HEALTH CARE BRIEFING: Democrats Put ‘Down Payment’ on ARPA-H

The NIH will receive less than half of what the Biden administration requested for its new big ticket entity known as ARPA-H, as a House spending panel seeks a heavier medical research boost across the board.

The House Appropriations Labor-HHS-Education Subcommittee approved its 2022 spending plan by a voice vote yesterday. The $253.8 billion spending package—a 28% increase from the current enacted level—includes $49.4 billion for the National Institutes of Health, or a $6.5 billion increase from its current level.

Of that $6.5 billion increase, $3 billion would fund the Advanced Research Projects Agency for Health, a new special projects agency to be housed within the NIH that aims to speed up game-changing biomedical discoveries. The remaining increase would fund research at the NIH’s 27 institutes and centers. President Joe Biden had asked for $6.5 billion for ARPA-H over three years and a $2.5 billion increase for the rest of the NIH across the board—for a $9 billion increase overall. The House spending panel appears to be providing startup costs to ARPA-H, but it’s pouring more money into the core work of the medical research agency.

“It’s a gorgeous bill,” Ellie Dehoney, vice president of policy and advocacy for Research!America, said in an interview. “My guess is that the president is not going to be fighting hard against the notion of starting with a $3 billion down payment on ARPA-H’s potential.

“But to me, what was very important was that it didn’t feel like they were cannibalizing one another. There was real recognition of the importance of uncovering more knowledge so you can get to a place where ARPA-H can be innovative and push things across the finish line,” Dehoney said. Read more from Jeannie Baumann.

Still, Republicans said they oppose the Labor-HHS spending bill over the price tag and the removal of the Hyde amendment, which bans federal funds for most abortion services.

“In my opinion a deal would mean the defense number would need to go higher, the domestic number would need to go lower, and obviously Hyde needs to come back in,” said Rep. Tom Cole (R-Okla.), the subcommittee’s ranking Republican, Andrew Kreighbaum reports.

Also Happening on the Hill

Senate Democrats Split on Budget Plans: Biden met with Senate Budget Committee Chair Bernie Sanders (I-Vt.) yesterday as Democratic lawmakers wrangled to find consensus on legislation designed to carry most of the president’s $4 trillion longer-term economic agenda. Later, at the Capitol, Sanders said negotiations had progressed over the July 4 congressional recess but there wasn’t yet a deal. Sanders has outlined a $6 trillion proposal covering Biden’s agenda as well as an expansion of Medicare, additional climate change items, immigration reform and a permanent extension of the child care tax credit. Senate Democrats remain divided on the size and scope of that fast-track budget reconciliation bill.

Maryland Democratic Senator Chris Van Hollen, a Budget Committee member, said there is a “decent chance” a lawmaker group that met last night will be able to finalize a deal tonight. He said that everything remained on the table. Democrats said they are trying to come to a deal by Thursday in order to bring the budget up for potential Senate floor votes next week. Read more from Erik Wasson and Justin Sink.

Biogen Alzheimer’s Drug Spurs Demand for Documents: Lawmakers probing the approval of Biogen’s controversial new Alzheimer’s treatment Aduhelm asked the company to turn over years of internal documents about the drug’s development and the company’s dealings with regulators. The request by Democratic leaders of two House committees probing the approval adds to the scrutiny of Aduhelm. Last week the acting head of the FDA, Janet Woodcock, asked for an independent government investigation into the approval process from the inspector general that oversees the agency.

“We are concerned by reports of an atypical approval process for Aduhelm amid significant questions about the drug’s clinical benefit, and the steep $56,000 annual price tag, which will have serious implications for seniors, federal health care programs, and future Alzheimer’s research,” wrote House Oversight and Reform Chair Carolyn Maloney (D-N.Y.) and Energy and Commerce Chair Frank Pallone (D-N.J.). Read more from John Tozzi.

• Meanwhile, The Biden administration is undertaking an analysis of Aduhelm to determine whether it needs a national coverage policy under Medicare. It’s the first indication from the Centers for Medicare & Medicaid Services that the drug will be scrutinized. Medicare is expected to bear the bulk of the cost of the drug’s use in patients. Read more from Tony Pugh.
• Related: Biogen’s Japan Partner Pushing on With Second Alzheimer’s Drug Despite FDA Fracas

Democratic Bill Would Expand Affordable Health Care: Sens. Raphael Warnock (D-Ga.), Tammy Baldwin (D-Wis.) and Jon Ossoff(D-Ga.), introduced legislation to expand health care coverage to more than 4 million Americans. The bill would would provide health care insurance to Americans with low incomes in the twelve states that haven’t expanded their state Medicaid programs under the Affordable Care Act.

Warren Urges DOJ, FTC to Probe Amazon on Masks: Senator Elizabeth Warren (D-Mass.), a staunch critic of the biggest technology companies, asked U.S. antitrust enforcers to review her findings that Amazon “seems to be actively misleading customers” who are searching for FDA-approved masks.

“Given the significant public health concerns facing consumers who may be receiving misleading information from Amazon about the masks that they seek for protection from Covid-19, I urge you to review the enclosed materials and use your authorities to protect consumers and public health,” Warren wrote in a letter to Attorney General Merrick Garland and Lina Khan, chair of the Federal Trade Commission, Jennah Haque reports.

• Related: FTC to Consider Restoring Prior Approval, Notice in Merger Cases

Democrats Ask Merkel for Vaccine IP Waiver Meeting: Rep. Jan Schakowsky (D-Ill.) led a group of Democratic colleagues in a letter to the German ambassador urging the nation to reconsider its continued opposition to a waiver of the WTO Agreement on Trade-Related Intellectual Property. Schakowsky, the chair of the Energy and Commerce Committee’s consumer protection and commerce panel, is requesting a meeting with German Chancellor Angela Merkel, who will be in Washington this week to meet with Biden, Laura Curtis reports.

Today’s Hearings and Votes:

• Drug Market Competition: The Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights plans a hearing on anticompetitive conduct in prescription drug markets.
• HHS Nominee: The Senate Finance Committee is scheduled to vote on nominations including Melanie Anne Egorin to be an assistant secretary for the Health and Human Services Department.

The Coronavirus Pandemic

Medical Stockpile Seeks 127 Million U.S.-Made Masks: The U.S. medical stockpile is looking for companies that can make a total of 127 million disposable surgical masks over the next year in the U.S. The Strategic National Stockpile issued the request for information seeking eligible companies that can also meet stringent safety requirements. The masks will need to be cleared by the FDA through the 510(k) process under which companies can market a medical device that is substantially similar to a device already cleared by the agency. Read more from Shira Stein.

• Meanwhile, Honeywell International and hospital supply-purchasing group Premier will launch a venture to manufacture 750 million nitrile exam gloves in the U.S. each year, the companies told Bloomberg Law. It is the latest effort to shore up problems in the medical supply chain for personal protective equipment, which gained widespread attention due to the Covid-19 pandemic. Nitrile gloves, used for nonsurgical purposes in hospitals, and other medical gloves have been in short supply since the beginning of the pandemic and are among of the main types of PPE that health workers still struggle to get. Read more from Shira Stein.

J&J Vaccine Linked to Side Effect: U.S. health officials said that they are monitoring reports of a rare immune-system disorder in some people who received the Johnson & Johnson coronavirus vaccine. The CDC said in a statement yesterday that adverse-event data indicate a “small possible risk” of Guillain-Barré Syndrome, a rare condition in which the immune system attacks the nerves. There were 100 preliminary reports of the syndrome out of some 12.8 million doses of the vaccine administered, the CDC said. The cases were seen mostly in men over the age of 50 about two weeks after they received the single-dose vaccine. Read more from Drew Armstrong and Riley Griffin.

U.S. Cases Surge: Confirmed cases of Covid-19 in the U.S. soared 47% to 136,351 in the week ended Sunday, data compiled by Johns Hopkins University and Bloomberg show. The largest weekly rise since April 2020 comes as the highly contagious delta variant spreads in the country amid declining vaccination rates. The death toll for the period ticked up to 1,629. While last week’s figures are a fraction of the weekly numbers during the winter, about half of Americans remain unvaccinated, slowing the battle against the virus. The U.S. has administered 334 million doses of vaccine, enough to cover about 52% of residents, according to the Bloomberg Vaccine Tracker.

More Headlines:

• Taiwan Envoy Calls BioNTech’s China Vaccine Rules ‘Ridiculous’
• England Faces Up to 200 Daily Covid-19 Deaths When Peak Hits
• U.S. Lowers Travel Warning Advisory for Germany
• Wellness Resorts Eye Long Covid Treatments as New Moneymaker

What Else to Know

Medicare Physician Pay Proposal Gets White House OK: The White House completed its review of a proposed rule to revise Medicare payments in 2022 under the physician fee schedule and to make other payment policy changes under Medicare “Part B,” which covers outpatient care, medical services, and supplies, Tony Pugh reports. The proposed rule can now be released at any time by the Centers for Medicare & Medicaid Services.

Former Menendez, Cantwell Aide Joins Akin: Top lobbying firm Akin Gump Strauss Hauer & Feld added Michael Barnard, former aide to Sen. Robert Menendez (D-N.J.) to its growing health policy team. Barnard comes from Johnson & Johnson Services, where he served as a director of federal affairs. He worked for Menendez—a senior member of the Senate Finance Committee—for six years, including serving as the senator’s lead health and human services adviser. His resume also includes a stint with Sen. Maria Cantwell (D-Wash.) and the late Rep. Ed Pastor (D-Ariz.).

The firm has also brought on to its healthy policy team Anna Abram, a former senior official at the Food and Drug Administration, in May. In February, it hired Jose Borjon, a former congressional aide with ties to the Congressional Hispanic Caucus. The firm’s health care clients include the Synthetic Biology Coalition, Air Evac Lifeteam, Pfizer, Gilead Sciences and Amgen USA, Megan Wilson reports.

More Headlines:

• Sanofi, Novo Insulin Price Suit Advances With Trimmed Claims
• Adobe, Aetna Sued Over Denial of Child’s Mental Health Treatment
• Akebia’s Suit Over CMS Refusal to Pay for Anemia Drug Proceeds
• Texas Pharmacy Board Sued Over Minimum Prescription Regulation
• Hospital Lacks Ability to Sue State to Enforce Medicaid Payments

With assistance from Andrew Kreighbaum and Megan R. Wilson

To contact the reporter on this story: Zachary Sherwood in Washington at zsherwood@bgov.com

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