TY  - JOUR
T1  - OVersight of fast-track drug approval by fda stuck in low gear, critics say
AU  - Mitka M
Y1  - 2010/10/27
N1  - 10.1001/jama.2010.1486
JO  - JAMA
SP  - 1773
EP  - 1775
VL  - 304
IS  - 16
N2  - 
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.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2010.1486
UR  - http://dx.doi.org/10.1001/jama.2010.1486
ER  -