drug approval
What if, rather than being too stringent about drug approval, the FDA is not being stringent enough?
oracknows | February 12, 2017There is a belief that is very prevalent among policymakers right now, particularly Republican policymakers, that the key impediment to drug development is the Food and Drug Administration. According to this narrative, the FDA is an overly strict, overly bureaucratic, and rigid organization that is the main barrier keeping fantastic cures to all sorts of deadly and debilitating diseases from flowing to the people at a reasonable price. The basic idea, as I've discussed many times, is that, if only the FDA would get out of the way, universities and pharma would be free to open the floodgates…
oracknows | January 15, 2017One 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 have good reason to be, about Donald Trump's plans for the FDA. After all, consider the people who have been under consideration for the post thus far (that we know of). First, there was Jim O'Neill, a flunky of Silicon Valley venture capitalist…
oracknows | August 9, 2015I 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 missed the news on Friday, but once the story showed up in my news feeds over the weekend, I knew I had to make her today's topic. Here's the short version:
The sedative was Kevadon, and the application to market it in America reached the new medical officer at the Food and Drug Administration…
lborkowski | December 8, 2014Last week, the US Food and Drug Administration published a final rule that updates requirements for what prescription-drug information must disclose about potential effects for pregnant and breastfeeding women and their babies. Under the old labeling rules, drugs were placed in one of five categories -- A, B, C, D, or X -- depending on research findings (or lack thereof). An "A" designation meant that human studies did not find adverse effects in pregnant women or their babies, while and "X" designation meant that studies in humans or animals found a risk of problems to the baby and that…
ddobbs | January 5, 2009Ezra Klein relays Jim Manzi's worry that public funding of drug trials
exposes you to the inverse problems of the current system. Namely, "bureaucrats and politicians tend to have enormous career risk from an unsafe drug introduction, but almost none from a rejected drug that would have been effective had it been introduced...[it] would likely result in fewer new drugs being brought to market."
There's a bit to this. But it misses something important: The biggest problem with the present system may not be that deeply unsafe drugs are approved but that too many drugs that carry modest safety…