Following criticism about the failure of the Food and Drug Administration to react to warnings and concerns by their own officials about the safety of some drugs and worries that it is linked too much to the pharmacology industry to make unbiased decisions, the FDA announced on November 5th that a top scientific review body is to take a look at their drug safety systems.
In response to fierce criticisms the FDA has also announced that it is going to set up drug safety review procedures that can be accessed by internal officials as well as external experts to warn about drug concerns. This follows two high profile cases; one involving long delays in warning about possible suicide risks poised by antidepressant used to treat children and teenagers and the FDA's slowness in responding to evidence that long term use of the analgesic Vioxx poised significant cardiac risks in some individuals.
The respected British medical journal, The Lancet, launched a stinging review of drug safety systems, calling the Food and Drug Administration, 'ruthless and irresponsible in its self interest' because of its failure to demand the removal of Merch & Company's popular painkilling drug Vioxx.
The FDA's change in its drug safety procedures have been welcomed. The FDA is going to employ the Institute of Medicine, part of the National Academy of Sciences, to look at how the FDA access side effects and risks of marketed drugs. There are many people who remain concerned that unless an independent body is created to approve and monitor drugs then the public will continue to be served by an agency with significant problems in the balance between the pressure to approve of new drugs and the monitoring of public health and safety.
