Biotech Exploits a Loophole in a Federal Transparency Law

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FromĀ STAT: A small biotech company, AveXis, recently offered a $3,000 honorarium along with paid airfare and lodging to several experts to attend a so-called advisory meeting. The company also told experts they would not have to report their compensation due to a loophole in a federal transparency law.

“A spokesman for the Centers for Medicare and Medicaid Services, which runs the database, explained that a company is not required to report payments if it does not yet market a medicine approved by the Food and Drug Administration. In this instance, the lead AveXis product is still being developed to treat spinal muscular atrophy, a rare disorder that is a common cause of infant deaths.

Even so, the AveXis overture concerned one hospital official who was approached by the company.

‘It may not be illegal, but itā€™s distasteful,’ said Scott Knoer, chief pharmacy officer at Cleveland Clinic Foundation, where he sits on a committee that decides which medicines are cost effective. ‘I get invited to advisory boards all the time, but this was unusual because they made a point of saying no one would know. I think the problem is they were touting a lack of transparency.'”

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