FDA bureaucracy decelerates accelerated approval

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The FDA has been excessively precautionary in facilitating approval for drugs to treat terminal diseases, says ACSH’s Dr. Gilbert Ross in an op-ed in the Atlanta Journal Constitution. The accelerated drug approval process permits early FDA approval for drugs that combat deadly illnesses if they show promising results in early clinical trials; the drug companies promise to perform follow-up trials assessing drug safety and efficacy to win final approval. As Dr. Ross points out, however, the FDA has begun to undermine this process by making it unnecessarily difficult for companies to gain approval:

The FDA has traditionally been highly risk-averse, preferring excess of precaution to being accused of laxity in its oversight. But the agency needs to recognize that when it comes to terminal diseases, its main focus should be expediting the approval process, so that patients can have the maximum number of options as soon as possible. As medicine races ahead, it would be a tragedy for bureaucracy to hold it back.