There is a tension inherent in the drug approval process between the desire to approve new drugs rapidly in order to treat suffering people and the need to be cautious, to make sure that new drugs are safe and effective before they are approved for sale. This weighing of the risks of too-rapid approval of […]
All of the candidates being considered by President Trump for FDA Commissioner believe that the FDA is too strict in its standards for approving new drugs. In a commentary in Nature last week, two bioethicists argued that, at least in terms of preclinical data, the standard of evidence is actually too low. Which is correct?
One of the most important, if not the most important, officials in the federal government responsible for applying science-based medicine to the regulation of medicine is the FDA Commissioner. As you might imagine, particularly after his having met with antivaccinationists like Andrew Wakefield and Robert F. Kennedy, Jr., I am concerned, and I think I […]
I learned over the weekend that a historic figure in science-based medicine has died. If you know anything about the history of the Food and Drug Administration (FDA), you will know this woman’s name, Frances O. Kelsey, MD, PhD. It turns out that Dr. Kelsey died on Friday at the age of 101. Somehow I […]