With Alice Miranda Ollstein
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— A Senate committee grills Biden’s FDA nominee today, with questions on the table about the opioid epidemic and his profitable jobs since government work.
— The ‘Byrd Bath’ begins in earnest this week with senators sparring over drug pricing provisions.
— Vaccine mandates are becoming a state patchwork amid a jumble of different lawsuits.
WELCOME TO TUESDAY PULSE — There’s always a health care angle … even for Sex and the City. Send tips and SATC health pitches (Miranda takes on surprise billing?) to [email protected] and [email protected].
CALIFF’S CONFIRMATION KICKS OFF — President Joe Biden’s nominee to lead the Food and Drug Administration appears before the Senate HELP Committee this morning. And despite his popularity on the last go-around — he snagged 89 votes as then-President Barack Obama’s nominee — Robert Califf isn’t guaranteed an easy day.
Of the four votes against Califf in 2016, three were Democrats. None of those three (all still in Congress: West Virginia’s Joe Manchin, Massachusetts’ Ed Markey and Connecticut’s Richard Blumenthal) are on the HELP Committee, but their old concerns remain.
“I can’t fathom why we would confirm someone whose actions failed to swiftly curb the tide of the opioid epidemic and protect the public’s health, especially someone who has already helmed FDA as its Commissioner,” Manchin said in a statement this morning. “Furthermore, Dr. Califf has indicated he plans to keep Dr. Janet Woodcock, who has led the FDA and directly overseen the approval of numerous highly addictive drugs to market, as part of FDA leadership.”
Califf is also likely to face questions about his most recent work leading health policy for Alphabet’s Verily Life Sciences, where he made more than $2.7 million over the past year, according to disclosure forms.
But Califf counts at least six former commissioners in his corner, including Trump’s FDA chiefs Scott Gottlieb and Stephen Hahn, who both co-signed a letter to HELP leaders endorsing Biden’s pick. Scores of patient groups have also backed the nominee, and he is largely expected to gather enough votes — even if several Democrats split with Biden.
Throwback: The last confirmation hearing for an FDA commissioner was in November 2019, when Trump’s pick, oncologist Stephen Hahn, spent the most of his time responding to questions about vaping-linked illnesses and tobacco regulation. Six weeks after his confirmation, this happened.
BBB DRUG PROVISIONS ON THE LINE — Republican and Democratic senators are set to debate more than 20 different provisions of the $1.7 trillion social spending bill before the parliamentarian this week, Senate Finance Chair Ron Wyden (D-Ore.) told reporters at the Capitol Monday night.
In the mix are provisions capping out-of-pocket costs for insulin and penalizing drugmakers for hiking prices faster than inflation in both Medicare and the private insurance market, Alice reports.
Wyden vented about Republicans for challenging the insulin provision in particular, saying his GOP colleagues are “out of step with the American people” and “don’t understand the intensity of feeling in this country” about rising insulin costs.
Timeline in jeopardy: With so many provisions in the Byrd bath queue, final rulings on the health provisions might not land before the end of the week, an aide told Alice, further scrambling Democrats’ efforts to pass the bill before the end of the year.
COURT DENIES STAY ON VAX MANDATE RULING — A federal appeals court Monday declined to lift a freeze on Biden’s vaccine mandate for health workers in 10 mostly conservative-led states.
The 2-1 vote decision from a panel of judges at the U.S. Court of Appeals for the Eighth Circuit means the Justice Department could take their case — which hinges on a rule through the Occupational Safety and Health Administration — to the Supreme Court or a larger panel of judges in the eight circuit.
In the meantime, the vaccine mandate will remain frozen in the states who challenged Biden’s order: Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming. Other litigation over the mandate, announced by Biden in September, is pending elsewhere.
NY MANDATE PRESERVED — Elsewhere on Monday, the Supreme Court denied a request to block New York’s vaccination mandate for health care workers, rejecting the argument that it should have a religious exemption.
The court announced its ruling Monday afternoon in a brief, unsigned order, POLITICO NY’s Shannon Young writes. Three of the court’s six conservative justices — Clarence Thomas, Samuel Alito and Neil Gorsuch — dissented, saying they would grant relief.
More than a dozen medical professionals and We the Patriots USA, Inc., sued Gov. Kathy Hochul’s administration over the mandate, which covers patient-facing staff in hospitals, nursing homes and other medical facilities. They asked the court last month to block the state from requiring those who were previously granted religious exemptions to get vaccinated or show proof of a medical exemption.
CANNABIS GROUP PRESSES BECERRA FOR REGULATIONS — The Council for Federal Cannabis Regulation wants to meet with HHS Secretary Xavier Becerra to discuss a “public health crisis” stemming from the proliferation of largely unregulated low-THC cannabis products.
The group is pushing for the FDA to address the burgeoning market for unregulated hemp-derived goods, including CBD and Delta-8 THC products, POLITICO’s Paul Demko reports.
Background: The FDA’s hands-off approach to hemp-derived products has sparked sharp criticism from many industry officials, who argue that ambiguity about those items’ legality has hamstrung the market, Paul writes.
MENTAL HEALTH NONPROFITS MOUNT CAMPAIGN — Mental health advocacy groups Inseparable and Fountain House today launched a grassroots campaign aimed at pushing Congress to pass the Behavioral Health Crisis Services Expansion Act (S. 1902 (117) and H.R. 5611 (117)). The bill would build out local systems to respond to mental health crises.
The six-month campaign, dubbed “A Better Response” comes a week after Surgeon General Vivek Murthy issued a public health advisory warning that young people in particular are struggling with mental health issues amid the ongoing pandemic.
CALIFORNIA REQUIRES INDOOR MASKING — California residents will be required to wear facial coverings in all indoor public spaces from Dec. 15 to Jan. 15 to help fend off a rise in Covid-19 cases as the holidays approach.
The rule will affect about 50 percent of the state that doesn’t have a similar mandate, Mark Ghaly, secretary of the California Health & Human Services Agency, said. Many parts of the state, including the Bay Area, already have indoor mask rules, but case rates are increasing particularly in areas where masks aren’t required, POLITICO California’s Victoria Colliver reports.
The state is also speeding up the testing window requirement for indoor events with more than 1,000 attendees and recommending, but not requiring, that people traveling outside the state get tested within three to five days of their return.
California has experienced a 47 percent increase in Covid cases since Thanksgiving, Ghaly said. Daily case rates have jumped from 9.6 cases per 100,000 people to more than 14 cases per 100,000 during that period.
Colorado Gov. Jared Polis in a candid interview with Colorado Public Radio, defended his decision to leave mask mandates to localities, telling the station that “at this point, if you haven’t been vaccinated, it’s really your own darn fault.”
Philadelphia at the start of the year will require proof of vaccination for indoor dining, after infection and hospitalization rates doubled in recent weeks, Philadelphia’s ABC affiliate reports.
A potential Senate battle over caps on patents’ insulin payments could leave diabetes patients without cost relief and Democrats without a fix they promised to deliver, The Washington Post’s Dan Diamond reports.
