Unproven Drugs Not Followed Up On by FDA
Posted by PKSD Law Firm on Oct 27, 2009 in Dangerous Drugs
The following is an article that was published in the Chicago Tribune on October 26, 2009.
FDA is rebuked on drug follow-up
The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients lives, the Government Accountability Office says.
A GAO report due out today also says the FDA has never pulled a drug off the market because of a lack of required follow-up about its benefits even when such information is more than a decade overdue.
The GAO says the FDA should do more to track whether drugs approved based on preliminary results actually have lived up to their promise.
For a more in-depth look at the story, please click here.
The FDA responded that the report paints an overly negative picture of its accelerated approval program, which is used to approve drugs only for the most serious diseases.is rebuked on drug follow-up