HEALTH CARE BRIEFING: Lawmakers Wary of ARPA-H and NIH Overlap

By Brandon Lee and Alex Ruoff

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Legislation to establish the biomedical innovation accelerator proposed by President Joe Biden must avoid duplicating NIH work by making it independent of the existing agency, top members of a House health panel agreed.

The health subcommittee on the House Energy and Commerce Committee held a hearing Thursday on a slate of 22 bills that the panel is largely eyeing to attach to must-pass FDA user fee legislation. Two of those bills would authorize the Advanced Research Projects Agency for Health (ARPA-H). The White House wants the new agency to deliver medical breakthroughs in the same way that existing programs in the Departments of Defense and Energy helped pave the way for the internet and GPS.

Rep. Cathy McMorris Rodgers (R-Wash.), the ranking Republican on the full committee, expressed disappointment that Congress has already provided $1 billion for ARPA-H in the omnibus spending bill (H.R. 2471) without authorizing language from Congress that clearly establishes the mission and framework of the new agency. “That’s more than we spend each year on block grants to states for mental health,” she said. “My concerns remain about accountability and the lack of a clear mission” for ARPA-H.

Francis S. Collins, the former NIH director who’s now the acting White House science adviser, told Bloomberg Law last year that ARPA-H would adopt a short-term project management approach to act more swiftly to pursue projects that wouldn’t work well under the NIH’s traditional grant-making process, such as a single shot to protect against the top 10 infectious diseases and an mRNA vaccine to shield against common cancers.

An unresolved issue about ARPA-H is whether it should exist within the National Institutes of Health or as an independent agency within the Department of Health and Human Services. Rep. Anna Eshoo (D-Calif.) introduced a bill (H.R. 5585) that would make it independent, but both Cures 2.0 (H.R. 6000), follow-up bill to the 2016 biomedical innovation law 21st Century Cures, and a bill approved by the Senate Health Education Labor and Pensions Committee (S. 3799) would put the new entity within the NIH as the Biden administration proposed.

The chamber will likely adopt Eshoo’s version, as the lawmaker said her bill has the backing of House leadership. The architects of Cures 2.0—Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.)—have also ironed our their differences in their ARPA-H authorizing language. “These bills will move together, and they’ll be revolutionary,” DeGette said during the hearing Thursday. Read more from Jeannie Baumann.

Generic, Biosimilar Pathways Get Focus: Also at the hearing, lawmakers said two House measures aiming to clarify application requirements for generic drugs and biosimilar products could help bring more products to market that are interchangeable with costly brand-name products. The two proposals (H.R. 7032, H.R. 7047) would push the Food and Drug Administration to simplify how it determines whether cheaper versions of currently marketed pharmaceutical and biological products are similar enough to be substituted for each other at the pharmacy counter. Read more from Celine Castronuovo.

Happening on the Hill

Warnock Says Insulin Bill May Get Action by Easter: The lead sponsor of legislation to cap what Americans pay for insulin told reporters on Thursday that he’s hoping to get his bill through committee and onto the Senate floor by Easter, which falls on April 17 this year. Sen. Raphael Warnock (D-Ga.) said, “I’m hoping by Easter there will be kind of resurrection of hope for people who struggle every day, millions of Americans, who have diabetes.” Warnock’s bill (S. 3700) would cap consumers’ out-of-pocket insulin costs at $35 per month without changing the price drugmakers charge for insulin. It would apply only to those who have insurance.

The proposal was originally part of Democrats’ sweeping domestic spending package, which is now stalled. Warnock’s measure has 29 co-sponsors, all Democrats or senators who caucus with Democrats. Warnock has said he thinks the idea ought to garner bipartisan support, but no Republicans have so far signaled they will, Alex Ruoff reports.

  • Meanwhile, the Congressional Progressive Caucus is urging Biden to issue executive orders to fulfill a number of key priorities that remain stalled in Congress. The 98-member caucus of liberal Democrats is pressing Biden to go it alone on policies tackling climate change and lowering prescription drug prices. “This isn’t about abandoning the legislative path,” they said. “It’s about realizing the promise of Democratic governance.” Read more from Jarrell Dillard.
  • The leader of the Congressional Progressive Caucus is sounding the alarm that the Democratic base may not turn out this November unless Democrats can notch more policy wins. Chair Pramila Jayapal (D-Wash.), who’s already hit the campaign trail to help candidates in Texas, said in an interview that voters are disheartened with Democrats’ failure to pass major the wide-ranging social spending and tax plan, Build Back Better. Read more from Emily Wilkins.

House GOP Wants to End Transportation Mask Rules: House Republicans demanded the Biden administration to “immediately reverse” the decision to extend the federal transportation mask mandate through April 18. “This policy continues to frustrate and damage an airline industry that has taken extraordinary measures to keep passengers safe,” wrote 129 House GOP members in a letter to Biden on Thursday. The letter comes after the Senate voted this week to pass a largely symbolic resolution (S. J. Res. 37) to end the mask mandate on public transportation, Lillianna Byington reports. Read the House GOP letter here.

Proxy Voting, Remote Hearing Problems Prompt Search for Fixes: House Democrats say they want to continue some form of proxy voting and remote committee hearings, but they acknowledge the need to root out abuse of the changes that were put in place to deal with Covid-19. At a Rules Committee hearing on Thursday, Chair Jim McGovern (D-Mass.) said lawmakers “didn’t get everything perfect” with proxy voting and remote hearings but cited a continuing usefulness of both. Emily Wilkins has more.

The Coronavirus Pandemic

Moderna Requests FDA Okay for Fourth Covid Shot for Adults: Moderna has filed for U.S. Food and Drug Administration clearance of a second Covid-19 booster shot for all adults, covering significantly more people than Pfizer and BioNTech’s earlier request for emergency authorization for those over 65. The application comes amid heated debate over how long vaccinations protect from infection and whether repeated shots are necessary to prevent severe disease and death. Several countries including Israel have started administering a fourth dose to adults, with data showing a fivefold increase in the production of infection-fighting antibodies. Read more from Michelle Fay Cortez and Robert Langreth.

  • A second round of Covid booster shots, if deemed necessary, would require additional resources to acquire and administer, CDC Director Rochelle Walensky said Thursday. Walensky said her agency is working with the Food and Drug Administration and vaccine makers to understand the benefit of a fourth dose, the timing of it, and whom should be recommended to receive it the weeks and months ahead. But the latest data indicate that people who received the first round of boosters still have about 78% protection against a severe Covid case. Read more from Jeannie Baumann and Alex Ruoff.
  • Meanwhile, Biden’s top public health adviser Anthony Fauci, said U.K. officials are already warning him of an increase in Covid cases there driven by the BA.2 sub-variant, easing restrictions and waning protection from vaccines, and that the U.S. tends to be a few weeks behind case curves in the U.K. The U.S. could soon see cases jump again and vulnerable people are likely to need a fourth vaccine dose. Without new pandemic funding, “a lot of things are going to stop. It really will be a very serious situation,” Fauci said. Read more from Josh Wingrove.

Biden Taps Brown’s Public Health Dean to Succeed Zients: White House coronavirus coordinator Jeffrey Zients plans to leave the Biden administration in April and will be succeeded by public health expert Ashish Jha, Biden said in a statement. “Jeff spent the last 14 months working tirelessly to help combat Covid,” the president said, calling him “a man of service and an expert manager.” The departure of Zients, a management consultant who led the National Economic Council during the Obama administration, comes as the White House has said the pandemic is entering a new phase. Read more from Justin Sink.

U.S. Said Buying Into ‘Delusion’ on Patent Waiver: A global plan to ignore drugmaker intellectual property rights over Covid-19 vaccine production could have severe consequences on drug investments for pandemic purposes and beyond, according to critics of a pitch backed by the U.S. before the World Trade Organization. Since 2020, South Africa and India have pushed WTO nations to permit third parties to replicate IP-protected Covid vaccines and therapeutics for global use. The U.S. and EU this week agreed to a trimmed down version of the plan, setting the stage for a vote that advocates say will set perilous precedent. Ian Lopez has more.

More Headlines:

What Else to Know Today

WHO Chief Says 43 Health Facilities Attacked: The head of the World Health Organization said there have been 43 confirmed attacks on health-care facilities in Ukraine since Russia’s invasion began and aid convoys have been stalled. Dr. Tedros Ghebreyesus told the UN Security Council that aid shipments to the cities of Sumy and Mariupol, surrounded by Russian forces, have been stymied. At least eight facilities that produce oxygen for health facilities have been closed because of the war, he added. Disease outbreaks are expected as the conflict continues. Read more from Bloomberg News.

Association Health Plans in Limbo Years After Trump Rule Voided: The Biden administration is under pressure to take action on association health plans, which have been mired in regulatory uncertainty since a federal court voided a Trump-era regulation three years ago. The plans allow small businesses to band together and offer health insurance as a large group. The Trump administration eased requirements for the plans with a rule that the U.S. District Court for the District of Columbia struck down in 2019. The Trump administration appealed the decision to the U.S. Court of Appeals for the D.C. Circuit, where the case has stalled as the Biden administration continues to review it. Read more from Shira Stein.

Biogen’s Rehearing Denial Lays New Hurdles for Pharma Patents: A recent dissent from three Federal Circuit judges signals that a potential Supreme Court petition might be on the horizon in a case that opened up a new avenue for challenging pharmaceutical patents. Two denials of full court rehearings for pharmaceutical patents that hit March 16 are the latest examples of how the U.S. Court of Appeals for the Federal Circuit is grappling with the standard for written description support. Judge Alan D. Lourie authored a dissent in one of the decisions, saying that the opinion in Biogen International GmbH v. Mylan Pharmaceuticals Inc. will have a “muddying effect” on case law. Read more from Samantha Handler.

Abortion Law Fight in Kentucky Paused for SCOTUS Case: Abortion providers in Kentucky convinced a federal court to continue pausing their challenge to a state law banning abortions after six weeks of pregnancy because a case pending in the U.S. Supreme Court undoubtedly will affect it. The decision by the U.S. District Court for the Western District of Kentucky means the state cannot enforce its so-called “heartbeat” law for now because a March 2019 order halting it will stay in effect until EMW Women’s Surgical Center’s case challenging the law’s validity is decided. Read more from Mary Anne Pazanowski.

More Headlines:

With assistance from Lillianna Byington

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: Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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