with Paulina Firozi
Gottlieb is a well-known health policy wonk who left a position at the conservative American Enterprise Institute to head the agency charged with ensuring medicines and devices consumed by Americans are safe. There’s been much buzz lately about how he’s moving to crack down on certain electronic tobacco products that can serve as a gateway for kids to get addicted to nicotine.
The FDA is expected to announce regulations soon that make it extremely difficult for most flavored cartridge-based cigarettes to be sold in convenience stores and gas stations, as my colleague Laurie McGinley first reported last week. The agency is also mulling a first step toward banning menthol cigarettes, per the Wall Street Journal.
And Gottlieb signaled to McGinley yesterday that the FDA is planning new regulations on flavored cigars — which, McGinley notes, could include a ban on most flavored cigars. “I think you can expect us to look at pursuing action on that,” he said at a Washington Post Live event:
The industry is paying close attention. Juul Labs, the company that controls more than 70 percent of the e-cigarette market, announced yesterday it would stop selling most of its flavored e-cigarette pods in convenience stores and vape shops and would halt social media promotion of the products.
The company is responsible for much of the recent spike in kids using e-cigarettes. “Juul, a sleek e-cigarette introduced in 2015, has taken much of the blame for the rise in use by youths,” McGinley explains. “A technical and design breakthrough, the e-cigarette looks like a USB flash drive and, in a break from past vaping products, delivers high levels of nicotine that are smooth, not harsh. Each of its pods, which come in such flavors as mango and cucumber, provides as much nicotine as a pack of cigarettes.”
E-cigarettes present a bit of a conundrum to those seeking to help Americans stop smoking. Some advocates view them as a useful tool to help adult smokers quit more dangerous cigarettes.
But research also indicates many e-cigarette users become addicted to nicotine and eventually switch to regular cigarettes. That’s troubling when you consider preliminary government data showing e-cigarette use rose 77 percent among high school students and nearly 50 percent among middle school students this year. According to that data, which McGinley cited in her piece, 3.5 million kids now engage in vaping.
Those sobering findings haven’t prevented some on the right from recently criticizing Gottlieb, accusing him of enabling the kind of government “overreach” they would more commonly expect from a Democrat-led administration.
“The FDA must stop this federal overreach in food and tobacco policy and respect personal freedom, markets and the plain language of laws,” Daren Bakst, a senior research fellow at the Heritage Foundation, wrote in a piece also criticizing the FDA for implementing Obama-era menu labeling requirements.
FreedomWorks, a conservative and libertarian advocacy group, blasted out a statement on Friday calling the FDA’s intention to crack down on e-cigarette sales “a profound disappointment” and a “serious step backwards” from the administration’s deregulating goals.
“Commissioner Gottlieb has tragically done a 180,” said Patrick Hedger, policy director for FreedomWorks. “Instead of working with industry to promote innovative and less harmful products, the FDA has continued to do nothing but smother new products and businesses in bureaucratic red tape and obstruction, emblematic of the culture in Washington that President Trump has tried to change.”
When I asked Gottlieb to respond to such criticisms, he pointed to the 2009 Tobacco Control Act and the authority it gives the FDA to try to lower smoking rates.
“This isn’t just about what role government should play; this is a legal mandate,” Gottlieb told me.
It's also an issue that involves kids and their potential for becoming addicted to a chemical (nicotine) that could one day take their lives.
“I must have said dozens of times …that allowing e-cigarettes to continue on the market could not come at the expense of addicting a whole generation of kids to these products,” Gottlieb said.
Sally Satel, a lecturer at Yale University and resident at AEI, where she worked with Gottlieb, said she thinks the FDA chief is under tremendous pressure by Congress to do something about the growing use of electronic tobacco products among children — and thinks he is doing the best he can.
“Adult access should not come at the expense of children, but there has to be a way to negotiate that tradeoff, and he’s trying, I think, under the circumstances,” Satel said.
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AHH: The Department of Health and Human Services is still considering a plan to discontinue more than $100 million in research projects that use fetal tissue and has planned a series of meetings to further discuss the review. The department is holding “listening sessions,” and has invited antiabortion groups like Susan B. Anthony List as well as scientists who are involved in such research to give their input on the administration’s considerations, Politico’s Dan Diamond reports.
The first of the one-hour sessions is scheduled for Friday. HHS spokeswoman also confirmed the series of meetings to Stat’s Lev Facher, adding they will feature “'scientists, pro-life groups, ethicists’ and other stakeholders.”
“Anti-abortion groups have decried HHS' use of fetal tissue after videos surfaced in 2015 purportedly showing Planned Parenthood officials profiting from the sale of the tissue,” Dan writes. “Scientists have blasted the Trump administration's review, warning that canceling the contracts would be a setback for medical research.”
“Assistant Secretary for Health Brett Giroir, the politically appointed official leading the review, is expected to issue recommendations on whether or not to continue funding the research,” he adds. “Giroir has been enthusiastic about the possibility of replacing fetal tissue with alternatives, said two people who have spoken to him.”
The administration launched the review of all federally funded research that uses fetal tissue in September after it canceled one such contract with a nonprofit group that had been “targeted by social conservatives in Congress and a coalition of antiabortion and faith-based groups,” our Post colleagues Amy Goldstein, Ariana Eunjung Cha and Laurie McGinley wrote then.
OOF: Some pharmacies across the country are not making opioid antidote naloxone available without a prescription, despite a push from lawmakers and health officials to expand access to the overdose-reversal medication, Stat News’s Andrew Joseph reports.
A new study published in the Journal of the American Medical Association on Tuesday found that in California in particular, fewer than a quarter of the surveyed pharmacies said customers would be able to pick up naloxone without a prescription, even though it’s been legal to do so since January 2016. “Only about half of the pharmacies that said they would give out the medication had any nasal naloxone in stock,” Joseph writes.
Another new study published in JAMA found that in Texas, 1 in 4 surveyed pharmacies did not have the antidote available, even as 83.7 percent of the pharmacies surveyed in Texas said they would dispense it without a prescription.
“To combat rising opioid overdoses, some states and cities in recent years have changed their laws to allow pharmacists to dole out naloxone without requiring a prescription,” Andrew writes. “Others have issued so-called standing orders, which act as blanket prescriptions for all residents. The goal is to reduce the obstacles people face in trying to get the lifesaving medication.”
OUCH: Our Post colleague Lena H. Sun has an extensive look at the rare condition called acute flaccid myelitis that’s experiencing its third spike of cases since 2014. While experts across the United States have “raced to understand the disease,” the Centers for Disease Control and Prevention has announced a new task force that will study the disease and look into potential new leads into what exactly is going on.
“In the meantime, parents of sick children are growing increasingly frustrated, “ Sun writes. “Competing theories have emerged about what triggers AFM; without clear guidance, doctors are trying several different kinds of treatment. While some children have seen improvement, so far no treatment has been found to lead reliably to full recovery. Many will need intensive physical therapy for years. Some need a ventilator to help them breathe.”
There have been at least 90 cases of AFM confirmed this year in 27 states, and there are 162 more cases still under investigation. “A few weeks ago, the CDC began reporting the larger number of suspected cases alongside confirmed ones to alert both parents and physicians to the latest spike,” Lena reports, and the agency said Tuesday it will “track the long-term outcomes of all AFM cases for this year and previous years.”
Michelle Melicosta, a pediatrician at the Kennedy Krieger Institute in Baltimore, told Lena, "It’s not that often we’re faced with something we’re still learning about … We just don’t always have the answer we wish we had. It makes it a little scarier for the family.”
— HHS Secretary Alex Azar said the Trump administration will allow states more flexibility to expand inpatient mental health treatment.
In a speech to Medicaid directors, Azar said the administration would allow states to apply for waivers to have Medicaid pay for mental health treatment at inpatient facilities. Current federal law, known as the “IMD exclusion," prohibits Medicaid from paying for such treatment in facilities with more than 16 beds. The decades-old exclusion was originally intended to help move mental health patients into community-based treatment settings, but is now considered to be a hamper on treatment.
“Different forms of treatment work for different patients, but the decades-old restriction on Medicaid reimbursement for inpatient treatment at institutions for mental diseases, or IMDs, has been a significant barrier,” Azar said Tuesday.
Azar said the Trump administration has approved 13 of these waivers and more are in the works.
— Scott Lloyd, the director of the Office of Refugee Resettlement at HHS, is planning to write a book about his opposition to abortion, Politico’s Dan Diamond reports.
“Scott Lloyd, who’s been under fire for his stewardship of separated migrant children in federal custody, has been working on the book while employed at HHS,” Dan writes. “Government employees typically are discouraged from writing books about subjects that overlap with their official responsibilities, and HHS lawyers have been involved in the matter.”
“Lloyd’s book would detail the need for anti-abortion policies, drawing on his own spiritual ‘awakening,’ ” Dan reports. “HHS has said that Lloyd’s personal beliefs have not influenced his leadership of its Office of Refugee Resettlement. However, Lloyd last year began personally intervening to prevent unaccompanied minors from obtaining abortions — prompting a rash of lawsuits and calls for his firing from Democrats and women’s rights organizations.”
— Cadaver dogs, mobile morgues and rapid DNA analysis have all been part of the extensive search effort for victims of the deadly fires in California.
The Camp Fire in Northern California has become the deadliest in the states history, killing at least 48. But hundreds are still missing.
“I want to recover as many remains as we possibly can, as soon as we can. Because I know the toll it takes on loved ones,” Butte County Sheriff Kory Honea said Monday night, the Associated Press’s Martha Mendoza and Gillian Flaccus report.
“More than a dozen coroner search-and-recovery teams looked for bodies across the apocalyptic landscape that was once Paradise, while anxious relatives visited shelters and called police and hospitals in hopes of finding loved ones,” they write. “Authorities said they were bringing in two mobile morgue units from the military, requesting an additional 150 search-and-rescue personnel, and seeking the setup of a rapid DNA system to speed the analysis of remains.”
— Insurance start-up Oscar Health has filed a federal lawsuit against Florida Blue, a licensee of the Blue Cross and Blue Shield Association, charging the insurer with practices that limited competition and restricted the role of brokers.
In the complaint filed Tuesday in U.S. District Court in Orlando, Oscar alleges Florida Blue implemented a “blatant scheme targeted at Oscar to keep it out of the state, thereby causing Florida consumers to continue to pay more for health insurance coverage.” The complaint alleges that because of Florida Blue's actions and “anticompetitive exclusive agreements,” more than 190 insurance brokers backed out of agreements to sell Oscar insurance plans.
Florida Blue told the Orlando Sentinel there was “no merit” to Oscar’s complaint. “When you see that the Florida Department of Financial Services website shows that the New York company has 1,600 appointed agents in Florida, you can’t help but wonder why that is not enough and they have chosen to resort to a Plan C, for Courts, now that Open Enrollment is underway,” Florida Blue spokeswoman Christie Hyde DeNave told the publication in an email.
— And here are a few more good reads from The Post and beyond:
Lawsuit claims University of Maryland medical school ignored sexual harassment complaints (Baltimore Sun)
At 8, Leana Wen Watched a Child Die In Front of Her. At 18, She Started Med School. Now She's the President of Planned Parenthood (Elle)
- The House Veterans Affairs Subcommittees on Disability Assistance and Memorial Affairs hold a hearing on oversight of contract disability examinations on Thursday.
Virginia Gov. Ralph Northam (D) says Amazon will expand STEM programs in local schools: