Nature Medicine | Spoonful of Medicine

The FDA doesn’t always listen to advice

fda_food_drug_admin.03.gifIt happened again: the US Food and Drug Administration has ignored the advice of an advisory committee by placing the drug Daliresp, described by at least one committee medical expert as “meager”, on the market.

Last April, the FDA Pulmonary-Allergy Drugs Advisory Committee struck down the drug, which treats chronic obstructive pulmonary disease (COPD), by a vote of 10-5 saying its “modest” benefits did not outweigh its potential risks. The decision was based in part by results from two studies published in 2009 that showed that subjects receiving the drug showed a 17% reduction in rates of symptom excerbations compared to those receiving a placebo.

“The benefit of this drug, although it’s there, it’s meager,” said committee member Richard Honsinger of the Los Alamos Medical Center Clinic at the April 2010 meeting of the advisory committee. “We didn’t have a lot of patient evidence that [suggested] it was a good drug, and the drug does have side effects.”

NycoMed stands by Daliresp and applauds the FDA for its approval. “The approval of Daliresp offers clinicians and patients a much needed new treatment option alongside existing inhaled therapies,” said Guido Oelkers, executive vice president of commercial operations at Nycomed, in a statement.

According to an October 2010 analysis, the FDA has heeded the advice of its team of outside medical experts an estimated 76% of the time since 2007. In most of the cases where the agency’s final decision on a drug does not match that of the advisory committee, it is when regulators have said ‘no’ to a drug recommended by the advisory panel. But in three cases, the FDA overruled its advisory committee to give a drug the thumbs up. And in two of these cases, the drug exhibited at best, modest benefits.

In the case of Daliresp, FDA regulators requested additional information last May from its manufacturer NycoMed. But without additional clinical trials, the question remains whether or not the FDA has according to some critics lowered the bar of what makes a good drug.

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