Getting blunt on Biden’s FDA pick

From: POLITICO Pulse - Wednesday Feb 02,2022 03:04 pm
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Quick Fix

— A top GOP senator is skeptical the White House is all in on its FDA commissioner nominee, Robert Califf.

— Pfizer asked the FDA to authorize two doses of its Covid-19 vaccine for children under 5 Tuesday despite still studying third doses.

— The House Energy & Commerce Committee will hold a hearing next week on ARPA-H, Biden’s proposed biomedical research agency.

WELCOME TO WEDNESDAY PULSEAnd more importantly, Groundhog Day. Send your tips and shadow predictions to bleonard@politico.com.

 

A message from PhRMA:

Washington is talking about price setting of medicines, but it won’t stop insurers from shifting costs to you. And it will risk access to medicines and future cures. Instead, let’s cap your out-of-pocket costs, stop middlemen from pocketing your discounts and make insurance work for you. Let’s protect patients. It’s the right choice. Learn more.

 
Driving the Day

LET’S BE BLUNT — Sen. Roy Blunt (R-Mo.), who is among the Senate Republicans the Biden administration had been hoping could boost Robert Califf’s beleaguered nomination as FDA commissioner, told POLITICO Tuesday he is doubtful the administration is fully backing Califf, POLITICO’s Alice Miranda Ollstein and David Lim report.

“I like him,” Blunt said. “But I haven’t made a final decision on that yet and don’t intend to until the administration appears to be truly ready to push his name forward.”

“Everything I’m reading suggests that’s not the case right now,” he said, a reference to reports that the administration hasn’t made a concerted push to rally lawmakers behind confirming Califf amid disapproval on both sides of the aisle.

A White House spokesperson said the ex-Obama administration commissioner has met with a third of the Senate so far and has 14 more meetings with Senators on the books. Among those he’s met with or plans to, 26 are Democrats and 21 are Republicans.

Two other moderate GOP senators Democrats have been eyeing as potential Califf backers — Sens. Rob Portman (R-Ohio) and Pat Toomey (R-Pa.) — also told POLITICO they were undecided Tuesday.

Here’s the deal: Biden will have to get at least five Republicans on board to counter the five Democrats who have signaled they’ll vote against Califf, pointing to his record related to opioids in the private sector and as commissioner.

PFIZER VACCINES FOR KIDS UNDER 5 — Pfizer and BioNTech revealed Tuesday they’re moving for FDA authorization for two Covid-19 vaccine doses for children under 5 as part of a three-shot regimen, POLITICO’s Lauren Gardner reports.

The FDA said Tuesday it would convene its independent experts Feb. 15 to weigh the data and make a recommendation. The CDC’s advisers could quickly follow if the FDA green-lights the request, which means kids younger than 5 could start getting shots later this month.

Although the news is certain to be welcomed by many parents, some pediatricians have warned that the companies were moving before finishing studying whether a third dose would provide needed protection for children. In December, Pfizer moved to expand its trial to include a third dose for children under 5 after some didn’t have an adequate immune response from two shots.

“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants,” Pfizer CEO Albert Bourla said in a statement.

The American Academy of Pediatrics was “encouraged” by the step toward younger children getting vaccinated, but others raised concerns about considering an emergency use authorization request amid mixed data for some ages and third-dose testing ongoing.

“That doesn’t make sense,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Third-dose data is expected by the end of March. Children four and younger have made up about 3 percent of total Covid cases nationwide but have been hospitalized at higher rates than older children, according to CDC data, especially as Omicron has surged.

 

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ARPA-H MOMENTUM? — The House Energy and Commerce Committee’s health subcommittee will hold a hearing Feb. 8 on President Joe Biden’s proposed biomedical research agency ARPA-H, the committee announced Tuesday.

White House office of science and technology director Eric Lander and other experts will speak at the hearing, E&C chair Frank Pallone (D-N.J.) and subcommittee chair Anna Eshoo (D-Calif.) said in a release. ARPA-H, inspired by the Defense Department’s research agency DARPA, would grapple with diseases like cancer and Alzheimer’s.

The proposed 21st Century Cures 2.0 legislation, which contains a broad host of health care proposals, including telehealth expansion, would give $6.5 billion to fund the ARPA-H agency, which would be housed within the NIH. The path forward for the legislation, though, has been unclear after Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) put forward the proposal in November.

Next week’s hearing signals a step forward in the process for the agency. Congress has been grappling with a number of other priorities, including Biden’s Build Back Better Act and funding talks ahead of the Feb. 18 continuing resolution expiration, leaving ARPA-H largely on the sidelines thus far.

BIDEN’S CANCER MOONSHOT — President Joe Biden is refueling his cancer "Moonshot" program focusing on prevention and screening on Wednesday, pushing to cut the cancer death rate by at least half in the next two and a half decades, saying the goal is now possible due to advances in science.

Biden launched the effort as vice president in the Obama administration. Biden aims to better the experience for people with cancer as well, with the end goal of “ending cancer as we know it today,” according to a White House fact sheet. The effort will include a White House Cancer Moonshot coordinator and a “Cancer Cabinet” convening departments and agencies, among other things.

The new push doesn’t include new funding commitments despite the Moonshot having one year left in its budget from the 21st Century Cures Act.

FIRST IN PULSE: TELEHEALTH USAGE DISPARITIES — Telehealth policy going forward will need to account for “significant disparities” in usage of audio versus video telehealth among groups, a new reportfrom HHS’ Assistant Secretary for Planning and Evaluation.

Overall reported telehealth usage (both audio and video) among nearly 675,000 adults surveyed between April and October 2021 was similar among education levels, and Black respondents used telehealth more than any other racial group on a percentage basis.

Nearly 27 percent of Black respondents reported using telehealth in the previous four weeks compared with 21 percent of white respondents, 24 percent of Latino respondents and 22 percent of Asian respondents. And lower-income respondents were more likely to use telehealth.

But differences emerged between groups in video telehealth usage by age, education, income and race in the study’s second half.

People earning less than $25,000 used video for less than half of virtual visits, a figure that steadily rose among income brackets, with nearly 69 percent of visits by people earning at least $100,000. And white respondents had the highest rate of video telehealth visits at 61.9 percent, followed by multracial or other respondents at 58.9 percent, Black respondents at 53.6 percent, Asian respondents at 51.3 percent and Latino respondents at 50.7 percent.

Why it matters: Telehealth use has exploded since the outset of the Covid-19 pandemic and figures to play a larger role in health care beyond the pandemic. The authors point to research suggesting that video-enabled telehealth may be better than audio-only in “many clinical contexts.”

Audio-only telehealth has been touted by many as a way to reach more vulnerable communities that may lack stable internet. In November, CMS moved to permanently allow payment for audio-only mental health care, but only if the patient can’t use or “does not consent to” two-way audio/video.

The report is sure to come up in talks about expanding telehealth access, which are intensifying ahead of the upcoming funding package that advocates are eyeing as a vehicle. It could fuel a push for expanding broadband access.

Biden’s COVID-19 Health Equity Task Force’s final reportin October recommended expanding telehealth and broadband access.

FIRST IN PULSE: SMALL PRACTICE BILL — Sens. Michael Bennet (D-Colo.) and Bill Cassidy (R-La.) will introduce legislation Wednesday to reauthorize a soon-to-expire CMS technical assistance program for small practices that aids them with the Quality Payment Program.

“Small health care providers in rural and underserved areas don’t have the big administrative staffs to deal with complex Medicare reporting requirements,” Cassidy said.

The program is set to expire Feb. 15 if Congress doesn’t act. The legislation would extend the program through 2027.

Names in the News

The USC-Brookings Schaeffer Initiative for Health Policy is adding three new nonresident fellows — MedPAC chair and Harvard Medical School professor Mike Chernew; Sherry Glied, the dean of NYU's graduate school of public service; and Rachel Sachs, a law professor at Washington University in St. Louis.

Heather Korbulic, previously the executive director of Nevada’s health insurance marketplace, is joining GetInsured, a technology provider for state exchanges.

What We're Reading

Native American tribes reached a $665 million opioid settlement with Johnson & Johnson and drug distributors, The Washington Post’s Meryl Kornfield reports.

STAT News' Casey Ross has this headline: “How a decades-old database became a hugely profitable dossier on the health of 270 million Americans”

Colleges are having a hard time recruiting therapists for students, Kaiser Health News’ Mark Kreidler reports.

 

A message from PhRMA:

Washington is talking about price setting of medicines, but it won’t stop insurers from shifting costs to you. And it will risk access to medicines and future cures. Instead, let’s cap your out-of-pocket costs, stop middlemen from pocketing your discounts and make insurance work for you. Let’s protect patients. It’s the right choice. Learn more.

 
 

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