CHPA Executive Newsletter

U.S. Senate introduces resolution designating October as National Medicine Abuse Awareness Month

CHPA and the Community Anti-Drug Coalitions of America (CADCA) issued a press release September 24 in support of a U.S. Senate initiative that calls for increased attention and awareness of prescription and over-the-counter medicine abuse among teens. Sponsored by U.S. Senators Charles Grassley (R-Iowa), Richard Durbin (D-Ill.), Dianne Feinstein (D-Calif.), Charles Schumer (D.-N.Y.), and Sheldon Whitehouse (D-R.I.), S. Res. 263 designates October as National Medicine Abuse Awareness Month. The resolution urges communities to educate parents and youths about the potential dangers associated with medicine abuse, including OTC cough medicine.

"By designating October as National Medicine Abuse Awareness Month, it will help raise awareness of the alarming numbers of young people who currently abuse prescription drugs and OTC cough medicines," said CADCA Chairman and CEO Gen. Arthur Dean. "Hopefully, this will spur a dialogue on this issue in communities across the country."

In May 2009, The Partnership/Metlife Parents Attitude Tracking Study indicated that more parents are talking to their teens about the dangers of using OTC cough medicines to get high. (See May 15 XNL). Additionally, in February 2009, the 20th annual Partnership Attitude Tracking Survey showed that an increased number of teens view the intentional abuse of OTC cough medicines as risky. (See March 6 XNL).

"While we are pleased with our progress, raising awareness about the abuse of cough medicine remains a top priority for us," stated CHPA President Linda Suydam. "Continued support from the U.S. Senate coupled with our educational initiatives will help us in our efforts to stop medicine abuse."

As a part of this effort, CHPA and CADCA are hosting town hall meetings nationwide during October. To learn more about all of CHPA's activities to help curb cough medicine abuse, visit StopMedicineAbuse.org.

FDA proposes to amend postmarketing safety reporting requirements for combination products

FDA issued a proposed rule in the October 1 Federal Register to amend the postmarketing safety reporting requirements for combination drug, device, and biological products. The agency states that the purpose of the proposed rule is to codify the reporting requirements in order to ensure consistency and appropriate regulation.

According to FDA, the current regulations and reporting standards for drug, device, and biological products are similar, but each has certain unique requirements. In the proposed rule, FDA has identified five provisions, unique to drugs, biologics, or devices, that it believes need to be preserved. One of those provisions requires that a postmarketing report associated with an adverse event with a drug or biological product must be submitted within 15 calendar days following receipt of the information.

Under the proposed rule, combination products marketed under a single application would adhere to the requirements for postmarketing safety reporting associated with the approved application under which the product is marketed. Depending on the type of combination product and the nature of the reportable event, a reporter would also submit additional types of reports to accurately reflect the combination nature of the product.

Holders of applications for one part of the combination product are subject to applicable requirements for postmarketing safety reporting for their respective part. In addition, information received about events related to that part must be submitted to FDA or the other reporter within five calendar days.

FDA states that a separate rule specific to combination products will clarify how to apply these provisions to combination products and avoid duplicative or unnecessary requirements.

FDA issued a notice in the October 1 Federal Register announcing a voluntary pilot program for the evaluation of proposed proprietary names. The two-year program, which will be conducted by the agency's Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, will allow participating pharmaceutical firms to evaluate proposed proprietary names and submit data to FDA for review. The agency hopes to include a cross-section of small, medium, and large companies and to receive and review 25 to 50 proprietary name submissions.

FDA's concept paper entitled PDUFA Pilot Project Proprietary Name Review describes the registration and data submission procedures for those companies that wish to participate in the pilot program.

Advisory committee to discuss the risks and benefits of FDA-regulated products

FDA published a notice in the September 24 Federal Register announcing its Risk Communication Advisory Committee will meet November 12-13 in Silver Spring, Maryland. According to FDA, committee members will discuss communications strategies and programs designed to inform the public about the risks and benefits of FDA-regulated products. The agency states that it will provide specific agenda topics on its web site at least 15 days prior to the public meeting.

Requests to make oral presentations and written submissions should be sent to FDA's Lee Zwanziger by November 4.

FDA issued a proposed rule in the September 23 Federal Register to codify the current good manufacturing practice (cGMP) requirements for combination drug, device, and biological products. The agency states that this rulemaking will help ensure the manufacture of safe and effective combination products by providing a clear and transparent regulatory roadmap for the application of cGMP requirements.

The proposed rule describes the cGMP requirements for single-entity and co-packaged combination products, lays out the requirements for combination products that include human cellular and tissue-based products, and explains which requirements would apply to the constituent parts of a combination product prior to being combined or packaged together.

The annual CHPA Market Exchange, held September 16-17 in New Brunswick, New Jersey, featured a new format with educational content. Over 225 executives participated in this year's event. A well-attended reception and dinner, sponsored by The Emerson Group, allowed attendees to take advantage of an additional networking opportunity.

Dan O'Connor of RetailNet Group spoke to a packed house at the first educational session at this year's Market Exchange.

Preliminary comments from the conference indicate that CHPA members embraced the new Market Exchange format. All attendees are strongly encouraged to complete a 2009 Market Exchange evaluation questionnaire by October 8. The questionnaires, which were generously produced by CHPA Associate member Persuadable Research Corporation, were sent to participants immediately following the event. Please note that CHPA will use member input in the planning of the 2010 meeting.

A panel presentation entitled "Marketing in a Multi-Platform World" gave attendees thought-starters for their media and marketing appointments. Pictured here from left: John Donnelly, Money Magazine; Rebecca Hanley, Time Inc.; Laura Palma, Novartis Consumer Health (panelist); Leslie Picard, Time Inc. Sales & Marketing (panelist); Ron Balasco, Time Inc.; and Bob Severance, DraftFCB (panelist).

The 2009 Market Exchange photos
were provided courtesy of Country Living and Good Housekeeping
(Hearst Magazines publications)

Scott Lamb of Shorewood Packaging discusses custom packaging options with Amy Fox and Thao Le of Hyland's, Inc.

Laura Petasnick, Prevention Magazine, explains how Rodale, Inc. publication can help grow product sales to Bayer HealthCare LLC's Mollie Lawrence.

CHPA Board Member Aki Yoshida, The Mentholatum Company (left), speaks to Jim Silverman of new member Care Media Holdings Corp.

Daren Mazzucca and Sarah Rad of Good Housekeeping, an event sponsor, explain their advertising strategy to Vivek Saxena of Boehringer Ingelheim Pharmaceuticals, Inc.

CHPA members enjoy the informal networking time during the reception and dinner sponsored by The Emerson Group. Pictured from left: Joe Gordon, Wyeth Consumer Healthcare; Jim Mackey, Schering-Plough HealthCare Products, Inc.; Bruce Lifka, CRT/tanaka; Sam Severino, Contract Pharmacal Corp.; and Dave Howenstine, Wyeth Consumer Healthcare.

CHPA thanks the sponsors of the 2009 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.

2009 Market Exchange Sponsors

CHPA members to meet with Walgreens execs at the 2009 Business Development Conference

In less than a month, CHPA members will sit down with executives from Walgreens Co. in a unique and unparalleled business-building forum: the 2009 Business Development Conference. Approximately 35 Walgreens executives, category managers, and buyers are expected to participate in the conference and attend the networking dinner, scheduled for October 27 in Wheeling, Illinois. Additional networking time will be available at the breakfast and lunch, and during scheduled meeting breaks.

In line with the conference theme, "Innovation at Retail," Walgreens representatives will share information concerning the company's overall strategy as well as its targeted approaches for beauty and personal care, front-end health, merchandising, and e-commerce, and more.

Walgreens' Ken Amos, divisional vice president, loss prevention, has been added to the conference agenda to provide a presentation on check point tagging and innovative package and display design. Amos is replacing Dave Van Howe, corporate vice president, new business development, who is unable to attend the event.

Business Development Conference
& Walgreens Immersion Schedule of Events

Tuesday, October 27

7:00 a.m. – 3:30 p.m.
Registration

7:00 – 8:00 a.m.
Continental breakfast

8:00 a.m. – 5:15 p.m.
Walgreens immersion

12:15 – 1:15 p.m.
Networking luncheon with Walgreens representatives

************
5:30 – 8:30 p.m.
Walgreens-CHPA reception and dinner

Register today

The Business Development Conference provides a terrific opportunity for small- to mid-tier CHPA member companies to spend time with one of the nation’s largest retailers. Members should register for the event online or by downloading a faxable registration form as soon as possible.

Hotel room block cut-off is Monday, October 5

The CHPA room block at The Westin Chicago North Shore will be released October 5. Reservations may be made online or by phone at 847.777.6500. Please be aware that Chicago’s O’Hare International Airport is approximately 16 miles from the hotel. The Westin does not provide airport shuttle service.

CHPA thanks the following generous sponsors of the 2009 Business Development Conference:

As last year’s recipient of the Community Anti-Drug Coalitions of America’s (CADCA’s) Champion for a Drug-Free Kids Award (see October 3, 2008, XNL), CHPA was pleased to present this year’s honor to André Lynch, Ingenium Corporation. During her remarks at the September 29 CADCA awards presentation in Washington, D.C., CHPA President Linda Suydam noted Lynch’s dedication to developing better leaders and addressing the impact of substance abuse in the workforce, the economy, and local communities. CADCA also honored Neil Austrian, past president of the National Football League, as CADCA’s 2009 Humanitarian of the Year.

Harold Henderson, NFL (left), joins Linda Suydam, CHPA, in presenting André Lynch, Ingenium Coporation, with CADCA's 2009 Champion for a Drug-Free Kids Award.

CHPA to U.S. Senate Committee on Finance: Keep OTCs tax deductible under FSAs

CHPA President Linda Suydam sent a letter to U.S. Senate Committee on Finance Chair Max Baucus (D-Mont.), September 23 requesting that the Chairman’s Mark of the America’s Healthy Future Act of 2009 be amended to preserve the ability of Americans to use funds from their flexible spending arrangements (FSAs) and other tax-preferred accounts to purchase OTC medicines. Title VI of the chairman’s act would limit the ability of consumers to use FSAs to purchase OTCs by requiring a prescription in order to use FSA monies.

Suydam noted that OTC medicines provide Americans with effective, affordable, convenient, and accessible means to address their healthcare needs. Requiring documentation from a doctor would increase consumer costs and single out cost-effective medications by establishing an artificial standard for OTC medicines.

October 15 will mark the 30-year anniversary for one of CHPA's most esteemed colleagues—Hyacinth Fray. Fray joined CHPA in 1979 and today serves as the accounting manager in the association's Finance & Operations Department. Fray is a valued member of the CHPA team and staff congratulate her for three decades of distinguished service.

A packaging conference and exhibition entitled PACK EXPO 2009 will be held October 5-7 at the Las Vegas Convention Center. The three-day event offers a series of presentations on such topics as digital printing for packaging, how FDA's new leadership will affect packagers, building store brands that will endure the recession, and how RFID and reusable packaging contribute to a successful supply chain track and trace system. In addition to the educational sessions, the event features an exhibit hall with over 1,200 packaging, processing, and converting vendors. Additional information is available online.