Azar in September said the ban would include not only fruity and dessert-flavored e-cigarettes, but also mint- and menthol-flavored products. (Officials later decided to exempt menthol because it’s less kid-appealing.) But at a Senate hearing yesterday, Mitch Zeller, director of the Food and Drug Administration's Center for Tobacco Products, was noncommittal when Democrats probed him on whether the ban would include the full range of flavors.
“Are you committed to finalizing the flavor compliance policy the administration announced?” Sen. Patty Murray (D-Wash.) asked Zeller at a hearing before the Senate Health, Education, Labor and Pensions Committee. “Yes or no?”
Zeller didn’t answer “yes.” Instead, he said this: “I think any questions the committee has about the announcement the White House made and anything related to what remains a deliberative process on policy is best referred to the White House itself.”
But it’s anyone’s guess as to where the White House will land.
Andy Slavitt, former administrator of the Centers for Medicare and Medicaid Services under President Barack Obama:
In the meantime, some lawmakers are acting on their own. A House Energy and Commerce subcommittee unanimously passed a measure from Chairman Frank Pallone (D-N.J.) yesterday that would raise the minimum age to purchase tobacco products to 21, prohibit all flavored tobacco products and direct the FDA to issue regulations prohibiting all sales of cigarettes and e-cigarettes that aren’t face-to-face.
Along similar lines, the Massachusetts state House passed a measure banning all flavored tobacco products and taxing vaping products. It also requires insurers and the state’s Medicaid program to pay for tobacco cessation counseling without any cost-sharing for patients.
But the Trump administration’s delay in releasing the ban is befuddling many. Questions are swirling around exactly when it will be released, what products it will target and whether it will exempt independent vape shops. As I wrote earlier this week, health-care advocates worry the administration will give in to conservatives and industry by walking back the aggressive approach Trump and Azar had announced with much fanfare.
The White House Office of Management and Budget signed off on a policy more than a week ago, but it hasn’t yet been published in the Federal Register — a likely indication the administration is rethinking the details. Trump, adviser Kellyanne Conway and Domestic Policy Council Director Joe Grogan have all made comments in the past week that could be construed as favorable toward the vaping industry.
Bloomberg News’s Jacquie Lee, reacting to remarks made by Azar at an Axios event yesterday:
CNBC’s Meg Tirrell:
The Hill’s Peter Sullivan:
The details — whatever they are — are being ironed out by the White House and not the FDA. Zeller made that much clear yesterday, frustrating the Democratic senators by repeatedly referring all policy-related questions to the White House.
A clearly annoyed Sen. Tim Kaine (D-Va.) read Zeller the FDA’s Sept. 11 news release saying the administration’s policy would clear the market of flavored e-cigarettes. “I think we are entitled to an answer from you” on whether and when the administration intends to move forward, Kaine said.
Zeller indicated the policy has not been finalized. “There is no final answer on the policy question,” he said. “That’s why we continue to have these internal discussions.”
“I do not like being played games with,” Kaine snapped back at him. “I don’t like being told to get someone from the White House” to answer questions, given the White House often doesn’t send officials to congressional hearings.
“We need you guys to focus on this,” Sen. Maggie Hassan (D-N.H.) told Zeller.
“We have children who are getting hooked on these products,” Hassan said. “We are looking for you guys to move through your deliberations. You’ve had enough time.”
Here’s why politicians are showing a sense of urgency: While fewer students are smoking traditional cigarettes, the popularity of vaping has skyrocketed in the past few years. More than 1 in 4 high school students and 1 in 10 middle-school students now use e-cigarettes, according to the latest data from the FDA. Experts say vaping puts teens at risk for nicotine addiction and often starts them on a lifelong dangerous habit.
There’s something else that has contributed to the sense of urgency. Vaping-related lung illness has sickened more than 2,000 people and led to at least 39 deaths, although officials now think the cases are related to the THC oil found in some vape products (we explained that here).
Health advocates are pouring on the pressure for the administration to fully follow through.
The American Cancer Society Cancer Action Network is running ads in The Washington Post and the New York Times today. Yesterday the group launched an ad buy on CNN, MSNBC and Fox News, which includes airtime during the Sunday morning politics shows.
Former FDA commissioner Scott Gottlieb, who left the administration in April, has gone so far as to call for products made by Juul — the largest e-cigarette maker — to be pulled off the shelves.
“It’s very clear that Juul can’t keep their products out of the hands of kids,” Gottlieb said on Monday. “What’s driving the youth use if primarily Juul.”
Laurie McGinley contributed to this report.
AHH, OOF and OUCH
AHH: Azar said the administration is revising its proposal to lower some Medicare drug costs by pegging prices to lower international levels. He said Trump wants the U.S. to pay no more than other developed countries.
Azar said during an event hosted by Axios that Trump was unsatisfied with the initial plan, the Hill’s Peter Sullivan reports. "What we suggested was reducing that 180 percent premium [above other countries] by 30 percent,” Azar said. “The president did not find that satisfactory. His view, which he has articulated publicly, is that America ought to be getting the best deal among developed countries. That was the terminology of ‘most favored nation status.’ And so that's the type of proposal we're working on.”
Trump first announced the action one year ago and in July said he was working on policy to require that the U.S. government pay no more than what other countries pay for prescription drugs.
“We’re working on a favored-nation clause, where we pay whatever the lowest nation’s price is,” he told reporters in July. “Why should other nations like Canada — why should other nations pay much less than us? They’ve taken advantage of the system for a long time, pharma.”
OOF: Federal regulators have opened an investigation into whether U.S. health privacy laws were followed in the effort between Google and health system Ascension that involved collecting detailed health information on millions of Americans.
Roger Severino, the director of Health and Human Services’ Office for Civil Rights, told Stat in a statement that “OCR would like to learn more information about this mass collection of individuals’ medical records with respect to the implications for patient privacy under HIPAA.”
“The initiative, code-named ‘Project Nightingale,’ gave Google the ability to analyze personal health information, including names and birth dates, compiled by Ascension, with the goal of helping deliver more personalized medical treatment,” Stat’s Rebecca Robins reports. “The [Wall Street Journal] reported that patients and physicians were not informed of the project, though Ascension said that some clinicians and nurses were involved.”
Google said in a statement that it is “happy to cooperate with any questions about the project. We believe Google’s work with Ascension adheres to industry-wide regulations (including HIPAA) regarding patient data, and comes with strict guidance on data privacy, security, and usage.”
OUCH: Every 11 seconds, someone in the United States acquires an antibiotic-resistant infection, and about every 15 minutes, someone dies of one.
New data from the Centers for Disease Control and Prevention reveal that deadly superbugs pose a greater risk than experts previously estimated. Previous figures missed about half of the illnesses and deaths, our Post colleague Lena H. Sun reports, but the new report found drug-resistant germs and infections sicken about 3 million people a year and kill about 35,000 annually.
“Five germs account for the most urgent threats. Three are long-recognized dangers: C. diff., drug-resistant gonorrhea, and carbapenem-resistant enterobacteriaceae (CRE), also known as ‘nightmare bacteria’ because they pose a triple threat,” Lena writes. “They are resistant to all or nearly all antibiotics; they kill up to half of patients who get bloodstream infections from them; and the bacteria can transfer their antibiotic resistance to other related bacteria, potentially making the other bacteria untreatable.”
“We want to have diagnostic tools and medical treatments for problems we know we’re going to have,” said Helen Boucher, chief of infectious diseases at Tufts Medical Center. “But we also need to prepare for the kind of resistance that we could never predict. We know from history that bacteria and Mother Nature are smarter than we are.”
— An outside review found that the University of Maryland followed protocol in the adenovirus outbreak on campus last year that led to the death of one student, 18-year-old freshman Olivia Paregol. But the report also found “areas of weakness” and included 14 pages of recommendations for how to deal with such emergencies.
In May, The Post reported that university officials waited 18 days before informing students about the presence of adenovirus that eventually sickened nearly four dozen students.
Maryland Gov. Larry Hogan (R) called for an investigation, and the University System of Maryland Board of Regents picked six people with “subject matter expertise” to conduct that review, our Post colleague Jenn Abelson reports.
“The report concluded that the university ‘adhered to the requirements of all local, state and federal regulations and statutes governing reporting and communication concerning infectious diseases’ and ‘the response to adenovirus was in accordance with the University's own internal policies and procedures,’ ” Jenn writes. She added the report’s recommendations “included more frequent monitoring of disease trends on campus, sharing health information with regional providers, designating an individual responsible for crisis communications and conducting air sampling after mold remediation.”
The Paregol family said it plans to move forward with a wrongful-death lawsuit against the college. Ian Paregol, Olivia’s father, said he appreciated efforts by the panel that conducted the review. But he also told The Post that university officials “still did withhold the information which caused my daughter’s death. They knew there was an adenovirus outbreak, and they should have told us and her to get checked when she came to the university health center after the first case of the virus.”
— And here are a few more good reads:
HEALTH ON THE HILL
- The Senate Health, Education, Labor and Pensions Committee will hold a hearing on the nomination of Stephen M. Hahn to lead the Food and Drug Administration on Nov. 20.