Califf’s profitable industry ties spark fresh criticism
November 23, 2021With help from Ben Leonard
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— Biden’s pick to lead the FDA made millions advising a Google-connected health company, according to new disclosures likely to fuel skepticism of his industry ties.
— Telehealth is taking off as a first stop for patient care as insurers increasingly sign on to virtual-first programs.
— House lawmakers have questions for former FDA Commissioner Stephen Hahn about controversial drug authorizations and whether the Trump administration pressured the agency.
WELCOME TO TUESDAY PULSE — Some positive news before the holidays: 95 percent of federal employees covered by the vaccine mandate are now vaccinated. Send tips to [email protected] and [email protected].
HOW MUCH BIDEN’S FDA PICK GOT PAID — Shortly after his first stint as FDA commissioner ended in 2017, Robert Califf jumped at an opportunity to advise a division of one of Silicon Valley’s largest companies.
Now, as he prepares a return to Washington, that time in the private sector could prove his biggest obstacle to winning another turn atop the agency.
Califf made more than $2.7 million over the last year as a senior adviser to Alphabet-owned Verily Life Sciences, according to new financial documents — an indication of how the 70-year-old capitalized on decades of medical and regulatory expertise to aid health care companies since leaving government.
That compensation comes on top of at least $77,688 that Califf collected serving on the boards of two other pharmaceutical companies in the last year, in addition to being granted various stocks and stock options that could end up padding the total. Califf also advised five other drug or health tech companies, though those roles were unpaid.
Taken together, the disclosures are likely to further fuel criticism from the left over Califf’s connections to industries he would oversee as FDA commissioner.
“Califf has cashed in on the revolving door both going into government and back out again into the private sector,” Craig Holman, a lobbyist and government ethics expert for Public Citizen, told PULSE, adding that his “relationships are so extensive that he is not an appropriate nominee.”
Califf faced similar scrutiny back in 2015, after serving as a paid consultant for various drug companies. He cruised to confirmation then, and the White House is counting on a repeat performance. A White House official defended Califf’s industry work, arguing that “almost anyone who is qualified to run the FDA will have experiences with drug makers.”
The official also highlighted an ethics agreement Califf signed that requires him to divest holdings in numerous companies if confirmed and recuse himself from various issues to avoid potential conflicts of interest.
But there’s far less margin for error this time around. Califf is unlikely to win as much Republican support as he did before because of the party’s hardened opposition to Biden’s agenda.
Democrats’ progressive wing, meanwhile, has grown more strident about perceptions of industry influence. And with three Democrats already on record as clear no’s or leaning that way, Califf will likely need to win over the Senate’s liberal wing to ensure a clear path to confirmation.
Califf’s financial disclosure | Califf’s ethics agreement
VIRTUAL FIRST TAKING OFF — Some of the nation’s largest health insurers are rolling out virtual-first plans that push patients to use telehealth before in-person care, POLITICO’s Ben Leonard reports.
The moves from UnitedHealthcare, Centene, Aetna CVS and Cigna come after the pandemic has driven more people to virtual care, and insurers say the plans offer potentially significant cost savings and improved outcomes, as well as expanded access. Humana had a telehealth-first plan before the pandemic. The offerings signify a broader endorsement of the once-niche field.
They come as Congress and Medicare administrators attempt to tackle payment policies for telehealth. A key issue is whether providers should get the same payment for virtual and in-person care, which isn’t always the case. The Centers for Medicare and Medicaid Services has extended telehealth flexibilities through 2023, but advocates have been pushing for permanent flexibilities to expand access.
The issue has been overwhelmingly bipartisan, and the broad Cures 2.0 package includes permanent telehealth expansion, but concerns about fraud and cost have been an obstacle.
HOUSE PANEL CALLS ON HAHN — A congressional committee investigating the Trump administration’s response to the coronavirus pandemic is pressing to question former Food and Drug Administration Commissioner Stephen Hahn.
The House Select Committee on the Coronavirus Crisis wants to question Hahn about his time dealing with the regulatory approvals of controversial drug products, the development of the Covid-19 vaccine and the White House’s interference in the FDA’s regulatory process, according to a letter Monday. Hahn did not respond to a request for comment for this story.
The hydroxychloroquine question: Hahn received warning from his peers about using the malaria drug for Covid-19 in the months surrounding its emergency authorization, but the FDA didn’t revoke the clearance until June 15, the letter states. Lawmakers also pointed to the quick authorization of convalescent plasma that was later pared down after mixed data emerged.
The committee has in recent weeks ramped up its probe, focusing on the Trump White House’s interference in federal health agencies’ work and efforts to control the messaging around the pandemic to downplay the virus’ threats, Erin Banco writes. The committee recently released interviews from Deborah Birx, the former coordinator of the Covid-19 task force, as well as two former top officials from the Centers for Disease Control and Prevention — Nancy Messonnier and Anne Schuchat.
ADUHELM RISKS RAISE WORRIES ABOUT COSTLY DRUG — Questions persist about how widely Biogen’s new $56,000 Alzheimer’s medicine Aduhelm can be used — and its cost isn’t the only concern.
Forty-one percent of patients who received high doses in two Phase III trials experienced brain swelling or bleeding, according to data published in JAMA Neurology Monday. The latest study backs up concerns that swirled after Biogen announced it was probing the death of a 75-year-old trial patient who had brain swelling, known as an amyloid-related imaging abnormality.
FDA already told Biogen to include the risk of this type of brain swelling on its label, but the questions now are how common the side effect could be and what additional costs — like those for MRIs and other diagnostics — patients and the health system will need to shoulder. That’s on top of the drug’s price tag, which Medicare already pointed to while raising expected premiums this month. Meanwhile, an advisory panel for Europe’s drug regulators voted last week against approving the drug, saying its benefit was still unclear.
LAWMAKERS, ORGS UP PRESSURE FOR PATENT WAIVER — Democratic Reps. Rosa DeLauro (D-Conn.) and Jan Schakowsky (D-Ill.) join leaders for Amnesty International, Médecins Sans Frontières, Public Citizen, and other organizations including the Association of Flight Attendants-CWA today to urge President Joe Biden to waive patents for coronavirus vaccines and other products.
The groups will present the White House with 3 million petitions urging the administration to work out a temporary waiver of intellectual property rights with the World Trade Organization. While they say this includes Covid treatments and tests, manufacturers have worked out licensing deals for several products, including new antiviral therapies. On the other hand, Biden this spring endorsed the idea of narrow waivers for vaccine patents.
Vaccine makers argue their shots are too complex to license out without concerns about safety and precise manufacturing. Pfizer CEO Albert Bourla this weekend defended his company’s choice to license manufacturing for a new antiviral pill to other countries while resisting a similar move for its coronavirus vaccine. “It's a very, very big difference in the way of manufacturing, very complicated,” he told Jack Otter, host of Fox Business’ Barron’s Roundtable.
BIDEN’S GLOBAL COVID COORDINATOR TO LEAVE — Gayle Smith, the State Department’s global Covid-19 coordinator, is stepping down at the end of the month.
A former Obama-era USAID administrator, Smith was appointed in April to help fulfill President Joe Biden’s vow to make America the “arsenal of vaccines” for the world. The U.S. has since pledged 1.1 billion Covid-19 doses to poorer countries as part of its effort to vaccinate 70 percent of the global population by next September.
But the administration has delivered just over 250 million doses to date — and is facing sharp criticism from global health advocates for not taking a more aggressive stance toward vaccine makers that have resisted sharing their vaccine technology or committing more supply to low-income nations.
A State Department spokesperson stressed that Smith’s assignment was always temporary and it plans to appoint a new coordinator. She will return to her position as CEO of the ONE Campaign.
Mary Beth Goodman, a senior adviser to Smith and former Obama administration National Security Council official, will be acting global Covid-19 coordinator in the interim.
The University of Washington will pay $97,000 to settle a lawsuit filed by The Seattle Times over its request for public records about Covid-testing student athletes, the paper’s Asia Fields reports.
Telehealth access isn’t expanding evenly: Some states are limiting telehealth services expanded during the pandemic, leaving some patients stranded, Stephanie Armour and Robbie Whelan write for The Wall Street Journal.
Health organizations should forge alliances with faith groups to foster trust in different communities and tackle health disparities, Bloomberg professor on health equity Lisa Cooper writes in a Baltimore Sun op-ed with Revs. Debra Hickman and Mary Ka Kanahan.
Source: https://www.politico.com/