GOP votes likely to secure Califf’s confirmation

From: POLITICO Pulse - Wednesday Dec 15,2021 03:02 pm
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Quick Fix

— Robert Califf largely sailed through a Senate confirmation hearing Tuesday, with Democrats and Republicans alike signaling support for the Food and Drug Administration veteran.

— HHS Secretary Xavier Becerra believes the Biden administration's new Covid-19 testing reimbursement plan could face legal challenges.

— Global vaccine distributor COVAX is reducing its supply forecast for this year once again.

WELCOME TO WEDNESDAY PULSE ICYMI: Joanne Kenen writes in POLITICO Nightly about why mild Omicron could still be bad for ending the pandemic. Send tips to sowermohle@politico.com and acancryn@politico.com.

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Driving the Day

CALIFF POISED FOR FDA DESPITE DEM COMPLAINTS — President Joe Biden’s pick to lead the FDA looks popular with Republican senators, setting him up for a confirmation in early 2022 even as some Democrats peel away over complaints that Califf and other FDA commissioners failed to rein in the opioid epidemic.

Several Senate HELP Committee Republicans — including North Carolina’s Richard Burr, Maine’s Susan Collins, Alabama’s Tommy Tuberville and Kansas’ Roger Marshall — told POLITICO’s David Lim, Lauren Gardner and Katherine Foley after Robert Califf’s confirmation hearing Tuesday that they back returning the cardiologist to the commissioner post he held at the tail end of the Obama administration.

“I encourage my colleagues to support the nomination of Rob Califf and to do that expeditiously,” Burr said.

The Biden administration will need GOP support. Sen. Bernie Sanders (I-Vt.) said he would vote no because of Califf's “revolving door” work for industry (most recently Alphabet’s Verily Life Sciences) that netted him millions.

“The Covid-19 pandemic has made clearer than ever the choice between pharmaceutical profits and the health of our people,” Sanders said in a statement after the hearing. “In this critical moment, Dr. Califf is not the leader Americans need at the FDA.”

Sanders’ comments follow clear opposition from West Virginia Democrat Joe Manchin, who on Tuesday cited the FDA’s opioid crisis response for his opposition to Califf.

What’s next: Senate HELP Chair Patty Murray (D-Wash.) is “working quickly” with Burr to schedule a committee vote on Califf’s nomination, a Democratic committee aide said. But that’s likely to stretch into the new year: Lawmakers can submit questions for the record up until 5 p.m. on Dec. 15, and the hearing record will close on Dec. 29.

 

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HHS BRACES FOR FREE-TEST CHALLENGES — Health officials are still sketching out the details of Biden’s pledge that Americans can be reimbursed for at-home tests in 2022, a critical component of the administration’s efforts to make Covid-19 tests that will yield rapid results more accessible.

But the administration is also anticipating legal questions, HHS Secretary Xavier Becerra told reporters in a briefing Tuesday. “We believe — under the authorities we have that Congress gave us with the public health emergency — that we can try to provide certain levels of reimbursement for the dispensing of those rapid tests,” he said. “I suspect someone is going to test us on that.”

Vaccine mandates prove a warning sign. The secretary likened potential testing hurdles to several ongoing challenges, primarily led by conservative states, to the president’s vaccine mandate for federally funded health workers. “Does the government have the ability to require vaccines? That’s an open question — we think we do,” he said. “Can we require insurers to pay for the testing? We think we’ve taken action which will make the tests available.”

The administration will roll out its testing reimbursement plan in January, but in the meantime, Becerra also anticipates hurdles outside the insured population. “That’s going to be the difficult one,” he said. “We have to make sure that they’re accessible to everyone. … That’s where the job is.”

HEALTH OUTLETS LEFT OUT OF BECERRA BRIEFING — The secretary’s hour-long Tuesday roundtable with 11 journalists — one of few press briefings since he took offices — notably omitted health-specific news outlets, weeks after an organization for health journalists pressed for more media access.

The Association of Health Care Journalists wrote Becerra in November, urging the department to hold regular briefings and streamable press conferences and upload accessible recordings and transcripts.

But while Tuesday’s briefing included major print and TV news outlets, notable health news publications including Stat News, Inside Health Policy, MedPage Today and BioCentury didn’t get the invite.

The response: “I am extremely frustrated and disappointed,” said MedPage Today’s Washington editor Joyce Frieden, who sits on AHCJ’s board of directors and co-wrote the November letter about press access. “We are glad the secretary is starting to hold these types of events, but the exclusive nature of this one is directly contrary to the kind of openness that we are hoping for from HHS, and we hope that future briefings will be more inclusive.”

Biotechnology-focused news outlet BioCentury was also not invited, said Washington editor Steve Usdin. “In my experience, there has been very little openness from the Office of the Secretary and HHS in the Biden administration, but communications and openness from agencies such as FDA and NIH have been excellent."

Why it matters: Reporters have been pressing for more access to top HHS officials amid the continuing pandemic and a range of looming health policies, including surprise billing regulations and the specter of drug pricing reform.

AHCJ’s letter pointed to President Donald Trump’s HHS Secretary Alex Azar as a precedent for “regularly held press briefings during which reporters could ask questions pertinent to their reporting responsibilities.”

HHS spokesperson Sarah Lovenheim defended the limited access as the only way to ensure each attendee had ample time to quiz the secretary.

“It wouldn’t be a true pen-and-pad conversation if I invited so many outlets that not every person could ask a question,” she said.

The department is planning a similar event in the near future for health-focused publications, though a date has yet to be set. HHS’ senior leadership returned to the office only last week, so this was the first opportunity for an in-person session with reporters.

Lovenheim also stressed that Becerra has held regular press availabilities during his trips throughout the country to tout Biden’s agenda — and plans to do more with the Washington press corps now that he and his top advisers are working out of the Humphrey building regularly.

 

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SUPPLY WORRIES CONTINUE FOR COVAX — Global vaccine equity initiative COVAX is cutting its 2021 supply forecast again, saying it now expects access to 1.38 billion Covid-19 doses by the end of the month, Carmen reports.

That’s down from its earlier projection of 1.425 billion doses — a dip that COVAX attributed to a range of factors, including delayed deliveries from Johnson & Johnson and technical issues at AstraZeneca manufacturing sites. Those slowdowns were somewhat offset by additional donations from wealthy countries, an easing of export restrictions in India and the accelerated delivery of 20 million Moderna doses.

Still, COVAX will deliver only 800 million shots by year’s end to low- and middle-income nations — less than half the amount it hoped when the initiative launched last year. One complicating factor is that the participating countries need to show they’re prepared to receive the shots.

The revised forecast comes as the World Health Organization’s Africa branch warns it will take until May 2022 for African countries to fully vaccinate at least 40 percent of their population, a benchmark the WHO had aimed to hit by year’s end. It could take until August 2024 for them to reach 70 percent full vaccination — well beyond the mid-2022 deadline set by the WHO and Biden administration.

FDA ADDS MORE CAUTION TO J&J VACCINE — The agency is updating its fact sheet for Johnson & Johnson’s Covid-19 vaccine after finding that 15 percent of those who developed rare and severe blood clots from the shot died, POLITICO’s Lauren Gardner reports.

Cases of thrombosis with thrombocytopenia, or TTS, tied to the vaccine are still uncommon. The highest rate of TTS occurred among women ages 30 to 49, with one in every 100,000 doses administered leading to the condition.

But the FDA is taking additional precautions, advising against administering the J&J vaccine to those who have a history of TTS after receiving the shot or any other adenovirus-based Covid-19 vaccine. Regulators believe the benefits of the J&J shot still outweigh the risks.

AMTRAK ABANDONS VAX MANDATEJoe Biden loves Amtrak, but the feeling isn’t mutual – at least when it comes to the president’s vaccine mandate. The company will no longer require its workers to get vaccinated against Covid-19, in a reversal that comes after Biden’s policy was blocked in court, POLITICO’s Tanya Snyder reports.

Amtrak will instead offer a testing alternative to vaccination that allows unvaccinated employees to keep working as long as they submit a negative test each week at a minimum.

“This will be in effect while the Executive Order is not being enforced,” CEO Bill Flynn wrote in a memo, adding that fewer than 5 percent of workers have yet to get fully vaccinated or secure an exemption.

The move allows Amtrak to avoid service disruptions it had previously predicted because of the vaccine holdouts.

 

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What We're Reading

Addiction-treatment groups argue that making naloxone available over the counter could help curb the drug epidemic, Kaiser Health News’ Aneri Pattani reports.

The NFL is facing its biggest Covid-19 test yet , with multiple outbreaks closing team facilities and forcing a move to enhanced protocols, Yahoo! Sports’ Charles Robinson writes.

Democratic governors who saw their approval ratings rise at the pandemic’s outset are now grappling with voter frustration over the prolonged crisis, POLITICO’s Zach Montellaro reports.

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