Good morning, and happy hump day. This week we learned of something new the FDA regulates. (No spoilers! Read on to find out.)

Today’s edition: We break down the details of the Biden administration’s $30 billion ask for additional covid-19 funding, and vaccination during pregnancy may provide protection to infants. But first:

Major questions on e-cigarettes, vaccines and Alzheimer’s drug await Califf

Robert Califf has a lot on his plate.

As the newly confirmed leader of the Food and Drug Administration, Califf will be charged with running a beleaguered agency crucial to the nation’s pandemic response. And he’ll be the face of critical — and, at times, contentious — policy decisions on everything from tobacco to coronavirus vaccines, drug approvals to clinical trials.

The sheer scope of the job is massive. 

• Let this line from our story written with Laurie McGinley sink in: “Even in non-pandemic times, the FDA has a far-reaching impact on the U.S. economy. It regulates products that account for 20 cents of every dollar spent by consumers, including cosmetics, sunscreen and almost four-fifths of the nation’s food supply. It oversees prescription drugs, the blood supply and medicinal maggots for wound care.”

But Califf’s allies say he has an advantage. He’s familiar with the ins and outs of the agency — and importantly, he knows the staff. That’s because he led the FDA during the last year of the Obama administration and worked as its deputy commissioner for medical products and tobacco the year prior.

• “He’s highly respected at the agency,” said Ellen V. Sigal, chairperson and founder of Friends of Cancer Research, an advocacy group. “He’ll be able to get going immediately.”

This comes as the Senate narrowly confirmed Califf to lead the FDA in a razor-thin 50-to-46 vote, giving the agency its first permanent head since President Biden took office.

What’s on tap

FDA officials have been stretched to the limit with the constant demands of the pandemic, such as greenlighting vaccines, treatments and tests.

• Put simply, “supporting staff that have been working nonstop for two years without any break,” is a key task, per Steven Grossman, the executive director of the Alliance for a Stronger FDA.

Meanwhile, the agency is facing a slew of divisive policy questions that Califf may weigh in on. Even if the decisions are made by career staff, he’ll likely be charged with communicating the agency’s actions to the public.

• “Never before has there been a more urgent need for FDA to have a permanent commissioner ready and prepared to not just act, but drive a vision for the future,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, told Laurie.

Big decisions loom on tobacco: Antismoking advocates are pressing for faster action to remove flavored e-cigarettes from the market. The agency has barred many products, yet blew past a September deadline to review whether some of the most popular products can stay.

• Also on tap: The agency aims to propose a ban on menthol cigarettes by April. It’s also been considering requiring tobacco companies to reduce the amount of nicotine in cigarettes to near nonaddictive levels — which Califf previously indicated he supports.

The ongoing Alzheimer’s drug controversy is a challenge: Califf will step into the top leadership role amid a battle over the FDA’s approval of Aduhelm, despite concerns from experts over whether it’s safe and effective.

• Though the agency has already approved the measure, it has sparked a congressional investigation and also scrutiny over the fast-track pathway used.
• Known as the accelerated approval program, Senate Finance Chair Ron Wyden (D-Ore.) has already received a commitment that Califf would hold drug companies accountable to conducting follow-up trials confirming a clinical benefit to patients for medicines approved this way.

Timing in question for pediatric vaccines: The agency is wrestling with the thorny decision of greenlighting shots for children under 5. Last week, the FDA reversed course on a strategy to authorize a two-dose regimen of the Pfizer-BioNTech shot for this age group. Instead, the agency is waiting until there’s data on a third dose, meaning it’ll probably be until at least mid-April before babies and toddlers can get the shot.

• An important caveat: Califf will almost certainly defer to the FDA’s career scientists here. But experts have said it’s important for the agency to effectively communicate its decisions, and Califf could play an important role in explaining the agency’s process and thinking.

Coronavirus

Biden administration outlines need for $30B in new coronavirus aid

The Biden administration estimates it will need about $30 billion in additional covid-19 funding from Congress to weather the surge of future variants and restock key public health programs, The Post’s Tony Romm and Tyler Pager report.

Top officials from the Department of Health and Human Services briefed key lawmakers Tuesday, two people familiar with the matter told our colleagues.

Here’s a breakdown of the funding asks, according to a document obtained by The Health 202. A person familiar, as well as an aide to Sen. Patty Murray (D-Wash.), confirmed the numbers. (Bloomberg first reported the exact asks.)

• $17.9 billion for treatments and vaccines,
• $4.9 billion for testing,
• $3 billion to cover care for uninsured Americans,
• $3.7 billion to develop vaccines to protect against future variants,
• $500 million for the Centers for Disease Control and Prevention surveillance and operations.

The backstory: Earlier this month, White House officials said they have enough money to carry the country through the current wave, but warned Congress that the administration is running low on future covid-19 response funding following an uptick in spending to battle the omicron variant.

Next steps: The discussion surrounding HHS’s request comes as Congress tries to nail down a bipartisan deal to fund the government through the remainder of fiscal year 2022.

…But the politics are split, Tony and Tyler write.

• Some Democrats have urged the White House to dedicate more funding to boost the global vaccine effort, while others want to revive expired pandemic programs like limited paid family and medical leave.
• Republicans have signaled they may not want to approve new spending until they have a better picture of the status of the roughly $6 trillion authorized since the pandemic’s outset. Some want the administration to first repurpose existing aid before asking for more dollars.
• And a bipartisan group of lawmakers is pushing for more pandemic relief funding for small businesses.

CDC: Vaccination during pregnancy may provide protection for infants

Getting vaccinated against the coronavirus during pregnancy may provide protection to babies after they’re born, according to a new CDC study.

What the study found: Infants whose mothers were fully vaccinated with either Pfizer-BioNTech or Moderna during pregnancy were 61 percent less likely to be hospitalized with the virus in their first six months of life.

• That number jumped to roughly 80 percent when mothers received their vaccination after the first 20 weeks of pregnancy.
• The study also found that a vast majority of infants who are hospitalized for covid-19 were born to unvaccinated mothers.

“The bottom line is that maternal vaccination is a really important way to help protect these young infants,” Dana Meaney-Delman, chief of the CDC’s infant outcomes monitoring research and prevention branch, said. That’s per a story from our colleague Brittany Shammas.

Chart check

Omicron case counts continue downward trend

The seven-day average of new coronavirus cases in the United States has slipped to a number not seen since the delta surge of last summer began to abate, Brittany and Jacqueline Dupree report.

Tracking the numbers:

• The United States had an average of 153,029 cases per day as of Monday, according to tracking by The Post. That’s 12,158 fewer cases than the highest seven-day average set by the delta variant on Sept. 1.
• The seven-day average of new cases is also a sharp drop from the pandemic high of 807,897 that the nation reached on Jan. 22.

Yet cases remain higher than during much of the pandemic. While deaths from the coronavirus are on the decline, the United States reported a seven-day average of 2,471 fatalities on Monday — a number still staggeringly high.

Broader consequences: The United States has surpassed 1 million “excess deaths” since the start of the pandemic, according to government mortality statistics, The Post’s Joel Achenbach reports. While most of the deaths were attributed to covid-19, a swell of other diseases during the health crisis, such as heart disease, hypertension and dementia, contributed to the toll.

In other health news

• San Francisco residents recalled three members of the city’s school board yesterday, citing misplaced priorities and putting progressive politics over the needs of children during the pandemic, the Associated Press reports.
• A middle-aged, mixed-race woman is the third patient to be potentially cured of HIV after receiving a transplant of stem cells harvested from umbilical cord blood, per The Post’s Carolyn Y. Johnson reports.
• The CDC lowered its travel health notice for cruises, indicating covid-19 levels on ships went from “very high” to “high,” The Post’s Hannah Sampson writes.
• A federal judge is allowing an Air Force officer to temporarily skirt the coronavirus virus mandate on religious grounds, reports our colleague Andrew Jeong.
• Abortion watch: The Republican-led Arizona Senate and the West Virginia House of Delegates each passed 15-week abortion bans in their respective states Tuesday. Both bills are modeled after the Mississippi bill currently pending before the Supreme Court that has the potential to undermine the landmark Roe v. Wade decision.
• Surgeon General Vivek H. Murthy tweeted that his 4-year old daughter tested positive for the coronavirus over the weekend, prompting him to reflect on the challenges of parenting during a pandemic in a series of tweets, Brittany reports.

More from the Surgeon General:

Democrats and Republicans both want federal spending on medical research

A survey commissioned by the advocacy group Research!America finds eight in 10 Americans believe spending on research is important to economic growth and creating jobs. Seven in 10 agreed the pandemic has heightened the need for investment in science and technology.

• Mental health replaced cancer as respondents’ third top health concern, behind covid-19 and the cost of health care.
• Confidence in scientists was down from a year ago. Sixty-eight percent of respondents said scientists act in the public’s best interest, compared with 80 percent who gave that answer in January 2021. Confidence in public health officials slipped from 78 percent to 62 percent.

Sugar rush

Thanks for reading! See y’all tomorrow.

https://www.washingtonpost.com/politics/2022/02/16/new-fda-commissioner-has-full-plate/