U of M Expert Perspective: FDA approval process puts patient safety first

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The U.S. Food and Drug Administration (FDA) has extended its review of the obesity drug Qnexa for three more months. The new target date provides the FDA additional time to review a new drug safety plan submitted by the company who manufactures Qnexa.

But according to the Associated Press, the drug may face an uphill battle for approval:

"The FDA has rejected three experimental drugs for obesity in the last three years, including Qnexa, raising questions about whether any new weight loss drugs can win approval. The agency has not approved a new prescription diet pill since 1999."

So what exactly does it take for a drug to receive the FDA's approval?

According to Stephen W. Schondelmeyer, professor of pharmaceutical care within the U of M's College of Pharmacy, the process can be complex.

"Once a drug is created by a company, there is still a long process before it is sent to the FDA," said Schondelmeyer. "It must go through three phases of rigorous trials and testing, often lasting five to ten years total."

After three phases of clinical trials are complete and confirm the drug's safety and success, the drug is submitted to the FDA Expert Advisory panel, which makes a recommendation to the FDA.

If recommended by the panel, the drug is then reviewed by internal divisions of the FDA, each reviewing for their area of expertise. Finally, the drug is brought to the FDA Commissioner's Office for the final approval.

"The FDA approval process is designed to ensure patients and consumers have access to the safest drugs available," said Schondelmeyer. "It's a process designed with safety in mind."

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