December 6, 2002 

No. 25-02   

CONTENTS

CHPA's Business Development Conference offers insights into self-care market

Use CHPA's 2003 meetings to advance your business 

More contacts and opportunities to boost business at CHPA's MarkePlace

Highlight your company's commitment to the industry

CHPA welcomes new technical affairs director

FDA approves a new switch

FDA awards AOAC with contract to develop analytical methods

Final monograph amended for diphenhydramine-containing OTCs

EP works on traditional herbal medicines directive

CHPA's Saldanha to participate in upcoming NIH conference

Pharmacovigilance and risk management seminar planned

Calendar of events

Use the table of contents to jump directly to a story of interest, or use the scroll bars. "Back to the top" options after every story will take you to the beginning of the table of contents.

CHPA's Business Development Conference offers insights into self-care market

CHPA held its Business Development Conference (BDC) in Newark, New Jersey, on November 14-15, chaired by Gregory C. Pulido, chairman of Humco Holding Group, Inc. The conference featured Ken Schmidt, the former director of communications for Harley Davidson, who spoke on repositioning a brand, and Douglas I. Ellsworth, the director of FDA's New Jersey district, who provided a frank perspective on the business implications of FDA’s new risk management paradigm.

Kevin A. Hassett, Ph.D., resident scholar at the American Institute for Public Policy Research, provided his perspectives on the economy, the new political environment in Washington, and the likely effects of a war with Iraq. Hassett, who delighted CHPA audiences at the Annual Executive Conference, offered updates on his prior insights about the Republican majority in both the House and Senate, actions by the Federal Reserve, and prospects for economic recovery.

Participants got both a legal and accounting perspective on the Corporate Responsibility Act, passed by Congress earlier this year, and the new disclosure and accounting requirements imposed by the law. A separate session on how to value a brand—whether by adding value by infusing new marketing tactics to build excitement and loyalty among consumers or assessing current value before selling a brand—also received high marks from attendees.

The final panel presentation offered a variety of views on the changing OTC and dietary supplement marketplace, with speakers from the wholesale, institutional healthcare, and retail communities. Participants got an in-depth look at self-care product consumers, how retailers are changing their marketing strategies, and innovative ways that the "front-end" of drug stores sells self-care products.

Plans have already begun for another BDC in 2003.

CHPA contact: Dr. Bill Soller

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Use CHPA’s 2003 meetings to advance your business
Mark your calendars and plan to attend CHPA’s AEC and MarketPlace

Registration materials and detailed information on CHPA's Annual Executive Conference (AEC) and inaugural 2003 MarketPlace will be made available electronically to members in the next two weeks. These two CHPA meetings are unparalleled business opportunities for self-care industry executives. 

  • CHPA’s AEC is the Association’s flagship event of the year. It is an opportunity to conduct Association business, network, and gain valuable insights from notable speakers.
  • Born from the AEC Member Business Appointments, MarketPlace will be more than 10 hours of interaction between senior personnel and decision-makers from CHPA Active and Associate members. 

Annual Executive Conference (AEC)
March 13-15, 2003
Turnberry Isle Resort & Club
Aventura, Florida

 

CHPA MarketPlace
September 18, 2003
Hilton East Brunswick
East Brunswick, New Jersey

 

CHPA contacts: Kass Kassouf and Phyllis Taylor

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More contacts and opportunities to boost business at CHPA's MarketPlace

The Member Business Appointments of the past four Annual Executive Conferences (AECs) have become more and more refined to the point where they are ready for their own spotlighted forum separate from the AEC: MarketPlace. This fall venture in New Jersey will allow over 10 hours of interaction between senior personnel and decision-makers from CHPA Active member companies—including their CEOs—and Associate members. The northeast corridor location and CHPA’s Board of Directors’ participation guarantee that appropriate management personnel will be in attendance.

MarketPlace will be a full day of meetings in 20-minute time slots to allow maximum exposure to the greatest number of clients possible (18-24 appointments), as well as networking time in the way of breakfast, lunch, and an evening reception.

To help members prepare for MarketPlace, a special announcement will be sent to Official Representatives (ORs) in early January. 

The tentative schedule for the day follows:

7:00 a.m.– 8:45 a.m. Continental breakfast

8:45 a.m.– 9:00 a.m. Welcome

9:00 a.m.– 5:30 p.m. Appointments (with short breaks throughout the day)

11:30 a.m. – 1:30 p.m. Staggered buffet lunch (when setting up appointments, allow for a one-hour lunch break)

5:30 p.m.– 7:30 p.m. Reception

Exhibitors are urged to personalize each presentation for their target audience: The more a presentation is personalized to the particular client or prospective client, the easier it will be for decision-makers. This is the perfect opportunity to present new developments in products and services your company is offering, or to reintroduce your company to new or former customers. And you can distinguish yourself further by sponsoring an event. 

This exclusive opportunity to meet with clients, prospects, and peers in the industry is open only to CHPA members. Register for both the AEC and MarketPlace at the same time and receive a special MarketPlace Early Bird "Exhibitor" rate. 

CHPA contacts: Kass Kassouf and Phyllis Taylor

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Highlight your company’s commitment to the industry
Sponsor a meeting activity

Stand out from the crowd and take advantage of one of the many sponsorship opportunities available at the Annual Executive Conference (AEC) or MarketPlace. 

AEC favor bags

It is that time of year when we ask our members to assist CHPA by contributing OTC and dietary supplement products to the favor bags that will be given to attendees, guests, and speakers during the AEC. These welcome totes—always a memorable favorite—demonstrate firsthand who we are and what we do. CHPA members have a long tradition of being extremely generous in the products supplied.

Active and Associate member company Official Representatives will be contacted in early January and asked to think of Florida-related, "fun in the sun" types of products for inclusion in the bags.

AEC sports night grand prizes

Plans are underway to create a "sports night" for the final evening at the AEC. Competing in a sports activity will earn a raffle ticket. At the end of the evening, grand prizes will be raffled off to those present.

We have seven prize sponsors to date:

  • Arnold Worldwide New York
  • Bates Worldwide
  • Carrafiello Diehl & Associates, Inc.
  • Grey Worldwide, Inc.
  • Saatchi & Saatchi
  • The Seiden Group
  • J. Walter Thompson Company

The more grand prizes, the more winners; the more winners, the more fun. Contact CHPA if you are interested.

MarketPlace sponsorships

As plans evolve for the first CHPA MarketPlace, so do sponsorship opportunities. Since this is an all-day event full of face-to-face networking opportunities between Active and Associate members, CHPA welcomes help from any member interested in sponsoring the continental breakfast, all-day beverage service, lunch, or reception at MarketPlace.

CHPA contacts for AEC and MarketPlace sponsorship opportunities: Kass Kassouf and Maria Sarabia

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CHPA welcomes new technical affairs director

Fred Razzaghi has joined CHPA's Science and Technology department as director - technical affairs. In that capacity, Razzaghi will serve as the staff executive to committees, subcommittees, and task groups relating to technical aspects of quality production of OTCs; manage national and local meetings of the OTC technical community and CHPA technical committees, including a summer workshop series on issues relating to good manufacturing practices and the annual Manufacturing Controls Seminar; serve as the liaison to outside organizations important in accomplishing CHPA’s program of work relating to technical affairs; represent CHPA before outside organizations, including FDA; and review and communicate interpretations of technical publications relating to CHPA’s program activities.

Razzaghi brings to CHPA over two decades of experience and leadership in quality and manufacturing in both domestic and international arenas. He has a diversified technical background in quality operations and manufacturing technology, complemented by compliance expertise. Razzaghi has worked for such companies as Organon Inc., Carter Wallace Inc., Wyeth Pharmaceuticals, and Glaxo Smithkline and has experience with pharmaceutical, medical device, and consumer healthcare products, as well as working with international, federal, and state government, trade association, and academic organizations. He can be reached via telephone at (202) 429-9260 or via e-mail at frazzaghi@chpa-info.org

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FDA approves a new switch

The Agency approved the Rx-to-OTC switch of Schering-Plough's Claritin November 27. Claritin is approved for seasonal allergic rhinitis, a condition that causes runny nose; nasal congestion; sneezing; and itchy nose, throat, eyes, and ears. Approximately 10 to 30 percent of U.S. adults suffer from such allergy symptoms.

According to FDA Commissioner Mark B. McClellan, M.D., Ph.D., in a press release, "This approval reflects FDA's commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription." The switches of loratadine 10 mg and loratadine 10 mg in combination with 240 mg pseudoephedrine sulphate mark the third and fourth of the year.  

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FDA awards AOAC with contract to develop analytical methods

AOAC International recently was awarded a five-year contract to provide FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the National Institutes of Health’s (NIH’s) Office of Dietary Supplements with accurate, validated analytical methods for 20 dietary supplement ingredients. The contract, which may be modified during its five-year period, amends a 2001 contract with AOAC to develop methods for ephedra and aristolochic acid.

The value of a validated analytical method is that it establishes an official standard, recognized in courts of law and by CODEX. This contract includes five main component projects:

  1. Establishment of a list of ingredients for which FDA and NIH want official analytical methods developed: This list was compiled by the AOAC Dietary Supplement Task Group.
  2. Prioritization of these ingredients: Already, an Ingredients Ranking Sub-Task Group, headed by CHPA, has developed a ranking matrix to provide an objective prioritization schedule of the ingredients. Criteria used by the ranking team included four factors: market share and industry needs, availability of methods, whether an NIH clinical trial on the ingredient is being planned or is underway, and FDA safety concerns and needs. 
  3. Formation of an NIH expert peer-review committee to review current methods for each ingredient and select the best method for each ingredient for further study: Experts from industry currently are being sought for this committee.
  4. Creation of training programs so that multiple laboratories will be proficient in evaluating methods.
  5. Dissemination of final, official methods: To this end, AOAC has created e-CAM, the Electronic Compilation of Analytical Methods, a universal classification and validation system that will be available to labs online.

More information is available online

CHPA contact: Dr. Leila Saldanha

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Final monograph amended for diphenhydramine-containing OTCs

FDA announced December 6 that it is amending the final monographs for OTC antiemetic, antihistamine, antitussive, and nighttime sleep-aid medicines. The new final rule, published in the Federal Register, requires oral products containing diphenhydramine to bear a warning statement advising consumers not to use such products with any other products containing the ingredient, including topical products. The regulation is effective December 8, 2003. The Agency plans to issue a final rule on topical diphenhydramine-containing products at a future date. 

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EP works on traditional herbal medicines directive

The European Parliament (EP) completed its first reading of a proposed directive on traditional herbal medicinal products in the EU November 21. The overall objective of the proposal is to harmonize Member State approaches to traditional herbal medicines by introducing a simplified registration procedure for certain products. Such a process would allow bibliographic or expert evidence on traditional uses and abridged safety reports rather than full documentation on safety and efficacy tests and trials. (See January 31 XNL.)

Following below are the amendments called for by the EP:

  • Parliament calls for a new committee under the European Medicines Evaluation Agency to evaluate application issues, rather than having these issues fall under the pre-existing committee which handles evaluation issues for other medicines.
  • Parliament adopted an amendment which would allow non-herbal ingredients such as vitamins and minerals to be included in herbal medicines.
  • Parliament adopted an amendment shortening a required statement for advertising claims of these products noting "the product is traditionally used and its efficacy relies on long term use and experience."

Parliament retained a 30-year requirement to establish traditional use, with at least 10 of those years within the European Community.

The Association of the European Self-Medication Industry reports that the Commission is likely to support most of the changes proposed by the Parliament. After the Commission drafts its amended proposal it will go to the Council of Ministers.

CHPA contact: David Spangler

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CHPA's Saldanha to participate in upcoming NIH conference

CHPA Vice President-Nutritional Sciences Leila G. Saldanha, Ph.D., R.D., will participate in a panel discussion during the January 14-15, 2003, Dietary Supplement Use in the Elderly Conference on the National Institutes of Health (NIH) campus. Saldanha's panel will explore the safety and effectiveness of dietary supplements, especially as they relate to the elderly population. The panelists will delve into such topics as critical research areas involving the elderly and how dietary supplements may interact with disease states, medication use, genetic factors, and environmental exposures. More information about the conference is available online

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Pharmacovigilance and risk management seminar planned

The Drug Information Association (DIA) is offering its second annual four-day conference in January on contemporary pharmacovigilance and risk management strategies. The January 13-16, 2003, conference will take place in Washington, D.C., and will incorporate the latest U.S., European, and Japanese regulatory frameworks for pharmacovigilance. More information about this conference is available on DIA's web site

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CHPA Annual Executive Conference
March 13-15, 2003
Turnberry Isle Resort & Club
Aventura, Florida

MarketPlace
September 18, 2003
Hilton East Brunswick
13 Tower Center Blvd.
East Brunswick, New Jersey

Manufacturing Controls Seminar
October 9-10, 2003
Hilton Parsippany Hotel
One Hilton Court
Parsippany, New Jersey

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Executive Newsletter is published every other week by the
Consumer Healthcare Products Association
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Tel: (202) 429-9260
Fax: (202) 223-6835
Web site: www.chpa-info.org
 
Forward contact information changes to CHPA's Membership Department.
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Copyright © 2002 by the Consumer Healthcare Products Association (CHPA). CHPA's Executive Newsletter is for general information purposes only. Information reported in this newsletter is compiled from various sources. All efforts are made to assure the accuracy of the content, but CHPA cannot guarantee the information.  
 
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