BDC helps Wal-Mart and independents sell more OTCs

A standing-room-only crowd of 137 participants packed the CHPA Business Development Conference (BDC) held in Bentonville, Arkansas, October 27 – 28, to hear business-growing insights and interact with Wal-Mart executives. 

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“You know, I think Wal-Mart may actually get more out of this [meeting] than the manufacturers.” 
—Chuck Felig, Wal-Mart 

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Gregory C. Pulido, chief executive officer, Humco Holding Group, Inc., and CHPA Business Development Chair, kicked off the conference by welcoming all participants and introducing the dynamic program. The theme of the conference—Sell more OTCs … more efficiently—was reflected in every presentation throughout the course of the conference. 

Bruce Roberts, R.Ph., chief executive officer of the National Community Pharmacists Association (NCPA), provided an update on the success of independent drugstores and invited CHPA member companies to participate in the new NCPA “E-Link” program to educate, advertise, merchandise, and sell OTCs through this Internet portal designed for use by 20,000 independent pharmacists across the country. Michael Bender, executive vice president of sales and marketing for Cardinal Health, then gave participants a view of Cardinal’s “front-end” initiatives, including its store within a store concept, and invited CHPA member companies to contact Cardinal to engage in this program. 

These presentations were followed by a well-executed “Retail Compliance” workshop moderated by James A. Nass, vice president, The Mentholatum Company, and BDC Retailer Relations Subcommittee Chair.  Edward C. Kuehnle, group president, North America, Information Resources, Inc., set the stage by reviewing data which quantified, in many cases, a lack of retail store execution at shelf; David J. Wendland, vice president, Hamacher Resource Group, spoke on the importance of plan-o-gram integrity; and Scott E. Simon, senior vice president, SPAR Group Inc., presented information on the importance of speed to shelf and use of 3rd party retail merchandising companies to improve in-store execution. 

Day one ended with a barbeque dinner and invaluable networking opportunity. The evening was sponsored by NUMARK Laboratories and the W.F. Young Company. 

		Rick Ricca (Blistex Inc.) clarifies a data synchronization point with Bruce Hawkins of Wal-Mart.
		Charlie Hinkaty and Randy Sloan (Del Pharmaceuticals) with Wal-Mart's Chuck Fehlig and Neill Walsdorf (Mission Pharmacal) during a break in the day's proceedings.
		CHPA President Dr. Linda Suydam with Bruce Roberts, R.Ph. (National Community Pharmacists Association) and Michael Bender of Cardinal Health, Inc., who presented a session on reaching independent pharmacists.

Day two: Suydam, Bootman, and Wal-Mart Day two of the BDC began with a breakfast sponsored by The Mentholatum Company. CHPA President Linda A. Suydam, D.P.A., spoke about how the recent IRS ruling on OTC inclusion in flexible spending accounts (FSAs) will benefit the industry. Suydam envisions a greater increase in industry growth when FSA participants begin purchasing OTCs with their FSA dollars.  J. Lyle Bootman, Ph.D., of the University of Arizona presented his findings on the future of healthcare in America and its implication on OTC products.  ...and Wal-Mart The Bentonville location, the great manufacturer interest, and the quality agenda developed by the BDC committee attracted a number of Wal-Mart executives to the dais.  Chuck Fehlig, merchandise manager, Department 40, Wal-Mart Stores, Inc., presented the Wal-Mart leadership model. Felig challenged CHPA members to work closely with Wal-Mart, worry less about the competition, and always keep the consumer as a focal point.  Barry Moehring, director of brand marketing, spoke about the Wal-Mart branding strategy and where the company is heading. Currently, Wal-Mart is heavily skewed toward the under $50,000 income market, but wants to increase business among consumers making more than $50,000 per year.  Todd Matherly, buyer, OTC, talked about what makes a good supplier. Matherly’s primary emphasis was for the manufacturers that supply goods to Wal-Mart to really know the company. He suggested manufacturers get to know store personnel and management at the local level, and then to communicate, execute efficiently, and be in-stock. He continued with the reminder to “make it simple” in presentations to buyers: one-page, succinct, focused e-mails work, according to Matherly.  Barry Greene, newly promoted to manager front-end impulse merchandising, spoke on the importance of “long-term” planning with Wal-Mart for product launches, especially switch products. Greene recommended that suppliers know their replenishment manager and reminded everyone to include Sam’s Clubs in their sales/merchandising plans. Mary Couchman, manager, supplier development, was a calming influence for companies not yet represented in Wal-Mart and for new manufacturer reps who aren’t yet familiar with Wal-Mart procedures. Couchman also explained Wal-Mart’s local purchase plan.  Shawn Sederholm, vice president, global sourcing, Wal-Mart International, closed the morning session by explaining that there are over 1,300 Wal-Mart owned stores outside the United States that will do over $40 billion of business in 2003. Sederholm encouraged direct interface between CHPA member company management and Wal-Mart International staff. Radio frequency identification (RFID) and UCCNet were the closing presentations for the day. Steve Van Fleet, director of smart packaging for International Paper gave an overview of RFID, followed by Simon Langford, strategy manager – ISD, Wal-Mart, presenting the Wal-Mart plan of action. Scott Moore, senior manager, eBusiness, Wyeth Consumer Health, took the group through UCCnet/data sychronization. Moore was followed by Bruce Hawkins, strategy architect – ISD for Wal-Mart, who described the importance of UCCNet compliance at Wal-Mart and where to get help if needed.  Leaving the conference, Chuck Fehlig said, “You know, I think Wal-Mart may actually get more out of this than the manufacturers.” Based on comments by the Wal-Mart representatives and responses to a brief evaluation questionnaire, the conference was mutually beneficial for all participants.  The day two luncheon was sponsored by SPAR Group Inc.  CHPA thanks the all the BDC sponsors for their support and for adding to the overall success of the conference. and W. F. Young, Inc. www.absorbine.com Monday night dinner Tuesday morning continental breakfast Tuesday luncheon CHPA contact: Ted Peterson

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CHPA’s Regulatory and Scientific Conference propels attendees into the new age of benefit-risk management

CHPA’s Regulatory and Scientific Conference (RSC), held November 6-7 in Washington, D.C., was declared a great success by attendees. The conference theme was “The New Age of Benefit-Risk Management.” A conference goal was to consider innovative ideas for improving benefit-risk assessments for OTC drug products while building stronger partnerships among government, industry, and other interested parties to provide safe and effective products for consumers. Stephen A. Cooper, D.M.D., Ph.D., senior vice president, global clinical and medical affairs, Wyeth Consumer Healthcare, as chair of the conference program planning committee, presided.

Distinguished keynote speaker Kay Holcombe, executive vice president, Policy Directions, Inc., offered her insights as a Washington insider into the role of self-medication in our future healthcare system. Holcombe noted that one in every six people in the United States do not have health insurance. She pointed out that the number of uninsured Americans grows every day, leading to more reliance on self-medication with OTC drugs. With increasing numbers of uninsured individuals, she observed, a corresponding increase in self-medication would be expected. Holcombe remarked that the greater use of OTCs in the future makes the need for clear, accurate information about their safe and effective use even more important.

Other presenters in the first general session discussed benefit-risk management from various points of view. Speakers included J. Michael Gaziano, M.D., director of cardiovascular epidemiology, Division of Preventive Medicine, Brigham and Women’s Hospital; Paul J. Seligman, M.D., MPH, director, Office of Pharmacoepidemiology and Statistical Science, FDA's Center for Drug Evaluation and Research (CDER); and Peter A. Gross, M.D., chairman, department of internal medicine, Hackensack University Medical Center. Gaziano spoke about types of epidemiologic studies and issues in their interpretation, noting that epidemiology is a powerful tool that must be used carefully. Seligman described FDA’s use of epidemiologic data, including adverse event reports, to anticipate and prevent risks as well as to assess and manage risks. He mentioned being proactive in decreasing medication errors as a strength of CHPA and the OTC industry. Gross focused on the challenges of understanding and communicating risk, particularly for medications. The speakers were joined by Charles J. Ganley, M.D., director, Division of Over-the-Counter Drug Products, Office of Drug Evaluation V, CDER, and Eric Brass, M.D., Ph.D., Director, Harbor-UCLA Center for Clinical Pharmacology, and professor of medicine, UCLA School of Medicine, in a panel discussion. The panel was moderated by Randy P. Juhl, Ph.D., vice chancellor for research conduct and compliance, University of Pittsburgh.

In the second general session, Curtis J. Rosebraugh, M.D., MPH, deputy director of the FDA Division of Over-the-Counter Drug Products, challenged industry to be innovative in bringing new OTC products to market and not rely only on switching drugs from prescription to nonprescription status. In his update on OTC issues, he encouraged companies to consider the time and extent application process as a mechanism to introduce additional OTCs into the U.S. market. Rosebraugh acknowledged the need for FDA and industry to work in partnership to make OTC drug approval processes more efficient.

The session was rounded out by two excellent presentations on the roles of the media and public relations professionals in communicating healthcare issues. Nancy Snyderman, M.D., vice president of medical affairs, Johnson & Johnson, and formerly a medical correspondent for ABC News, called the press a healthy watchdog that is important to the public. She said the news media has a responsibility to teach, educate, and inform, rather than just breaking bad stories. Richard W. Edelman, president and chief executive officer, EDELMAN, emphasized risk management principles, particularly building and maintaining credibility, to enable companies to manage issues.

Three workshops provided other learning opportunities for conference participants. One focused on the benefit-risk equation for chronic-use OTC switch candidates, another included presentations by experts on state-of-the-art tools for improved benefit-risk assessments, and the third explored ways to optimize the FDA Nonprescription Drugs Advisory Committee.

CHPA President Linda A. Suydam, D.P.A., closed the conference with a call for indsutry and FDA to work cooperatively to learn about consumer behavior in the use of OTC drugs and how to communicate more effectively with consumers about the appropriate use of medicines.

CHPA thanks the following conference sponsors for their support:

• Bayer Consumer Care
• McNeil Consumer + Specialty Pharmaceuticals
• Novartis Consumer Health
• Perrigo Company
• Pfizer Inc
• The Procter and Gamble Company

CHPA contact: Dr. Lorna Totman

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CHPA supports timely review and approval of additional sunscreen ingredients

CHPA and The Cosmetic, Toiletry, and Fragrance Association (CTFA) submitted a letter in October in support of "regulatory action that allows industry to develop and market additional safe and efficacious sunscreen products." According to the groups, "approval of more sunscreen active ingredients expands the formulation options that allow the industry to produce a wide variety of sunscreen products intended to protect the public against the hazards associated with sun exposure." 

The letter was sent in response to an FDA notice of eligibility and request for data and information on three sunscreen active ingredients: amiloxate, enzacamene, and octyl triazone. 

CHPA contact: Eve Bachrach

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FDA considers PQRI's recommendations on blend uniformity

Citing the assistance of the Product Quality Research Institute (PQRI), the Agency published November 7 a guidance for industry, Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment. This guidance is intended to ensure uniformity of powder blends and finished dosage units. Specifically, it provides recommendations on how to: 

• Conduct powder blend sampling and analyses. 

• Establish initial criteria for stratified sampling of in-process dosage units and evaluation of test results. 

• Analyze the stratified samples and evaluate data.

• Correlate the stratified sample data with the powder blend data. 

• Assess powder mix uniformity.

• Correlate the stratified sample data with the finished dosage unit data and assess  uniformity of content. 

• Test exhibit and validation batches for adequacy of powder mix. 

• Test and evaluate routine manufacturing batches. 

• Report the use of stratified sampling in the application.

FDA's guidance is published just in time for the upcoming PQRI Blend Uniformity Workshop scheduled for December 4-5 in Bethesda, Maryland. More information on the workshop is available online. 

CHPA contact: Fred Razzaghi

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Codex going with science-based maximums for vitamins, minerals

In a win for the U.S. government, the Codex Committee on Nutrition for Foods for Special Dietary Uses last week decided that recommended maximum levels for vitamins and minerals in dietary supplements should be based on scientific assessments of risk, and not hard caps based on multiples of a recommended daily allowance.

The issue had long been a sticking point in discussions on a proposed draft guideline for vitamin and mineral supplements, with the United States and others supporting the risk-based approach, and a number of European countries advocating hard caps.

While a Codex guideline for vitamin and mineral supplements would not be binding on countries belonging to Codex, such guidelines are very influential, particularly in the developing world.

From here, the proposed draft guideline goes to countries for another round of consultation, the fifth step in the eight-step Codex process.

CHPA contact: David Spangler

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Senate approves $600,000 increase for OTCs at FDA

The U.S. Senate approved the appropriations bill containing FDA funding for fiscal year 2004 November 6. The bill contains an increase of $600,000 for OTC drug programs at the Agency. The Senate approved an amendment by Senator Richard Durbin (D-Ill.) that designates $250,000 for FDA to complete its review of ephedra comments that have been filed recently. The Senate bill also contains a total of $11.4 million for dietary supplement activities.

The bill now goes to a conference committee to resolve differences between the House and Senate versions of the bill. The House previously approved an increase of $700,000 for OTC drug programs, but did not earmark funding for dietary supplements. If a conference agreement is reached between the Senate and House versions of the FDA funding bill, it likely will be added to an omnibus appropriations bill that will combine six or seven bills into one package. There is also the possibility that the FDA funding could be reduced by .65 percent in an effort to keep total discretionary spending below budget caps established by congressional leadership.

CHPA contact: Kevin Kraushaar

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FDA provides guidance to industry on product recalls

The Agency published Product Recalls, Including Removals and Corrections, October 31. The document is intended to provide industry with guidance on how to handle all aspects of product recalls. In the Federal Register notice announcing the guidance document, FDA stressed the importance of cooperation by manufacturers and distributors, and noted that the local FDA District Recall Coordinator assists firms engaged in a product recall by offering review, comment, and monitoring of the process. 

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Time is running out to register for IIR switch conference

November 19-21 is the date for the "Rx-to-OTC Switch Marketers Forum" hosted by the Institute for International Research (IIR). CHPA's Vice President of Regulatory and Scientific Affairs Douglas Ws. Bierer, Ph.D., will chair the Philadelphia, Pennsylvania, conference, which promises to deliver the latest intelligence on the current switch market and reveal new models for successful switches. 

IIR also will present a second switch conference, January 14-16, 2004, in Orlando, Florida. Again, CHPA's Bierer is on the agenda. Bierer will present a perspective on the regulatory considerations of transforming the patient into the consumer on day two of the program. "Preparing and Managing Rx-to-OTC Switch" is specifically developed to benefit pharmaceutical switch teams. 

CHPA members are eligible for a special discount to these conferences. Contact IIR's Customer Service department at (888) 670-8200 and mention Priority Code XCHPA1.

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Marketing compliance manual offers free online access

Thompson Publishing Group's FDA Advertising and Promotion Manual is now offering free single-user online access with subscription. The online access provides users the ability to search the manual, newsletter archives, the warning letters database, and source documents. The manual itself includes information on federal requirements for promoting pharmaceuticals and dietary supplements. For more information, visit Thompson online. 

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New magazine offers association members free subscription

A new publication covering information specific to tablets and capsules has hit the newsstands. Called, appropriately enough, Tablets & Capsules, the fledgling magazine is offering free subscriptions to industry personnel. For more information, please visit www.tabletscapsules.com. 

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NCPIE readies for annual meeting

The 14th National Conference on Medicine Information and Education is scheduled to take place December 8-9 in Washington, D.C. Hosted by the National Council on Patient Information and Education (NCPIE), the conference will be keynoted by FDA Commissioner Mark McClellan, M.D., Ph.D., and promises to deliver information on a number of topics, including consumer medicines and the BeMedWise campaign, which stresses the important role of the pharmacist in consumer healthcare. To review the conference program or to register, visit NCPIE online. 

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2004 Annual Executive Conference
March 17-19, 2004 [Wednesday-Friday]
Grand Hyatt Washington
Washington Center, 1000 H Street, NW
Washington, D.C.

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