New study indicates that FDA drug approval process is flawed

As many of our readers know, one of the primary missions of the Food and Drug Administration (FDA) is to ensure that prescription and certain non-prescription medications are both safe and effective for public use. When these medications are potentially unsafe, the FDA does its best to educate the public about possible dangers by requiring drug manufacturers to include this information on warning labels and on advertisements.

The American public counts on the FDA’s approach. Many trust that dangerous drugs will be properly labeled as such and that defective prescription drugs will either never made it to market or will quickly be recalled. However, a study recently published in the Journal of the American Medical Association indicates that the FDA’s approval process may not be as reliable as the American public has been led to believe.

According to the study, the quality of evidence that the FDA analyzes in order to determine whether specific drugs should be approved or denied for public use varies widely. Some drugs are approved for certain indications on the basis of numerous trials, while some are approved one the basis of a single trial. In addition, these trials vary widely in terms of completion rates, duration, comparators, patient size and endpoints.

Perhaps it is therefore not so shocking that drugs initially approved by the FDA are being recalled in massive numbers and are proving to be truly dangerous in unexpected ways. If the FDA’s mission is truly to ensure the safety and effectiveness of prescription medications, it may need to embrace a more uniform and stringent basis of evidence for approvals.

Source: Forbes, “Quality of Evidence Used By FDA To Approve New Drugs Varies Widely,” Ed Silverman, Jan. 21, 2014