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

UsernamePublicRestriction

Healthcare "Rationing" Not Acceptable Reason For Denying Switches - FDAer

This article was originally published in The Tan Sheet

Executive Summary

The practice of "rationing" a drug, or wanting to keep it out of the hands of the general public, is not an acceptable singular reason for disapproving a switch candidate, FDA Office of Drug Evaluation V Director Robert DeLap, MD/PhD, stated at a switch summit held by the Consumer Healthcare Products Association July 16 in Washington, D.C.

You may also be interested in...



Rx-To-OTC Switch Candidate Negative Lists "Stifle Innovation" - CHPA

FDA should consider all Rx-to-OTC switch candidates on a case-by-case basis and avoid creating "presumptive negative lists" of drug classes not suited to OTC use, the Consumer Healthcare Products Association stresses in Aug. 25 comments to the agency.

OTC Statin Target Population Receives Significant FDA Attention

The type of people most suited for OTC statin therapy received considerable attention from FDA during the agency's discussion on the OTC availability of vascular drugs at a public meeting in Gaithersburg, Md. June 28-29.

OTC Switch Criteria For Chronic Illnesses, Risk Factors Differ - DeLap

Prescription drugs that treat risk factors, rather than a chronic illness, may not be ideally suited for Rx-to-OTC switches due to the danger of side effects, FDA's Robert DeLap, MD/PhD, suggested at the Drug Information Association annual meeting in San Diego June 12-13.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS140609

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

Cancel