HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


FDA Digs Deeper On “New Paradigm” To Expand Rx Switches

This article was originally published in The Tan Sheet

Executive Summary

The questions FDA poses for a March 22-23 hearing indicate the agency is delving into greater detail than in its previous discussions of alternative routes to access pharmaceutical treatments. FDA says decisions would be made case by case, but refers to treating conditions including high cholesterol, high blood pressure, migraines and asthma.

You may also be interested in...

Statin Label Change Stirs OTC Switch Discussions

FDA eliminates the label statement that liver function tests should be performed prior to and at 12 weeks following therapy or dose elevation, and periodically thereafter. A study design expert predicts better chances for a statin switch, but a consumer health advocate doubts nonprescription access will be safe.

Lipitor OTC Switch Would Force Pfizer To Clear Big Research Hurdles

Pfizer would face major hurdles in research on consumers’ safe self-selection for FDA to approve an OTC switch of the firm’s cholesterol treatment Lipitor.

CDER Director Sees Behind-The-Counter Switches As Best Bet

FDA drug center chief Janet Woodcock says behind-the-counter switches would be the most effective method to make Rx drugs available without prescriptions, particularly to help treat chronic conditions.

Related Content


Related Companies




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