Mystery objectors delay weight loss drug

http://www.ft.com/intl/cms/s/0/ef3ca4ae-aa65-11e2-9a38-00144feabdc0.html#axzz2RDD5TuHr

The launch of a new weight loss drug is being held up by the US Drug Enforcement Authority, after a surge in anonymous objections that some investors fear is manipulating the process.

Belviq, developed by Arena, the US biotech company, was authorised as safe and effective by the Food and Drug Administration last June, but has yet to be ratified by the DEA under a process designed to ensure controlled use of medicines that come with a risk of abuse.

The FDA recommended that Belviq, known generically as Lorcaserin, be classified as a “schedule IV” drug, a low-risk category, which gives regulators some supervisory powers to oversee prescriptions.

But an unusually high number of 69 comments have been filed on Belviq, creating a greater workload for DEA officials in making an assessment.

The stalling has allowed Qsymia, a weight-loss drug made by Vivus, a rival US biotech, to gain a lead over Belviq, even though the drug was approved after Belviq by the FDA. While most of the 47 positive remarks on the DEA website are identified by the name of the author, 19 of 22 negative ones are anonymous, sparking debate over whether individuals with a vested interest in delaying Belviq have been posting criticisms.