The FDA has approved lenacapavir, marketed as Yeztugo, a groundbreaking twice-yearly injection offering nearly complete protection against HIV. This capsid inhibitor, recognized as a major scientific breakthrough, has the potential to end the 44-year-long epidemic. To ensure global access, the manufacturer has entered royalty-free licensing agreements with generic drug producers and will supply the drug at no profit to countries in need, in partnership with the Global Fund. This preventative medication aims to transform HIV prevention by addressing adherence and stigma challenges associated with previous PrEP regimens.
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Newly released FDA documents reveal that the government’s top vaccine official, Dr. Vinay Prasad, under Health Secretary Robert F. Kennedy Jr., restricted the approval of two COVID-19 vaccines, Novavax and Moderna, overriding recommendations from government scientists. These scientists had initially planned to approve the shots for individuals 12 and older, concluding the benefits outweighed the risks. However, Prasad decided to limit the vaccines to those at higher risk, such as seniors and those with underlying medical conditions, citing concerns about potential side effects and reconsidering the benefits in light of changing infection rates. This decision is part of a series of vaccine restrictions imposed by officials under Kennedy.
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The Trump administration announced a significant policy shift, eliminating routine annual COVID-19 vaccinations for healthy younger adults and children. This new FDA framework mandates extensive clinical trials before approving updated vaccines for this group, prioritizing those 65 and older or with underlying health conditions. The decision raises concerns about vaccine accessibility and potentially contradicts established FDA procedures by preemptively influencing the CDC’s advisory panel. This approach marks a departure from the previous “one-size-fits-all” strategy and aligns with a more restrictive stance on COVID-19 vaccination.
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US Health Secretary Robert F. Kennedy Jr. has directed the FDA to review mifepristone regulations based on new data from a flawed, non-peer-reviewed analysis. This analysis, promoted by anti-abortion groups, alleges higher complication rates than previously known, prompting calls to reinstate prior restrictions or remove the drug entirely. The data significantly overstates risks, including misclassifying ectopic pregnancies as complications of mifepristone. Anti-abortion groups intend to use this analysis to pressure the FDA and lawmakers to severely limit mifepristone access, potentially through ending telemedicine prescriptions as a first step. Despite over 100 studies confirming mifepristone’s safety and effectiveness, this campaign aims to significantly restrict access to the abortion pill.
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The FDA announced plans to phase out ingestible fluoride supplements for children, citing potential risks to gut health and possible links to decreased IQ, despite previous studies showing no serious health risks. The agency will request manufacturers voluntarily remove these products, initiating a process that could take years. This action follows Health Secretary Robert F. Kennedy Jr.’s campaign against fluoride and comes as some states are removing fluoride from their water supplies, potentially increasing the need for supplements. The FDA’s plan does not affect other fluoride-containing dental products.
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Due to reduced capacity within the FDA’s food safety and nutrition division, a quality control program for dairy product testing has been suspended. This suspension follows the termination of 20,000 Department of Health and Human Services employees and impacts multiple food safety programs, including bird flu and pathogen testing. The suspension affects the proficiency testing program for Grade “A” milk and related products, highlighting a significant setback for food safety oversight. This reduction in capacity comes despite a long history of FDA efforts to ensure the safety of the nation’s milk supply.
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During a 40-minute address to FDA staff, Robert F. Kennedy Jr. used a disability slur, promoted “deep state” conspiracy theories, and accused the agency of being controlled by the industries it regulates. His remarks, which included invoking the Milgram experiment and downplaying the severity of the measles outbreak, shocked employees, with some reportedly walking out. An HHS spokesperson defended Kennedy’s statements, claiming he was advocating for transparency and accountability within the FDA. This incident follows recent mass firings at the FDA and adds to the ongoing controversy surrounding Kennedy’s tenure.
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Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, resigned after being given an ultimatum to resign or be fired by HHS Secretary Robert F. Kennedy Jr. Marks’ letter cited a lack of desired “truth and transparency” under Kennedy’s leadership. This forced resignation, along with other recent HHS actions, has raised serious concerns from health experts who fear a decline in scientific rigor and transparency within the FDA. The move follows HHS’s request for a CDC study on vaccines and autism, despite existing evidence refuting a link.
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RFK Jr.’s actions regarding Peter Marks, the FDA’s top vaccine scientist, are deeply concerning. Marks’ resignation letter paints a disturbing picture, alleging that truth and transparency were not valued by the Secretary, who instead preferred subservient agreement with misinformation and lies. This suggests a deliberate attempt to undermine the scientific integrity of the FDA, a crucial institution for public health.
The situation is further aggravated by RFK Jr.’s hiring of a widely discredited vaccine researcher as a senior data analyst at HHS. This appointment, tasked with investigating the debunked link between vaccines and autism, represents a blatant disregard for scientific consensus and fuels the spread of dangerous misinformation.… Continue reading
FDA staff are struggling to meet product review deadlines, a situation exacerbated by recent significant layoffs. The sheer number of employees let go is staggering, adding to already existing staffing shortages and creating a perfect storm of delayed approvals. This isn’t just impacting review times; it represents a systematic weakening of regulatory oversight.
The reduced workforce directly translates into a longer wait for product approvals. This backlog means medical devices and pharmaceuticals are taking significantly longer to reach the market, potentially delaying access to vital treatments for patients. The impact extends beyond simply slowing down the process; it introduces a significant risk to public health.… Continue reading
John Q. Hosedrinker 
Matt Underwood