Daily on Healthcare: FDA faces deadline on adding graphic labels to cigarette packs

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FDA FACES DEADLINE ON CIGARETTE PACKS: The Food and Drug Administration faces a court-ordered deadline Thursday to issue a proposal that would require cigarette packets and ads to carry graphic warning labels.

Many other countries already require such labels. The U.S. version would mandate that tobacco companies display color graphics on the upper half of the front and back of packets, and on 20% of the space on print advertisements. The images will depict the health consequences of smoking and are meant to turn off potential smokers and urge people who currently smoke to quit.

The deadline ahead comes after federal Judge Indira Talwani, a Barack Obama appointee, ruled in 2018 that the FDA “unlawfully withheld” and “unreasonably delayed” action on putting out rules about the graphics, and then earlier this year ordered the agency to issue the proposed rule by Aug. 15. The final rule is due March 15, 2020.

The Family Smoking Prevention and Tobacco Control Act passed in 2009 allowed the FDA to regulate tobacco products, and with that also came rules for graphic warning labels. The law said that FDA had until June 22, 2011, to issue a final rule on the warnings, and though the agency had issued them on time, the rules were struck down by federal Judge Richard Leon, who recommended the labels contain “only purely factual and uncontroversial information rather than gruesome images designed to disgust the consumer.” The labels included images of decaying lungs and teeth, and one of them depicted a man smoking through his tracheostomy.

A three-judge panel upheld the ruling, saying the labels violated the First Amendment and telling the FDA to re-draft the labels. It said the agency didn’t provide “a shred of evidence” showing that the warnings would reduce the number of smokers in the U.S.

The ruling was narrowly issued, meaning that it struck down the specific FDA rule and not the overall requirement that cigarette packets contain graphic warning labels.

The court denied the petition for a rehearing, and the government in 2013 decided not to seek further court action. Still, the FDA hasn’t yet reissued the labels. As a result, eight public health groups filed suit against the FDA almost three years ago to force the agency to put out the rules, which may come as early as Wednesday but need to arrive no later than Thursday.

Good morning and welcome to the Washington Examiner’s Daily on Healthcare! This newsletter is written by senior healthcare reporter Kimberly Leonard (@LeonardKL) and healthcare reporter Cassidy Morrison (@CassMorrison94). You can reach us with tips, calendar items, or suggestions at [email protected]. If someone forwarded you this email and you’d like to receive it regularly, you can subscribe here.

PRESCRIPTION DRUG USE HIGHER IN THE US THAN IN CANADA: Data released Wednesday by the Centers for Disease Control and Prevention indicates that among adults ages 40-79 in the U.S., 69% used one or more prescription drugs in the past 30 days and 22.4% used five or more. In comparison, 65.5% Canadian adults in that same age group used one or more prescription drugs in the past 30 days and 18.8% used five or more.

Antidepressants and cholesterol-lowering drugs were much more common among Americans: The study found that 15.4% of Americans between the ages of 40-59 took antidepressants, while 8.8% of Canadians in that age group took the drugs. Another finding showed 13.9% of Americans in middle age took cholesterol-lowering drugs, while 8.1% of Canadians did.

EMPLOYEES TO TAKE ON $4,500 IN AVERAGE HEALTHCARE COSTS IN 2020: Employers project that the total cost of health benefits will rise 5% in 2020, according to the 2020 Large Employers’ Health Care Strategy and Plan Design Survey released Tuesday. When counting both premiums and out-of-pocket costs, healthcare expected to cost $14,642 per employee this year and rise to $15,375 in 2020, with employers paying for 70% of the costs. Just over half of those surveyed said that next year they plan to offer their employees more options for receiving care virtually.

STATE ATTORNEYS GENERAL CRITICIZE HHS MOVE TO ROLL BACK OBAMACARE ANTI-DISCRIMINATION RULE: California Attorney General Xavier Becerra and Massachusetts Attorney General Maura Healey led 22 state attorneys general in criticizing Health and Human Services for a proposed rule that would roll back LGBT anti-discrimination provisions in Obamacare.

Roger Severino, director of the Health and Human Services Office for Civil Rights, said in May when the rule was proposed that the agency’s tradition of protecting all groups against discrimination and substandard healthcare was “unwavering,” but he didn’t say in the announcement whether the rule would allow providers to deny care to transgender patients.

OVERDOSE DEATHS HAVE INCREASED EVEN AS LEGAL FENTANYL SALES HAVE DECLINED: Legal fentanyl sold and dispensed by pharmacists decreased by almost 30% from 2014 to 2017, but overdose deaths on synthetic opioids like fentanyl increased 414% in that same timeframe, according to a study by Avalere healthcare consulting firm. Kelly Brantley, managing director at Avalere, said: “Public data cannot distinguish between opioid overdose deaths from legitimate pharmaceuticals and illegally manufactured products…Much of the evidence shows that recent increases in fentanyl-related deaths are linked to illicit products.”

FOR THE FIRST TIME, EXPERT PANEL RECOMMENDS SCREENING FOR ADDICTION AND ILLEGAL DRUG USE: For the first time, the U.S. Preventive Services Task Force, an independent panel of health experts, has issued a draft recommendation that primary care doctors screen their patients for drug use.

Many doctors already check patients for drug use. “We may not be checking boxes on a screen, but we’re mentally checking boxes saying something is wrong,” Dr. Gary LeRoy, president-elect of the American Academy of Family Physicians, told Stat News.

WARREN WANTS TO HAVE GOVERNMENT COVER ‘GENDER-AFFIRMING HEALTH CARE’: Democratic Presidential contender Elizabeth Warren said Tuesday she wants to cover gender-reassignment surgery under her plan for government-funded healthcare. She was criticized in January for saying in 2012 alongside fellow senator Scott Brown, a Republican, that she didn’t favor spending taxpayer dollars on surgery for a transgender inmate in Massachusetts.

The Rundown

Stateline Where doctors can recommend marijuana to replace opioids

Washingtonian Here’s how some of the 2020 candidates break a sweat

The New York Times ‘Juul-alikes’ are filling shelves with sweet, teen-friendly nicotine flavors

Associated Press Opponents warn a Tennessee abortion ban will cost taxpayers

NPR ‘Cadillac Tax’ on generous health plans may be headed to congressional junkyard

Calendar

WEDNESDAY | Aug. 14

Congress in August recess.

FRIDAY | Aug. 16

2 p.m. Substance Abuse and Mental Health Services Administration-sponsored webinar on “Best Practices for Employment for People with Serious Mental Illness.” Details.

MONDAY | Aug. 19

Aug. 19-20. Atlanta. Centers for Disease Control and Prevention Advisory Committee on Breast Cancer in Young Women. Details.

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