Contraceptive An
'Additional Condition'?

The FDA’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule would add a step to the process consumers are expected to follow when determining whether to buy and use an OTC drug.

In addition to information on Drug Facts labels about a product’s ingredients, indications and use and warnings against use or about potential side effects, an additional condition switch would provide consumers with a questionnaire accessed digitally as an extended self-selection test to determine whether they should use the product. (Also see "Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process And For Consumers" - HBW Insight, 28 June, 2022.)

Consumers must respond with specific answers in order to purchase an ACNU OTC drug product; their passes to buy products would be barcoded vouchers provided digitally.

The proposed rule also bodes well for a potential OTC daily oral contraceptive switch because it allows the same drug at the same dose and for the same indication to remain available Rx after it’s approved for OTC sales. The FDA included the provision in recognition that some consumers can’t or won’t use digital channels to determine whether they should use a drug product and that others would otherwise prefer to consult a doctor. (Also see "Dual Rx/OTC Status In US ‘Additional Condition’ Switch Proposal: Necessary Or Questionable?" - HBW Insight, 30 June, 2022.)

‘Storm Of Change’ Could Propel Industry On Making Daily Oral Contraceptive Available OTC In US

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