HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Former Division Of Nonprescription Clinical Evaluation Head Leonard-Segal Talks About OTC Switches Past, Present And Future

This article was originally published in The Pink Sheet Daily

Executive Summary

Andrea Leonard-Segal and Melissa Furness talked with “The Tan Sheet” about the evolving opportunities for Rx-to-OTC switch and the significance of recent switches. Leonard-Segal, the former director of FDA’s Division of Nonprescription Clinical Evaluation, and Furness, a former DNCE supervisory consumer safety officer, started a consultancy to offer guidance on OTC switch programs and other regulatory areas.

You may also be interested in...

Plan B One-Step OTC Proposal Leaves Plaintiffs, Judge Korman Wary

The Center for Reproductive Rights and other plaintiffs suing FDA say the agency’s plan to approve only Teva’s Plan B One-Step for universal OTC sales, but not less-expensive generic emergency contraceptives, would not provide sufficient access for all women.

FDA’s Broad Power Can Overcome NSURE Labeling Obstacles – Attorney

Attorney Richard Kingham says the agency has authority to require broadly defined labeling for Rx-to-OTC switches, as well as to obligate generics to follow the same measures as innovator products. Consultant George Quesnelle says FDA’s openness to novel switch strategies on a case-by-case basis is key.

Sponsors Should Hang Tight On “New Paradigm” Switch – CDER’s Leonard-Segal

The director of FDA’s Division of Nonprescription Clinical Evaluation advises firms to wait to submit Rx-to-OTC switch applications until the regulations are revised to allow for expanded conditions of safe nonprescription use.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts