Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

Rx AND OTC DRUG GERIATRIC LABELING DEFICIENCIES

Executive Summary

Rx AND OTC DRUG GERIATRIC LABELING DEFICIENCIES are the subject of a joint hearing scheduled for April 28 by House Small Business/Regulation Subcommittee Chairman Wyden (D-Ore.) and Aging/Consumer Interests Subcommittee Chairman Lloyd (D-Tenn.). The hearing will include testimony on the sparcity of label information pertaining to kidney and liver effects of prescription and nonprescription products, particularly on elderly patients with impaired renal and hepatic function. Witnesses are expected to include representatives from FDA, the Nonprescription Drug Manufacturers Association, the General Accounting Office, elderly patients and independent drug information experts. GAO's Kwai-Cheung Chan is scheduled to testify on an agency report regarding the laxity of FDA regulation of OTC products relative to prescription drugs ("The Pink Sheet" March 2, T&G-11). Testimony on OTC labeling will focus on information about adverse drug reactions that is not currently provided in product labeling. Such information might include interactions between OTC nonsteroidal anti-inflammatory drugs, like American Home Products' Advil and Bristol-Myers Squibb's Nuprin, and prescription antihypertensives. ADRs associated with the OTC weight loss aid phenylpropanolamine and antacids also are likely to be discussed. Regarding prescription products, Wyden and Lloyd are said to be concerned that, of the 50 drugs purchased most frequently by the elderly, only Glaxo's anti-ulcer drug Zantac (ranitidine) and Merck's Pepcid (famotidine) include warnings specific to geriatric use. In addition, notwithstanding FDA's efforts in recent years to require companies to generate information on the effects of their drugs in geriatric populations, the subcommittees reportedly are puzzled that the U.S. Pharmacopeia's patient labeling compendium USP-DI contains far more geriatric information than FDA-required labeling for physicians. The joint hearing will be the third House hearing in recent weeks to address OTC drugs. Rep. Weiss (D-N.Y.) held a hearing on OTC antihistamines before his Government Operations/Intergovernmental Relations Subcommittee ("The Pink Sheet" April 13, p. 6), and a hearing before Rep. Waxman's (D- Calif.) Energy & Commerce/Health Subcommittee discussed the slowness of the OTC Review, cardiovascular uses of aspirin and phenylpropanolamine ("The Pink Sheet" April 6, p. 15 and April 13, T&G-5).

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

OM011381

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