HEALTH CARE BRIEFING: Trump Pick for Pandemic IG Vows Vigilance

President Donald Trump’s nominee to oversee trillions of dollars in the effort to rescue the economy from the coronavirus pandemic pledged to “conduct every audit and investigation with fairness and impartiality.”

“I will be vigilant to protect the integrity and independence of the Office of Special Inspector General” and will work “to uncover fraud, waste and abuse,” Brian Miller said in prepared remarks released yesterday. He’s scheduled to face the Senate Banking Committee today at 2:30 p.m. in Washington as lawmakers weigh his nomination as Special Inspector General for Pandemic Recovery.

Created by the $2.2 trillion CARES Act (Public Law 116-136) that Congress passed in March, the SIGPR’s purview will include key stimulus programs, including $454 billion in backstops to lending programs through the Federal Reserve, as well as money for airlines and defense companies. The central bank is leveraging funds from the Treasury Department into trillions of dollars in liquidity for the economy.

Miller had experience as a watchdog earlier in his career, probing health-care fraud for the Justice Department and monitoring spending at the General Services Administration. But Democrats have questioned his independence in light of his current post as a top White House lawyer who participated in Trump’s impeachment defense.

It’s unclear how deep Miller may probe if, as expected, he wins confirmation in the Republican-led Senate. Trump already has sought to rein in the post Miller would fill by limiting its communications with Congress.

While Democrats demand aggressive oversight, the president has moved in recent weeks to strip power from inspectors general he views as disloyal. Trump dismissed one watchdog, criticized another for spotlighting reports of equipment shortages at hospitals and shunted another from a post overseeing pandemic spending beyond the Treasury Department. Read more from Saleha Mohsin and Laura Davison.

Congressional Coronavirus Efforts

Democrats Seek Nursing Home Provisions: House Democrats want to expand inspections at nursing homes and bolster reporting of deaths at long-term care facilities. Members told reporters yesterday they’re also seeking more funds for protective equipment for workers at long-term face facilities, where more than 10,000 residents and workers have died of the virus. House Democratic Caucus Chairman Hakeem Jeffries (D-N.Y.), said he expects to see legislation on this “sooner rather than later.” Rep. Jan Schakowsky (D-Ill.) said she believes Democrats will get “some support from Republicans who are seeing the same kind of startling statistic about these nursing homes,” Alex Ruoff reports.

  • House Majority Leader Steny Hoyer (D-Md.) told fellow Democrats yesterday there is no timetable for them to return to Washington for votes on the next coronavirus bill or other legislation, according to members and officials who participated in a caucus-wide call. Democratic House members are being asked to send their suggestions for the a new pandemic response measure to House leaders and committee chairmen by Friday, one official said. Read more from Billy House and Erik Wasson.

Gilead Questioned on Remdesivir Supply Chain: Democratic lawmakers sent a letter to Gilead CEO Daniel O’Day asking for details on the company’s plans for remdesivir, an anti-viral medication being studied to treat Covid-19, including measures to secure the supply chain, disclosures about taxpayer investment in the medication and pricing. “American taxpayers have made a big investment in remdesivir, but now in return, those who need treatment may get only a big bill while Gilead gets a big payoff,” Rep. Lloyd Doggett (D-Texas), chairman of House Ways and Means Health Subcommittee, said in a statement yesterday. Read the letter here.

  • At $4,500 for a round of treatment, remdesivir could be reasonably priced and still generate over $2 billion in revenue for the biotech, according to analysts at Piper Sandler. That’s the maximum price that the Institute for Clinical and Economic Review had recommended for a 10-day treatment of remdesivir, which received emergency approval from U.S. regulators Friday. Gilead promised to give away the first 1.5 million vials but has been quiet on its pricing plans after that supply is used up. Read more.
  • Meanwhile, Mike Ryan, head of the World Health Organization’s health emergencies program, said there are signals of hope for the potential use of remdesivir. The WHO plans to engage in talks with Gilead and the U.S. government over how the drug can be made more widely available as further data emerges on its effectiveness.

Jaguar Health Questioned for Drug Price Hike: House Oversight and Reform Chairwoman Carolyn Maloney (D-N.Y.) called on Jaguar Health to reverse its recent decision to increase the price of Mytesi, a drug used to relieve diarrhea as a result of HIV/AIDS medication. “We are concerned that the nearly three-fold price increase your company imposed” may prevent Americans from accessing Mytesi if approved for use during the coronavirus outbreak,” Maloney and Rep. Jackie Speier (D-Calif.) wrote in a letter to CEO Lisa Conte. In addition to reversing the price increase, the two requested all communications regarding the decision to increase the list price, Megan Howard reports.

Bill Seeks NIH Study on Long-Term Virus Effects: Sens. Jacky Rosen (D-Nev.) and Marco Rubio (R-Fla.) yesterday unveiled a bipartisan bill that would direct the National Institutes of Health to “conduct a longitudinal study on mild, moderate, and severe cases of COVID-19 to ensure we gain a full understanding of both the short and long-term health impacts” of the disease, according to a statement. Companion legislation will be unveiled in the House by Reps. Michael Burgess (R-Texas), Anna Eshoo (D-Calif.), Diana DeGette (D-Colo.) and Brett Guthrie (R-Ky.), according to the statement.

Inspections of ICE Facilities Sought: Sens. Rosen, Catherine Cortez Masto (D-Nev.), Tom Udall (D-N.M.) and 24 others called for the Homeland Security Department’s Office of Inspector General to conduct an assessment, including site inspections, of Immigration and Customs Enforcement detention facilities across the country to determine whether ICE has “sufficiently adapted operations, management, standards, and conditions to address the threat of COVID-19 to both the staff and detainees,” according to a statement. Read the letter here.

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Death Toll Projections & Reopening

White House Disclaims CDC Toll Projection: An internal projection created by the Centers for Disease Control and Prevention shows the nation’s coronavirus outbreak vastly accelerating by June to more than 200,000 new cases and 2,500 deaths per day—far more than the country is currently experiencing. The White House disclaimed the CDC projection, calling it an “internal CDC document” but saying it had not been presented to Trump’s coronavirus task force. The White House said it didn’t comport with the task force’s own analysis and projections.

It isn’t clear who produced the document, obtained and published first by The New York Times, or what assumptions underlie such forecasts. The projections, on two slides of a 19-slide deck, are dated May 1 and attributed to a “data and analytics task force.” The document carries the seal of both the departments of Health and Human Services and Homeland Security. Alex Wayne has more.

Reopenings Muddy Trump Death Toll Projection: The Trump administration’s push to get states to reopen their economies clouds efforts to predict the toll of coronavirus and increases uncertainty about how much Americans will suffer from a little-understood illness. Trump on Sunday said that he expects up to 100,000 Covid-19 deaths in the U.S., a significantly higher estimate that comes after over 60,000 Americans have already died. Meanwhile, FEMA is preparing for another wave of death, looking to place mobile morgues across the nation.

Evidence suggests that after weeks of social distancing and home isolation, the U.S. has been successful in flattening the curve, experts say, as Covid-19 deaths stabilize at around 2,000 a day. But because of the time it takes to test patients and for severe cases to develop, outcomes in states that are aggressively on the path to reopening—such as Georgia, Florida, and Texas—may not be seen for two or three weeks, said Brian Castrucci, president of the de Beaumont Foundation, a public health charity. Read more from Emma Court and Angelica LaVito.

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Research, Treatment & Testing Efforts

Ambitious Vaccine Timeline Requires Risks: A Covid-19 vaccine could happen in as little time as nine months as federal government looks to eliminate “dead space,” said Peter Marks, who oversees vaccine regulation as the director of the FDA’s Center for Biologics Evaluation and Research. His comments mark one of the shortest and most ambitious timelines laid out by government scientists at the forefront of the coronavirus response. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, has projected a vaccine would take up to 18 months to develop since the outbreak first began. But there have been questions about whether the Trump administration is overestimating its ability to fast track a vaccine.

“We have to make sure that whatever comes out of this process meets our high standards for safety and efficacy for vaccines,” Marks said during an Axios event on medical research during a crisis. “That said, in this particular crisis we need to try to move things through very quickly to get there—working meticulously—because there’s just so much at stake here.” Read more from Jeannie Baumann.

Virus Tests to Get Tighter Oversight: Blood tests that can tell whether patients have been infected with the new coronavirus will get stricter oversight from U.S. health regulators, after some manufacturers allegedly made wrong claims and questions mounted about the accuracy of some of the tests. The FDA yesterday said that makers of the tests, which since mid-March have been permitted to be sold without any government sign-off, will have to apply for authorization within 10 days of their products reaching market. The FDA also laid out requirements tests must meet to gain clearance. Anna Edney and Kristen V. Brown have more.

  • Meanwhile, U.S. researchers plan to track thousands of children and their family members over six months to determine how they are affected by the virus, the National Institutes of Health said yesterday. The study has already begun enrolling participants and aims to sign up 6,000 people from families already participating in pediatric studies. Researchers will follow them over the course of six months, with caregivers taking nasal swabs every other week and mailing the samples to researchers. Read more.

Synthetic Antibody Kills Virus in Lab: Scientists grew a monoclonal antibody that can defeat the novel coronavirus in the lab, an early but promising step in the push to find treatments and curb the pandemic’s spread. The experimental antibody may help prevent or treat Covid-19 and related diseases, either alone or in combination with a drug, according to a study published yesterday in the journal Nature Communications. More research is needed to see if the findings are confirmed in a clinical setting, Berend-Jan Bosch of Utrecht University in the Netherlands and colleagues wrote in the paper. Read more.

100 Million Sample Tubes Sought by HHS: The federal government is looking to buy 100 million transport tubes that are used to carry Covid-19 samples and distribute them to states, according to the General Services Administration. HHS said May 1 it’s seeking proposals from potential contractors that could supply Remel’s viral transport media. A contract would still need to be negotiated and signed before it’s final, Shira Stein reports.

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What Else to Know Today

Tens of Millions Could Lose Coverage: Up to 43 million Americans could lose their employer-sponsored health coverage if the unemployment rate reaches 20%, according to a report from the Urban Institute released yesterday. A giant shift in how Americans get health care is likely already underway, with millions moving away from getting coverage through an employer to enrolling in state Medicaid programs or the Affordable Care Act marketplaces, the report shows. The number of those who have no health insurance could grow by 7 million to 12 million, according to the projections. Read more.

  • A separate estimate last week suggested almost 13 million Americans have already lost coverage amid the outbreak. The Labor Department will report unemployment statistics on Friday. Economists project the unemployment rate will spike from 4.4% in March to 16% in April, in the median estimate of economists surveyed by Bloomberg.

Embattled Juul to Scale Back Global Reach, Relocate Headquarters:Juul Labs plans to move its headquarters from San Francisco to Washington, D.C., scale back its overseas operations and cut almost a third of staff, said a person familiar with the company’s plans. The moves represent a dramatic reversal for the once-unstoppable company, which has come under regulatory pressure as it’s increasingly blamed by lawmakers and consumers for igniting a teen vaping epidemic.

The embattled e-cigarette company is planning to exit South Korea and reduce its presence in France, the person said, adding that the company is also exploring its options in Austria, Belgium, Portugal and Spain. Read more from Angelica LaVito.

Trump Uninsured Immigrants Ban Can’t Be Enforced Pending Lawsuit: The Trump administration can’t enforce a ban on the entry of immigrants without health insurance while litigation plays out over the presidential proclamation announcing the policy, a divided Ninth Circuit ruled yesterday. The government is unlikely to prevail on the merits, given that “the proclamation here was issued with virtually no factual findings, minimal reasoning, and an extremely limited window for public comment,” Chief Judge Sidney R. Thomas wrote in a wide-ranging opinion. Read more from Mike Leonard.

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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; Zachary Sherwood at zsherwood@bgov.com; Michaela Ross at mross@bgov.com

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