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Behind the Scenes of the Drug Approval Process

This week, the Food and Drug Administration (FDA) approved a new prescription weight loss drug – the first in more than a decade. Advocates of the drug, which trials showed helped users lose an average of about five percent of their body weight, say it provides an important new weight loss option for the 35 percent of Americans classified as obese. But the medication, which will be sold under the name Belviq, is not without risks. Some studies showed that it could cause heart valve problems, an issue that echoes the reasons why the weight-loss drug combination known as Fen-Phen was pulled from the market in 1997.

A Penn medical toxicologist and emergency physician, Jeanmarie Perrone, played a role behind the headlines about the drug’s approval, as a member of an FDA advisory committee tasked with reviewing the data about the drug and making recommendations to the agency about whether or not it should be approved. Last year, Perrone began work with the Drug Safety and Risk Management Committee, which is convened to review any drugs for which there are safety concerns.

As in all the hearings during the approval process for new drugs, the advisory committee meeting about Belviq included testimony from the drug’s maker, Arena Pharmaceuticals (who had been asked to present additional safety data about the drug after it was denied FDA approval in 2010) and physician-scientists who have studied the drug’s efficacy and safety in both humans and animals. Patients who have taken the drug and physicians who have prescribed it, as well as advocates from groups like the Obesity Action Coalition, also provided their input.

“The process really allows everyone to give their perspective – it’s a very well-orchestrated, democratic opportunity for everyone to weigh in,” Perrone says. “It’s set up in a way that allows us to inquire about all aspects of the drug and delve deep enough to really assess the safety.”

These FDA meetings are one of the last stops on a drug, treatment, or medical device’s long road to approval and release for sale to the general public. They follow as much as a decade – sometimes even longer – of drug development efforts in laboratories, pre-clinical studies in animals such as mice, and human drug trials to assess both safety and efficacy of the drug.

The Belviq hearing was Perrone’s second meeting since beginning her work with the FDA’s advisory committees. Last December, she participated in a hearing evaluating the efficacy of a program requiring women taking the anti-acne drug Accutane to demonstrate negative pregnancy tests before obtaining their drugs each month, since the drug carries a tremendous risk of miscarriage and birth defects.

The new obesity drug works by impacting the neurotransmitter serotonin within the brain – the same brain chemistry reaction involved in many antidepressants – to help dieters feel full after eating less food than they’re accustomed to. After reviewing the data from the clinical trials of the drug, Perrone says she worries that when the Belviq becomes more widely used – particularly among people who already take drugs that impact serotonin levels – even more heart valve problems may be seen. Since trial participation criteria often eliminate people who are taking certain medications that might pose drug interaction risks, it’s typically not until years after drugs are approved that those types of problems are observed and reported.

That’s an area that the FDA will turn more attention to in the coming years, Perrone said, by increasing requirements that drug companies to conduct post-approval, post-marketing surveys to monitor for those types of interactions and late effects. In the case of Belviq, the pharmaceutical manufacturer will be required to conduct six post-marketing studies, including a long-term cardiovascular outcomes trial to assess the effect of the drug on the risk for major adverse cardiac events such as heart attack and stroke. 

Watch the CBS Evening News segment in which Perrone discusses the new drug:


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