CONTENTS

CHPA highlights the benefits of nicotine replacement therapy

CHPA files pediculicide comments

News on business development

FDA plans more prep work for ICH meeting

NIH's Office of Dietary Supplements finds a new home

FDLI to explore the ins and outs of marketing drug products

Thompson technology removes the tribulations from clinical trials

Calendar of events

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CHPA highlights the benefits of nicotine replacement therapy

Over-the-counter medicine trade group lauds members’ commitment to their consumers’ good health

In an August 14 news release, CHPA pointed to the benefits of nicotine replacement therapy (NRT) and the unrelenting efforts of the OTC medicine industry to aggressively promote the public health benefits of quitting smoking. Smoking cessation products are considered the "gold standard" of preventive self-care interventions, and have been available without a prescription in the United States since 1996. The Association issued its release in response to an August 14 Journal of the American Medical Association report. 

"The public benefits tremendously from having access to safe and effective NRT products and the information to use these products successfully," said CHPA President Linda A. Suydam, D.P.A. "The manufacturers of OTC NRT products are committed to providing the estimated 70 percent of smokers who wish to quit the proper tools to do so." Specifically, all OTC NRT packages contain outer labeling and educational inserts approved by FDA. Many products also host web sites to provide information, resources, and personalized behavioral support plans to help consumers quit smoking.

"It goes far beyond just marketing a single product or product line; CHPA members are campaigning for the principle of tobacco-free good health," confirmed Suydam. "CHPA members are actively engaged in partnerships and education efforts to communicate the hazards of smoking and the tools for quitting successfully." CHPA members work alongside such partners as the World Health Organization (WHO) and public health officials and researchers worldwide on anti-smoking education, and provide contributions and fundraising and other support to such anti-smoking organizations as the American Cancer Society, Campaign for Tobacco Free Kids, the American Heart and Stroke Associations, and the American Lung Association. 

CHPA members also have been or are currently involved in numerous stop-smoking activities at the local, national, and international levels, including:

• World No Tobacco Day
• WHO European Partnership to Reduce Tobacco Dependence
• 11th World Conference on Tobacco OR Health
• treatobacco.net (a database and educational resource for the treatment of tobacco dependence produced and maintained by the Society for Research on Nicotine and Tobacco, in association with the World Bank, the U.S. Centers for Disease Control and Prevention, WHO, the Cochrane Group, and a panel of international experts)

"Bottom line: Smoking kills," underscored Suydam. "Consumers have a number of safe and effective treatment options and resources to help them kick the habit, including NRT medications. CHPA members encourage consumers not to smoke, and to avail themselves of FDA-approved products to quit."

Click here to view the Smoking Cessation Fact Sheet.

CHPA contacts: Donna Edenhart and Mimi Pappas

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CHPA files pediculicide comments

CHPA submitted comments August 8 on FDA’s proposed amendment to the final monograph for OTC pediculicide drug products. The FDA proposal, published in the May 10 Federal Register, would revise the statement of identity, warnings, indications for use, directions, and other required statements on the labeling of those products. FDA’s stated reasons for the proposed amendment are to make pediculicide drug product labels conform to the new labeling format for OTC products and to increase the probability of treatment success.

CHPA's comments were generally supportive of the Agency’s proposed changes for the statement of identity and indications, noting that simplified, straightforward wording and clear formatting should make products even easier for consumers to use correctly. CHPA also agreed that FDA’s proposed revised, shortened, bulleted warning statements under appropriate subheadings were more likely to be read, easily understood, and followed. CHPA, however, did not agree with the Agency’s proposed requirement for extensive additional information regarding environmental control and combing procedures in the directions on the outer labels of pediculicide products. CHPA recommended that such additional information beyond essential treatment directions instead be included in a package insert with a statement on the outer package directing consumers to the important information in the insert.

The Association also asked that FDA coordinate consistent labeling changes for pediculicide products that are marketed under new drug applications at the same time as the effective date for a final amendment requiring labeling changes for OTC monograph products within the same category.

CHPA contact: Dr. Lorna Totman

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News on business development

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CHPA Business Development Conference
November 14-15, 2002
Newark Airport Hilton
Elizabeth, New Jersey
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FDA plans more prep work for ICH meeting

FDA has called for a public meeting to continue its preparatory work for the September 9-12 International Conference on Harmonisation (ICH) steering committee and expert working group meetings in Washington, D.C., as well as to solicit additional comments on the Common Technical Document. The public meeting will be held September 5 from 10:30 a.m. to 2:00 p.m. at 5360 Fishers Lane, Room 1066, in Rockville, Maryland. Registration and oral presentation requests should be sent to Kimberly Topper at Topperk@cder.fda.gov by August 29. Additional meeting details are available in the August 8 Federal Register. For more information on ICH, visit www.ich.org.

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NIH's Office of Dietary Supplements finds a new home

The National Institutes of Health's (NIH's) Office of Dietary Supplements (ODS) has moved to a new location. The new address for ODS is in care of the National Institutes of Health, 6100 Executive Boulevard, Room 3B01, MSC 7517, Bethesda, Maryland 20892.

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FDLI to explore the ins and outs of marketing drug products

The Food and Drug Law Institute (FDLI) is hosting a conference on the regulations and requirements of advertising and promotion of medical products. "Marketing Drugs and Biologics: Key Issues" features speakers from FDA, the U.S. Federal Trade Commission, the U.S. Department of Justice, and the Washington Legal Foundation. To be held September 11-12 at the Renaissance Hotel in Washington, D.C., the event will include a host of topics ranging from the politics of drug marketing to First Amendment issues. More information about the conference can be found on FDLI's Internet site.

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Thompson technology removes the tribulations from clinical trials

Thompson Publishing Group, Inc., announced the development of technology that will help individuals comply with federal and state research requirements when conducting clinical trials. The new online database—CLINLAW—is a comprehensive listing of clinical trial requirements for all 50 states and the District of Columbia, as well as federal provisions. For more information, e-mail Thompson's Customer Care Division.

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Manufacturing Controls Seminar
October 10-11, 2002
Hilton Parsippany Hotel
One Hilton Court
Parsippany, New Jersey

Research & Scientific Development Conference
November 7-8, 2002
Hyatt Regency Hotel
One Bethesda Metro Center
Bethesda, Maryland

CHPA Business Development Seminar
November 14-15, 2002
Hilton Newark Airport
1170 Spring Street
Elizabeth, New Jersey

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