An FDA panel voted 11-3 to approve the sale of orlistat—sold under the prescription name Xenical since 1999—for over-the-counter purchase. The panelists had some reservations about whether GlaxoSmithKline had studied the long-term use of the drug, but approved it anyway. There were also concerns that normal-weight or underweight teenagers might abuse the drug, and that the drug, which will be marketed under the name “Alli” (pronounced “ally”) doesn’t really have any effect on behavior, so most users have gained back the 4-5 pounds they lose within 2 years after they stop taking the drug. The FDA generally follows the recommendations of its expert panels, so it is likely the drug will be on sale soon.
Of course, when the drug in question is a “morning after” pill which can safely prevent a woman from becoming pregnant after unprotected sex, then the FDA rejects its experts’ decisions and requires more study on the premise that minors can’t be prevented from using the drug.
It’s so nice to see consistency and well-reasoned standards in scientific debates.
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