Daily on Healthcare: Democrats want FDA to have more drug recall power

By | January 12, 2020

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DEMOCRATS WANT TO GIVE FDA MORE POWER ON UNSAFE DRUGS: Democrats are working to give the Food and Drug Administration more power to recall dangerous drugs.

Under current law, the most forceful action the FDA can take is to ask companies to voluntarily recall their products from the market, but then the agency doesn’t have control over how products get recalled. The FDA leans on pharmacies and drug companies to contact customers directly about the dangers of the medicines and getting rid of them, and drug companies are allowed to simply refuse to take action.

This isn’t true for other products the FDA regulates. It has the power to recall medical devices, nicotine products, and vaccines. For drugs, the FDA can put out a safety warning but it cannot order stores to take products off shelves or make manufacturers pull marketing of a drug from their websites.

Democrat Rosa DeLauro of Connecticut, who oversees the House subcommittee that determines funding for the Department of Health and Human Services, has been pushing for a few years to let the FDA have more power over recalls. She’s been successful at giving the FDA more authority before: She introduced a bill over food recalls that Barack Obama signed into law in 2011.

On Friday, she’s reintroducing the Recall Unsafe Drugs Act alongside other Democratic co-sponsors that would give the FDA mandatory recall authority over drugs.

Much of Congress’s focus on prescription drugs during the past year has been on their prices, but reports of unsafe medicines could give the bill more momentum this session. The legislation is landing at a time when millions of customers are reeling from news that the heartburn treatment Zantac, available both over the counter and with a prescription, has been tested and found to have the carcinogen NDMA. The blood pressure drug valsartan contained the chemical, too, and faced recall requests from FDA last year.

Bloomberg reported in December that FDA officials don’t seem to want more control over recalls, and the pharmaceutical industry also opposes the move because it largely complies with FDA requests. It remains to be seen what the position of the new chief of the agency, Dr. Stephen Hahn, will be.

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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 dailyonhealthcare@washingtonexaminer.com. If someone forwarded you this email and you’d like to receive it regularly, you can subscribe here.

ANTI-OBAMACARE STATES FACE DEADLINE ON SUPREME COURT RESPONSE: Republican-led states that have signed onto a lawsuit threatening to invalidate all of Obamacare have until 4 p.m. Friday to respond to Democrat-led states that want the Supreme Court to hear and decide on the case this year, ahead of the presidential election.

KANSAS REACHES DEAL ON MEDICAID EXPANSION: Kansas Gov. Laura Kelly, a Democrat, reached a deal with Republicans to expand Medicaid, estimated to enroll 150,000 more people in government coverage. The deal sets up a reinsurance fund, charges enrollees around $ 25 in premiums, and will allow people to get referrals to work — but won’t require them to work as a condition of staying enrolled in Medicaid. Neighboring Oklahoma is set to put the question of Medicaid expansion to voters through a ballot measure, and Missouri is headed in the same direction.

GUTTMACHER URGES MORE STATES TO LOOSEN ABORTION RESTRICTIONS PAST VIABILITY: The Guttmacher Institute, a research organization that supports abortion rights, has released a policy document urging states not to have any limits on abortions, saying that “using gestational age as a legal cutoff for abortion care is harmful at any point in pregnancy” and that “states can and should expand access to abortion throughout pregnancy.” The District of Columbia and seven states do not specify gestational age in their abortion laws.

‘WAKEUP CALL’: ALCOHOL-RELATED DEATHS HAVE SKYROCKETED SINCE 1999: The National Institute on Alcohol Abuse and Alcoholism reported Friday that nearly 1 million people died of alcohol-related causes, such as liver disease and overdoses, between 1999 and 2017. Researchers analyzed death certificates and noted that the number of deaths linked to alcohol more than doubled from 35,914 in 1999 to 72,558 in 2017.

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“The current findings suggest that alcohol-related deaths involving injuries, overdoses, and chronic diseases are increasing across a wide swath of the population,” said NIAAA Director Dr. George F. Koob. “The report is a wakeup call to the growing threat alcohol poses to public health.” Researchers found that people aged 45-74 had the highest rates of alcohol-related deaths but the steepest increases were among people ages 25-34. The said increases in alcohol consumption over the past 20 years are consistent with increasing rates of “deaths of despair,” or deaths by suicides and overdoses.

Flashback: We’ve done data analyses on the rise in alcohol-related deaths, and how complicated it is to push for regulations given that any restrictions arouse fear of making the problem worse through prohibition-like policies.

VAPING LUNG INJURIES ARE UP: As of Jan. 7, 2,602 people have been hospitalized for vaping-related lung injuries, according to the Centers for Disease Control and Prevention. The death toll has also risen to 57 across 27 states.

IS CALIFORNIA GETTING INTO THE PHARMA INDUSTRY?: Democratic Governor Gavin Newsom said Thursday that his state might create its own generic drug label in an effort to increase market competition to lower prices for Californians. Newsom has included the proposal in his 2020/2021 budget plan, which he will discuss in a Friday press briefing. “A trip to the doctor’s office, pharmacy or hospital shouldn’t cost a month’s pay,” Newsom said. “The cost of healthcare is just too damn high, and California is fighting back.”

Health policy experts are skeptical: Healthcare industry experts’ ears perked up Thursday but said Newsom’s plan may not have much of an impact on prices. “This is not a bad move,” USC health economist Geoffrey Joyce told the Los Angeles Times. “But I wouldn’t oversell it. It will make a modest dent in overall drug spending and drug pricing in California. You are benefiting a modest group of patients, but you are benefiting them in a significant way.”

GETTING PEOPLE TO SPIT INTO TEST TUBES MAY HAVE PAID OFF: Ancestry DNA test company 23andMe used all of that genetic material it has collected and developed an antibody to treat inflammatory diseases, such as psoriasis. The company inked a deal with Spanish drug company Almirall to license the antibody as a treatment for dermatological diseases.

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JUSTIN BIEBER REVEALS LYME DISEASE DIAGNOSIS: Bieber, 25, revealed on Instagram Thursday that he has Lyme disease and responded to months of scrutiny that his disheveled appearance was linked to a possible drug habit. “While a lot of people kept saying justin Bieber looks like shit, on meth etc. they failed to realize I’ve been recently diagnosed with Lyme disease, not only that but had a serious case of chronic mono which affected my, skin, brain function, energy, and overall health,” he wrote. Bieber also teased a docu-series that YouTube will publish so that fans can get a closer look at Lyme disease and his diagnosis.

Lyme disease has gotten a bit more attention recently as Congress included funding for Lyme disease research and prevention efforts in December’s year-end spending package. New Jersey Republican Chris Smith, the bill’s lead sponsor, has been working to pass Lyme disease legislation for nearly 30 years and called the bill a “whole-of-government approach” when he spoke to Cassidy last month.

The Rundown

Bloomberg Two big drug flops show how health-care economics have changed

Modern Healthcare Justice Department recovered $ 2.6 billion from healthcare fraud cases in 2019

CNN A massive study of 200,000 veterans identifies genetic links to anxiety

North Carolina Health News Nurse Family Partnership programs guide first-timers through transition to motherhood

The New York Times Second U.S. baby to be born from a dead donor’s uterus is delivered


MONDAY | Jan. 13

9:30 a.m. U.S. Court of Appeals for the D.C. Circuit to hear pharmaceutical companies’ challenge of a Trump administration rule requiring drug prices in commercials. Details.

TUESDAY | Jan. 14

10 a.m. Rayburn 2123. House Energy and Commerce’s Oversight and Investigations Subcommittee hearing on “A Public Health Emergency: State Efforts to Curb the Opioid Crisis.” Details.


Noon. Cato Institute event on “Needle Exchange Programs: Benefits and Challenges,” with Surgeon General Jerome Adams. Details.

10 a.m. 2123 Rayburn. Energy and Commerce’s Health Subcommittee hearing on “Cannabis Policies for the New Decade.” Details.