New FDA Craziness
October 12, 2006
An analysis by the Institute of Medicine found that the federal system for approving and regulating drugs has serious problems, and dramatic changes are required to fix them.
The report fixed the blame on the FDA, Congress, and the pharmaceutical industry, and called on all of them to share responsibility in implementing solutions.
Several of the suggested changes are ones that have been requested for many years by drug safety advocates.
Many of the recommendations would require Congressional approval to enact, including such changes as:
- FDA commissioners would serve a single six-year term
- Newly approved drugs would include black triangles on their labels, warning consumers their safety was still in question
- New drugs would only be approved for five years, at which point the FDA would review their safety
- A ban on advertising would be in effect while drugs remain on this probationary period
The panel also recommended that a substantial majority of FDA advisory panel members not have industry ties, and suggested that manufacturers should be required to produce the outcomes of all studies, not just those published in medical journals. Studies that show positive results for a drug are more likely to be published.