Life in the biotech fast lane is good for investors, not so great for patients--or so says the Cleveland Plain Dealer after a seven-month investigation of the FDA's record on fast-track drugs. Created in 1998, the fast-track designation was held out as a potential savior for patients with life-threatening illnesses. Helpful drugs could make it to market more quickly, rescuing victims of serious disease.
That's not how it's worked, though. The fast track hasn't increased the number of drugs approved or put them on the market faster, the newspaper concluded after poring over government documents. Instead--in a manifestation of the law of unintended consequences--the designation has lined the pockets of day traders, hedge funds, and executives who get stock options when the FDA shuttles one of their drugs into the express lane.
Meanwhile, many of the drugs in that express lane were subsequently scrapped by their developers, and the FDA only ushered a small number of them onto the market.
- read the report [1] from the Cleveland Plain-Dealer
Related Articles:
EU, U.S. regulators offer single orphan drug path. Report [2]
The FDA: Caught between a rock and a hard place. Report [3]
New drug approval lags in 2007. Report [4]
FDA quick to reject drugs as it gets more cautious. Report [5]
Industry exec says FDA approval process too strict. Report [6]
Links:
[1] http://www.cleveland.com/news/index.ssf/2007/12/fdas_fast_track_designation_mo.html
[2] http://www.fiercebiotech.com/story/eu-u.s.-regulators-offer-single-orphan-drug-path/2007-11-27?utm_medium=nl&utm_source=link
[3] http://www.fiercebiotech.com/story/fda-caught-between-rock-and-hard-place/2007-11-09
[4] http://www.fiercebiotech.com/story/new-drug-approval-lags-2007/2007-11-02?utm_medium=rss&utm_source=rss
[5] http://www.fiercepharma.com/story/fda-quick-reject-drugs-it-gets-more-cautious/2007-08-20
[6] http://www.fiercebiotech.com/story/industry-exec-says-fda-approval-process-too-strict/2007-08-01