook CEO Mark Zuckerberg how the company is fulfilling its promise to remove vaccine misinformation from its site and sought data on the effort. Sens. Bob Menendez (N.J.), Mark Warner (Va.), and Mazie Hirono (Hawaii) sent a letter to Zuckerberg this week asking him to detail how many users veiwed vaccine-related misinformation. Rebecca Kern has more.

Sanders Budget Document Goes Beyond Biden’s: Senate Budget Chairman Bernie Sanders (I-Vt.) is preparing a budget document that goes further than Biden’s plans on Medicare, public housing, and electric vehicles, and which would partially revive the federal deduction for state and local taxes, Jack Fitzpatrick reports.

Sanders wants $299.6 billion in spending in fiscal 2022 to provide coverage for dental, vision, and hearing through Medicare, according to a side-by-side comparison of the Sanders and Biden budgets obtained by Bloomberg Government. It also calls for $200 billion to lower the Medicare age of eligibility to 60. Read the accompanying document with more details here. Erik Wasson and Laura Davison have more.

Bill Seeks to Improve Mental Health Care in E.R.: Sens. Shelley Moore Capito (R-W.Va.) and Maggie Hassan (D-N.H.) unveiled a bill that would improve the way patients receive care for mental illness in emergency departments, according to a statement. The measure would create a competitive grant program for emergency departments to adopt more collaborative and connected mental health care models, the statement says. Read text of the bill here.

Film Director Lobbies Meditation on Capitol Hill: David Lynch credits meditation with helping him create some of his legendary works. The film director’s eponymous foundation is turning to Congress to help spread the word to others who might benefit. The David Lynch Foundation recently hired its first lobbying firm, Michael Best Strategies, to discuss with congressional offices the role meditation can play in treating post-traumatic stress, anxiety, and trauma. Read more from Megan R. Wilson.

The Coronavirus Pandemic

Biden Team Concedes Falling Short of July 4 Target: Biden’s advisers acknowledged that they will fall short of the White House goal of getting 70% of U.S. adults a first Covid-19 shot by the July 4 holiday. Biden’s Covid-19 Coordinator Jeffrey Zients conceded yesterday the White House won’t hit the target, but cited other milestones. About 70% of adults 30 and older have received their first dose, and the same share of people 27 and up will have done so by Independence Day, Zients said. Josh Wingrove has more.

Jill Biden Pitches Shots for Reluctant Arms: First lady Jill Biden headed to the Deep South yesterday to encourage vaccinations, as the White House tries to combat widespread hesitance to get shots in areas that are politically hostile to her husband. Mississippi and Tennessee, where Jill Biden is visiting, have some of the lowest vaccination rates in the U.S. Unvaccinated adults who say they definitely won’t get the vaccine are more likely to be Republicans, a Kaiser Family Foundation poll found. Jordan Fabian has more.

Covid-19’s Wallop Reached 2 of 5 Medicare Nursing Home Residents: About 40% of Medicare beneficiaries in nursing homes were diagnosed with Covid-19 in 2020 or were likely infected, including half of Black, Hispanic, and Asian enrollees and 41% of white beneficiaries, new federal data shows.

In addition, nearly 1,000 more beneficiaries died each day in nursing homes in April 2020 than in 2019, according to the report by the Department of Health and Human Services’ Office of Inspector General. In that month alone, 81,484 Medicare beneficiaries in nursing homes died. Read more from Tony Pugh.

More Headlines:

• Secret Service Covid-19 Caseload Hit Nearly 900 Over a Year: Records
• China to Keep in Place Covid-19 Border Restrictions for Another Year
• Covid-19 Cases Surge to Record High in South African Economic Hub

More Vaccine Headlines:

• World Bank, African Union Agree on Plan to Expedite Vaccinations
• Denmark Makes AstraZeneca Covid-19 Vaccine Donation to Kenya
• Duterte Threatens to Jail Those Who Refuse to Get Covid-19 Vaccines
• Abu Dhabi Offers Pfizer, Sinopharm Covid-19 Vaccines for Tourists

What Else to Know

Alzheimer’s Therapy Sparked Behind-Scenes FDA Clash on Approval: Statisticians at the Food and Drug Administration who had a thorough look at the clinical-trial data didn’t support approval of Biogen’s Alzheimer’s therapy, internal documents released by the agency show. The documents released yesterday show how top FDA officials weighed the concerns of their staff against the need of patients suffering from a serious fatal disease with no treatments that can halt its progression. The drug was granted an accelerated approval on June 7. Read more from Anna Edney and Robert Langreth.

• Meanwhile, the $56,000 yearly cost of Biogen’s newly approved Alzheimer’s therapy is drawing increasing criticism ahead of a decision by the federal government on reimbursement policies for the medication. The Employers’ Prescription for Affordable Drugs, a coalition of health-care purchasers, told congressional leaders yesterday that taxpayers and employers will have to pay billions of dollars for “Aduhelm,” without even knowing whether it works. Read more from John Tozzi.

Legal Headlines:

• Former Chief Counsel at FDA Lands Role as MoFo Practice Co-Lead
• Temple University Loses Medicare Wage Classification Legal Battle
• Hand Sanitizer Benzene’s False-Ad Claims Barred, Artnaturals Says
• Walgreens Defrauded Virginia Medicaid, Feds’ Complaint Says

More Headlines:

• Texas the Latest State to Legalize Psychedelic Medical Research
• Health Groups Urge Biden EPA to Reconsider Ozone Air Standards
• Fennec Pharmaceuticals Gets FDA Acceptance of NDA for Pedmark
• UniQure Falls Most Since March After FDA Delays Hemophilia Drug
• FDA Panel to Vote on Deferring MacroGenics/Incyte Drug Decision
• Nine Months After Lockdowns, U.S. Births Plummeted by 8%

With assistance from Jack Fitzpatrick

To contact the reporters on this story: Brandon Lee in Washington at blee@bgov.com; Alex Ruoff in Washington at aruoff@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