A slate of popular peptide therapies has won the backing of a key advisory panel to the federal government – a step that could eventually open up broader access to the experimental drugs.
In a marathon two-day meeting, the panel of doctors, academics and pharmacists recommended the Food and Drug Administration reclassify almost all of the compounds under consideration so that specialized pharmacies in the U.S. could begin offering them.
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While the level of evidence for each compound varies, all of them lack the kind of large, well-controlled trials in humans that are necessary to establish safety and effectiveness ….
The divide among the experts on the panel was a study in contrasts.
Ahead of the meeting, eight new members were appointed. Most have ties to the peptide industry and include physicians who work for medical practices and companies that promote them.
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In almost all cases, they voted in favor of lifting restrictions.
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“I’m concerned that we are responding to market induced demand rather than a decision based in solid science,” Dr. Elizabeth Rebello, an anaesthesiologist at the University of Texas MD Anderson Cancer Center, commented after casting a no vote.
