The FDA
Of the 144 studies the FDA has required under the program since 1992, 64 percent have been completed and more than one-third are still pending, according to the GAO. Investigators said the FDA does not rigorously track whether companies are making progress on their required studies, although the agency is improving.
FDA officials say they have overhauled their tracking system since the GAO completed its report. And an outside analysis by contractor Booz Allen Hamilton concluded last month that most companies are meeting their study requirements on time.
But in the case of Shire Laboratories’ low blood pressure treatment ProAmatine, the required study has gone incomplete for more than 13 years. The GAO found that ProAmatine has generated more than $257 million in sales, even though “the clinical benefit of the drug has never been established.”
Some companies are getting drugs fast-tracked by the FDA, making (at times a ton of) money and never completing the final studies. Yet the drugs, once placed on the market never get withdrawn. You be the judge.
