More user fees paid to the FDA by the drug industry and the push for less rigorous scientific proof in clinical trials may lead to faster drug approvals, but also more deaths due to side effects. Where’s the balance between speed and safety?
For the last few years I have been tracking data from the FDA regarding how much money it collects from the drug industry in prescription drug user fees to see those payments influence more than just how quickly the FDA is able to approve new drugs for marketing.
One stark correlation I noted with the rise in user fees was the sharp drop in the number of warning letters the FDA sends out. I guess this is actually a negative correlation. Interesting…
But the fees seem to be working. In 1992 it took the FDA 19 months on average to approve new drug applications. Today, when user fees account for about 70% of FDA's budget for the review of new drug applications, it takes the FDA only 10 months to approve a drug for marketing (see here).
But what about drug safety, which is the other responsibility of the FDA?
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Speedy Drug Approval Versus Safe Drugs: Can We Have Both?
