Statement From the Consumer Healthcare Products Association on Today's Joint FDA Advisory Committee Recommendations on

WASHINGTON, DC, Jun 30 (MARKET WIRE) --
Following is a statement by Linda A. Suydam, D.P.A., president of the
Consumer Healthcare Products Association (CHPA), regarding the
recommendations issued today by the U.S. Food and Drug Administration's
Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs
Advisory Committee, and the Anesthetic and Life Support Drugs Advisory
Committee. The joint committee addressed the use of over-the-counter (OTC)
and prescription (Rx) drugs containing acetaminophen.

"CHPA strongly believes that patients and physicians should continue to
have access to the current range of over-the-counter (OTC)
acetaminophen-containing products, and we are pleased the committee did
not recommend eliminating these important nonprescription products. While
we are pleased with the committee's recommendation to allow continued
access to OTC combination medicines containing acetaminophen because we
know they provide real benefits to consumers, we are disappointed in
their divided vote to lower the maximum daily dose and the single dose of
1000 mg acetaminophen. There was a notable lack of data referenced by the
committee to support these recommendations and overwhelmingly strong data
affirming the efficacy and safety of acetaminophen in its current dosage
forms.

"There is universal agreement on the safety of acetaminophen when used as
directed on the label. We know that the overwhelming majority of adults
use this product safely and that the majority of serious adverse events
related to unintentional acetaminophen overdose are associated with
prescription medicines containing acetaminophen. In addition to the
label, the most effective and most appropriate intervention to address
overdose is education. We support educational efforts to encourage
appropriate use of acetaminophen and have already begun developing a
comprehensive research-based education program that includes a consortium
of pharmacists, physicians, retailers, FDA, and other healthcare
professionals.

"We strongly urge FDA to add dosing instructions on pediatric products
intended for children (6 months to under 2 years of age). All of our
companies provide dosing instruments with their products. We support the
current range of concentrations to easily and safely dose young children.

"We remain committed to continuing our efforts to promote the safe use of
acetaminophen and look forward to working with FDA as they review the
committee's recommendations."

For more information and b-roll, please visit
http://www.firstlinemedia.com/epk/chpa

CHPA is the 128-year-old trade association representing U.S. manufacturers
and distributors of over-the-counter medicines and nutritional
supplements.

chpa-info.org | OTCsafety.org

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