CONTENTS

FDA announces sweeping cGMP initiative

PQRI forms technical group to work with FDA on cGMP initiative

Rule proposed to amend OTC internal analgesic tentative final monograph

Coal tar and capsaicin undergo Cosmetic Ingredient Review

CFSAN announces AER activities 

CHPA asks CFSAN to keep safety a top priority in 2003

NCCAM advisory council increased by six

Reserve your room for the MCS!

Webber to take over as WSMI director general

WSMI general assembly will seek new frontiers for self-medication

CHPA concurs with government's draft Codex position

CHPA's Totman to talk switch at OTC Update conference

APhA offers promotion for National Pharmacy Week

Gum-Tech changes name to Matrixx Initiatives

Calendar of events

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FDA announces sweeping cGMP initiative

For the first time in nearly 25 years, FDA has announced a major initiative to evaluate and revise current good manufacturing practices (cGMPs) for veterinary and human pharmaceuticals, including human biological drug products. The initiative is outlined in "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach." FDA’s program, announced August 21, seeks to assert a risk-based approach to cGMPs so that the Agency can most effectively apply its limited resources to achieve the best public health protection. The initiative stresses science-based policies and standards and plans to incorporate current, and encourage future, technological advances in manufacturing practices. Additionally, reflecting the global nature of the pharmaceutical industry in the 21^st century, FDA will foster cooperation among international regulatory bodies.

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PQRI forms technical group to work with FDA on cGMP initiative

CHPA contact: Dr. Bill Soller

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Rule proposed to amend OTC internal analgesic tentative final monograph

FDA published a proposed rule in the August 21 Federal Register which would amend the internal analgesic, antipyretic, and antirheumatic tentative final monograph to:

• Include ibuprofen 200 mg in tablet form as generally recognized as safe and effective for adults and children 12 years of age and older (responding to citizens petition on the subject); 
• Add more explicit warning language than ibuprofen currently includes to the "Ask a doctor before use if you have" section of the label; 
• Add another warning in the "Ask a doctor or pharmacist before use if you are" section of the label; and 
• Add an "Allergy alert" and additional allergy warning statements for all OTC drugs with nonsteroidal anti-inflammatory active ingredients (including aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen, and sodium salicylate).

Comments are due to the Agency by November 19. For more information, contact Ida Y. Yoder at FDA's Center for Drug Evaluation and Research at (301) 827-2222.

CHPA contact: Dr. Bill Soller and Dr. Lorna Totman

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Coal tar and capsaicin are being reviewed in CIR

Two OTC drug active ingredients, coal tar and capsaicin, are being assessed in the Cosmetic Ingredient Review (CIR). CIR’s purpose is to thoroughly review and assess the safety of ingredients used in cosmetics and to publish the results in open, peer-reviewed scientific literature. The CIR is not intended to deal with ingredients as drug actives but rather only as they are used in cosmetics.

The full agenda for the September Expert Panel Meeting and information about CIR Scientific Literature Reviews can be obtained at www.cir-safety.org/staff_files/agenda.pdf. The CIR web site is www.cir-safety.org.

CHPA contact: Dr. Lorna Totman

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CFSAN announces AER activities

Click here for more information about the new CAERS system.

CHPA asks CFSAN to keep safety a top priority in 2003

In its comments to FDA regarding fiscal year 2003 program priorities for the Center for Food Safety and Applied Nutrition (CFSAN), CHPA urged FDA to keep safety a top priority so that a comprehensive quality and safety program for dietary supplements exists that encompasses all the requisite areas. CHPA also encouraged further development of the regulatory environment for dietary supplements, consistent with the Dietary Supplement Health and Education Act of 1994 (DSHEA). Specifically, CHPA called on FDA to:

• Issue the long-awaited final regulation on good manufacturing practices;
• Implement a framework for evaluating the safety of dietary supplements, currently under development by the Institute of Medicine;
• Execute a reasonable enforcement program consistent with DSHEA that includes an appropriate level of inspections;
• Employ a well-developed adverse event monitoring system with adequate staffing for electronic-based collection activities, competent medical reviews, training, etc.;
• Develop a framework for potential public health interventions by FDA based on CFSAN-initiated safety reviews (e.g., labeling, product withdrawal, education); and
• Initiate a more efficient working relationship with the Federal Trade Commission that ensures more consistent development of label statements.

CHPA Contact: Dr. Leila Saldanha

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NCCAM advisory council increased by six

The National Institute of Health (NIH) announced August 23 that six new members have been added to the National Advisory Council of the National Center for Complementary and Alternative Medicine (NCCAM). The council meets three times a year, and with the addition of the six new members, it is now comprised of 18 individuals. Each new member was appointed by U.S. Department of Health and Human Services Secretary Tommy Thompson. The new members are: 

• Zang-Hee Cho, Ph.D., professor, Department of Radiological Sciences, Psychiatry and Human Behavior, and Ophthalmology, University of California at Irvine; 
• Kristina M. Collins, D.C., owner and chiropractor, Old Dominion Chiropractic, Inc.;
• Murray Goldstein, D.O., M.P.H., medical director, United Cerebral Palsy Research and Educational Foundation;
• Michael R. Irwin, M.D., professor and director, Norman Cousins Center for Psychoneuroimmunology, University of California at Los Angeles;
• Barbara Timmerman, Ph.D., regents professor, Department of Pharmacology/Toxicology, College of Pharmacy at the University of Arizona; and
• Benjamin Chi-Kuo Yang, C.A., O.M.D., commissioner and member, State of California Industrial Medical Council.

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Webber to take over as WSMI director general

WSMI Chairman Akira Uehara, president, Taisho Pharmaceutical Co., Ltd., and Chairman-Elect Tom Blinn, vice president, Global Personal Healthcare, The Procter & Gamble Company, announced August 27 that the next director general of the World Self-Medication Industry (WSMI) is David Webber, Ph.D.   

Webber is currently director of Economic Policy and fellow of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), and will take over the WSMI post December 1 from Jerry Reinstein, Ph.D. Reinstein will remain with WSMI until March 1, 2003, to assist Webber with the transition.  

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"I am looking forward to taking up this new challenge at a time when responsible self-medication is increasingly recognised as an invaluable resource in health care systems worldwide" — Webber on his new role at WSMI

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In his present role at IFPMA, Webber is responsible for formulating cross-industry policy positions on issues of global interest. With an extensive background in international pharmaceutical marketing, corporate strategy, and public affairs, Webber has represented the industry on projects with the World Health Organization, World Bank, and Commission for Macroeconomics & Health, as well as at meetings in Europe, the Americas, and Asia.

Currently based in Geneva, Switzerland, Webber will operate out of WSMI’s new office in Ferney-Voltaire, France.

CHPA contact: Dave Spangler

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WSMI general assembly will seek new frontiers for self-medication

"Beyond the conventional boundary of self-medication" is the theme for this year's World Self-Medication General Assembly. The meeting will be held November 12-16 in Tokyo, Japan.

Session discussions will focus on a variety of topics such as the public health implications and benefits of self-medication session chaired by CHPA President Linda A. Suydam, D.P.A.. Government speakers will examine switch experiences in countries such as Australia and Mexico, where 31 ingredients or indications were changed to OTC status in a single year. Saul Shiffman, Ph.D., University of Pittsburgh, will provide a case study on the public health benefits of nicotine replacement therapies. Kohichi Kawabuchi, M.D., Tokyo Medical and Dental University, will present new information on consumer attitudes and thoughts on self-diagnosis.

For more information on this and other sessions during the assembly, contact CHPA’s Sandra Archer at sarcher@chpa-info.org for a preliminary program and registration form, or WSMI at wsmi@ics-inc.co.jp.

CHPA contact: Dave Spangler

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CHPA concurs with government’s draft Codex position

The Association issued its general support August 19 for the government’s draft vitamin and mineral guidelines position for the next meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses. "In general . . . [the government’s position] appropriately notes the importance of consumer choice and access to safe vitamin and mineral supplements . . . and appropriately stresses that any maximum levels should be based on safety assessments and not [on] arbitrary application of a percentage of recommended daily intake," CHPA Vice President – International and Assistant General Counsel David C. Spangler wrote on behalf of the Association.

The Codex nutrition and foods committee will consider the "Proposed Draft Guidelines on Vitamin and Mineral Supplements" at its next meeting, November 4-8, in Germany.

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CHPA's Totman to talk switch at OTC Update conference

"Crossing New Frontiers," Nicholas Hall & Company's 2nd OTC Update conference and workshop, will feature one of CHPA's own: Lorna C. Totman, Ph.D., DABT, director of scientific affairs. In her presentation, Totman will discuss issues that affect the future of Rx-to-OTC switch, as well as the role of OTCs in the prevention and management of chronic diseases and conditions. The conference, which will be held October 16-17 in Princeton, New Jersey, will feature a variety of other speakers on issues such as OTC marketing and retail trends, managed care, and emerging minority markets. For more information on the conference, visit www.nicholashall.com/events/events4.html.

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APhA offers promotion for National Pharmacy Week

The American Pharmaceutical Association (APhA) is gearing up for National Pharmacy Week October 20-26, by offering promotional information and materials for pharmacists to use. A National Pharmacy Week Planning Guide includes tips for possible events, lists of resource materials, and publicity suggestions including how to work with the media. Other promotional products may be ordered through APhA's Product Guide. In addition, APhA is offering a series of patient brochures that pharmacists may give to consumers on subjects such as nasal allergies, osteoporosis, asthma, and heartburn. More information on the guides and brochures is available on APhA's web site at www.aphanet.org. 

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Gum-Tech changes name to Matrixx Initiatives

CHPA Active member Gum-Tech International, Inc., has changed its name to Matrixx Initiatives, Inc. The company's new web site is www.matrixxinc.com and employee e-mail addresses now end in ...@matrixxinc.com rather than ...@gum-tech.com. All other company contact information, such as telephone numbers and its mailing address, remain unchanged. 

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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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