The firing of FDA staff involved in reviewing Neuralink’s applications, allegedly coinciding with layoffs at DOGE, raises serious concerns about potential conflicts of interest and regulatory capture. The timing is undeniably suspicious, leading many to question whether these dismissals were merely coincidental or a deliberate attempt to influence the regulatory process.
The narrative that Elon Musk holds no legal authority over DOGE and therefore couldn’t orchestrate these firings seems questionable, given the interconnectedness of his business empire and the influence he wields. The sheer scale of resources and power at his disposal makes it difficult to dismiss this as a simple coincidence.… Continue reading
Over the weekend, approximately 20 FDA employees in the office of neurological and physical medicine devices were terminated, impacting the agency’s review of medical device applications, including those from Neuralink. While the firings weren’t explicitly targeted at Neuralink reviewers, the loss of these employees, many of whom worked on Neuralink’s applications, will hinder the agency’s efficiency and potentially compromise safety. These probationary employees were dismissed despite positive performance reviews, raising concerns about the process and potential implications for Neuralink’s clinical trials. Outside experts express worry about the impact on the safety of trial participants.
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Following a judge’s order, federal health agencies have reinstated numerous webpages and datasets previously removed due to a presidential executive order mandating the use of “sex” instead of “gender.” The restored information includes CDC data on adolescent health, HIV, and environmental health disparities, as well as FDA guidelines on gender in clinical trials. This action comes after a lawsuit filed by Doctors for America, alleging the removal of vital public health information. While some material has been restored, some links remain broken, indicating that the process is not yet fully complete.
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Following a lawsuit by Doctors for America, a federal judge issued a temporary restraining order compelling the Department of Health and Human Services, CDC, and FDA to reinstate previously removed webpages and data. The judge found that the agencies’ actions, taken in compliance with President Trump’s executive order on gender ideology, likely violated federal law guaranteeing public access to information. This removal of vital health information, the judge argued, disproportionately harmed underprivileged Americans seeking healthcare. The agencies were ordered to restore the websites by 11:59 p.m. Tuesday, pending further litigation.
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The Trump administration, through HHS deputy chief of staff Stefanie Spear, has instructed federal health agencies, including the FDA, CDC, and NIH, to halt external communications. This sweeping order encompasses routine reports, website updates, and health advisories, with little explanation provided regarding its scope or duration. While temporary communication pauses are not unprecedented during transitions, the scale of this directive is unusual, raising concerns about potential delays in critical public health information dissemination. The timing is particularly notable given ongoing public health issues like the H5N1 bird flu outbreak.
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Due to resolved shortages of Eli Lilly’s weight-loss and diabetes medications, Zepbound and Mounjaro, the FDA has ordered a phase-out of copycat versions sold by specialty and online pharmacies. This decision, effective within 60-90 days, benefits Lilly and potentially impacts patient access and costs. The FDA cited improved supply and safety concerns regarding the compounded drugs as reasons for the action. This reversal follows an earlier decision that was met with public opposition and legal challenge.
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The Food and Drug Administration has proposed removing oral phenylephrine, a common ingredient in over-the-counter cough and cold medicines, from the market due to its ineffectiveness as a nasal decongestant. This decision follows the agency’s own scientific review, which found that oral phenylephrine is poorly absorbed into the bloodstream and its effectiveness is questionable, contradicting earlier studies. The FDA is seeking public comment on this proposal, and if finalized, manufacturers will need to remove or reformulate products containing oral phenylephrine. While the FDA considers oral phenylephrine safe at current levels, it acknowledges that higher doses would be needed to achieve any meaningful effect, raising safety concerns.
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Robert F. Kennedy Jr., a former presidential candidate and potential member of President-elect Donald Trump’s Cabinet, has called for the elimination of the Food and Drug Administration’s nutrition departments, citing their alleged failure to protect children from unhealthy food choices. He specifically criticizes the inclusion of numerous ingredients in U.S. products like Froot Loops, contrasting them with the simpler ingredients found in Canadian versions. Although Kennedy acknowledges the need for congressional approval, he plans to tackle perceived “corruption” within the FDA, believing that a healthier nation will result from reduced government interference. Trump has expressed support for Kennedy’s potential role in addressing health issues within the administration.
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Robert F. Kennedy Jr.’s potential appointment to a prominent position within the U.S. government, specifically overseeing public health, has sparked intense fear and outrage amongst many Americans. The concern stems from his outspoken skepticism surrounding vaccines and his ardent opposition to government regulations, which are seen as crucial for protecting public health.
RFK Jr.’s proposed role has prompted the fear that entire departments at the Food and Drug Administration (FDA) might be dismantled or radically restructured. This fear is rooted in the belief that under his leadership, the FDA, a vital agency responsible for ensuring the safety and efficacy of food, drugs, and medical devices, could become significantly weakened.… Continue reading
The FDA recently made the decision to reject the use of MDMA-assisted therapy for the treatment of PTSD, citing a myriad of concerns including poorly designed studies and allegations of sexual misconduct. As someone who works in the clinical trial space, I understand the strict guidelines and the importance of well-designed studies when it comes to getting approval from regulatory bodies like the FDA. It’s clear that the issues within the studies conducted for MDMA therapy need to be addressed before any progress can be made.
The therapeutic potential of MDMA for individuals struggling with PTSD is undeniable. I’ve heard firsthand accounts of the emotional breakthroughs and healing that can occur when utilizing this drug in a therapeutic setting.… Continue reading
Matt Underwood 
John Q. Hosedrinker