Tag: accelerated approval
COVID-19 contrarian Dr. Vinay Prasad meets real world responsibility
Dr. Vinay Prasad parlayed his COVID-19 contrarianism into a high-ranking position in the FDA. Now he's facing real world responsibility, and knives are out for him. Can he survive?
The FDA’s accelerated drug approval program is failing to protect cancer patients
Drug approval is a process that should be and, for the most part, is rooted in rigorous science. However, there is always a countervailing pressure to approve new drugs rapidly, particularly in cancer. That's why the FDA created the accelerated approval program in the early 1990s. Unfortunately, increasingly this approval process appears to be failing us in oncology. Reform is needed.
When Drugs Cost Too Much
Our ability to develop new drugs is fast outstripping our ability to pay for them; some are exorbitantly expensive and not very effective. Funds are limited, and as a society we need to have a serious discussion about how they are to be allocated.