FDA might widen path for OTC contraception, statins
“As quickly as folks know that one thing doesn’t require a prescription, they deal with it otherwise,” mentioned Diana Zuckerman, president of the Nationwide Heart for Well being Analysis.
At the least one producer is already adjusting its technique. Cadence OTC is planning to make use of the proposed pathway — as soon as finalized — for its mixture estrogen and progestin contraception tablet Zena, following conversations with the FDA, firm co-founder and co-CEO Samantha Miller mentioned.
The corporate initially resisted the concept of requiring shoppers to take an extra step earlier than buying the tablet, however in the end started testing a web based questionnaire designed to exclude these at larger danger of unintended effects.
“We and our consultants consider we didn’t want it, and that we might have a well-performing, well-communicating label with out it. And we did label growth and testing for a number of years, and we did find yourself with a powerful label that examined very properly,” she mentioned. “The FDA was not happy with it, and I believe a part of the rationale they weren’t happy was that that they had of their thoughts that this match with this new strategy.”
The FDA didn’t reply to a request for remark.