Law In The News
The perils (or not) of fast-tracked drugs by the FDA
According to an article posted in the British medical journal last year, 253 drugs have been fast tracked for for FDA approval since 1992 but nearly have have been shown to deliver minimal, if any, effect.
The New York Times reported yesterday (“Do Fast- tracked Drugs Need More Scrutiny?”) Science Section Page 1, 3/29/22) focused on a pending claim by 13 plaintiffs against AMAG Pharmaceuticals, an early manufacturer of the drug Malena which was touted to forestall preterm births and improve fetal health, which didn’t hit the mark, and supports the view by some that science, not speed, should dictate the approval of drugs by the FDA before they are unleashed on an unsuspecting public.
The news here, is that this is not really news. The clams about big pharma rushing its drugs to market has long been an issue. Take for example the controversial drug Aduhelm which promises relief to Alzheimer’s patients and was fast-tracked by the FDA in the wake of a slew of criticism from the medical community that the drug doesn’t deliver.
Fast-tracking by the FDA has been around for thirty years and has given an edge in certain cases (such as HIV and AIDS in the 1990s).
Many of these fast-tracked drugs come onto the market with only a limited amount of research confirming efficacy and safety, but the manufacturer is expected to continue its clinical trials and safety studies following this interim approval to verify the clinical benefit.
This accelerated pathway process is critically important to patients suffering from serious and often life- threatening diseases who would otherwise be denied access to medications which remain unavailable until the completion and submission of all FDA mandated efficacy trials…a process which is often years in the making.
Many physicians continue to support the fast-track pathway for just that reason.
So, the quandary remains: for those who have been injured, do we support their position that fast-tracking is a dangerous process which would be abated, or do we ask those desperate individuals clinging to the hope that a new accelerated drug is the answer to their prayers?