Drug Companies Fail to Carry Through on Post Marketing Safety Trials
In an effort to speed up the drug approval process, the FDA allows companies to perform safety studies after the drug has been approved and is on the market. However, many promised studies are never performed. A recent NY Times articles uncovered that hundreds of these studies have been pending for years, with no follow up by the drug companies.
The problem is that there is little incentive to follow through on the post-marketing studies. The studies are very expensive, and there is little threat of reprisal from the FDA if the studies go unfinished. The FDA's only recourse is to withdrawal the drug, which is considered so drastic that the notion is never considered in these circumstances.
Read the NY Times article here.
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