FDA is proposing to withdraw the "unproven" drug ProAmatine used to treat low blood pressure because the company producing this drug (Shire in Ireland) got it approved "fast-track" with some promising "early" results but never then confirmed the finding with a more rigorous trial. (AP report via Yahoo!)
ProAmatine has been on the market for 14 years, and Shire has made over $200 million in revenues from it. (This is not a "blockbuster" drug.)
I may be wrong about this but the number 14 rings a bell. Isn't it the term of a patent? So the drug developer gets to enjoy monopoly rent during this term, and thereafter, generic drugs are allowed to compete in the market, and prices collapse. Cynical I say Shire is laughing all the way to the bank.
GAO said the FDA has never before forced any drug company to withdraw a drug due to missing or unimpressive data.