DEA's Scott Collier was joined by George Cazenavette of the New Orleans Field Division, one of the seven DEA demand-reduction officers attending the seminar.

ONDCP's Scott Burns of the White House ONDCP presented a national perspective on the policy efforts and law enforcement initiatives toward curbing meth abuse.

The leadership training session is only one aspect of CHPA's involvement in helping interested states implement Meth Watch. As part of its major commitment to fight the national meth problem, CHPA has:

• Provided a total of one million dollars in seed money to help states get their local programs started;
• Developed a uniform Meth Watch model that is available at www.MethWatch.com; and
• Produced a training video for retailers to use to train their employees.

CHPA will continue to work with states as they organize and formulate their own Meth Watch proposals, as well as to promote the Meth Watch program on Capitol Hill.

CHPA contacts: Elizabeth Assey and Virginia Cox

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CHPA reasserts the efficacy and safety of pediatric cough/cold medicines

CHPA issued a statement July 7 in response to an article published in the July issue of Pediatrics entitled, "Effect of Dextromethorphan, Diphenhydramine, and Placebo on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents."

In its statement, the Association stressed the fact that OTC cough/cold products provide therapeutic relief to millions of consumers of all ages each year. Additionally, FDA and other regulatory agencies world-wide support the use of OTC cough/cold products containing dextromethorphan (DM) and diphenhydramine (DPH) for providing relief of coughs and other symptoms associated with the common cold, and studies support the efficacy of these ingredients.

CHPA noted that clinical studies usually have not included children or pregnant women and applauded the researchers' efforts to study the efficacy of these ingredients on cough relief in children. However, the Association stated that the conclusions of the study would need to be tested with a larger population that uses the products according to the label directions.

The Association pointed out that even the study authors acknowledge "the reporting of children's symptoms by their parents is subjective and imprecise, and the medicines in the study were not dispensed in doses according to label directions."

Indeed, the study states:

"It is important to note that this study evaluated the effect of the medications versus placebo using one dose administered on a single evening. It is possible that an effect could have been demonstrated with DPH or DM if children were given either multiple doses throughout the day or repeated nocturnal doses for several consecutive evenings."

Lastly, the Association added that OTC cough/cold products are effective for relieving the symptoms of colds, and because of their wide margin of safety, have very few side effects when used according to the label.

CHPA contacts: Elizabeth Assey and Virginia Cox

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Association asks FDA to permit use of certain abbreviated health claims

CHPA recently went on public record to recommend that FDA allow abbreviated health claims in which a clear statement of the ability of the substance to reduce the risk of a disease or health-related condition to be placed on the front of dietary supplement packaging. The Association also asked that additional labeling requirements of the health claim be allowed to appear elsewhere on the package. CHPA presented these recommendations in a July 6 submission to the Agency regarding the reopened 1995 proposed rule on nutrient content and health claims (see May 6 XNL).

CHPA also addressed FDA’s request for comments on whether consumers potentially could be misled by abbreviated health claims. The Association opined that these types of claims should not cause confusion as long as the statements themselves are truthful and not misleading, and there is a “prominent and immediate adjacent reference that refers consumers to additional labeling.” For example, simple statements such as “soluble fiber from [name soluble fiber source] reduces the risk of heart disease” followed by a statement such as “see additional important information on the back [or side] panel,” should not cause confusion if permitted on the principal display panel of a package. 

The Association's comments also supported the FDA Task Force on Consumer Health Information for Better Nutrition's recommendation to remove the word “may” or “might” from unqualified health claims. Citing that the word “may” could have several meanings, CHPA stated that a simple declaration of the association of the substance with the disease or health-related condition for an unqualified health claim will be the clearest to the consumer. 

FDA is currently considering these comments along with others that were submitted in drafting regulations for health claims on food products, including dietary supplements.  

CHPA contact: Dr. Doug Bierer

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New Jersey FDA/industry summer workshop provides answers to many cGMP questions

Over 230 people representing a wide range of sectors of the industry from medicines to medical gases to cosmetics, attended the July 12 FDA/industry workshop in Parsippany, New Jersey, to discuss issues surrounding current Good Manufacturing Practices (cGMPs). Attendees gained valuable insight from a number of expert speakers on the following questions:

What is FDA’s current thinking and progress to date?

David Horowitz, director, Office of Compliance, Center for Drug Evaluation and Research (CDER), FDA, provided a detailed update on the progress of the cGMP initiative, noting that it will come to close in September with an update. He then elaborated on ways industry can engage and participate in future developments. He reiterated that because science and technology has advanced significantly since the cGMPs were issued 25 years ago, updating the cGMPs was a necessity. He pointed to the goals of the initiative by adding that there has been a dramatic increase in the number of facilities domestically and internationally and a relative decrease in the number of inspectors. He also stressed the advances in risk management in both governmental and business organizations. Regarding CDER's activities in the effort, he pointed to:

• The development of a 25-person pharmaceutical inspectorate;

• CDER's review of warning letters;

• Dispute resolution of technical and scientific GMP issues;

• CDER’s own internal quality system which is underway;

• Part 11 reform;

• Aseptic processing; and

• Risk based model for prioritizing manufacturing sites for GMP inspections.

What is industry doing to help map the future direction?

Edward Bernasky, director/team leader, Site Compliance Assessment, Pfizer Inc., provided outlined a site compliance assessment (SCA) program being used at all Pfizer facilities. Bernasky was key in the development of this program while employed with Pharmacia.

Bernasky explained that the following five steps are needed to ensure a successful SCA program:

1. Establish priorities;

2. Collect registered data;

3. Perform gap analysis;

4. Develop and action plan; and

5. Ensure gap closure.

What are industry's practical experiences to date in implementing systems?

To help answer this question, Ralph Napolitano, director, QA, North America, Hoffman-LaRoche, Inc., provided a comprehensive view of the practical applications of manufacturing science to comply with GMP requirenments. In addition, George Smith, consumer safety officer, Office of Compliance, CDER, detailed how Part 11 can be applied as necessary.

What are FDA's current observations?

Robert Maffei, compliance officer, New Jersey District, FDA, provided a national score card on how firms are performing under the current system and where the trends are. He included the total number of inspections, injunctions, and warning letters issued by the Agency from 1993 to 2003. Additionally, Maffei cited the top ten GMP violations made by manufacturers.

CHPA wishes to thank attendees from both FDA and industry whose participation and interest helped to make this event a success. The second workshop of the summer will take place August 9 in Chicago, Illinois. Online registration is available.

CHPA contact: Fred Razzaghi

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CHPA marketers meet in New Jersey

Several senior marketing executives from CHPA Active and Associate member companies met in Short Hills, New Jersey, June 29, to help Association staff better understand members’ needs in the marketing discipline. 

The group discussed several common marketing issues, as well as a potential ongoing promotion plan in support of the flexible spending account ruling with respect to OTC medicines–to encourage more employee participation and increased sales of OTCs.

CHPA will be surveying the membership in the weeks ahead to determine longer-term potential deliverables to the membership.

CHPA contact: Virginia Cox and Ted Peterson

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Business Development Conference to feature CVS immersion

CHPA members should mark their calendars for the Association's 2004 Business Development Conference (BDC), to be held November 3-4 at the Westin Hotel in Providence, Rhode Island. This year's BDC will include presentations by and interaction with CVS's senior merchandising and marketing team led by Mike Bloom, senior vice president, Merchandising. The program also will feature representatives from CVS's logistics staff to review the organization's supply-chain initiatives.

The 2004 BDC is open to CHPA members only. A program brochure and registration materials will be made available in the near future.

CHPA contact: Ted Peterson 

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Dietary supplement trades participate in University of Minnesota seminar on AER system

A conference on adverse event reports (AERs) for dietary supplements was held June 30 at the University of Minnesota. The seminar, Adverse Event Reporting and Dietary Supplements: Towards a National System of Surveillance, explored the recent agreement among U.S. Senators Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), and Richard Durbin (D-Ill.), to develop legislation for mandatory AERs for dietary supplements and approaches to implementation and management. The event was co-sponsored by the College of Pharmacy at the University of Minnesota, and the Utah Natural Products Alliance (UNPA), in association with CHPA, the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the American Botanical Council, and the United States Pharmacopeial Convention, Inc.

There were a wide array of expert speakers at the event including Douglas Ws. Bierer, Ph.D., vice president of scientific and regulatory affairs, CHPA; Annette Dickenson, Ph.D., president, CRN; and Rick Kingston, Pharm.D., from the newly-created College of Pharmacy Center for Dietary Supplement Safety.

During his remarks, Bierer stated that CHPA's Board of Directors was supportive of legislation that would include a mandatory reporting system for serious adverse events for dietary supplements marketed in the United States, preemption of state and local AER systems, and nondisclosure of individual records or names. He said that a third-party reporting service has advantages, especially for smaller companies that may not have the infrastructure for AERs and follow-up, and that use of a common database could provide early signals for adverse events of ingredients used by different companies. While Bierer noted the merits of a third-party system, he indicated that such a system should be voluntary, and decided upon by each company on a case-by-case basis. 

Dickenson's presentation included a report on the recent congressional agreement among Senators Hatch, Harkin, and Durbin. She also related CRN’s support of mandatory reporting of serious adverse events. 

Kingston described a third-party system in which the center could be useful in developing collection tools specifically tailored to dietary supplements, analyzing and defining the safety profile of dietary supplements, evaluating which AERs are “serious” and need to be reported, and creating a national product database with standardized coding of product categories for tracking products with the same ingredients. He added that the current U.S. Environmental Protection Agency (EPA) rule for insecticides and related products provides a basic framework to consider for dietary supplement AERs. 

Shortly after the seminar, the dietary supplement trade associations—CHPA, AHPA, CRN, the National Nutritional Foods Association, and UNPA—united in a July 6 news release commending the interest sparked at the seminar in exploring a broader voluntary, third-party AER system that would improve the quality of reports and provide context for evaluating their significance.

CHPA contacts: Elizabeth Assey and Dr. Doug Bierer

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USDA and FDA bolster security measures for BSE

Several documents were issued by FDA and the U.S. Department of Agriculture (USDA) in the July 14 Federal Register to further improve safeguards against bovine spongiform encephalopathy (BSE). The new measures taken by the agencies were in response to the finding of an adult cow, imported from Canada, that tested positive for BSE in the state of Washington late last year. The actions include:

• An FDA interim final rule that prohibits the use of certain cattle material in human food, including dietary supplements. FDA is proposing to require manufacturers and processors of human food and cosmetics that are processed with or contain material from cattle to establish and maintain records sufficient to demonstrate the the products are in compliance. The interim final rule went into effect July 14. Comments are due by October 12.
• A proposed FDA rule on recordkeeping requirements to further implement the interim final rule relating to the ban of certain cattle material. Comments are due to FDA by August 13.
• A joint USDA Food Safety & Inspection Service, USDA Animal and Plant Health Inspection Service, and FDA advance notice of proposed rulemaking on additional preventive actions that are being considered for BSE. Comments are due to USDA by September 13. FDA will consider comments on or before August 13.

According to the agencies, all of these actions are being taken to further minimize the risk of human exposure to materials that possibly could contain the BSE agent.

CHPA contacts: Dr. Lorna Totman and David Spangler

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Codex vitamin and mineral guidelines move to next step

During its meeting in Geneva, Switzerland, June 28-July 3, the Codex Alimentarius Commission okayed draft guidelines for vitamins and mineral supplements. This moves the draft to step number five in the eight-step Codex process.

As adopted, the draft guidelines successfully address the issue that postponed progress: 

Maximum levels of vitamins and minerals in supplements should reflect scientific safety concerns and not be based on strict multiples of recommended daily allowances. 

The U.S. government, as well as the Council for Responsible Nutrition, CHPA, and others, had long urged the science-based approach (see November 13, 2003, XNL).

The next step will be discussion at a November meeting in Bonn, Germany, of the Codex Committee on Nutrition and Foods for Special Dietary Uses.

CHPA Contact: David Spangler

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WSMI Beijing Conference to feature key regulators from around the globe

From Past to Future: Public Health, Regulatory, and Industrial Opportunities in Responsible Self-Medication is the theme of the World Self-Medication Industry (WSMI) Asia Pacific Regional Conference set for October 26-29 in Beijing, China.

As mentioned in previous issues of the Executive Newsletter, this year's conference will include sessions on improving access to self-medication in China, as well as bigger picture regional change drivers. Additionally, the conference will feature a session with key regulators from Australia, Singapore, China, and Japan, on developments in the regulation of nonprescription medicines in their respective regions. Topics such as channels and scheduling, approval process changes, medicines communication and information, and harmonization initiatives will be covered.

Anyone with business interests in the region should take advantage of this opportunity for one-stop shopping to meet with contacts and policymakers from not only China, but other countries in the region.

For more information and registration information, visit the www.SelfMed.cn.

CHPA contact: David Spangler

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FDA seeks safety and effectiveness information for antigingivitis ingredient

As part of its ongoing OTC Review, FDA issued a call for safety and effectiveness data in the July 6 Federal Register for triclosan, 0.3 percent maximum, as an antigingivitis ingredient in OTC dental pastes and oral rinses. According to the Agency, it has reviewed a time and extent application and determined that this condition is eligible for consideration in its monograph being developed for OTC oral health care drug products. Data, information, and general comments supporting the safety and effectiveness of this active ingredient for this use must be submitted to the Agency by October 4.

CHPA contact: Dr. Doug Bierer

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Annual guidance agenda published by FDA

FDA released its annual guidance agenda in the July 9 Federal Register. This document provides a list of possible topics for future guidance document development or revision during the next year.

Topics for the Center for Drug Evaluation and Research (CDER) include:

• Gingivitis;
• Psoriasis;
• Premarketing risk assessment;
• Good pharmacovigilance practices;
• Standards for electronic clinical data submissions;
• Drug names and dosage forms;
• Labeling dietary supplements for women who are or could be pregnant [also under the Center for Food Safety and Applied Nutrition (CFSAN)];
• Submitting proprietary names for evaluation;
• OTC actual use trials;
• Labeling comprehension studies for OTCs;
• Labeling for OTCs;
• Labeling of OTC skin protectants;
• Labeling of OTCs–questions and answers; and
• Qualifying for pediatric exclusivity.

Topics for CFSAN, the FDA center responsible for dietary supplements, include:

• Dietary supplement labeling for women who are or could be pregnant (also listed under CDER);
• Seventy-five day premarket notifications for new dietary ingredients; and
• Substantiation of health claims.

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House approves Plan B amendment

During the July 13 debate on the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, the U.S. House of Representatives approved, by voice vote, an amendment offered by Representative Carolyn Maloney (D-N.Y.). The amendment prevents FDA from using funding in the bill to restrict to prescription use a contraceptive (e.g., Plan B) that is determined to be safe and effective for use without the supervision of a practitioner licensed by law to administer prescription drugs. The amendment was agreed to by Representative Henry Bonilla (R-Tex.), chairman of the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Subcommittee.

CHPA contact: Kevin Kraushaar

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CHPA staff travel inside the Beltway and beyond

CHPA Vice President for Corporate Development Ted Peterson and Vice President for Communications Virginia Cox met with senior marketing executives from CHPA Active and Associate member companies in Short Hills, New Jersey, June 29, to help Association staff better understand members’ needs in the marketing discipline (see related story).

Vice President of Government Relations Kevin Kraushaar traveled to Vail, Colorado, July 12, to participate on a methamphetamine panel at the Council of Western Attorneys General...

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Associate science director and regulatory affairs manager sought

A Westchester County, New York, CHPA member is seeking applicants for two positions:

• Associate Director, Scientific Affairs: Candidates for this position should possess a Ph.D. and be an experienced researcher in the areas of diabetes, cardiovascular disease, obesity, other metabolic diseases, or nutritional science. Responsibilities include reviewing scientific publications, medical editing of abstracts and other materials, writing articles for publication in peer-reviewed medical journals, analyzing clinical study results to support marketing with positioning statements for products, and presenting and appearing at scientific conventions and national trade shows. This position will supervise a Ph.D. nutritional scientist. All candidates must possess excellent presentation skills; a network of industry and academic contacts; a publication track record in peer-reviewed journals; and great command of English, written and verbal. Minimum of five years in the field; a knowledge of statistics is a plus. 
• Regulatory Affairs Manager: Candidates must have at least three years of regulatory experience. Overall responsibilities include managing regulatory aspects of projects and products, including the preparation of regulatory submissions such as new dietary ingredient applications, health claim petitions, labeling claim submissions for both domestic and international regulatory agencies, and acting as direct liaison with regulatory authorities to facilitate the prompt review and approval of applications. The regulatory affairs manager will help assure that the company is in compliance with all United States and international regulatory requirements; interpret existing or new regulatory requirements as they relate to company products and clinical trials; and review and advise on labeling, product claims, or marketing programs to assure compliance with regulations. Requirements include the minimum of a B.S. or M.S. in a science-related field or a J.D. specializing in regulatory or food law, including knowledge and experience with FDA. European Marketing Authorization experience is a plus. Candidates must possess excellent presentation, communication, and analytical skills.

For more information, visit CHPA’s members-only Job Board in the Members Only section of www.chpa-info.org or e-mail Nancy Hutter.

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The National Alliance for Hispanic Health launches new online resource

A new online resource tool called the "Hispanic Health Action Forum" was recently developed by The National Alliance for Hispanic Health on its award-winning web page: www.hispanichealth.org. The action forum was created to allow Internet visitors to send messages to the U.S. Congress, the President, and appointed officials on Hispanic health issues; find information on voting records and biographies of members of Congress; search for legislation; and get national and state election results and candidate biographies. Visitors also may register to receive "Action Alerts" that report breaking issues related to Hispanic health.

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National Library of Medicine announces new health web site for Native Americans

The National Library of Medicine, part of the National Institutes of Health, recently announced the creation of a new web site to address the health concerns of American Indian or Alaskan Natives. The site, "American Indian Health," available at http://americanindianhealth.nlm.nih.gov, offers consumer health information specific to the Native American population, research results, traditional healing resources, and links to other web sites. This latest web page joins existing sites developed by the library for specialized populations, such as Asian Americans, senior citizens, and Spanish-speaking Americans. All of the special population web pages may be accessed at http://www.nlm.nih.gov/databases.

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FIP to hold pharmaceutical congress in The Big Easy

The International Pharmaceutical Federation (FIP) is hosting its 64th annual World Congress of Pharmacy and Pharmaceutical Sciences September 4-9 in New Orleans, Louisiana. This year's event offers a number of symposia on such topics as the changing role of the pharmacist, getting medicines right for children, and the increasingly knowledgeable patient. Section programs cover different areas of interest in pharmacy practice including counterfeit medicines, clinical trials, and direct-to-consumer advertising. For more information on this event, visit www.fip.org/neworleans.

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FDA/CHPA Summer Workshop
August 9, 2004
Hyatt Regency Chicago
Chicago, IL

CHPA Market Exchange
September 23, 2004
Hilton East Brunswick
East Brunswick, NJ

Manufacturing Controls Seminar
October 7-8, 2004
Hilton Parsippany
Parsippany, NJ

Business Development Conference
November 3-4, 2004
The Westin
Providence, RI

2005 CHPA Annual Executive Conference
March 10-12, 2005
Fairmont Turnberry Isle Resort & Club
Aventura, FL

2005 Regulatory & Scientific Conference
May 5-6, 2005
Mandarin Oriental Hotel
Washington, DC
 

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