Progress On Adding OTC Drugs To US Market? Room To Move But Label Format Limits Options
Changes for supporting OTC labeling for drugs currently available Rx-only and indicated for chronic, more complicated conditions, aren’t minor and won’t happen within limits of one-dimensional text media printed on OTC drug containers, packages and inserts.
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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.
“What can we do to help self-care and consumers in their journey? One is innovation, bringing different types of products to market and two, educating consumers because it's complicated. Health care is complicated, and people have a lot of things on their minds,” says CHPA president and CEO Scott Melville.
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.