Evidence Quality That FDA Uses to Approve Drugs Varies Widely

Evidence Quality That FDA Uses to Approve Drugs Varies Widely

January 23rd, 2014 // 3:09 pm @

FDA has been trying to approve drugs faster and to also show more flexibility in the endorsement of therapies for many types of serious diseases. But an interesting wrinkle is starting to emerge, according to a recent Forbes report. There is a lot of variety in the quality of the evidence that is being used by FDA to approve some drugs.

A study that was published in the Journal of the American Medical Association recently looked at 200 drugs that were approved by the agency from 2005-12 for 208 illnesses, based upon 450 efficacy trials. It was determined that about 1/3 of the indications got FDA approval based upon a single clinical trial. Trials that use surrogate endpoints as the main outcome were the approval basis for 90 indications.

Also, trials varied a good deal in their choice of comparators, endpoints, patient size and duration, as well as completion. The bottom line is that FDA does need to be more flexible, but some of the designs of the trials and the approvals indicate that some of the approved drugs may need more scrutiny when they are out in the marketplace.

The researchers reported that flexible approval standards can lead to some drugs being approved on the basis of many clinical studies, but others may be approved based upon only a few studies. This can lead to very different certainty levels about benefits and risks of some drugs that have been approved.

FDA stated this month that there were 27 new molecular entities approved in 2013, and two of them were accelerated. Also, 10 of them were given fast track status, as they were for medical needs without good therapies. Also, 10 were given the status of priority review, as there was a hope of advancing medical care, and three of them were called breakthrough drugs because they showed major improvements in a clinically significant endpoint.

The study by JAMA stated that quicker drug approvals by FDA can be done without expensive clinical trials. This is very much the case for cancer drugs.

The researchers noted that they were not saying that FDA did not do a good job in its drug approval processes. But they noted that both patients and doctors assume that drugs are safe and they work, but there is more  here than people realized. The data indicates that in some cases, FDA does not know as much as we think, and some of these drugs need to get more scrutiny in the post marketing phase.


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