CHPA Executive Newsletter

CHPA comments on FDA public meeting on pediatric OTC cough and cold medicines

CHPA issued the following statement in response to an October 2 FDA public meeting on pediatric cough and cold medicines:

We are pleased that the U.S. Food and Drug Administration (FDA) continues to gather information surrounding children’s over-the-counter (OTC) cough and cold medicines. The makers of OTC oral pediatric cough and cold medicines have developed a multiyear plan specifically designed to help improve the safe use of these products and reaffirm the efficacy of these medicines. The leading makers of these medicines remain committed to working with FDA and pediatric experts to ensure that parents and caregivers continue to have appropriate treatment choices for their children.

As outlined earlier today at FDA’s public meeting, the makers of these medicines have begun implementation of a ground-breaking, comprehensive program. The initiative will advance the science, confirm effectiveness, enhance packaging and dosing technologies, and reach millions of parents, caregivers and healthcare providers with valuable information and education on the proper use and storage of OTC oral pediatric cough and cold medicines. This program includes:

A comprehensive and scientifically rigorous efficacy and safety program for children age two to under 12 to advance the science and ensure the highest level of scientific rigor. This program includes pharmacokinetic studies to confirm the dosing for the eight most commonly used OTC oral cough and cold ingredients. Once these dosing studies are finalized, we will begin our research to revalidate the effectiveness of these medicines.
Continued collection and review of available safety data. A comprehensive safety review in 2007 and data from the U.S. Centers for Disease Control and Prevention show that the majority of adverse events associated with OTC oral pediatric cough and cold medicines are a direct result of accidental ingestion. Reducing these preventable errors is the cornerstone of CHPA’s national educational program.
A comprehensive, national education program which to date has reached more than 100 million parents and caregivers and will reach even more over the next year. The campaign focuses on the root causes of adverse events and speaks directly to parents, day care providers, healthcare providers, and other caregivers. CHPA is partnering with a number of organizations in these efforts, including the American Pharmacists Association and the American Association of Family Physicians. These education campaigns will underscore the importance of following the directions on the label, using the correct dose, storing medicines safely and consulting with a doctor if there are any questions. More information is available for parents and caregivers at OTCsafety.org.

The leading makers of pediatric OTC cough and cold medicines look forward to continuing their work with the U.S. Food and Drug Administration as well as the healthcare community to ensure that parents have continued access to these safe and effective treatment options for their families.

CHPA's presentation is available online.

CHPA contact: Elizabeth Funderburk | Back to the top

CHPA named CADCA's 2008 Champion for a Drug-Free Kids

A press release issued September 22 announced that CHPA was named the 2008 Champion for a Drug-Free Kids by the Community Anti-Drug Coalitions of America (CADCA). The association received this honor in recognition of its work to combat cough medicine abuse. The award was presented at CADCA's Drug-Free Kids Campaign 10th Anniversary Awards Dinner September 23 in Washington, D.C.

CHPA has worked with CADCA since 2006 to educate Americans about the dangers of youth medicine abuse, particularly the troubling issue of OTC cough medicine abuse. One of the most successful joint initiatives, launched in 2007, is CHPA and CADCA's A Dose of Prevention: Stopping Cough Medicine Abuse Before It Starts campaign. This nationwide effort includes a toolkit to help communities address the problem, an informative web site, and a series of town hall meetings held in conjunction with National Medicine Abuse Awareness month.

"CHPA remains committed to alerting parents to the potential risks associated with teens who abuse cough medicine to get high," said CHPA's Linda Suydam. "We are pleased to have CADCA as a valuable resource and ally in this fight and look forward to continued progress on our efforts to engage communities and raise awareness among parents about the dangers of cough medicine abuse."

In addition to honoring CHPA at the awards dinner, CADCA also presented Home Box Office, Inc., (HBO) with its Humanitarian of the Year Award for its Emmy-winning ADDICTION project.

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CHPA's Market Exchange enjoys another successful year

The annual CHPA Market Exchange, held September 17-18 in New Brunswick, New Jersey, had more table hosts in more diverse categories than ever before. A record number of company representatives attended the reception and dinner sponsored by The Emerson Group, which provided another networking opportunity for attendees of both days.

In addition to participating in Market Exchange, several of CHPA's committees took advantage of the opportunity to conduct meetings on general association business: international growth, retailer relationships, and import quality.

CHPA's Retailer Liaison Steering Committee, chaired by Dave Howenstine, Wyeth Consumer Healthcare, met to discuss retailer engagement, opportunities, and association partnerships.

CHPA’s Logistics Steering Committee leadership team discussed future programs. (From left to right: Larry Brown, GlaxoSmithKline; Jerry Darby, Combe Incorporated; and John Herzig, Bayer HealthCare LLC)

“I plan on bringing my other brand manager next year; the event provides a good venue to meet with a lot of marketing consulting groups.”

“I have no time to see magazine reps during the year. This [meeting] is the one chance for someone to get to see me.”

The 2008 Market Exchange photos
were provided courtesy of Country Living and Good Housekeeping
(Hearst Magazines publications)

Information Resources, Inc., representatives Marci Hackel
and Steve Johnson meet with Greg Pukas of
Novartis Consumer Health, Inc.

CHPA thanks the following event sponsors of the 2008 Market Exchange for their continued support. Active members are encouraged to look to these and all of CHPA's Associate members for their company's needs.

FDA allocates $2.5 billion to update IT and data management services

FDA issued a press release September 30 announcing the agency has awarded $2.5 billion to 10 contractors to modernize its information technology (IT) and data center management services over a 10-year period. "We are creating a high-tech, efficient, data management system designed to meet the needs of those who must accomplish our mission―protecting and promoting the health of the American public," said FDA Commissioner Andrew von Eschenbach.

FDA has awarded three task orders that the 10 contractors will compete for over the next decade. The first order is for the design, implementation, and migration of existing FDA applications to the agency's White Oak Data Center, which will support all FDA test and development applications. The second task order provides the operations and maintenance of the White Oak Data Center. The final order is for the design, implementation, migration, and operations and maintenance of existing FDA applications to a contractor-owned, contractor-operated, hosted data center for the agency's production operations.

FDA notes that all of the agency's software applications and hosting operations will transition to the new data centers over a two-year timeframe.

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Federal Register Update

FDA changes start time for prep session for ICH meetings

FDA published a notice in the October 1 Federal Register that makes corrections to its September 16 Federal Register notice regarding a public meeting entitled "Preparation for International Conference on Harmonization Meetings in Brussels, Belgium." The public meeting will still be held October 21 in FDA's Rockville, Maryland, offices; however, the start time for the meeting has been moved up to 2:30 p.m. For security reasons, the agency is asking all attendees to arrive at the meeting site no later than 2:15 p.m.

Registrations and requests to make oral presentations should be sent to FDA's Tammie Jo Bell by October 14.

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DEA publishes its 2009 list of annual needs for certain List I chemicals

The U.S. Drug Enforcement Administration (DEA) issued its 2009 assessment of annual needs in the September 19 Federal Register for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in accordance with the Combat Methamphetamine Epidemic Act. The assessment, expressed in kilograms of anhydrous base, is as follows:

DEA based its assessment on applications for import, manufacturing, and procurement from registered manufacturers and importers.

Comments are due by October 20.

CHPA contact: David Spangler | Back to the top

Meetings

Space is filling quickly for the 2008 CHPA Business Development Conference

Next month, CHPA members will sit down with executives from four major retailers headquartered in the Seattle, Washington, area in a unique and unparalleled business-building forum: the 2008 Business Development Conference. This event will provide attendees with the chance to explore new channels of distribution, meet potential customers and discover new distribution opportunities, and learn how to fully penetrate new market segments and reach a new consumer audience.

Information on arranging individual meetings with one of the Seattle-area retail partners on the day following the conference is available from CHPA’s Phyllis Taylor upon request. Interested parties must contact the retail buyers directly to set up a meeting for Wednesday, October 29.

Register today

The Business Development Conference provides a terrific opportunity for small- to mid-tier CHPA member companies to spend time with some of the nation’s largest and most unique retailers. Space is limited to 90 CHPA members, so interested parties should register online or by downloading a faxable registration form as soon as possible. Both options are available on CHPA's web site.

Hotel room block cut-off is October 6

The CHPA room block at The Woodmark Hotel in Kirkland, Washington, will be released October 6 or sooner if the block is sold out. After that, rooms will be on a space- and rate-available basis. Reservations may be made online or by phone at 800.822.3700.

CHPA contacts: Ted Peterson and Phyllis Taylor | Back to the top

Register now for the CHPA/DIA SPL conference in Philadelphia

CHPA and the Drug Information Association (DIA) are co-sponsoring a two-day meeting entitled “Structured Product Labeling: Preparing for FDA Electronic Registration and Drug Listing.” The program, which will be held October 29-30 in Philadelphia, Pennsylvania, will focus on the FDA Amendments Act (FDAAA) requirement to use electronic drug establishment registration and drug listing. OTC products must meet these requirements by June 1, 2009.

Speakers from industry and FDA including Lonnie Smith, Medical Informatics Staff and FDA Data Standards Council; Vada Perkins, FDA's Center for Drug Evaluation and Research; John Lorenc, Reed Technology and Information Services, Inc.; and Tom Marsden, Dun & Bradstreet Government Solutions, will cover a host of topics related to structured product labeling (SPL).

FDA is adopting the use of extensible markup language (XML) files in a SPL format as the standard format to exchange drug establishment registration and drug listing information. Meeting attendees will learn about the SPL process, 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 submissions. Registered exhibit vendors also will be on site to demonstrate their services and share results.

Registered conference attendees may submit questions in advance of the meeting to 2008SPLConference@diahome.org until 5:00 p.m. on October 24. Questions received by the deadline will be sent anonymously to the speakers.

Register today

Don’t miss this opportunity to be prepared for the June 1, 2009, deadline. Register now for this educational opportunity. DIA members who register by October 7 are eligible for a discounted registration fee (save $180).

For program and registration information, please visit CHPA's web site. Vendors and table top exhibitors should contact DIA's Erin Gilliland for more information regarding showcase opportunities.

CHPA contact: Dr. Marcia Howard | Back to the top

CHPA members get up to speed on new media at November summit

CHPA members are encouraged to take advantage of a free members-only event that will explain how to best utilize the latest digital communications technology, applications, and resources available online. CHPA's New Media Summit, scheduled for November 17 in New Brunswick, New Jersey, will feature representatives from Edelman's digital public affairs team who will share their expertise in the online world.

The New Media Summit is sponsored by the CHPA's Public Affairs Committee. Additional information on this event, as well as a tentative schedule, is available online.