Is the FDA getting gun-shy? The agency has rejected so many drugs this year--and slapped warnings on so many others--that industry observers suspect the agency of a self-preserving caution [1]. It's approved only 61 percent of drug applications so far this year, compared with 73 percent during the same period of 2006, according to BioMed Tracker. New molecular entities--drugs based on totally new chemical compounds--have perhaps fared worst. Only seven have been given the FDA go-ahead this year, compared with an average of 12 during the same seven months of every year since 1998.
None of this is news to battle-scarred drug companies, from Big Pharma on down. But the FDA says it hasn't made any systematic changes in its drug review process. Some experts say the jury's still out. Besides, with so many drugs getting pulled offstage after the show's already started, pre-opening night jitters might not be an excess of caution, but an increase in common sense.
- read the article [2] from The Baltimore Sun
Related Articles:
Industry exec says FDA approval process too strict. Report [3]
Poll finds problems at the FDA. Report [4]
FDA offers safety reforms to skeptical lawmakers. Report [5]
IOM slams FDA, calls for major reforms. Report [6]
Links:
[1] http://www.fiercebiotech.com/story/report-faults-fda-s-postmarketing-vigilance/2006-07-10
[2] http://www.baltimoresun.com/features/health/wire/sns-ap-fda-drug-rejections,0,837513.story
[3] http://www.fiercebiotech.com/story/industry-exec-says-fda-approval-process-too-strict/2007-08-01
[4] http://www.fiercebiotech.com/story/poll-finds-problems-at-the-fda/2006-07-21
[5] http://www.fiercebiotech.com/story/fda-offers-safety-reforms-to-skeptical-lawmakers/2007-01-31
[6] http://www.fiercebiotech.com/story/iom-slams-fda-calls-for-major-reforms/2006-09-22