The FDA Has to Level the Playing Field with Generic Antibiotics

The FDA cannot continue to allow Americans to use generic drugs that would not meet FDA's modern standards. All drugs have to meet the same standard of efficacy and safety. Specifically, I'm speaking about all the antibiotics that have ever been approved by the FDA for otitis, sinusitis, bronchitis and pneumonia. If the FDA has decided that the trials that were previously carried out do not show benefit, than by definition the risk to benefit ratio for those drugs is zero. Their marketing approval for those indications should be withdrawn. This is especially important since the use of the older generic drugs tends to be much greater than the use of the new antibiotics which is so closely monitored for approval. With the greater use of the older drugs comes the potential for greater danger.

Of course, the better idea would be to rescind the guidelines requiring placebo-controlled trials for these indications and allow new drugs to be developed. As we discussed earlier, placebo-controlled trials are infeasible and sometimes unethical and no one will participate in them - frequently for good reason. If the FDA rescinds their requirement for placebo-controlled trials, the generics can stay on the market and the market can be opened for new antibiotics that we need.

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