February 21, 2003 

No. 4-03   

CONTENTS

AEC speakers to cover broad range of timely issues

Details, details: CHPA offers final  AEC 'checklist'

Plan to attend AEC networking dinner

CHPA MarketPlace 2003: Update

FDA announces completion of initial phase of pharmaceutical good manufacturing practices initiative

CFSAN realigns its Office of Nutritional Products, Labeling, and Dietary Supplements

FDA busy on ophthalmics monograph

Pharmaceutical science manufacturing subcommittee to meet on cGMPs

Agency updates guidance on drug impurities

Kington appointed deputy director of NIH

Staff travel inside the Beltway and beyond

APhA readies for its annual meeting

3rd annual medical research conference slated for March

2003 CHPA member dues deadline reminder

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.

AEC speakers to cover broad range of timely issues
  


Doug Degn


Dave Pinto
  

 
JUST ADDED! The first general session at CHPA’s Annual Executive Conference has added a conversation with Wal-Mart’s Doug Degn, moderated by Chain Drug Review’s David Pinto, to round out the Friday, March 14, morning session. 
  

Degn serves as executive vice president, Food and Consumables Merchandising, Wal-Mart Stores, Inc.; Pinto is the editor and co-founder of Chain Drug Review and president of Racher Press. Conference attendees will hear a Wal-Mart corporate update, thoughts on the corporation’s merchandising direction, and perspectives from the world’s largest retailer on the OTC/health and beauty care categories.

Earlier Friday morning and courtesy of Hearst magazines, political commentator Mike Barnicle kicks off the line-up of speakers for the CHPA Annual Executive Conference (AEC) at the Hearst breakfast session Friday, March 14.

Barnicle is a regular contributor to WCVB-TV in Boston on the station’s nightly news magazine. He is known for his biting, to-the-point commentaries, both in print and on the air. A graduate of Boston University and a native Bostonian, he also has written speeches for a variety of political figures, including the late Robert F. Kennedy and the late Hubert H. Humphrey.

Conservative political pundit Tucker Carlson will join members Saturday, March 15, to speak at the Reader’s Digest breakfast. A columnist for host Reader’s Digest, Carlson is considered by many one of the best political analysts in broadcast journalism today. Carlson also provides insight and commentary "from the right" on CNN’s political debate program Crossfire, squaring off against "from the left" commentators James Carville or Paul Begala. Carlson provides a spirited, candid, incisive look into the day’s political events, both domestic and international, as well as perspectives on the leaders driving them.
 

Key business elements targeted in "coffee with…" sessions

CHPA members at the AEC will have the opportunity to attend two of the three "coffee with…" sessions offered Friday afternoon. Each session will focus on issues important to the self-care industry. The sessions run concurrently and each will be repeated.

  • FDA perspectives: Sandra L. Kweder,M.D., deputy director, Office of New Drugs, FDA Center for Drug Evaluation and Research, will be providing her perspectives on how the drug approval process continues to evolve. She also will brief attendees with information about FDA’s thoughts on streamlining drug development, as well as on the roles of review divisions where more than one review division is involved.
      
  • Rx direct-to-consumer (DTC) advertising: CHPA members will get three professionals’ impressions on a host of DTC issues at this session. Panelists Robert C. Burruss (Grey Worldwide, Inc.), Edward C. Kuehnle (Information Resources, Inc.), and Edwin P. Slaughter (Rodale, Inc.) will provide perspectives on the evolving views by consumers and health professionals toward Rx DTC marketing and what it means for OTC marketers.
      
  • Hispanic marketing: Martin Barreto, Barreto & Brightwell Associates, a public relations firm specializing in marketing communications reaching the Hispanic population, and Bennett Fogel, Univision Communications, will delve into some of the best practices for reaching the growing Hispanic market in the United States.

CHPA contact: David Spangler

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Details, details: CHPA offers final AEC 'checklist'

With CHPA's Annual Executive Conference (AEC) less than three weeks away, the Association has compiled a 'checklist' of important venue-related information to help members make their stay enjoyable and trouble free:

Turnberry information:

Check-in/check-out—Check-in is 4:00 p.m. at the hotel. Since this is high season for Turnberry and the resort is at full capacity, the hotel cannot guarantee any early check-ins or late check-outs. 

  • Wednesday, March 12: Hotel check-in is in the main lobby.
  • Thursday, March 13: Hotel check-in is in the conference center.
  • Friday-Sunday, March 14-16: Hotel check-in and check-out are in the main lobby.

Room reservations—The CHPA room block has been released. If you haven’t already, please fax your room reservation form with deposit to Ana Luna at Turnberry (305) 933-6560. If you have any questions regarding the hotel rooms, please call Ana Luna directly at (800) 327-7028, ext. 3465.

Spa and fitness center—Reservations are required for all spa services; please call (305) 933-6930.

On-site charging privileges for off-site guests—On-site charging privileges are available for AEC attendees not staying at the conference venue, the Turnberry. Please contact CHPA's Kass Kassouf in the Meetings department at (202) 429-3544 for more information or to make arrangements. 

Golf—If departing the hotel before 7:00 a.m. on any day of the week, you must let the golf club know in advance so they can pull your golf bag(s) from the bag storage room the day before. The golf storage room is closed until 7:00 a.m. every day.

Sports sign-up:

It's not too late to sign up for the CHPA golf or tennis tournament. Fill out the CHPA Sports Form and fax to the Meetings department at (202) 223-6835.

Please contact the CHPA Meetings department if you have any AEC-related questions at (202) 429-3545 or -3544.

CHPA contacts: Kass Kassouf and Maria Sarabia

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Plan to attend AEC networking dinner

Friday, March 14, 7:30-10:00 p.m.

The Condé Nast Publications and Parade Publications are hosting a networking dinner immediately following the Grey Worldwide opening reception at the Annual Executive Conference (AEC). There is no additional fee for attending. Table numbers will be available outside the function room that evening.

CHPA will assign seating for dinner attendees in an effort to facilitate both business and social interaction between Associate and Active members. Since this is a seated event, please let CHPA know as soon as possible if your plans to attend the AEC change. Similarly, if another company representative attends the conference in your place, please inform your substitute of the dinner commitment. 

CHPA contact: Phyllis Taylor

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CHPA MarketPlace 2003: Update

A preliminary list of exhibitors for CHPA MarketPlace 2003 will be available at the upcoming Annual Executive Conference. Exhibitors are asked not to set their own appointments until after their CHPA-scheduled appointments are sent to them later this spring. This opportunity is available only to CHPA members, and space is limited to 50 tables.

CHPA contact: Phyllis Taylor

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FDA announces completion of initial phase of new pharmaceutical good manufacturing practices initiative

The Agency announced February 20 via press release and teleconference that it has completed the short-term goals of its "Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk Based Approach" initiative. (See August 30, 2002, XNL.) According to Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER), who opened the teleconference, and other Agency personnel who reported during the call, the following "immediate" steps have been addressed: 

21 CFR Part 11 implementation

Joseph Famulare, director of CDER's Division of Manufacturing and Product Quality, reported that a new draft guidance on the electronic records and signatures rule, 21 CFR Part 11, has been issued. This draft clarifies the scope and application of the regulation and provides for enforcement discretion in certain areas that have been problematic according to the Agency. Additionally, Famulare announced that a Notice of Availability was issued explaining FDA's intention to reexamine the rule. 

GMP warning letter review

Fred Blumenschein, chief of CDER's Case Management and Guidance Branch in the Division of Manufacturing and Product Quality, indicated that all cGMP warning letters will be reviewed by their relevant FDA center prior to issuance to help identify possible inconsistencies. This procedure will begin March 1.

Technical dispute resolution process

David Horowitz, director of CDER's Office of Compliance, provided an update on FDA's progress regarding a procedure to resolve technical and scientific disputes during inspections. The Agency's goal in this area is to make the process transparent and to allow for discussion. 

Risk-based approach to inspections

FDA's Associate Commissioner for Regulatory Affairs John Taylor briefed the teleconference audience on the reorganization of his office at the Agency and on the three pharmaceutical manufacturing categories FDA considers potentially higher risk and thus of greater priority for inspections: sites making sterile drugs, sites making prescription drugs, and sites of new registrants not previously inspected by the Agency. 

Other issues included the upcoming meeting of the Product Quality Research Institute (See February 7 XNL) and the hiring of new staff under the Process Analytical Technologies Initiative. 

The FDA steering committee of the cGMP initiative plans to complete its overall work plan within four months. Topics that require further work by the steering committee include the definition of "quality" for pharmaceutical products, risk assessment, and the current regulatory structure for quality management systems.

CHPA contact: Fred Razzaghi

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CFSAN realigns its Office of Nutritional Products, Labeling, and Dietary Supplements

The Center for Food Safety and Applied Nutrition (CFSAN) at FDA has realigned its Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS). The office is now organized by product categories to better coordinate staff activities and to make ONPLDS more identifiable to the Agency’s stakeholders. The realigned office features separate units for dietary supplements, nutrition labeling and program activities, infant formula and medical food, foods standards and labeling, and analytical and database research.

Christine L. Taylor, Ph.D., continues as the director of ONPLDS; Virginia Wilkening is the office’s deputy director. The Office of the Director consists of four divisions, including the Division of Dietary Supplement Programs. This division, temporarily headed by Dr. Susan Walker, is the focal point for dietary supplement policy, reviews, and regulations.

CHPA contact: Dr. Bill Soller

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FDA busy on ophthalmics monograph

The February 19 Federal Register included two items from FDA on ophthalmics. The first was a technical amendment to the final monograph to allow either "eye irrigation" or "eyewash," rather than "eye lotion," to be used as the statement of identity/purpose. The amendment also clarifies that "purified water" should be listed (with tonicity, and pH and buffering) as the active ingredient, and preservatives should be listed as inactive ingredients. The second item published was a proposed amendment to the OTC ophthalmic monograph to include OTC emergency first aid eyewashes. FDA tentatively has concluded that there is support for the safety and effectiveness of emergency first aid eyewashes to remove acid or alkali chemicals and that immediate flushing of the eye is urgently needed to lessen the impact of alkalis. Comments are requested by May 20.

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Pharmaceutical science manufacturing subcommittee to meet on cGMPs

FDA announced February 12 an upcoming meeting of the manufacturing subcommittee of the Pharmaceutical Science Advisory Committee. The meeting with take place March 21 in Rockville, Maryland. The agenda of the meeting includes the Agency’s new initiative on pharmaceutical good manufacturing practices (cGMPs). Those wishing to make presentations or submit written comments are invited to do so by March 7.

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Agency updates guidance on drug impurities

A revised guidance on impurities in drug substances not previously registered in a country, region, or member state was announced in the February 11 Federal Register. This guidance updates and clarifies a 1996 guidance on the same subject.

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Kington appointed deputy director of NIH

National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., has appointed Raynard S. Kington, M.D., Ph.D., as the new deputy director of the institutes. Kington previously served in the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics. He is board-certified in internal medicine and public health and preventive medicine. His research has focused on social factors as determinants of health, including the health status and health behaviors of Hispanic and black immigrant populations. 

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Staff travel inside the Beltway and beyond

Virginia A. Cox, CHPA vice president for communications and strategic initiatives, attended the Bayer Aspirin Saving Lives A.S.A.P. campaign February 12 at the National Press Club in Washington, D.C...

CHPA Vice President-International and Assistant General Counsel David C. Spangler met with Harrison Cook, chief of deregulation and trade policy at the U.S. Department of Commerce, February 19. Spangler and Cook talked about the Association's objectives in Japan...

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APhA readies for its annual meeting

The American Pharmaceutical Association (APhA) is getting ready to convene pharmacists from every practice setting for its annual meeting in New Orleans, Louisiana. The March 28-April 1 meeting will offer more than 80 educational sessions, as well as exhibiting opportunities. More information is available on APhA’s dedicated meeting web site.

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3rd annual medical research conference slated for March

The Third Annual Medical Research Summit—sponsored by Train for HIPAA—will take place in Washington, D.C., March 5-7. It will feature plenary sessions as well as instructive workshops designed to provide up-to-date approaches to managing medical research initiatives with regard to the current and future legal, regulatory, and ethical context. In addition, exhibiting opportunities are available. Click here for details.

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2003 CHPA member dues deadline reminder

CHPA 2003 member dues statements were sent out December 9, 2002. Dues for Active members should be calculated on total net sales of OTC and dietary supplement products. For advertising agency members, dues should be calculated on total billings for these products. All Active and Associate member dues payments were due by January 31. Payments not received by February 28 are subject to a one percent per month late fee. Please note: Annual Executive Conference registration confirmations will be provisional until member dues are paid.

If you have not received your notice or have any questions, please contact CHPA’s Roman Blazauskas at (202) 429-3552 or rblazauskas@chpa-info.org.

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

FDA/Industry Summer Workshop
June 16, 2003
Sheraton Meadowlands
East Rutherford, New Jersey

FDA/Industry Summer Workshop
July 14, 2003
San Juan Marriott Resort & Stellaris Casino
San Juan, Puerto Rico

FDA/Industry Summer Workshop
August 12, 2003
Hyatt Regency Chicago
Chicago, Illinois

(Program and registration details on the FDA/industry summer workshops will be announced shortly.)

CHPA 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

Research & Scientific Development Conference
November 6-7, 2003
The Fairmont Washington
2401 M Street, NW
Washington, D.C.

SAVE THE DATE

2004 Annual Executive Conference
March 17-19, 2004 [Wednesday-Friday]
Grand Hyatt Washington
Washington Center, 1000 H Street, NW
Washington, D.C.

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Executive Newsletter is published every other week by the
Consumer Healthcare Products Association
1150 Connecticut Avenue, NW, Suite 1200, Washington, DC 20036
 
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 © 2003 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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