In a post entitled The Path Forward: Coronavirus Treatment Acceleration Program (here) penned by FDA Commissioner Steven Hahn, CBER M.D., Director Peter Marks, M.D., Ph.D., and CDER Director Janet Woodcock, M.D., the FDA describes the accelerated actions the Agency is taking to move the most promising therapeutic treatments to patients as quickly as possible.
Just to give you an idea of how fast things are moving, in an April 8 post written just 14 days ago (here) it was reported that 10 FDA sanctioned clinical trials were ongoing, in the article cited above it is noted that there are now “72 clinical trials of potential therapies for COVID-19 underway with FDA oversight”. Talk about lightning speed!
The Agency is looking at treatment, vaccines, preventative interventions, products that reduce inflammation to limit the COVID 19’s viral damage to the lungs and various antibody treatments using plasma and hyperimmune globulin to treat the most seriously ill patients. Normal review paradigms are being put aside and FDA’s attention is immediate when reviewing INDs and various protocols and providing guidance to firms, and hopefully, soon we may see some emergency use authorizations ahead of NDAs and BLAs if the data supports a strong presumption or finding of safety and efficacy.
FDA’s concerted and increased cooperation with industry and the urgency with which both parties are attacking this pandemic has not been seen since the attack on HIV and the protests outside of the Parklawn building, FDA’s old headquarters. FDA has moved even faster during this attack on public health as the science, technology and analytical tools have improved drastically since those days.
Time to give credit where credit is due (to the FDA and expert scientists of this nation – I won’t mention any names here but AF comes to mind) and it is also time to listen to the medical experts and not let the politicians try to practice medicine. Many of which have not even shown the ability to govern effectively.
