Is FDA approval over-rated? Not everyone is aware of the fact that it usually takes ten years and approximately 100 million dollars to fully bring a new pharmaceutical through Phase1 to Phase 3 trials, and ultimately to the marketplace. This process, of course includes the acquisition of approval by the Food and Drug Administration of the pharmaceutical. Is there a quicker and more efficient process?
Alternative pharmaceuticals or therapies for various ailments are available from other countries, if one is not precluded from traveling abroad. But this is a cumbersome solution because one might have to be separated from his or her immediate family at a time when they may especially need their support. If the pharmaceutical or therapy is available to a patient abroad, why have US companies and hospitals not become aware of these alternatives and incorporate them into their own treatment regimes. Many times, the reason is that FDA approval has not yet been granted. But, in actuality, maybe that they have not yet attained this FDA approval because they have not yet spent the requisite time and money to push them through and time-consuming and arduous process.
Maybe the US FDA requirements are too exacting and many times unnecessary. What about the children (or any patients for that matter) that can be saved from unregulated treatments; and whose lives will be ultimately lost because they have to wait for official FDA approval. It’s a complicated problem, because some scientists would argue that there may be extreme side effects. But, who is one to believe. The population which will adhere to the conservative approach of inaction; rather than losing a life to the side-effects of a given treatment; or the enthusiastic individuals who would take the risks of a given therapy, without spending the now requisite time and money of experimenting on the therapy completely. Time will tell.