Washington, D.C., (September 14, 2010) — The Consumer Healthcare Products Association issued the following statement on the Drug Safety and Risk Management Advisory Committee’s recommendation not to schedule over-the-counter (OTC) medicines containing dextromethorphan:
“Today’s FDA advisory committee decision not to recommend scheduling OTC cough medicines containing dextromethorphan as a controlled substance reflects a sound balancing of the benefits of over-the-counter medicines containing dextromethorphan.
“Today, 40 million American households turn to dextromethorphan-containing OTC medicines each year to relieve their cough symptoms. More common than heartburn and severe headaches, cough burdens the sufferer, families, and society (as a very rapid way to spread virus). Because of cough’s widespread prevalence and effects, it’s vital for people to have OTC access to safe and effective self-treatment. Dextromethorphan is in nearly 90 percent of OTC cough suppressants sold today. We agree that dextromethorphan should not be scheduled as a controlled substance.
“We do, however, recognize the need for continued education to keep any abuse levels low. We also have long called for federal legislation that would limit purchases of bulk quantities of dextromethorphan to manufacturers who are registered with FDA. We believe that a statutory ban on sales of dextromethorphan medicines to those under 18 would limit abuse. We also believe legislation must be matched with targeted research-based education, which has been shown to be effective in reducing substance abuse.
“Research over the past 35 years clearly shows that targeted educational interventions focusing on increased parental awareness and increased perceptions of the risks and social disapproval are the most effective abuse-reduction strategies. Since 2003, we have had educational programs focusing on the dangers of misuse of over-the-counter medicines, including those containing dextromethorphan. We will continue to expand upon these programs through our comprehensive Abuse Mitigation Plan that targets the key risk factors leading to abuse, along with limiting the various points where teens are accessing these medicines.
“It is our hope that FDA will follow the advisory committee’s guidance and weigh the important public benefit of continued over-the-counter access to these medicines in making its final recommendation.”
Press Kit for FDA advisory committee meeting on dextromethorphan
Contact: Elizabeth Funderburk
202.429.9260 (work) | 202.256.5677 (mobile)
CHPA is the 129-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.