Chronic Conditions Data Emphasize Need For Additional, Innovative OTCs
This article was originally published in The Pink Sheet Daily
An NIH-funded study shows 92% of older consumers have chronic conditions, the primary target of FDA’s Nonprescription Safe Use Regulatory Expansion initiative to facilitate more Rx-to-OTC switches.
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Rx-to-OTC switch sponsors should not wait for FDA to act on NSURE before proposing innovative switch solutions, because reviewers are open to discussing ideas now, an agency official says. Some experts predict the new switch paradigm will not yield concrete regulatory changes, and are promoting other ways to expand OTC access.
FDA drug center chief Janet Woodcock says behind-the-counter switches would be the most effective method to make Rx drugs available without prescriptions, particularly to help treat chronic conditions.
CHPA members’ feedback on RRAs indicate that “time and resources saved by FDA do not translate to time saved by the manufacturer.” CRN suggests FDA “clearly identify the purpose of the RRA in its initial request and limit requested documents to only those directly related to the purpose of the RRA.”