New FDA Rules
Byline: THE WASHINGTON TIMES
The Food and Drug Administration this week took sensible steps toward 21st-century medicine by requiring that prescription-drug package inserts be more readable and less threatening. Drug companies initially wanted to keep the current mumbo-jumbo of chemistry and legalese for fear of lawsuits.
But the FDA persisted, maintaining reasonably and courageously - particularly in this era when a single senator from Iowa knows he can spuriously trash the agency about heartworm medicine and get media coverage - that an FDA approval is not just a minimum standard of safety. It is an evaluation, based upon the best science available or the relative risks and benefits of each medicine. Failure to clearly convey both aspects of a medicine could "discourage appropriate use of a beneficial drug." Further, the FDA signaled that the package insert is a temporary method for providing consumers and doctors information, in an era when new insights into the best use of medicines are now being revealed through the use of genetic tests and post-market studies analyzing genetic variations in drug response. (The labeling information will be updated daily for free at the National Library of Medicine at http://dailymed.nlm.nih.gov.)
Finally, the FDA makes clear that it will assert its authority defended vigorously by the Clinton administration and upheld by several circuit and appellate courts - as the ultimate authority about what makes a medicine safe and effective. …