Five Moms launches tell-a-friend feature in Spanish

CHPA's Five Moms Campaign to stop cough medicine abuse has expanded its reach to Hispanic audiences with additional Spanish-language content and utilities. The latest addition is a tool to help Spanish-speaking parents communicate the Five Moms message of awareness with other Spanish-speaking parents.

The Five Moms tell-a-friend feature is an easy-to-use tool to help Spanish speakers share information and resources in order to prevent teen cough medicine abuse. The feature joins new content and an entire en español section on FiveMoms.com.

CHPA contact: Mimi Pappas |  Back to the top


Federal Register Update

FDA seeks comments regarding international drug scheduling

FDA issued a notice in the September 5 Federal Register seeking comments on the following 10 drug substances: dextromethorphan, gamma-hydroxybutyric acid, ketamine, N-benzylpiperazine, 1-(3-trifluoromethylphenyl) piperazine, 1-(3-chlorophenyl) piperazine, 1-(4-methoxyphenyl) piperazine, 1-(3, 4-methylenedioxybenzyl) piperazine, gamma-butyrolactone, and 1,4-butanediol. The agency plans to use the comments it receives to help in preparing the United States' response to the World Health Organization's (WHO) inquiry concerning the abuse liability and diversion of these substances.

As required by the 1971 Convention on Psychotropic Substances, of which the United States is a party, WHO provided a questionnaire on the 10 substances to the U.S. government. WHO will use the questionnaire responses to consider whether to recommend that certain international restrictions be place on any of these substances. FDA points out that the U.S. Department of Health and Human Services (HHS) will not make recommendations to WHO at this time on whether any of these substances should be subjected to international controls. Rather, HHS will refrain from any consideration until WHO has provided its recommendations to the Commission on Narcotic Drugs.

Comments on the WHO questionnaire should be submitted to FDA by October 6.

CHPA contact: David Spangler |  Back to the top


FDA requests nominations to serve on the agency's Science Board

FDA issued a notice in the September 5 Federal Register seeking nominations to the agency's Science Board. The Science Board provides advice to the FDA Commissioner and the agency on a number of matters, including keeping pace with evolutions in the fields of regulatory science, formulating an appropriate research agenda, and upgrading the agency's scientific and research facilities.

FDA requires that persons nominated to serve on the board should be knowledgeable in the fields of food safety, nutrition, chemistry, pharmacology, toxicology, clinical research, or other scientific disciplines such as systems biology, wireless healthcare devices, nanotechnology, medical imaging, robotics, cell- and tissue-based products, regenerative medicine, and combination products. Science Board members will be selected from academia and industry. In addition, the FDA Commissioner or a designee may select one technically qualified member with consumer interests. The Science Board may also include technically qualified federal members.

All nominations should include the name of the committee; complete curriculum vitae of each nominee; and the nominee's current business address, telephone number, and e-mail address. FDA states that nominations received by by October 6 will be given first consideration. Nominations received after that date will be considered should members of the Science Board still be needed.

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ICH prepares draft guidance on nonclinical safety studies

FDA issued a notice in the September 3 Federal Register announcing that the International Conference on Harmonization (ICH) has developed a new draft guidance called M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. The draft document, which revises an existing guidance, recommends international standards for, and promotes harmonization of, nonclinical safety studies to support human clinical trials of a given scope and duration. The recommendations in the draft guidance are intended to promote the safe and ethical development of new pharmaceuticals.

Comments on the draft guidance are due by October 20.

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FDA issues draft guidance on integrated summary of effectiveness

FDA published a notice in the August 28 Federal Register announcing the availability of a new draft guidance entitled Integrated Summary of Effectiveness. The draft guidance explains how an integrated summary of effectiveness should be prepared for new drug applications (NDAs). According to FDA, while the integrated summary of effectiveness has been required as part of an NDA submission for over 20 years, the regulation does not describe its specific components. FDA notes that when final, this guidance will supersede section G of the 1988 guidance entitled Format and Content of the Clinical and Statistical Section of an Application.

Comments on the draft guidance are due by October 28.

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FDA schedules meeting on OTC pediatric cough and cold medicines

FDA issued a notice in the August 25 Federal Register announcing the agency has scheduled a public meeting to gather input on OTC cough and cold medicines marketed for pediatric use. The meeting will be held October 2 from 8:00 a.m. to 5:00 p.m. at the Sheraton Washington North Hotel in Beltsville, Maryland.

FDA is developing a proposed rule to revise pediatric labeling in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. The agency says that it is holding the public meeting to gather public comment about scientific, regulatory, and product use issues to help in the process of developing the new rulemaking and its review of new drug applications for these product ingredients. FDA included a list of nine questions in its Federal Register notice that it is interested in obtaining information about.

Seating at the public meeting is limited and registration is on a first-come, first-served basis. Persons interested in attending the hearing must register with FDA's Faith Dugan by September 15. Individuals wishing to make an oral presentation must express that intention on the registration submission and identify each question from the Federal Register notice they plan to address in their presentation. Written or electronic comments will be accepted until December 2.

A separate revised Federal Register notice on the public meeting was issued by FDA September 2. The agency published the notice in order to clear up confusion regarding electronic registration for the meeting and to correct the address for the contact person. Please note that the registration and contact information contained in this article was taken from the September 2 notice.

CHPA contact: Dr. Heinz Schneider |  Back to the top


Meetings

The countdown begins for CHPA's 2008 Market Exchange

The excitement is building as CHPA's membership prepares for the much-anticipated Market Exchange. Table hosts are polishing their presentations for this important networking event which is now less than two weeks away. Hosts and manufacturers that need to change appointment times are asked to contact each other directly. Please refer to the preliminary registration list posted to CHPA's web site for contact information. This list also includes a brief description of each table host company. Any other questions concerning appointments should be directed to CHPA’s Phyllis Taylor.

Attention table hosts

Table numbers for both day 1 and day 2 of Market Exchange have been posted to CHPA's web site. These numbers should be used for shipping materials to the hotel, ordering floral arrangements, and making audiovisual requests. While the deadline for placing floral or audiovisual orders has expired, you still may fax your requests to the Hyatt Regency's Kristie Paxson at 732.867.2234 until September 10. Order forms are included in the Market Exchange guidelines. Please note that mailing labels also were sent along with the guidelines. Be sure to include your table number and use the correct label for the day you will be hosting. Additional details and information for table hosts is contained in the guidelines.

Thank you sponsors

CHPA thanks its member sponsors that play a crucial role in ensuring the continued success of Market Exchange.

2008 Market Exchange Sponsors          Contacts: Paul Liptak and Jan Sahai Contacts: Steve Grune and Eric Gruseke         Contacts: Scott Emerson, Les Hamilton, and Rick Wellinger Contacts: Daren Mazzucca and Sara Rad         Contacts: Marci Hackel and Steve Johnson Contact: Michele Deutschman     Contacts: Mike Debartolo,  Connie Gallo, and Jim Hackett Contacts: Barbara Laplaca and Bob Ziltz     Contacts: Ann Gobel and Sari Kleinman   Contacts: Tamara Bedrosian,  Shari Gamm Guardino, Julia Holland, and Rebecca Johnson

This year’s Market Exchange promises to be the best yet. CHPA looks forward to greeting you in New Brunswick, New Jersey, on September 17.

CHPA contact for appointments and sponsorships: Phyllis Taylor  
All other inquiries, contact: Kass Kassouf or Maria Sarabia | Back to the top


Learn how to diversify and grow your business at CHPA's Business Development Conference

CHPA’s 2008 Business Development Conference is scheduled for October 27-28 in Kirkland, Washington. This year's event features an immersion with Seattle-area retailers, including Amazon.com, The Bartell Drug Company, Costco Wholesale, and drugstore.com & beauty.com. CHPA's Business Development Committee, chaired by Chris DeWolf, Lil’ Drug Store Products, has put together an impressive program for the association's mid- to small-tier companies focused on growing their business.

Conference sessions include:

Amazon.com

• Amazon vision, strategy, and tactics

• Amazon and health

• How to do business and grow with Amazon.com

Amazon speakers: Tom Furphy, vice president, consumables and Amazon Fresh; Jeff Fernandez, buyer, health & personal care; and Peggy McDevitt, category manager, health and personal care

The Bartell Drug Company

• Bartell Drugs history, culture, and market position

• Vendor success stories

• Chain drug consortium opportunities

Bartell Drug speakers: George Bartell, chairman & chief executive officer; Jean Bartell-Barber, vice chairman & treasurer; Ed Littleton, chief operating officer; Ron Miller, senior vice president, merchandising; and Rebecca Slegmund, assistant vice president, marketing

Costco Wholesale

• Costco and health

• Supplier expectations

• Merchandising opportunities

Costco speakers: Vic Curtis, R.Ph., vice president, pharmacy, and Teresa Thompson, buyer, vitamins & dietary supplements

drugstore.com & beauty.com

• drugstore.com & beauty.com overview and customer

• Merchandising and marketing at drugstore.com

• Large and small vendor success stories

drugstore.com & beauty.com speakers: Julie Johnston, vice president, OTC merchandising, and Michael Teague, senior director, purchasing

Register today

Please note that attendance at the Business Development Conference is limited to the first 90 CHPA members who register. Members are urged to register as early as possible to guarantee a place. Registration materials as well as additional program and hotel information are included in the brochure posted to the members-only section of CHPA's web site.   

CHPA contact: Ted Peterson |  Back to the top


CHPA cosponsors DIA conference on structured product labeling

CHPA, together with Drug Information Association, is cosponsoring a conference entitled "Structured Product Labeling: Preparing for FDA Electronic Registration and Drug Listing." Scheduled for October 29-30 in Philadelphia, the event will focus on the FDA Amendments Act requirement that calls for the use of electronic drug establishment registration and drug listing.

FDA is adopting the use of extensible markup language (XML) files in a structured product labeling (SPL) format as the standard format for the exchange of drug establishment registration and drug listing information. Experts at the conference will explain how to appropriately register drug establishments and list drug products. Specific topics to be explored include Data Universal Numbering System (D-U-N-S®), Electronic Submissions Gateway (ESG), SPL reference documents and lifecycle management, listing data elements, and transitioning from paper to electronic format.

Pose questions to FDA

FDA representatives at the conference will participate in a special session to address specific questions concerning electronic drug registration and drug listing in SPL. Registrants for the meetings are asked to e-mail any inquiries to 2008SPLconference@diahome.org by October 24. Please note that all questions will be forwarded to FDA anonymously.

SPL vendor showcase

The SPL conference also features a vendor showcase which will provide attendees with the opportunity to evaluate available services and tools. During the session, several participating vendors will demonstrate their services and tools and present their results to the audience.

Registration information

Program materials and registration information for the conference are available online.

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Register today for the 2008 WSMI symposia

China is known for many things including its rich and deep history in traditional medicine. This is the focus of an International Pharmacy Federation-World Self-Medication Industry (WSMI) symposium and a World Health Organization Congress on Traditional Medicine, November 7-9, in Beijing. Both of these events will take place during the week of the WSMI symposium in Beijing, where those registered for either the WSMI or the FIP-WSMI symposia will be able to take part in a range of traditional and alternative medicine or industry exhibits with a chance to meet with a number of potential local business partners.

Once used as a summer residence by China's imperial rulers,
the Summer Palace, located in west Beijing, is now a popular
attraction for both domestic and international tourists.

Information on the WSMI symposia is available through WSMI's web site. Additional details on the World Health Organization events surrounding the WSMI meeting are available online.

CHPA contact: David Spangler |  Back to the top


Learn how to "speak digital" at CHPA's New Media Summit

In recent years, digital communication has proved to be a powerful force within the healthcare community. Health bloggers are building strong audiences and followers by writing about new trends in healthcare. They also are using services such as Twitter to keep their conversations going. To familiarize yourself with this new dynamic and to learn more about these different kinds of social media, CHPA members are invited to attend the association’s New Media Summit November 17 at the Hyatt Regency New Brunswick Hotel in New Brunswick, New Jersey.

CHPA's New Media Summit November 17, 2008 New Brunswick, New Jersey

By the end of the event, attendees will have heard from several of the biggest online influencers on the effects of new technology on healthcare. These experts of the digital world will discuss different services, including Twitter; demonstrate how to leverage other important tools in the online landscape; and introduce important online communities that may be talking about healthcare organizations.

Registration is complimentary and is open to CHPA members only. Registration information as well as a tentative schedule is available online.

CHPA contact: Elizabeth Funderburk |  Back to the top


In Brief
Gustav leaves many Americans in need

When Hurricane Gustav made landfall in the United States on Labor Day, many residents along the Gulf Coast breathed a cautious sigh of relief when it became apparent that the weakening storm would not emulate Hurricane Katrina's massive destruction three years ago. Also different was the fact that many citizens followed a well-organized evacuation plan and various government agencies seemed to be working in sync.

While the death toll thankfully was kept extremely low, many residents still living in temporary shelters have yet to return to their homes to assess what damages they have sustained. And the destruction is likely to be extensive. Rough projections put the total somewhere between $6 and $10 billion, which would make Gustav one of the most costly storms in U.S. history.

How you can help

Companies interested in contributing to the hurricane relief effort may contact the American Red Cross or AmeriCares. Additionally, Louisiana Governor Bobby Jindal has put a call out to corporations to offer assistance to displaced residents in shelters. Information on making financial contributions or product donations is available online.

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