“Each year, especially during cold season, the economy takes a big hit from missed time from work and loss of on-the-job productivity,” said study economist Teresa Waters, Ph.D., associate director for research, Center for Health Services Research, and associate professor, Department of Preventative Medicine, University of Tennessee Health Science Center. “By alleviating symptoms, OTCs keep people more productive and reduce physician visits, without compromising health outcomes. This may be the first study to clearly demonstrate these benefits from the use of nonprescription medications.”

The study has been covered by a number of print, wire, and online publications, including United Press International and HealthDayNews. Broadcast news also has picked up the story, as did MSNBC with a live interview of co-author Waters.

CHPA contact: Mimi Pappas

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FDA proposes adding phenylephrine bitartrate to OTC nasal decongestant monograph

FDA announced in the November 2 Federal Register that the Agency is proposing to amend the OTC cold, cough, allergy, bronchodilator, and antiasthmatic drug products final monograph to include phenylephrine bitartrate as generally recognized as safe and effective (GRAS/E) when used in an effervescent tablet. FDA states that based on the ingredient's marketing history, absence of safety concerns, and additional data provided in a Citizens Petition, phenylephrine bitartrate in an effervescent tablet should be GRAS/E for use as a single-ingredient OTC oral nasal decongestant. The Agency notes, however, that additional pharmacokinetic data are needed to include the phenylephrine bitartrate capsule formulation in the OTC nasal decongestant final monograph.

Additionally, FDA is proposing to include in the final monograph the combination of chlorpheniramine maleate (antihistamine), phenylephrine bitartrate (nasal decongestant), and aspirin (analgesic-antipyretic) in an effervescent tablet. The Agency points out that it is including only this specific combination product in the monograph because it is not aware of other marketed combination products containing phenylephrine bitartrate.

In the area of labeling, FDA is recommending the same uses and warnings for phenylephrine bitartrate as those for phenylephrine hydrochloride because the two are salts of the same ingredient. The Agency is suggesting the following doses for phenylephrine bitartrate:

• Adults and children 12 years and over—15.6 milligrams every four hours, not to exceed 62.4 milligrams in 24 hours.
• Children six to under 12 years of age—7.8 milligrams every four hours, not to exceed 31.2 milligrams in 24 hours.
• Children under six years of age—consult a physician.

Comments on the proposal or FDA's economic impact determination are due by January 31, 2005. FDA proposes that any final rule become effective 30 days after publication.

CHPA contact: Dr. Lorna Totman

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CHPA seeks comment extension for FDA's NDI premarket notification program

Dietary supplement trades file joint request for more time

CHPA joined forces once again with the other leading dietary supplement trade associations to request a 60-day comment extension period from FDA on the Agency's premarket notification program for new dietary ingredients (NDIs). FDA published a notice in the October 20 Federal Register seeking comments on the program, as well as to announce a November 15 public meeting on the issue (See October 22 XNL). In a November 3 joint submission signed by CHPA, the American Herbal Products Association, the Council for Responsible Nutrition, the National Nutritional Foods Association, and the Utah Natural Products Alliance, the associations argued that the December 3 deadline FDA set for comments is not enough time for their respective members to thoroughly assess and thoughtfully respond to the notice. The trade groups also stated that their members will need time to review the transcript from the November 15 public meeting and that it is unlikely that document will be publicly available before comments are currently due.

If granted, the new comment deadline would be February 1, 2005.

CHPA contact: Dr. Doug Bierer

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Texas governor announces the launch of Meth Watch

The governor was joined by Sheriff Steve Bundy of Rice County, Kansas, who offered his support for the state’s efforts while sharing his county’s personal experiences and success stories with the Meth Watch program. Bundy noted, “Implementing programs like Meth Watch and putting resources into education, prevention, and demand reduction is one of the best ways to address the meth problem in our communities.”

At the event, Governor Perry announced a $50,000 grant to help establish the Meth Watch pilot program in east Texas, and indicated the state’s intentions to apply for additional funding through CHPA’s Meth Watch grant process in an effort to expand the program statewide. 

CHPA contact: Elizabeth Assey

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WSMI conference examines self-medication developments in Asia and around the globe

Over 300 delegates from 21 countries gathered in Beijing, China, October 26-29, for the World Self-Medication Industry's (WSMI's) Asia Pacific Regional Conference entitled “From the Past to the Future: Public Health, Regulatory, and Industrial Opportunities in Responsible Self-Medication.”  While the focus was on China, a number of developments in Asia and beyond also were covered.

Among the speakers at the conference was Ulf Wiinberg, president, Wyeth Consumer Healthcare. He discussed the growing global awareness in self-medication and stated that the reason is twofold: 1) Consumer interest and greater overall access to medication, and 2) Government desires to impact healthcare spending. He highlighted greater access through Rx-to-OTC switch, countries embracing better consumer information, and expanding in-store visibility or distribution channels for OTCs as drivers in the development of self-medication.

Ulf Winberg of Wyeth Consumer Healthcare (far left), Tian Ruihua of China Beijing Tong Ren Tang Group Co., Ltd., Sang Joon Lee of Chong Kun Dang Pharm. Co., and Sachiaki Ibe of Zeria Pharmaceutical Co., Ltd., take questions during a session on regional change drivers.

Sachiaki Ibe, president, Zeria Pharmaceutical Co. Ltd., and chair, Japan Self-Medication Industry (JSMI), also focused on embracing consumer information and education in his presentation. He stated that JSMI has ramped up its educational activities under the banner “let’s protect your health by yourself” in Japan. He added that industry in Japan is currently developing an ambitious medicines education program aimed at the junior high school level for launch within the next several months.

The audience heard an update on Japan’s new Pharmaceuticals and Medical Devices Agency (PMDA), which was established out of Japan's Ministry of Health, Labor, and Welfare (MHLW) in April 2004. PMDA's Yasuhide Furusawa stressed that companies now have increased responsibilities for post-marketing surveillance and quality assurance systems due to wide changes in Japan’s Pharmaceutical Affairs Law.

The meeting also included a session on "new opportunities in self-medication" chaired by CHPA President Linda A. Suydam, D.P.A. The session began with an examination of global developments in switch by Juliet Seifert, Australia Self-Medication Industry, and Stewart Jessamine, Ph.D., Medsafe (New Zealand's drug regulatory authority). Seifert pointed to the switch of a weight-loss drug in Australia as setting a new benchmark for supplementary information and materials connected to a switch. Jessamine addressed the switch of a cholesterol-lowering drug in the United Kingdom as representative of converging energies for governments, consumers, and companies to drive switch in the treatment of chronic conditions. He also reviewed the UK’s consumer-focused and pro-switch policies announced in 2001 and 2002 (See March 1, 2002 XNL).

Suydam’s session also included Charles Hennekens, M.D., professor of biomedical science, Florida Atlantic University, who reviewed what he called "one of the largest and most persuasive bodies of evidence in a number of cardiovascular diseases"—the use of aspirin for prevention. Martin Lipsky, M.D., followed Hennekens by providing his analysis of OTC use in upper respiratory infections as reported in this week’s XNL (See related story).

Yank Coble, M.D., president of the World Medical Association (WMA), concluded the session by touching on some of the risks to consumers in taking care of their health, including managing expectations, assuring that health information is truthful, and what he termed "confusion in roles" of various partners in the healthcare equation.

CHPA President Suydam addresses the WSMI audience on the importance of building partnerships and educating consumers.

Suydam also spoke about community pharmacy and public education. She stressed the importance of building partnerships to leverage the expertise of pharmacists and companies, and pointed to new developments with traditional or emerging tools to educate consumers. For a complete copy of Suydam’s presentation, click here.

Regulators’ forum 

Regulators from Australia, Canada, China, India, Japan, Korea, Malaysia, Nepal, New Zealand, and Thailand, in addition to the chair of the European Medicines Evaluation Agency Committee on Herbal Medicinal Products, met in connection with the WSMI conference. The purpose of the forum was to discuss recent developments in nonprescription medicines and to strengthen exchange and collaboration among drug regulatory authorities in the Asia Pacific. The group agreed on a declaration highlighting the need to:

• Include drug classification in national drug policies;

• Affirm individual commitments to cooperative projects such as short-term staff exchange programs;

• Address Internet promotion challenges;

• Make available to consumers regulated information for preventive therapies where substantive evidence supports claims;

• Consider for OTC availability products for the prevention of chronic conditions where there is sufficient evidence; and

• Return to the topic of adverse event reaction information exchanges.

Business workshop

Running in parallel to the regulators’ forum, meeting participants had the chance to look at the practicalities of international markets in a business workshop featuring speakers from Euromonitor, IMS, and Combe Incorporated. Euromonitor estimated the Chinese OTC market at $2.1 billion, with strong growth tied to increased disposable income, public healthcare reforms, and the development of the retail infrastructure in urban China. Chris Combe, chairman and president of Combe Incorporated, emphasized three fundamentals in entering foreign markets: the need for long-term commitment; the importance of on-the-ground forecasting, financial risk assessment, and market research; and the importance of selecting the right people and partners.

CHPA contact: David Spangler

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WSMI conference shines the spotlight on host, China

"China is an engine of the world economy...and a country market of great potential," said World Self-Medication Industry (WSMI) Chairman Gary Balkema, president of Bayer Consumer Care Division, in his opening statement at WSMI's Asia Pacific Regional Conference (See previous story). The federation took advantage of the conference's Beijing location to examine in-depth some of the healthcare challenges in the host country, China.

One of the fundamental challenges in China is the growing rural versus urban divide in that nation. Roughly 60 percent of China's workers are described as rural, and most of that population does not have access to the newly introduced medical insurance system enjoyed by about a quarter of the country's 500+ million urban population. In addition, although China introduced a prescription and nonprescription distinction in 1999, there are not enough pharmacists in the rural areas of the country to make enforcement of a prescription requirement or pharmacy involvement realistic. No timetable, therefore, has been established for enforcing the distinction in the rural areas in most cases, while December 2005 has been set for the rest of the country.

Implementation of the prescription and nonprescription distinction accordingly is being made in incremental stages. Since July 2004, China's State Food and Drug Administration (SFDA) has been cracking down on the dispensing of antibiotics without a prescription, particularly in urban areas. In addition, by the end of this year, SFDA notes that all firms involved in drug distribution other than retail pharmacies in rural areas will need to get “Good Supply Practice” certification to maintain their operational licenses. By the end of 2005, only certified pharmacies will be able to sell prescription drugs and “Class A” OTC drugs; non-certified pharmacies would still be able to sell “Class B” OTC drugs. It is still unclear, however, what distinguishes "Class A" from "Class B" OTCs. The importance of timing in the various implementation steps is heightened as China shifts from a system driven by hospital-dispensing to retail-dispensing of medicines.

Looking to the future, SFDA speakers at the conference displayed an open and constructive attitude toward Rx-to-OTC switches, noting new regulations for switch and registration of new OTCs were issued in 2004 and that further changes are anticipated in 2005. 

Overall, Zheng Xiaoyu, the commissioner of the SFDA, stated China had established a good foundation for responsible self-medication based on three fundamentals:

1. Social and public awareness to reduce the misuse of prescription drugs, especially antibiotics;
    

2. Safe and effective OTC medicines offering a wide variety of choices for consumers; and
    

3. Standardization leaflets for OTC products making information easier to understand for Chinese consumers.

CHPA contact: David Spangler

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CHPA staff travel inside the Beltway and beyond

CHPA's Eve Bachrach, senior vice president, general counsel and secretary, attended the American Bar Association's administrative law conference October 21 in Washington, D.C. During the course of the meeting, Bachrach met with Deborah Majoras, chairman, U.S. Federal Trade Commission...

Marcia Howard, Ph.D., associate director, scientific affairs, participated in the Council for Responsible Nutrition's annual conference held October 24-25 in Landsdowne, Virginia. The conference focused on various aspects of dietary supplements...

Lorna Totman, Ph.D., senior director of scientific affairs and toxicology, and Marcia Howard, Ph.D., associate director, scientific affairs, attended "A Day of Science," sponsored by the Council for Responsible Nutrition. The meeting, held October 28, discussed several dietary supplement ingredients and recent studies performed on them, as well as their potential impact on different health issues...

Lorna Totman, Ph.D., senior director of scientific affairs and toxicology, and Marcia Howard, Ph.D., associate director, scientific affairs, traveled north on the Beltway to Bethesda, Maryland, November 2, to participate in a meeting entitled "Toxicology of Dietary Supplements." The meeting was sponsored by the National Capital Area Chapter of Society of Toxicology and National Capital Area Chapter of Society of Risk Analysis...

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Pharmaceuticals targeted at women is the focus of FDLI seminar

The Food and Drug Law Institute (FDLI) will conduct a first-of-its-kind seminar on critical issues at the intersection of women's health and the law. The seminar, entitled "Developing and Marketing Pharmaceuticals and Other Products Targeted at Women," will be held December 3 in Washington, D.C. The program will include experts from FDA, the legal community, and the public policy arena who will explore such issues as conducting clinical trials; direct-to-consumer advertising to women; and  developing legal and regulatory concerns with food, dietary supplements, and cosmetic products. Visit FDLI's web site for more information on this event.

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DMA marketing forum teaches how to do more with less

The Direct Marketing Association (DMA) is sponsoring a pharmaceutical marketing forum for executives December 6 in Philadelphia, Pennsylvania. Marketing experts from the pharmaceutical industry will share strategies to help increase a company's bottom line with less marketing money. Some of the topics to be covered include determining where marketing dollars can be best used, improving direct-to-consumer marketing, and optimizing the performance of a marketing team. More information on this event is available online.

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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
Washington, DC

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