Pharma companies taking part in the Food and Drug Administration's accelerated approval process for new drugs routinely fail to complete post-marketing studies required by the agency, a Congressional review has found. The review, conducted by Rep. Edward Markey (D-Mass.), looked at studies required under the program between 1993 and October 2004. Markey's staff found 46 of the 91 clinical trials ordered during that period had not yet been completed. Markey is a sponsor of legislation which would authorize the FDA to order pharma companies to conduct post-marketing studies of drugs with questionable safety records.
- see this story [1] from the Boston Globe
Links:
[1] http://www.boston.com/business/articles/2005/06/01/speedy_drug_review_process_broken/