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FDA’s Drug Approval Process Varies Greatly

Update Date: Jan 22, 2014 11:01 AM EST
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Drugs that are approved by the United States' Food and Drug Administration (FDA) are considered "safe and effective." The FDA reviews all drugs and only approves them if the benefits outweigh the side effects. Despite the fact that the FDA must approve all drugs, a new study found that not all drugs are approved in the same way, but rather, approved based on a variety of reasons.

"Not all FDA approvals are created equally," stated the lead author, Nicholas Downing according to the Washington Post.

For this study, the researchers reviewed 188 drugs that were approved by the agency between 2005 and 2012. The researchers discovered that roughly one-third of the drugs were approved based only on one trial. Other drugs were only approved if the results came from large and high-quality drug trials. Drug trials help gather information on the efficacy and safety of the drug. The researchers also calculated that roughly 40 percent of the approved drugs were compared to existing drugs that have been approved.

"Flexible approval standards may lead to some therapeutics agents being approved by the FDA on the basis of numerous rigorously designed clinical trials and others on the basis of fewer or less robust studies, leading to differing levels of certainty about the risks and benefits of newly approved drugs," the authors explained according to Forbes.

The team reported that the agency allowed varying trial features when making their decisions to approve different drugs. The FDA looked at trials with different choices of comparators, endpoints, duration, sample size and completion rates. Even though flexibility is important when making the decision to approve drugs, the researchers found that for some drug approvals, the FDA's rationale was inconsistent.

"There was a lack of uniformity in the level of evidence the FDA used," commented senior author, Joseph Ross, an assistant professor of internal medicine at Yale University.

FDA spokeswoman, Stephanie Yao, stated, "The agency applies the same statutory approval standards of safety and efficacy to all drugs, but uses regulatory flexibility in applying those standards. Some drugs may be tested in clinical trials that enroll hundreds of participants while others, particularly those seeking to treat rare diseases, may be tested in trials that enroll only a handful of participants. [The FDA maintains] a robust program for postmarketing surveillance to help ensure the benefits of marketed drugs continue to outweigh their risks."

Despite the findings, the authors acknowledged the fact that approving drugs based on different levels of evidence would be necessary in some cases. The study was published in the Journal of the American Medical Association (JAMA).

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