Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Do patients care? No.
- The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs.
- The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process.
- The FDA has been under criticism, but an internal investigation will focus on approval processes, not “why” a drug was approved.
- Our healthcare system cannot continue to support marginally effective drugs. We need to learn to say NO.
- Drug companies know how to play the system.
SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. In the meantime, caregivers are going to put their hope in a drug that doesn’t work and in garbage science with cherry-picked data.
SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs.
QUICK READ: In a major development, a Japanese pharmaceutical company has started the final stages of human trial for its antiviral flu drug to treat COVID-19. But will their clinical trials meet the criteria for new drug approval for the FDA if successful?