FDA Commissioner Scott Gottlieb’s interest in OTC drug regulations galvanizes the industry to endure “chaos” on Capitol Hill, amplified by uncertainty about the direction of Congress with mid-term elections approaching, say Consumer Healthcare Products Association executives.
Gottlieb An Anchor For OTC Drug Industry On Stormy Congressional Seas
Commissioner Gottlieb has been a “very strong champion” of FDA and his interest in improving the OTC monograph and switch processes provides hope to the industry during a tumultuous legislative era, say CHPA executives at their annual meeting in Florida. They expect monograph reform will happen this year but doubt much else will happen before mid-term elections in November.
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Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.
Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.
Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.
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