Outside experts have proposed additional ideas to improve the FDA’s work: eliminating the current drug company fees that support new drug reviews to minimize conflicts of interest, mandating post-approval studies to look for uncommon adverse events (phase 4 studies), providing more information on relative efficacy of new drugs compared with current medication treatment and attention to real clinical outcome end points, and prohibiting direct-to-consumer advertising in the first 3 years after a new drug is released.13
Considering the turmoil surrounding the FDA’s performance right now, it is very possible we will see some of these proposed changes come to pass. Given the importance of prescription medications, these changes will be very relevant to the practices of family physicians and their patients’ health.
CORRESPONDENCE
Eric A. Henley, MD, MPH, Department of Family and Community Medicine, University of Illinois College of Medicine at Rockford, 1601 Parkview Avenue, Rockford, IL 61107-1897. E-mail: ehenley@uic.edu