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 and drug studies
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.
GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Since when is consumer behavior ever scientific?
SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post, says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science?
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.
HEY NOW: The number of people who said that they would get a COVID vaccine is dropping rapidly because they don’t trust the FDA, drug companies, or the government to approve fully tested medications. This is going to affect DTC in a big way.
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?