The Food and Drug Administration

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Fact check: FDA still recommends COVID-19 vaccine, contrary to viral claim

Our rating: False

https://www.usatoday.com/story/news/factcheck/2023/04/26/fact-check-fda-still-recommends-covid-19-vaccines-safe-effective/11703507002/

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Over-the-counter birth control pill faces FDA questions

WASHINGTON (AP) — U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.

https://apnews.com/article/birth-control-pills-without-prescription-3228f5d93f5b6583cdc1be9ce4557373?

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Thousands of unauthorized vapes are pouring into the US despite the FDA crackdown on fruity flavors

WASHINGTON (AP) — The number of different electronic cigarette devices sold in the U.S. has nearly tripled to over 9,000 since 2020, driven almost entirely by a wave of unauthorized disposable vapes from China, according to tightly controlled sales data obtained by The Associated Press.

https://apnews.com/article/fda-vapes-vaping-elf-bar-juul-80b2680a874d89b8d651c5e909e39e8f?

5 takeaways from the AP’s report on Chinese disposable e-cigarettes flooding the US market

How good a job is the Food and Drug Administration doing in its crackdown on kid-friendly electronic cigarette flavors? The Associated Press sought to answer that question by looking at tightly controlled sales data.

https://apnews.com/article/fda-vapes-vaping-elf-bar-juul-5e45cf57dc78f6b94213047c97b10f7e?

FDA warns stores to stop selling Elf Bar, the top disposable e-cigarette in the US

WASHINGTON (AP) — The Food and Drug Administration on Thursday said it has sent warning letters to dozens of retailers selling fruit- and candy-flavored disposable e-cigarettes, including the current best-selling brand, Elf Bar.

https://apnews.com/article/ecigarettes-elf-bar-vapes-4353becf747846b528ec2aea609ed2f9?

Juul Labs agrees to pay $462 million settlement to 6 states

NEW YORK (AP) — Electronic cigarette-maker Juul Labs Inc. will pay $462 million to six states and the District of Columbia, marking the largest settlement the company has reached so far for its role in the youth vaping surge, the attorneys general in several states announced Wednesday.

https://apnews.com/article/juul-tobacco-million-settlement-youth-vaping-318854025e4ee05d8b18296cb7dae772?

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First over-the-counter birth control pill gets FDA approval

WASHINGTON (AP) — Federal regulators on Thursday approved the nation’s first over-the-counter birth control pill in a landmark decision that will soon allow American women and girls to obtain contraceptive medication as easily as they buy aspirin and eyedrops.

https://apnews.com/article/birth-control-pills-without-prescription-fda-b6728e98af5f1625520e0fa5fbc911c3?

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FDA approves AstraZeneca, Sanofi shot that protects infants and toddlers against RSV

The Food and Drug Administration on Monday approved AstraZeneca and Sanofi’s shot that protects infants and toddlers against respiratory syncytial virus, which is the leading cause of hospitalization among babies in the U.S.

https://www.cnbc.com/2023/07/17/fda-approves-astrazeneca-sanofi-rsv-shot-for-infants-toddlers.html

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FDA Approves First Oral Treatment for Postpartum Depression

Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression

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FDA approves first RSV vaccine given to pregnant mothers to protect babies

Pfizer’s RSV vaccine transfers protective antibodies from mother to infant before birth. 

https://www.nbcnews.com/health/health-news/fda-approves-rsv-vaccine-pregnant-mothers-protect-babies-rcna100946?

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US approves updated COVID vaccines to rev up protection this fall

WASHINGTON (AP) — The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter.

https://apnews.com/article/covid-vaccines-coronavirus-234f27c74438fb4812a014dbd98ddbde?

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Popular nasal decongestant doesn’t actually relieve congestion, FDA advisers say

WASHINGTON (AP) — The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.

https://apnews.com/article/sudafed-decongestants-phenylephrine-pseudoephedrine-fda-0f140bafae9a500c5fba05fe764ecb66?

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Elf Bar finds an easy way around US vape import ban: a name change

WASHINGTON (AP) — Four months after U.S. regulators tried to block imports of Elf Bar, the top-selling Chinese disposable e-cigarette remains widely available thanks to a simple but effective tactic: changing its name.

https://apnews.com/article/ecigarettes-elf-bar-fda-disposable-vaping-5245aed253ca9cdcf119483bd9cee1f1?

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Eyedrops from CVS, Rite Aid and others carry possible infection risk, FDA says

WASHINGTON (AP) — U.S. health regulators are warning consumers not to use more than two dozen varieties of over-the-counter eyedrops because of the risk of infections that could lead to blindness.

https://apnews.com/article/eyedrops-recall-fda-infection-cvs-rite-aid-a9471104de34efd152137d3fdba9c260?

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FDA advisers see no roadblocks for gene-editing treatment for sickle cell disease

The Food and Drug Administration appears poised to approve the first medical therapy that uses gene-editing to treat a disease.

https://www.npr.org/sections/health-shots/2023/10/31/1208041252/a-landmark-gene-editing-treatment-for-sickle-cell-disease-moves-closer-to-realit?

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A new version of the diabetes drug Mounjaro can be used for weight loss, FDA says

A new version of the popular diabetes treatment Mounjaro can be sold as a weight-loss drug, U.S. regulators announced Wednesday.

https://apnews.com/article/weight-loss-mounjaro-wegovy-tirzepatide-9718480e110eace3e91e0a2bcdc5e536?

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Barefoot workers and cracked floors were found at a factory that made recalled eyedrops, FDA says

WASHINGTON (AP) — An Indian company that recently recalled eyedrops sold in the U.S. had a host of sanitation and manufacturing problems, including barefoot workers, cracked floors and altered records, U.S. health inspectors found.

https://apnews.com/article/eyedrops-recall-fda-warning-india-11624105e31a68102d414594c85766f0?

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Millions of People Used Tainted Breathing Machines. The FDA Failed to Use Its Power to Protect Them.

In 2021, after Philips Respironics sold millions of defective medical devices to those who struggle to breathe, the federal agency charged with protecting the health of the American public swept in.

https://www.propublica.org/article/how-the-fda-failed-to-protect-millions-of-people-tainted-breathing-machines?

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FDA approves CRISPR-based therapy for sickle cell disease

The Food and Drug Administration on Friday approved the first therapy based on CRISPR gene-editing technology to address the painful effects of sickle cell disease.

https://www.axios.com/2023/12/08/crispr-sickle-cell-fda?

FDA approves 2 gene therapies for sickle cell. One is the first to use the editing tool CRISPR

Regulators on Friday approved two gene therapies for sickle cell disease that doctors hope can cure the painful, inherited blood disorder that afflicts mostly Black people in the U.S.

https://apnews.com/article/sickle-cell-fda-approval-vertex-crispr-8d85279d7de0c60888d37afbfa06d39e?

In historic decision, FDA approves a CRISPR-based medicine for treatment of sickle cell disease

The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology, a groundbreaking treatment for sickle cell disease that delivers a potential cure for people born with the chronic and life-shortening blood disorder.

https://www.statnews.com/2023/12/08/fda-approves-casgevy-crispr-based-medicine-for-treatment-of-sickle-cell-disease/

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🧬 Gene-editing breakthrough

Illustration: Rebecca Zisser/Axios

The FDA on Friday took a big step toward ending the most common inherited blood disorder by approving a pair of gene therapies for sickle cell disease — a debilitating sickness that affects an estimated 100,000 Americans, mostly of African descent. Why it matters: It's the first FDA-approved therapy using the CRISPR gene-editing system, a kind of genetic scissors whose discovery won a Nobel Prize in 2020, Axios' Adriel Bettelheim writes. The new treatments edit genes directly in a patient's body and expand the kinds of diseases and conditions researchers can target to other blood disorders, certain cancers and infectious diseases. 🥊 Reality check: The treatments are both grueling and could cost millions of dollars, raising questions about equity and access. Patients first have to undergo extensive chemotherapy to rid their bodies of the defective cells and make way for reengineered ones — a process that may not be appropriate for older or frail patients. There's also the risk of "off target" edits that zero in on the wrong genetic sequence and could increase the risk of developing cancer. Go deeper.

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Florida surgeon general told FDA that COVID vaccines aren’t safe. FDA calls that misinformation.

The U.S. Food and Drug Administration fought back on Friday against what it calls “the proliferation of misinformation” by Florida’s Surgeon General Joseph Ladapo about the safety of COVID-19 vaccines.

https://www.orlandosentinel.com/2023/12/15/floridas-surgeon-general-told-the-fda-that-covid-vaccines-arent-safe-the-fda-calls-that-misinformation/?

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FDA for the first time approves plan to import drugs

The Food and Drug Administration on Friday approved a plan allowing Florida to import cheaper prescription drugs from Canada, opening the door for states to buy direct from pharmacies there to stock their state-run health programs.

https://www.axios.com/2024/01/05/fda-drug-importation-florida-canada?

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FDA warns against smartwatches and rings that claim to measure blood sugar without needles

Smartwatches and rings that claim to measure blood sugar levels for medical purposes without piercing the skin could be dangerous and should be avoided, the U.S. Food and Drug Administration warned Wednesday.

https://apnews.com/article/smartwatch-ring-diabetes-blood-sugar-glucose-fda-d96ca0372cd9f55c39aa9dee6fea687e?

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Mifepristone access is coming before the US Supreme Court. How safe is this abortion pill?

The U.S. Supreme Court will take up a case Tuesday that could impact how women get access to mifepristone, one of the two pills used in the most common type of abortion in the nation.

https://apnews.com/article/mifepristone-abortion-pill-supreme-court-1d2221251197a391c9bca833918e4554?

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FDA Finally Moves to Scrutinize Specialized Health Screenings

The Food and Drug Administration issued a rule on Monday that brings new scrutiny to a vast array of critical lab tests, including some popular prenatal genetic screenings, that reach patients without any federal agency checking to ensure they work the way their makers claim.

https://www.propublica.org/article/fda-rule-lab-developed-tests-health-screenings?

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Panel rejects psychedelic drug MDMA as a PTSD treatment in possible setback for advocates

WASHINGTON (AP) — A first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD was roundly criticized Tuesday — a potentially major setback to psychedelic advocates who hope to win a landmark federal approval and bring the banned drugs into the medical mainstream.

https://apnews.com/article/mdma-psychedelics-fda-ptsd-ecstasy-molly-1f3753324fa7f91821c9ee6246fa18e1?

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FDA advisers urge targeting JN.1 strain in recipe for fall’s COVID vaccines

WASHINGTON (AP) — Government advisers Wednesday said it’s time to update the recipe for the COVID-19 vaccines Americans will receive in the fall -- targeting a version of the ever-evolving coronavirus called JN.1.

https://apnews.com/article/covid-vaccines-updated-moderna-pfizer-novavax-72c2c5fafc46ccc9f2fd89fcda5d99df?

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💨 FDA OKs first menthol vapes

Illustration: Rebecca Zisser/Axios

Yesterday, the FDA authorized the sale of the first menthol e-cigarettes for adults, saying evidence showed they could reduce the health consequences of traditional cigarette smoking. Why it matters: It's the strongest government endorsement to date of manufacturers' argument that e-cigarettes are effective smoking cessation tools, despite their appeal to youths, Axios' Adriel Bettelheim reports. What we're watching: Anti-smoking groups criticized the move, saying it appears inconsistent with the FDA's conclusions that flavored e-cigarettes, including menthol products, have fueled a youth vaping epidemic.