The FDA’s leading vaccine regulator has announced stricter approval processes, citing a review that linked Covid vaccines to the deaths of at least ten children, primarily due to myocarditis. This shift involves re-evaluating existing vaccination policies, potentially limiting simultaneous vaccinations, and demanding more robust safety data. Experts suggest these changes could significantly slow the vaccine approval pipeline and may even discourage innovation in vaccine research. Critics, including former FDA officials and independent scientists, question the lack of detailed evidence supporting these claims and the potential politicization of the agency’s approach, emphasizing the importance of thorough investigation and peer review.
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A recent outbreak of infant botulism has been linked to ByHeart brand powdered formula, with at least 37 infants affected. The California Department of Health found Clostridium botulinum bacteria in an opened can of formula, leading to a nationwide recall of specific batches, and eventually all ByHeart products. Despite the recall, the FDA reports that ByHeart formula remains on store shelves in multiple states, including major retailers. Investigations are underway to determine how the formula became contaminated, with concerns that the outbreak may expand as officials review earlier cases.
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The Food and Drug Administration (FDA) is removing black box safety warnings from hormone therapy treatments for menopause, citing a review of recent scientific evidence. The warnings, which previously highlighted risks of cancer, dementia, heart attacks, and strokes, will be removed to increase accessibility and facilitate shared decision-making between patients and clinicians. Despite this change, systemic estrogen products still carry potential risks, and the American College of Obstetrics and Gynecology (ACOG) emphasizes the importance of individual consultations. The FDA’s decision, however, has drawn some criticism, as it bypassed the usual advisory committee process.
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A recall has been issued for specific lots of ByHeart Whole Nutrition Infant Formula after the FDA linked the product to a multi-state infant botulism outbreak. The recall includes two lots of the powdered formula with December 1 “use by” dates, following reports of 13 children being hospitalized since August. The FDA is advising parents and caregivers to discard the affected product and monitor infants for botulism symptoms, with cases reported across ten states. Although ByHeart has not confirmed a direct link through their own testing, they are taking this proactive measure, and the FDA is investigating the source of contamination.
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In a recent ruling, a federal judge in Hawaii found that the U.S. Food and Drug Administration unlawfully restricted access to mifepristone, a medication used for abortions and miscarriage management. The court determined the FDA violated the law by failing to provide a justified explanation for maintaining its restrictions, which include special certifications for prescribers and pharmacies. The ACLU, which brought the lawsuit, argued that the restrictions disproportionately impact patients with limited healthcare access, highlighting the medication’s safety and effectiveness. Although the FDA is instructed to reconsider its stance, the restrictions currently remain in place as the case navigates ongoing political pressures surrounding the medication.
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Health Secretary Robert F. Kennedy Jr. stated there is insufficient evidence to definitively link Tylenol to autism, despite previous warnings from the White House regarding its use during pregnancy. This comes after the state of Texas sued Tylenol maker Kenvue, alleging failure to warn consumers about potential health risks. Kennedy suggests a cautious approach to Tylenol use during pregnancy, citing suggestive studies while acknowledging a lack of conclusive proof of causation. The FDA is also reviewing the issue, acknowledging conflicting studies and planning to initiate a safety label change for acetaminophen.
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The FDA has approved another generic version of the abortion pill mifepristone, a routine regulatory step. This approval, announced by Evita Solutions, immediately drew criticism from anti-abortion groups and Republican politicians. Despite the FDA’s assertion of limited discretion in generic drug approvals and statements on the safety and efficacy of the drug, some conservatives have expressed concern. The approval of this additional generic version is unlikely to affect access to the drug, which is typically taken in combination with misoprostol, though access to the medication is already restricted in many states.
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The FDA recently approved a request to manufacture a generic version of mifepristone, a drug used in medication abortions, which has drawn sharp criticism from anti-abortion advocates. This approval allows Evita Solutions to produce its version of the drug, despite ongoing efforts to restrict access to mifepristone since the overturning of Roe v Wade. Critics, including some politicians and anti-abortion groups, have expressed outrage and questioned the FDA’s decision, citing safety concerns and recent studies. However, abortion rights supporters and medical professionals maintain that mifepristone is safe and effective, pointing to numerous studies supporting its use.
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Federal health officials are now targeting telehealth companies that promote unofficial versions of prescription drugs, including popular weight loss medications. The FDA issued over 100 letters to various drugmakers and online prescribing companies, like Hims & Hers, warning them to remove “false and misleading” promotional statements from their websites. Specifically, the agency took issue with claims that compounded products contain “the same active ingredient” as FDA-approved drugs. Furthermore, the FDA also addressed misleading advertising from manufacturers of GLP-1 drugs, including an infomercial featuring Oprah Winfrey.
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Next week, the FDA plans to present data suggesting a link between the COVID vaccine and 25 child deaths, according to a source. This data stems from the Vaccine Adverse Event Reporting System (VAERS), a database where anyone can submit reports of adverse events following vaccination, though reports are unverified. Critics, including vaccine policy experts, caution against drawing definitive conclusions from VAERS data, emphasizing the need for larger studies to establish causation. Concerns have been raised over the potential misuse of VAERS data to influence vaccine recommendations during the upcoming Advisory Committee on Immunization Practices (ACIP) meeting.
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John Q. Hosedrinker