| Good morning — and welcome to Tuesday's Health 202. We'll publish our last edition of the year Thursday, and want to hear from you: What were health care's biggest moments in 2021? Drop us a line: rachel.roubein@washpost.com. The Supreme Court declined to block New York's vaccine mandate for health care workers, and Sen. Joe Manchin (D-W.Va.) is still an obstacle to passing Democrats' social spending bill before the holidays. But first: | Senators want to know whether Robert Califf will go tougher on tobacco |  Robert Califf, President Biden's pick to lead the Food and Drug Administration, will testify before the Senate HELP Committee today. (Pablo Martinez Monsivais/AP) | | | President Biden's pick to lead the Food and Drug Administration would step into the role at one of the most critical junctures for tobacco regulation. The agency has delayed consequential decisions for years — and across both Democratic and Republican administrations. But it's running up against deadlines for divisive measures, like banning menthol cigarettes and whether popular e-cigarette brand Juul Labs can keep selling its products. At least one senator has already privately quizzed Robert Califf, who Biden chose to again run the FDA, on his views on cracking down on the tobacco and vaping industry. Califf will testify before the Senate HELP Committee today, where he's expected to face these questions publicly, according to two aides. | - "He was very careful in his observations, guarded in light of this hearing," Sen. Dick Durbin (D-Ill.), the chamber's No. 2 Democrat and a vocal vaping critic, said in an interview just hours after pressing Califf on the agency's tobacco strategy in a one-on-one meeting Thursday.
| | If the prominent cardiologist is confirmed, one of his biggest tests will be over tobacco control efforts — policies that could mark an enormous shift on a long-standing public health issue. Advocates for tighter regulations are exasperated over what they view as the FDA's sluggish response. Meanwhile, efforts to curb nicotine products are sure to be met with the full force of the industry's lobbying muscle. Here's a quick breakdown of the issues looming at the agency: | - E-cigarettes: The FDA blew past a September deadline to review whether products, like those from Juul, can stay on the market. Agency spokesperson Alison Hunt declined to give a timeline for finishing the reviews but noted the agency has taken action on 99 percent of e-cigarette applications.
- Menthol ban: The Biden administration aims to propose a ban on menthol cigarettes and cigars by April, in response to a 2013 citizen petition seeking such action.
- Nicotine reduction: The FDA is still considering requiring tobacco companies to reduce the amount of nicotine in cigarettes to nonaddictive levels, Hunt confirmed.
- Synthetic nicotine: The agency is investigating the issue and exploring how to address products where regulatory authority is in question, as some Democrats push it to do more. This comes amid reports vaping manufacturers may be switching to the lab-made product to sidestep the agency.
| | It's unclear how exactly Califf would approach each issue (and he declined to comment for this piece). But we can look to his record to get a sense of his priorities. Califf served as FDA commissioner for nearly a year under President Barack Obama. During his tenure, the agency extended its regulatory authority to include all tobacco products, such as e-cigarettes, cigars and hookah. The nominee made what is perhaps his most extensive statements on e-cigarette regulation in 2019, amid a rise of a then-mysterious vaping illness. (It turned out contaminated marijuana vapes were the primary source of the outbreak.) In an article for the Association of American Medical Colleges, he detailed a "trifecta" of sweeping regulations to "limit the harm done by vaping products." This included lowering the amount of nicotine in tobacco products to subaddictive levels; banning over-the-counter vaping products; and supporting prescription vaping so tobacco users don't go through withdrawals. | - "Outright prohibition of vaping products seems impracticable on several grounds," Califf wrote, citing Americans' belief in personal freedoms and concerns a blanket ban could dissuade people from seeking treatment.
| | Since then, Califf has continued to be supportive of reducing the level of nicotine in cigarettes. But he cautioned it would be "politically challenging" and "divisive" in comments to Alexandra earlier this year. | | Robert Califf, FDA nominee: |  | | | | | Califf got the endorsement of six former FDA commissioners yesterday, our colleague Laurie McGinley reports, citing the urgency of addressing omicron. But outside groups will be watching his tobacco efforts closely. | | On the tobacco control side: For Matthew Myers, president of the Campaign for Tobacco-Free Kids, the decisions the FDA will soon make will "define whether the agency is a force for fundamental, positive public health change or not." But for those advocating for pro-vaping policies — such as Gregory Conley, president of the American Vaping Association — the question remains whether Califf will allow for fair reviews of products that the group argues could help smokers quit. "Or will he fall back on the tired belief that prohibition can solve all the world's issues?" | | |  | On the Hill | | | Deadline time: Senate Democrats are barreling toward a self-imposed deadline to pass Biden's roughly $2 trillion economic package before Christmas, our colleague Tony Romm reports. The chief obstacle is Sen. Joe Manchin (D-W.Va.), who has repeatedly refused to endorse the measure. He spoke with Biden on the phone yesterday to discuss the path forward, with the senator telling reporters afterward that the pair talked about "different iterations" of the bill. | - "Anything's possible here," Manchin said about the prospects of a vote before Christmas. Asked if he intends to continue negotiating with the White House, he replied, "I'm engaged, we're engaged."
| | ICYMI: The Senate Finance Committee released a new round of legislative text over the weekend. Here are the notable changes: | - A cut to hospital payments was killed. Democrats removed a 12.5 percent cut to certain hospital payments in the dozen states that haven't taken up Obamacare's Medicaid expansion. The change came amid fierce lobbying from the provider industry, as well as Georgia's Democratic delegation.
- Generic drugmakers get some reprieve: The generics lobby had been agitating for a carveout from the provision penalizing drugmakers for hiking prices faster than inflation. Some generics will get exemptions to the inflation rebate for Medicare's voluntary prescription drug benefit.
| | |  | Coronavirus | | The Supreme Court declined to stop New York's vaccine mandate for health workers | | The Supreme Court on Monday rejected a request from medical workers who said New York's coronavirus vaccine mandate for health workers forced them to choose between their livelihood and their religious beliefs, The Post's Robert Barnes reports. The New York mandate doesn't include a religious exemption. | | As is often the case in emergency relief requests, the justices in the majority did not give a reason for denying the request. The court has on three previous occasions declined to stop states from mandating coronavirus vaccines. Justice Neil Gorsuch argued in a dissent that the state's rule "clearly interferes with the free exercise of religion." He was joined in the dissent by Justice Samuel A. Alito Jr. Justice Clarence Thomas also said he would have blocked the vaccine requirement but did not give a reason. | Meanwhile, states and cities are imposing restrictions amid rising cases and the threat of omicron | - California and New York are reinstating indoor mask mandates as officials worry about the spread of the virus during the holiday season and a rising number of omicron cases.
- Philadelphia will require proof of vaccination at bars, restaurants, movie theaters and any other establishments that serve food or drinks on-site.
| Officials identify omicron cases in the D.C. area. | | The District, Maryland and Virginia have each detected cases of omicron, The Post's Jenna Portnoy and Dan Keating report. The variant has been present in the region for at least three weeks, officials say. The earliest known case of omicron in the United States was found in a woman from Maryland who was tested Nov. 21, three days before the existence of the new variant was publicly announced. | - Public health officials have expected cases in the United States and have cautioned the public not to panic. Early research shows it may be more transmissible than delta, but scientists are still assessing the variant. Officials — and early data from Pfizer-BioNTech — indicates a booster shot provides an added layer of protection.
- Omicron appears to cause less severe illness than earlier variants, but is more resistant to the two-dose Pfizer-BioNTech regimen, according to a new study by South Africa's largest health insurer. However, the shot was effective against severe complications, our colleague Lesley Wroughton reports.
| Here's what else you need to know: | - Pfizer's antiviral pill sharply reduces severe illness and should work against omicron, the company announced this morning.
- More than 1 in 100 people 65 years or older have died of the coronavirus, The New York Times reports.
- Americans' worries about the coronavirus are on the rise but fewer say they are regularly taking precautions, like wearing masks or staying away from large groups, a new poll from The Associated Press and NORC Center for Public Affairs Research finds.
| | |  | Medical missives | | | The power of music: Suicides dropped following the release of a song whose title is the number of the national suicide prevention hotline, a study published in the British Medical Journal reported. The release of the song "1-800-273-8255" by the artist Logic, as well as its performances at the 2017 MTV Video Music Awards and the 2018 Grammy Awards, were correlated with an increase in calls to the helpline and a decrease in suicides, Stat's Maddie Bender reports. | | |  | Sugar rush | | | Thanks for reading! See y'all tomorrow. | |
