When my Smartphone delivered an e-mail at 5:12 p.m. on Friday: “FDA approv…,” I knew that FDA had just announced something controversial. All public relations people (including those at FDA) have been taught that late Friday is the time to release stories you don’t want to receive much attention.

Indeed, it was the 5-day emergency contraceptive pill, Ella, that was approved. So far, FDA seems to have achieved its goal of less coverage. But I was left wondering if the announcement required that treatment and why it led one advocate to describe the decision as “further evidence that the FDA is committed to restoring scientific integrity in its decisions.” (more…)

Tweet This Post

FDA supposedly swings back and forth between emphasizing “expedited approvals of promising therapies” and “extended pre-approval examination of every safety issue.” Current thinking is that FDA is now leaning more toward the safety end of this spectrum.

FDA Matters thinks a lot of this is perceptual. Approval decisions reflect FDA’s honest and relatively clear judgment on medical need, quality of the clinical data, and the risks and benefits of a specific product. Mostly, I can understand FDA’s decisions, even when I don’t agree. Still, there is a lot of tension within FDA and with various stakeholders about approvals versus safety risk. (more…)

Tweet This Post

FDA is working on an approval pathway for bio-similars, re-examining the way medical devices are reviewed, trying to upgrade the quality and speed of generic drug reviews and will soon be evaluating its process for granting accelerated approvals to drugs.

These seemingly unconnected activities all have in common that they are supposed to be abbreviated processes to get new products to patients more quickly without risking safety or quality problems. FDA Matters thinks FDA should articulate its philosophy about how these short-cuts should work and what standards apply in all instances. (more…)

Tweet This Post