Before Asking FDA For Novel OTC Switch, Be Sure DFL Alone 'Can't Get There'
"You need to demonstrate to the best of your ability that you can't get there with just the Drug Facts label," says ONDP Director Theresa Michele during presentation on the FDA office' work over the past year at Consumer Healthcare Products Association's annual regulations and science conference.
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OTC switches are more challenging for sponsors as concerns over label communication, drug interactions and consumers understanding increase, says FDA official Francis Becker. Rx label precautions and warnings must go on OTC labels, too.
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.
Acquiring HRA Pharma, Perrigo could take OTC switch lead, likely starting with HRA’s daily oral contraceptive before moving to numerous other potential candidates. Pharmas previously busy in switch have other priorities for their consumer health businesses.