RT Journal
A1 Mitka M
T1 OVersight of fast-track drug approval by fda stuck in low gear, critics say
JF JAMA
JO JAMA
YR 2010
FD October 27
VO 304
IS 16
SP 1773
OP 1775
DO 10.1001/jama.2010.1486
UL http://dx.doi.org/10.1001/jama.2010.1486
AB 
But the system does not always work as planned. A company with a product that was approved this way and that is already generating revenue has little incentive to conduct a postmarketing study that may or may not validate the drug. And even if a company cannot produce a postmarketing trial showing efficacy, the FDA will still have a hard time removing a drug from the market, as patients, who may believe the drug is helping them, make their worries known to the agency, the media, and elected officials.