Prescription drug advertising has increased year after year, but are THE ads really effective? The FDA is requiring a statutory requirement that in human prescription drug advertisements presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads), the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner.
When developing a new drug, the path to FDA approval is a long and complex journey, often taking years. The process is designed to rigorously evaluate the safety and efficacy of drugs before they can be marketed to the public. Here’s why it takes the FDA a lot of time to approve drugs.
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.
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?