The protracted fight over approving $10 billion to combat Covid-19 has shaken the pharmaceutical industry’s confidence that Congress will keep buying new pandemic-fighting drugs and funding research.

It’s crucial the government buy existing countermeasures while developing better treatments or a vaccine that could protect against multiple coronaviruses at once, drug industry insiders say. If federal funding dries up, the U.S. could see shortages of Covid drugs and delays in new, better therapies and vaccines.

“You need money for the investments of what we’re going to have to face in the winter, next year and in subsequent years,” Anthony Fauci, White House chief medical adviser for Covid-19, said in an interview. “There is no money that is specifically designated in the budget yet for us to do the kinds of things that we need to do to continue to be better prepared,” he said. Fauci also heads the National Institute of Allergy and Infectious Diseases.

The situation makes it difficult for drugmakers to plan. “Companies are trying to figure out how much to make if you have an existing product that will be procured by the U.S. government—and they’re also trying to figure out if they have a technology that could help us get to an even better stage during the pandemic and post-pandemic,” said Phyllis Arthur, vice president of infectious diseases and diagnostics policy for the Biotechnology Innovation Organization, in an interview.

Some lawmakers say the government has spent enough. “You can’t expect the government dole to be there based on it being a pandemic, because it’s now an endemic,” Sen. Mike Braun (R-Ind.) said. “Anybody that’s relying on this place when we’re borrowing a trillion-and-a-half bucks now a year—I’d be careful about wanting more of it.”

A $10 billion Covid aid package has languished for months after the White House requested more than $20 billion to replenish pandemic programs and buy more vaccines and therapeutics. Read more from Jeannie Baumann and Alex Ruoff.

Also Happening on the Hill

Hearings Today:

• Food and Drug Administration Commissioner Robert Califf is scheduled to testify to the Senate Appropriations Agriculture, Rural Development, Food and Drug Administration Subcommittee on the agency’s fiscal year 2023 budget request.
• BGOV Calendar: See all hearings happening this week.

Eshoo Pledges ARPA-H Independence From NIH: A debate over where a new biomedical accelerator agency should sit within the federal government isn’t over, as a top health lawmaker said she’ll keep working to keep the new office outside of the NIH. “Congress authorizes. Congress appropriates,” Rep. Anna Eshoo (D-Calif.), chair of the House Energy and Commerce Health Subcommittee, said at a hearing on the Health and Human Services Department’s budget request. Eshoo said that HHS Secretary Xavier Becerra “has his view. I don’t agree with it. So I will present authorizing legislation.”

She was referring to Becerra’s announcement last month that he plans to set up the Advanced Research Projects Agency for Health, or ARPA-H, within the National Institutes of Health. The ARPA-H director would report to Becerra instead of the NIH director under the plan. Eshoo, who leads the health subcommittee, told Bloomberg Government after the hearing that she doesn’t have a date on when she plans to advance her ARPA-H authorizing bill. “It will be in the near future,” she said.

Eshoo is one of several lawmakers in the House with concerns that making ARPA-H part of the NIH means it will be too close to the NIH’s more incremental culture and mindset, preventing it from achieving the transformative technologies it’s designed for. There are also concerns about duplication between ARPA-H and the NIH. Eshoo introduced legislation last fall (H.R. 5885) to set up ARPA-H as an independent HHS agency and held a hearing in February in which witnesses that largely held that view. Read more from Alex Ruoff, Jeannie Baumann, and Shira Stein.

House Moderates Pushing Bipartisan Bills Before Midterm Election: The centrist New Democrat Coalition will endorse 22 bills on mental health, opioids, and health care this morning as part of a larger push to move bipartisan legislation before the end of the month. House leadership and the White House are generally supportive of the measures, and while there’s no firm timeline for a vote, Rep. Annie Kuster (D-N.H.) said some of the bills could be marked up by the House Energy and Commerce Committee in the next month and potentially get a floor vote in the summer. Read more from Emily Wilkins.

Congress Seeks Budget Update Amid Accidental Cuts: A top appropriator wants a revised budget proposal from President Joe Biden after officials inadvertently sought cuts to Violence Against Women Act funding and other programs—although the White House cited Congress’ own tardiness in pushing through the latest spending package. Senate Appropriations Chairman Patrick Leahy (D-Vt.) asked for an update after the March 28 fiscal 2023 proposal didn’t reflect recent changes to the Violence Against Women Act, including an LGBT grant program and Centers for Disease Control and Prevention programs.

Biden’s budget proposal called for $29.3 million for the CDC’s National Diabetes Prevention Program, down from $33.3 million in the 2022 omnibus measure; $20.5 million for the CDC’s Alzheimer’s program, down from $30.5 million in the omnibus; and $16 million for its Lyme disease program, down from $20.5 million in the omnibus. It also accidentally requested cuts for the CDC’s Lead Exposure Registry focused on Flint, Mich. Read more from Jack Fitzpatrick.

McKinsey Chief Says Firm Failed to Identify Opioid Epidemic: The head of McKinsey acknowledged it failed to see the opioid epidemic unfolding, while simultaneously doing work for drug regulators and makers of products such as OxyContin in his first appearance before the House Committee on Oversight and Reform investigating the consulting firm’s actions. “While our intent was not to fuel the epidemic, we failed to recognize the broader context of what was going on in society around us,” said Bob Sternfels, who assumed his role as global managing partner in 2021. “That’s why we have new protocols and policies in place to prevent this happening again.” Sternfels however denied conflicts of interest in advising both the Food and Drug Administration and opioid makers including Purdue Pharma. Read more from Matthew Boyle.

Senate Votes Down Motion to Restore Trump-Era Abortion Block: A measure to restore a prohibition on clinics that receive federal money from advising women on ending their pregnancies failed to pass the Senate Wednesday night. The Senate voted 49-49 on a resolution (S.J. Res. 41) from Sen. Marco Rubio (R-Fla.) that sought to restore a Trump-era regulation barring clinics in the federal program known as Title X from making referrals to abortion providers.

Rubio said Wednesday before the vote it was “important to hold a vote” regardless of outcome to highlight the issue. Sen. Joe Manchin (D-W.Va.), a long-time abortion opponent and rare anti-abortion Democrat in Congress, joined 48 Republicans in supporting the measure. Sens. Susan Collins (R-Maine) and Lisa Murkowski (R-Alaska), abortion right supporters, joined most Democrats in opposing it. The Biden administration reversed the so-called gag rule late in 2021 in a move applauded by Democrats and abortion rights supporters, Alex Ruoff reports.

• Earlier: Senate to Vote to Restore Trump-Era Abortion Block
• Related: BGOV Bill Summary: S. J. Res. 41, Title X Grant Abortion Rules

What’s Next for Congress: Lawmakers returned from spring recess this week with a long to-do list and midterm elections on the horizon. The Bloomberg Government legislative analyst team held a webinar to discuss the agenda for the remainder of the year, including fiscal 2023 appropriations, Ukraine and Covid-19 aid, and a U.S.-China competition package. Download the BGOV webinar.

More on the Pandemic

Court Pauses Biden Bid to Lift Pandemic Border Restrictions: A federal judge temporarily blocked the administration from ending Title 42, a pandemic-related rule that has allowed U.S. officials to turn away asylum-seekers and other migrants at the border. The Western District of Louisiana granted a request from a multi-state coalition to issue a temporary order barring the Homeland Security Department from reducing its use of Title 42 for two weeks. But DHS retains a case-by-case discretion over migrants’ cases. Maeve Allsup and Ellen M. Gilmer have more.

Covid Rule Hearing Highlights Employer-Union Gap: A new Covid-19 safety standard for the health-care industry will either create confusion for employers or ensure workers are protected, opposing witnesses told OSHA officials Wednesday, the first of four days of public hearings on creating permanent regulations to succeed their embattled, temporary predecessors. The day-long online session focused on the Occupational Safety and Health Administration’s proposal to issue a permanent Covid-19 standard for health care later this year. Read more from Bruce Rolfsen.

More Headlines:

• EU Embraces New Pandemic Phase Where Every Case Won’t Be Counted
• Tenet Sues U.S. to Stop El Paso Workers’ Covid-19 Vaccine Check

What Else to Know Today

CDC Data Plan Too Vague, U.S. Watchdog Says: The U.S. Centers for Disease Control and Prevention’s plan to modernize its data operations is too vague, lacks deadlines and doesn’t assign clear responsibility for completion, a government watchdog said in a report. The Data Modernization Initiative was launched in 2020 as part of a broader effort to overhaul the country’s public health information systems and improve capacity to respond to epidemics.

While the pandemic pushed some of those efforts into high speed, the Government Accountability Office report said that the agency’s overall plan “does not articulate the specific actions, time frames, and allocation of roles and responsibilities needed to achieve its objectives.” Drew Armstrong has more.

Reports of Kids’ Mysterious Liver Ailment Expand in U.S.: At least six U.S. states are reporting confirmed or suspected cases of an unexplained, severe liver disorder in children that’s been spotted in countries around the globe. The Wisconsin Department of Health Services said Wednesday afternoon that one of four cases under investigation resulted in a fatality. If confirmed, it would be the first death linked to the illness in the U.S. Read more from Madison Muller.

• Related: What We Know About the Mysterious Liver Disease Hurting Children

Ky. Abortion Clinic Can Join Planned Parenthood Suit: Kentucky’s only abortion providers are now joined in the same suit to combat a new law that bans abortions at 15 weeks and requires compliance with multiple administrative rules and regulations. U.S. District Judge Rebecca Grady Jennings cleared EMW Women’s Surgical Center’s motion to intervene in Planned Parenthood Great Northwest, Hawaii, Alaska, Indiana, and Kentucky’s suit to have H.B. 3 declared invalid. Read more from Mary Anne Pazanowski.

More Headlines:

• Medicare Accreditors Must Give Advance Notice of Sale Under Rule
• Hospitals Lose Third Bid to End Health Records Class Action Suit
• West Virginia Lawyer Device, Drug Case Solicitation Law Upheld
• Calif. Lawmakers Propose Compromise Medical Malpractice Cap
• J&J Suit Alleges ‘Counterfeiting Ring’ Sells Fake HIV Medication

With assistance from Alex Ruoff

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

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