7 ms·
I never understood why the FDA won't approve drugs that improve an aspect of our body, but only those that treat something.
by jakeonthemove 14y ago
I never understood why the FDA won't approve drugs that improve an aspect of our body, but only those that treat something.
- refurb 14y agoA lot of it comes down to the risk vs. benefit equation. The FDA decides to approval/deny new drug for marketing by (attempting) to balance the benefits of the therapy with the drawbacks. This is why a drug like Tysabri (used to treat MS) can cause a potentially fatal brain infect (PML) and the FDA still gives it an "OK" to be marketed. And it's also the reason why it's so hard to get obesity drugs approved. Huge population + small risk = a lot of patients harmed. The FDA considers a healthy human to be the "optimal outcome". If you want to improve an aspect of human health beyond that, you'll have to show that there are zero risks associated with it.