Proposal for the FDA: Regulate Safety, Not Efficacy
This is from an editorial by Andy Grove, former CEO of Intel:
The biomedical industry spends over $50 billion per year on research and development and produces some 20 new drugs….A breakthrough in regulation is needed to create a system that does more with fewer patients.
While safety-focused Phase I trials would continue under their [FDA] jurisdiction, establishing efficacy would no longer be under their purview. Once safety is proven … the response of any patient or group of patients to a drug or treatment would be tracked and compared to those of others in the database who were treated in a different manner or not at all. These comparisons would provide insights into the factors that determine real-life efficacy: how individuals or subgroups respond to the drug. This would liberate drugs from the tyranny of the averages that characterize trial information today.
More analysis and references by Alex Tabarrok at Marginal Revolution.
Why approve a drug if it’s not effective at something? I’m not sure that these regulations are a great idea.
The current efficacy standards aren’t too terrible stringent as it is. They give consumers a false sense of safety. Vioxx was a huge drug that everyone thought was safe, but the FDA missed that one by a long shot.
The whole process is convoluted.
Good idea.
The FDA should definitely keep its hands off of vitamins and nutritional supplements. I