FDA & Trump at Odds Over “Fast Track” Cure?Print This Post
Desperate times call for desperate measures. In an effort to gain control of the Coronavirus pandemic, President Trump is issuing an executive order to expand the use of investigational drugs for a possible cure. This decision is being met by objections from the Food and Drug Administration (FDA) concerned over risks the drugs could pose to patients. But is this dispute real and should we trust the FDA?
During such an unsettling time in our country, the public should be aware there is more than meets the eye.
Long before Trump came into office, the FDA introduced a process meant to “curtail the duration in drug regulation and approval process, and to facilitate the discovery and marketing of drugs targeted for serious or rare diseases and to accelerate the approval of molecules showing superior efficacy than the existing one.” This practice is referred to as “Fast Track” and it was introduced back in 1988. Fast track is intended for situations such as the coronavirus, when there is an unmet medical need. So why is the FDA acting like this is unheard of? Why is the FDA all of sudden concerned about Fast Track and drug safety? If the FDA really cared about drug safety, they would educate the public on the MedWatch program, a program designed specifically to track adverse side effects.
Medwatch is intended to benefit the consumer, who can report directly to the FDA any adverse side effects. Medwatch is used by the FDA to publish safety alerts, guidelines on these products, and work with the drug manufacturers to create safer medications. Medwatch is such an important life-saving tool for the consumer, particularly at a time like this, yet few people know it even exists. One must ask, why isn’t the FDA educating the public and lawmakers on MedWatch? It is almost a sure bet that President Trump isn’t even aware of the MedWatch consumer reporting program.
Fact, adverse drug reactions are a leading cause of death, claiming 350 lives each day.