Califf goes to Congress – POLITICO


With Alice Miranda Ollstein

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– Senate committee discusses Biden’s FDA candidate today, with questions on the table about the opioid epidemic and its profitable jobs since government work.

‘Byrd Bath’ starts in earnest this week with senators arguing over drug pricing arrangements.

– Vaccine mandates become a state patchwork in the midst of a jumble of different trials.

WELCOME TO IMPULSE OF TUESDAYThere is always a health care angle… even for Sex and the City. Send SATC health tips and arguments (Miranda takes charge of surprise billing?) To [email protected] and [email protected].

CALIF’S CONFIRMATION KICK-OFF – President Joe Biden’s nominee for the Food and Drug Administration appears before the Senate HELP committee this morning. And despite his popularity in the last go-around – he landed 89 votes as then-President Barack Obama’s candidate – 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: Joe Manchin from West Virginia, Ed Markey from Massachusetts, and Richard Blumenthal from Connecticut) are on the HELP committee, but their old concerns remain.

“I can’t understand why we would confirm someone whose actions failed to quickly stem the tide of the opioid epidemic and protect public health, especially someone who once led the FDA as commissioner, “Manchin said in a statement this morning. “In addition, Dr. Califf indicated that he plans to keep Dr. Janet Woodcock, who led the FDA and directly oversaw the approval of many highly addictive drugs in the market, under the leadership of the FDA.”

Califf is also likely to face questions about his most recent work in health policy for Alphabet’s Verily Life Sciences, where he has earned more than $ 2.7 million in the past year, according to reports. disclosure forms.

But Califf has at least six former commissioners in his corner, including Trump’s FDA chiefs Scott Gottlieb and Stephen Hahn, both of whom have co-signed a letter to HELP executives endorsing Biden’s choice. Dozens of patient groups have also backed the candidate, and he is largely expected to garner enough votes – even if several Democrats part ways with Biden.

Return: The last confirmation hearing by an FDA commissioner was in November 2019, when Trump’s choice, oncologist Stephen Hahn, spent most of his time answering questions about vaping-related illnesses and tobacco regulation. Six weeks after its confirmation, it happened.

BBB DRUG PROVISIONS ON THE LINE – Republican and Democratic senators are expected to debate more than 20 different provisions of the $ 1.7 trillion social spending bill before the parliamentarian this week, Senate Finance Chairman Ron Wyden (D- Ore.) To journalists at the Capitol.

In the mix there are provisions capping reimbursable charges for insulin and penalizing drugmakers for faster-than-inflation price increases in both the medicare market and the market. private insurance, reports Alice.

Wyden slammed Republicans for challenging the supply of insulin in particular, saying his GOP colleagues are “out of step with the American people” and “don’t understand the intensity of feelings in this country” about the hike. insulin costs.

Timeline at risk: With so many provisions in the Byrd bath queue, final decisions on health arrangements might not come until the end of the week, an aide said to Alice, further pushing Democrats’ efforts to pass the bill before the end of the year.

THE COURT REFUSES TO STAY MANDATE VAXE DECISION – A federal appeals court on Monday refused to lift the freeze on Biden’s vaccination mandate for health workers in 10 conservative-majority states.

The 2-to-1 ruling of a panel of U.S. Court of Appeals for the Eighth Circuit means the Justice Department could take their case – which depends on an Occupational Safety and Security rule. Health Administration – before the Supreme Court or higher. jury in the circuit of eight.

Until then, the vaccine’s mandate will remain frozen in the states that challenged Biden’s order: Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming. Other disputes over the mandate, announced by Biden in September, are pending elsewhere.

NY MANDATE PRESERVED – Elsewhere on Monday, the Supreme Court rejected a request to block New York’s vaccination mandate for healthcare workers, dismissing the argument that it should have a religious exemption.

The court announced its decision on Monday afternoon in a brief unsigned order, writes Shannon Young of POLITICO NY. Three of the court’s six conservative justices – Clarence Thomas, Samuel Alito and Neil Gorsuch – have expressed their dissent, saying they will grant relief.

Over a dozen medical professionals and We the Patriots USA, Inc. have sued Gov. Kathy Hochul’s administration over the tenure, which covers patient-contact staff in hospitals, nursing homes and other medical institutions. They asked the court last month to prevent the state from requiring those who previously had a religious exemption to either get vaccinated or show proof of a medical exemption.

CANNABIS GROUP BECERRA PRESS FOR REGULATIONS – The Council for Federal Cannabis Regulation would like to meet with HHS Secretary Xavier Becerra to discuss a “public health crisis” resulting from the proliferation of largely unregulated low-THC cannabis products.

The group is pushing the FDA to tackle the burgeoning market for unregulated hemp-derived products, including CBD and Delta-8 THC products, reports Paul Demko of POLITICO.

Fund: The FDA’s hands-off approach to hemp-derived products has drawn strong criticism from many industry officials, who argue that the ambiguity over the legality of these products has crippled the market. writes Paul.

MENTAL HEALTH NON-PROFIT MOUNTAIN CAMPAIGN – Mental health advocacy groups Inseparable and Fountain House today launched a popular campaign to push Congress to pass the Behavioral Health Crisis Services Expansion Act (S. 1902 (117) and HR 5611 (117)). The bill would put in place local systems to respond to mental health crises.

The six-month campaign, titled ‘A Better Answer’ comes a week after Surgeon General Vivek Murthy issued a public health warning that young people in particular are struggling with mental health issues amid the pandemic in Classes.

CALIFORNIA DEMANDS INTERIOR MASKINGCalifornia residents will be required to wear face coverings in all indoor public spaces from December 15 to January 15 to help counter an increase in Covid-19 cases as the holidays approach.

The rule will affect about 50 percent of the state which does not have a similar mandate, said Mark Ghaly, secretary of the California Health & Human Services Agency. Many areas of the state, including the Bay Area, already have rules on indoor masks, but case rates are increasing, especially in areas where masks are not needed, reports Victoria Colliver of POLITICO in California.

The state is also speeding up the testing window requirement for indoor events with more than 1,000 attendees and recommends, but does not require, that people traveling out of state be tested within three to five. days after their return.

California has seen a 47% increase in Covid cases since Thanksgiving, Ghaly said. Daily case rates increased from 9.6 cases per 100,000 people to more than 14 cases per 100,000 during this period.

Colorado Governor Jared Polis, in a candid interview with Colorado Public Radio, defended his decision to leave the mask warrants to the localities, telling the station that “at this point if you haven’t been vaccinated , it’s really your own fault ”.

At the start of the year, Philadelphia will require proof of vaccination for indoor meals, after infection and hospitalization rates have doubled in recent weeks, reports the ABC subsidiary in Philadelphia.

A potential Senate battle over insulin payment caps on patents could leave diabetic patients without cost relief and Democrats without a solution they promised to provide, reports Dan Diamond of the Washington Post.

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