Developing and winning regulatory approval for new medicines can now take as long as it takes to raise a child to adulthood. But, can we make the FDA’s standards flexible enough to allow vital new drugs onto the market in a timely fashion, yet strict enough to protect us from potentially dangerous medicines?

Sidney Wolfe of Public Citizen’s Health Research Group and Kenneth Kaitin, a professor at the Tufts University School of Medicine look at challenges of developing — and approving — new medicines.....

.........The approval process for drugs is heavily tilted toward establishing evidence of benefit, but statistically underpowered to detect all but the most commonly occurring harms. Consequently, a number of new drugs have been withdrawn when dangerous, sometimes fatal, side effects are discovered, often within their first seven years after release. Also, serious new adverse reactions or drug interactions that require stronger warnings are usually detected within the first seven years after a drug’s release.

http://cognoscenti.wbur.org/2013/12/...kenneth-kaitin