Innovation In OTC Switches Takes Multimedia Approach In US FDA Draft Guidance
This article was originally published in The Pink Sheet & The Rose Sheet
Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.
You may also be interested in...
Responding to Sen. Roger Marshall’s question on rulemaking to accelerate OTC switches by allowing NDA sponsors to use extra-label information to guide consumers through self-selection of a drug, Robert Califf said he’d support making progress on a proposal FDA began considering in 2012 in its NSURE initiative.
For first time rules for novel switches and OTC hearings aids are parts of “significant regulatory actions” in agency’s plans. Information is added in Unified Agenda items explaining likely benefits and costs from the changes.
OTC drugs’ quick treatment of acute conditions outweighs risks from absence of physician oversight, says OTC switch consultant Bernie Simone. At CHPA regulatory conference, he discussed other drug categories during his presentation on the downside of keeping some drug ingredients Rx-only.