"To improve the necessary measures to monitor the safety of marketed drugs, the drug approval process must be decoupled from the postmarketing safety and surveillance system. It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong (i.e., that the decision to approve the product was subsequently shown to be incorrect.) One option worth strong consideration, as others have suggested, is to establish an independent drug safety board or independent agency for drug safety, specifically to oversee postmarketing surveillance for drugs and devices." … "Above all, the agency must be completely independent of influence from the pharmaceutical industry, biotechnology firms, and medical device manufacturers."
"The postmarketing surveillance system requires a long overdue major restructuring. Until that occurs – as indicated by the articles in this issue of JAMA, as epitomized by recent evidence of serious harms from widely used and heavily promoted medications, as demonstrated by the influence of industry over postmarketing data, and as illustrated by the lengths to which some manufacturers will go to protect their interests – the United States will still be far short of having an effective, vigilant, and trustworthy system of postmarketing surveillance to protect the public."
(JAMA. 2004;292: 2647 – 2650. Available post-embargo at JAMA.com .)
JAMA