Pharmacy Interests Back BTC Models For Third Class
This article was originally published in The Pink Sheet Daily
Retailers CVS and Walmart, as well as the National Association of Chain Drug Stores, advocate for a central role for pharmacists in enabling a new class of nonprescription drugs. In comments to FDA, NACDS also supports a switch model that will protect the existing OTC class.
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Allowing for post-market monitoring would incentivize sponsors to consider switches and generate data that could inform a decision about potential conditions for safe use “without applying potentially burdensome – and possibly unnecessary – conditions upfront,” Pinney Associates health care consultancy says.
A particularly public pre-emptive stance by FDA's in vitro diagnostics oversight office halts Pathway Genomics' plans to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move does not signal any changes to its enforcement policy for laboratory-developed tests
“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”