The “times are changing,” but has the FDA remained in the past? Aduhelm, the failed Bioigen drug, should never have been approved, and the FDA’s guidance on DTC needs to be revised. The FDA needs new leadership and a visionary to lead the agency.
Category Archive: FDA
The FDA has approved an Alzheimer’s drug that slowed the rate of cognitive decline in clinical trials without using an advisory committee. The high drug cost — priced at $26,000 per year, Eisai said — combined with strict restrictions on reimbursement by US government-funded health schemes will severely limit the number of patients able to access the medicine, at least for now. What is going on here?
ALS is a fatal neurodegenerative condition that affects chewing, talking, and walking, progresses to paralysis, and culminates in respiratory failure, typically within three to five years. An estimated 30,000 Americans live with ALS, sometimes called Lou Gehrig’s disease. On Sept. 29, the Food and Drug Administration approved Relyvrio from Amylyx Pharmaceuticals. It’s the first ALS medication to be approved in five years and only one of three currently prescribed to patients to slow the progression of the disease, but should it have been approved?
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?