In the Huffington Post, LegitScript’s President discusses the problem of unapproved drugs – medications that may have been “grandfathered in” to the US drug safety system, but have not been subjected to the same safety and efficacy evaluation as FDA-approved medicines.
In describing the problem, the article says:
Why are unapproved drugs so readily available in the US? To understand the problem, consider the history. The current drug approval process was launched in 1962, following a previous overhaul in 1938. Since 1962, the FDA has prohibited the dispensing of any prescription drug unless it has been proven safe and effective by a science-based system designed to put the patient’s safety first.
But in 1938 and again in 1962, Congress created a loophole for drugs already on the market – allowing drugs already in use prior to 1938, and then prior to 1962, to be “grandfathered in,” exempting them from the requirement to be proven safe or effective. Each time, the loopholes made sense: immediately removing nearly every existing drug from the market en masse would have left the United States bereft of the best medicines available at the time.
While it’s not to say that all unapproved drugs are safe or ineffective, the simple fact is that there is less certainty as to safety and efficacy, due to the absence of participation in the FDA drug-approval process. The article additionally states:
While it is true that there are a limited number of drugs not subjected to the FDA approval process for which no substitute exists and so they should continue to be available unless there is information that they are unsafe, we have to ask whether most of these once-reasonable exemptions have lived past their natural age, becoming great- and great-great-grandfather clauses. After all, science has evolved; new drugs have been approved; and our collective understanding of drug safety has improved beyond measure.
Read the full article here.