April 4, 2025 — On Tuesday, as part of mass firings, the powers that be at FDA lined people up to fire them. Security guards delivered the news. Clumsily. Now, just two days later, it seems they want a do over. The Washington Post reports the agency is trying to bring back a big chunk of people they fired: […]
April 2, 2025 — Yesterday was a profoundly sad day for people who care about American greatness in health. With a measure of gratuitous cruelty, the U.S. Department of Health and Human Services slashed 10,000 jobs, wiping out a stunning breadth of health expertise at FDA, CDC, and NIH. Robert Califf, an international expert in clinical research and cardiovascular […]
January 8, 2025 — Drug development for obesity may well be in a golden age. In large part, this is because the scientific understanding of obesity has grown exponentially in the past two decades. Unfortunately, little or none of that is reflected in new draft guidance from FDA, issued yesterday for public comment, on developing the next generation of […]
September 23, 2024 — FDA is working hard to push drug companies to get more diversity into the clinical trials that are the foundation for bringing new, safe, and effective drugs into the market. In June, the agency issued guidance for diversity action plans to improve the representation of marginalized populations. But unfortunately, it has nothing to say about […]
June 1, 2024 — This is a problem of human mistakes. Compounding pharmacies are exploiting the failure of pharmaceutical companies to meet the scale of need for effective obesity medicines. So people with a serious medical need for these medicines face a hideous choice. Suffer without them or take a chance on dodgy compounded products. The fact that this […]
