Association News

D.A.R.E. applauds CHPA's leadership on medicine abuse prevention

CHPA received D.A.R.E. America’s D.A.R.E. Champion award this month for its leadership in the fight against medicine abuse.

CHPA Vice President, Communications & Strategic Initiatives Virginia A. Cox accepted the award on the association’s behalf during D.A.R.E.’s 2007 International Training Conference in Nashville, Tennessee, July 17-19. Other award recipients included the Pharmaceutical Research and Manufacturers of America (PhRMA) and Abbott Laboratories. Thousands of chiefs of police, sheriffs, and D.A.R.E. instructors and educators from throughout the nation and around the world attended the conference.

CHPA's Virginia Cox accepts the association's D.A.R.E. Champion award from D.A.R.E. America CEO Charlie Parsons during D.A.R.E. America's awards ceremony in Nashville.

CHPA received the honor because of the pivotal role the association is playing in the development of OTC and Rx lesson plans for D.A.R.E. officers. Other partners in the project include:

• White House Office of National Drug Control Policy,

• U.S. Drug Enforcement Administration,

• FDA,

• National Institute on Drug Abuse,

• Substance Abuse and Mental Health Services Administration's Center
    for Substance Abuse Prevention,

• Partnership for a Drug-Free America,

• Abbott Laboratories, and

• PhRMA.

The OTC and Rx medicine abuse curricula will be available as a supplemental lesson plan this fall. It features information for 5th, 7th, and 9th graders, as well as a community education presentation. CHPA will continue to collaborate with D.A.R.E. to promote the program within communities and schools.
 

CHPA's Virginia Cox shares details about some of the association's efforts to combat medicine abuse.

This innovative programming is the latest in CHPA’s comprehensive efforts to combat medicine abuse. The association has developed public service announcements and educational brochures with the Partnership for a Drug-Free America, community toolkits and a series of town hall meetings in August with the Community Anti-Drug Coalitions of America (CADCA), and an online awareness campaign through www.FiveMoms.com. All of CHPA’s efforts, including a calendar of CADCA town hall events taking place nationwide, can be found at www.StopMedicineAbuse.org.

CHPA contact: Virginia Cox |  Back to the top


CHPA kicks off nationwide dialogue on teen medicine abuse in Southwest Florida

In conjunction with the Coalition for a Drug-Free Southwest Florida, CHPA participated in a town hall meeting July 25, which brought together Southwest Florida’s community leaders, parents, substance abuse treatment experts, law enforcement officials, and healthcare professionals. The purpose of the meeting was to raise awareness about teen medicine abuse. Panel participants included Dr. Dean Goldberg, trauma surgeon, Lee Memorial Hospital; Elizabeth Funderburk, director, communications & media relations, CHPA; Sergeant Gary Nosbusch, Lee County Sheriff’s Office; Kevin Lewis, executive director, Southwest Florida Addiction Services; and Keral Kronseder-Vogt, executive director, Lee County Coalition for a Drug-Free Southwest Florida.

Filmed before a live audience at the Lee County Sheriff’s office, the event provided attendees with an opportunity to learn more about current trends associated with both prescription drug and over-the-counter cough medicine abuse among teens, while offering community residents to join in the discussion and pose questions to the panelists. Individuals who were unable to attend the event will be able to view the entire meeting on local cable stations throughout the month of August. Select panelists also took to the airwaves to educate parents by participating in a one hour call-in show, Gulf Coast Live, on WGCU Public Radio.  

Sponsored jointly by the Lee County Coalition for a Drug-Free Southwest Florida, the Lee County Sheriff’s Office, the Community and Drug Coalitions of America, and CHPA, the town hall meeting coincides with the first-ever, congressionally designated National Medicine Abuse Awareness Month (See June 29 XNL). This town hall is one in a serious of town hall meetings occurring across the country throughout August providing communities with information about medicine abuse.

CHPA contact: Elizabeth Funderburk |  Back to the top

CHPA staff promote association at national conferences

CHPA's Andy Fish, senior vice president, legal & government affairs and general counsel, attended the Congressional Tri-Caucus Annual Health Summit in San Diego July 20‒21. The Tri-Caucus is made up of the Congressional Asian Pacific American, Black, and Hispanic Caucuses. During the summit Fish introduced CHPA's key priorities and public education initiatives to members of Congress and their staff, as well as other national and California public health stakeholders, including the California Community Clinics Association, the California Hispanic Physicians Association, National Asian Pacific American Families Against Substance Abuse, and the Children's Health Forum.

Prior to attending the summit, Fish met with staff in the Office of Mayor Antonio Villaraigosa of Los Angeles to offer CHPA's resources and materials.

CHPA's Mandy Hagan, director, state government relations, attended the annual convention of the National Council of La Raza (NCLR) in Miami, Florida, July 21‒24. NCLR is the largest national Hispanic civil rights and advocacy organization in the United States, with nearly 300 affiliated community-based organizations (CBOs). NCLR's annual conference is the largest gathering of its kind in the Hispanic community, with an estimated 20,000 participants. 

During the convention, Hagan met with representatives of NCLR, as well as staff of some NCLR affiliates. NCLR and its affiliated CBOs offer limitless partnering opportunities for CHPA to provide education and outreach to the Hispanic community. NCLR has developed models in Georgia and California to document the most pressing health and nutrition needs of Hispanics, including strategies to address these needs and to increase the capacity of Latino community-based organizations to serve as statewide advocates on Latino health. CHPA will continue to follow up with contacts made at the conference and explore ways the organizations can work together.

CHPA contacts: Andy Fish and Mandy Hagan |  Back to the top


Retail Liaison Steering Committee holds first meeting

The inaugural meeting of CHPA’s Retail Liaison Steering Committee was held July 24 at Novartis Consumer Health, Inc., in Parsippany, New Jersey. The new committee was established to foster positive relationships with retailers and related industry associations and to identify retail trends impacting consumer healthcare products as a platform for overall industry growth.

Vic Mazzacone, senior vice president, corporate relations, OTC North America, Novartis Consumer Health, Inc., is chair of the group. David Howenstine, vice president, category and trade development, Wyeth Consumer Healthcare is vice chair.

    Members of the committee from left: Dale Nepsa, Hyland's; Les Hamilton, The Emerson Group; Helene Silverman, Information Resources; Jim Mackey, Schering-Plough; Ted Peterson, CHPA; Mike Jones, Del Laboratories; David Howenstine, Wyeth; Vic Mazzacone, Novartis; and Bill Fogarty, Adams Respiratory.

CHPA contact: Ted Peterson |  Back to the top


CHPA commends Senate Subcommittee's funding package for FDA

CHPA issued a press statement July 17 in support of the U.S. Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies’ approval of increased funding for FDA.

The association commended Subcommittee Chair Herbert H. Kohl (D-Wis.), Ranking Member Robert Bennett (R-Utah), and the other members of the subcommittee for charting a different course for FDA and calling on Congress to approve their recommended increase in FDA funding to help meet the nation’s commitment to advancing and protecting public health. CHPA also pointed out that for years, FDA’s growing responsibilities and challenges in ensuring the safety of the U.S. food and drug supply have far outpaced the funding it has been given to get the job done. While the funding increase is a good first step toward restoring FDA's capacity to fulfill its critical mission, CHPA said that substantial increases also will be needed next year and beyond.

CHPA contacts: Virginia Cox and Elizabeth Funderburk | Back to the top


CHPA joins other association execs at unsaleables conference

CHPA, along with GMA/FPA, the Food Marketing Institute, the National Association of Chain Drug Stores, the National Grocers Association, and the Packaging Machine Manufacturers Institute, cosponsored the 2007 Joint Industry Unsaleables Management Conference July 17‒19 in Lake Las Vegas, Henderson, Nevada. 

Executives with a broad range of expertise in the food, drug, and cosmetic industries attended the conference, which also included a small-scale exhibit room. CHPA member companies that participated included Bayer HealthCare LLC; CLS; Church & Dwight Co., Inc.; Colgate-Palmolive; GlaxoSmithKline; Information Resources, Inc.; Johnson & Johnson; Kimberly-Clark Corporation; The Mentholatum Company; The Procter & Gamble Company; and Wyeth Consumer Healthcare.

CHPA member CLS was among the exhibitors at
the unsaleables conference.

The conference featured a number of informative presentations that focused on such issues as unsaleables reduction, sustainability programs, damage reduction through packaging improvements, the future of automated warehousing, secondary packaging, handling discontinued items, and open-dated guidelines for manufacturers and distributors. A favorite break-out session was the unsaleables share group, in which industry representatives assessed and shared information on the challenges and opportunities related to unsaleables management. 

Another highlight of the conference was the annual opening session entitled "Unsaleables 101." Tailored specifically to those new to the reverse logistics arena, this session provided insight and foundational understanding of reverse logistics based on a review of studies and industry trends.

CHPA contact: Phyllis Taylor | Back to the top


CHPA cosponsors stability testing workshop

CHPA is joining the American Association of Pharmaceutical Scientists, the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association, and the Eastern Analytical Symposium, Inc., in cosponsoring a workshop entitled "Pharmaceutical Stability Testing to Support Global Markets." The event will be held September 10‒12 at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland.

The purpose of the workshop is to provide the regulatory perspective of stability testing and to explore ways to globally position the stability program for the future. Expert speakers will facilitate discussions on a number of technical issues that impact global submission. Several sessions, organized into dual tracks, will explore such stability-related challenges as monitoring impurities, evaluating shipping excursions, setting specifications for drug substances as well as various types of drug products, estimating expiry, and stability testing of OTC and generic products. 

Scientists and managers with responsibilities in process development, formulation and analytical development, stability, regulatory affairs, and production, are encouraged to attend this workshop. Program and registration materials are available online.

CHPA contact: Fred Razzaghi |  Back to the top


Find out who's who at Market Exchange

July is almost over and CHPA's 5th annual Market Exchange is now just weeks away. Scheduled for September 19‒20 in New Brunswick, New Jersey, this valuable networking forum is the perfect venue for Active and Associate members to learn more about each other and to explore potential business-building opportunities.

In order to provide attendees with information about who will be attending Market Exchange this year, CHPA has created a preliminary registration list, which is now available in the members-only section of www.chpa-info.org. This list will be updated periodically as new registrations are received. Based on the caliber of members who already have signed up, this event is sure to be a success.

 

Members are encouraged to make hotel reservations online as soon as possible. CHPA's room block cut-off date is September 5, or sooner, if the block is sold out.

All table hosts have requested their appointments and CHPA is beginning the process of creating the appointment schedules. Completed schedules will be sent to all registrants, as well as to each member company’s Official Representative, the week of August 15. CHPA recommends that Active members review their schedules in a timely manner to make certain the right company representatives have registered to attend on the appropriate day. Additionally, Active members are asked to provide the name of their company's appointment coordinator to Phyllis Taylor. This contact information will be helpful to table hosts as they prepare their personalized presentations. 

Guidelines

Market Exchange guidelines will be sent to all table hosts the week of July 30.  The guidelines will include everything table hosts need to know about acceptable meeting materials and signage, shipping dates and instructions, and audio and visual ordering information. Table hosts are asked to review the guidelines and return the company description and audio-visual order forms by the requested date to ensure your correct information is printed in the Market Exchange attendance book. 

 Sponsorship opportunities 

There are still a few sponsorship opportunities left for Market Exchange. Interested companies should contact Ted Peterson or Phyllis Taylor for more information. 

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

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Focus on driving growth in consumer healthcare at the 2007 Business Development Conference

Registrations are starting to arrive for CHPA’s 2007 Business Development Conference & Wal-Mart Immersion scheduled for October 29‒30 at the Clarion Hotel & Convention Center in Bentonville, Arkansas. With the theme of “Driving Growth in Consumer Healthcare,” the first day of this exclusive, members-only event is dedicated to examining a number of industry activities including innovative new product development, growth through acquisition of products or other intellectual property, and growth via licensing of trademarks and technology. 

The second day of the conference features a Wal-Mart immersion and will include presentations by company executives on such topics as:

• Wal-Mart and health,
• Consumable merchandising/modular/promotional strategy,
• Getting started as a supplier with Wal-Mart,
• Supplier expectations,
• Supply chain initiatives, and
• Sustainability.

Register today

CHPA members may register for the Business Development Conference & Wal-Mart Immersion either online or by downloading a faxable registration form. Both options are available in the members-only section of www.chpa-info.org. A detailed conference brochure will be posted to CHPA’s web site very soon.

Please note that this is a CHPA members-only meeting. If you are currently not an association member but are interested in learning how to join, contact Ted Peterson or Phyllis Taylor. 

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


CHPA on the Road

CHPA staff travel inside the Beltway and beyond

Elizabeth Funderburk, director, communications & media relations, participated in Lee County Coalition for a Drug-Free Southwest Florida's town hall meeting on medicine abuse July 25 (See related story)...

Mandy Hagan, director, state government relations, traveled to Miami, Florida, July 21‒24, to attend the National Council of La Raza's annual conference (See related story)...

Andy Fish, senior vice president, legal & government affairs and general counsel, was in San Diego, California, July 20‒21 to participate in the Congressional Tri-Caucus Annual Health Summit in San Diego (See related story)...

Virginia A. Cox, vice president, communications & strategic initiative, attended D.A.R.E. America's International Training Conference in Nashville, Tennessee, July 17‒19. During the event, CHPA was presented with the D.A.R.E. Champion award for its efforts to prevent medicine abuse (See related story)...

Phyllis Taylor, membership & corporate development manager, participated in the Joint Industry Unsaleables Management Conference in Lake Las Vegas, Henderson, Nevada, July 17‒19 (See related story)...

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Industry News

Federal Agency Update

FDA receives nanotechnology report

FDA issued a press release July 25 announcing that its Nanotechnology Task Force has released a report that provides recommendations to the agency concerning the use of nanotechnology materials in FDA-regulated products. According to FDA, the task force, which was established last summer (see August 11, 2006, XNL), has suggested that the agency consider developing nanotechnology-associated guidance for manufacturers and researchers. In the guidance, FDA should clarify what information the agency would require with respect to the development of new nanotechnology products as well as explain when the use of nanoscale materials may change the regulatory status of certain products.

The task force reported that while it found that nanoscale materials potentially could be used in many FDA-regulated products, those materials may present complex challenges due to the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale. The group also pointed out that because of the new and uncertain nature of nanotechnology, it is very important the agency establish transparent, consistent, and predictable regulatory pathways. The task force also recommended that FDA work to assess data needs to better regulate nanotechnology products; develop internal expertise to ensure consideration of new nanotechnology information; and evaluate the adequacy of current testing approaches to assess safety, effectiveness, and quality of nanoscale materials.

In addition to the report, FDA posted a consumer article on nanotechnology on its web site.

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HHS to chair new interagency import safety group

President George W. Bush issued an executive order July 18 that calls upon U.S. Department of Health and Human Services Secretary Michael Leavitt to establish and chair a new Interagency Working Group on Import Safety. In addition to Leavitt, members of the working group include the secretary of state, the secretary of the treasury, the U.S. attorney general, the secretary of agriculture, the secretary of commerce, the secretary of transportation, the secretary of homeland security, the director of the Office of Management and Budget, and administrator of the Environmental Protection Agency, the chairman of the Consumer Product Safety Commission, and other government officials as determined by the chair.

The purpose of the working group is to identify actions and appropriate steps to promote the safety of imported products including:

• Reviewing or assessing current procedures and methods aimed at ensuring the safety of products exported to the United States, including existing cooperation with foreign governments, foreign manufacturers, and others regarding their inspection and certification of exported goods and factories producing exported goods and considering whether additional initiatives should be undertaken;

• Identifying potential means to promote all appropriate steps by U.S. importers to enhance the safety of imported products, including identifying best practices in the selection of foreign manufacturers, inspecting manufacturing facilities, inspecting goods produced on their behalf either before export or distribution in the United States, identifying the origin of products, and safeguarding the supply chain; and

• Surveying authorities and practices of federal, state, and local government agencies regarding the safety of imports to identify best practices and enhancing coordination among agencies.

The executive order states that the working group must provide its recommendations on these matters to the president by September 15.

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Draft guidance on pharmaceutical quality system now available

FDA issued a notice in the July 13 Federal Register announcing the availability of a draft guidance entitled Q10 Pharmaceutical Quality System. Prepared by the International Conference on Harmonisation (ICH), the document describes a model for an effective quality management system that applies to drug substances and drug products throughout the product lifecycle. The draft guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization concepts. It includes Good Manufacturing Practice regulations and complements the ICH guidances on Q8 Pharmaceutical Development and Q9 Quality Risk Management.

Comments are due by October 11.

CHPA contact: Fred Razzaghi |  Back to the top


Nutritional Supplement Activities

FDA schedules public hearing on using symbols for nutrition info

FDA issued a notice in the July 20 Federal Register announcing that it has scheduled a public hearing to gather input from interested parties on the current programs that use symbols to communicate nutrition information on food labels. The public hearing will be held September 10‒11 at the Inn & Conference Center by Marriott at the University of Maryland in Adelphi, Maryland.

To facilitate discussion at the hearing, the agency included 20 questions in the Federal Register notice seeking specific information in three areas: 1) food products currently available in the domestic and international marketplace that bear nutrition symbols and the nutrient requirements for those symbols, 2) consumer research that supported the development of nutritional symbol programs and research that illustrates how these programs are utilized and understood by consumers, and 3) the possible economic impact of the use of nutrition symbols for both industry and consumers.

Requests to make an oral presentation at the hearing must be submitted by August 24. Persons wishing to attend must submit a notice of participation by August 31. All requests should be sent to Kathy Houston at Z-Tech Corp.

Comments on the hearing are due by November 12.

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In Brief

PQRI sponsors course on leachables and extractables

The Product Quality Research Institute (PQRI) is conducting a training course on addressing best practices for orally inhaled and nasal drug product leachables and extractables pharmaceutical development programs. Hosted by Ciba Specialty Chemical Corporation, the course is scheduled for September 26‒27 in the Novartis Pharma AG Training & Development Learning Center Horburg in Basel, Switzerland.

The training content will be based on the PQRI's Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. Specific topics to be covered include the selection of container and closure system components, safety evaluation of extractables and leachables, evaluation of special case compounds, and control strategies for quality.

Online registration for this event is now available. For additional information or updates, visit www.pqri.org.

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