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November 19, 2004 |
No. 23-04 |
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CONTENTS
CHPA President BDC helps companies focus and prioritize Fourteen new members elected by CHPA board CHPA explains the U.S. switch process at DIA meeting in Canada FDA takes steps to further implement DSHEA FDA revises compliance policy guides concerning Bioterrorism Act Comment period reopened for certain food claims Acting Commissioner Crawford moves to beef up FDA's drug safety program New FDA initiative uses RFID technology to protect U.S. drug supply Chief Counsel Troy resigns from FDA CHPA staff travel inside the Beltway and beyond Freestorefoodbank helps distribute OTCs to the needy New publication explains how FDA advisory committees operate
Use
the table of contents to jump directly to a story of interest, or use the
scroll bars. "Back to the top" options after every story will take
you to the beginning of the table of contents. |
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CHPA President Suydam advocates comprehensive meth solution before government subcommittee CHPA President Linda A. Suydam, D.P.A., testified before the U.S. House of Representatives Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources at a November 18 hearing entitled “Law Enforcement and the Fight Against Methamphetamine.” The hearing explored the federal role to address the methamphetamine problem in this country, and officials from the Office of National Drug Control Policy, the Department of Justice, and the U.S. Drug Enforcement Administration were on hand to provide the administration’s perspective. A second panel followed, which included a broader perspective of the methamphetamine problem, with representatives from the retail community, industry, and law enforcement. While pseudoephedrine is a nonprescription nasal decongestant used safely and effectively by millions of consumers each year to treat symptoms of colds, allergies, and the flu, Suydam noted the industry’s deep concern that the ingredient can be illegally diverted and used with other products to manufacture the illicit drug methamphetamine. In her testimony, Suydam advocated “tough, comprehensive measures to attack this problem at every level of its manufacture and use.” Specifically, Suydam encouraged:
Suydam also addressed the approach of putting OTC pseudoephedrine-containing medicines on Schedule V, which requires such medications be sold only in pharmacies, placed behind pharmacy counters, and sold only by pharmacists or pharmacy technicians. Oklahoma passed such legislation earlier this year. She cautioned subcommittee members that “there is “no ‘quick fix’ to this complex problem. We must take comprehensive steps that work, not half-measures that have a greater impact on sick kids, care givers, and flu sufferers than on criminals.” CHPA contacts: Elizabeth Assey and Virginia Cox |
BDC helps companies focus and prioritize Over 100 company executives attended the CHPA Business Development Conference held in Providence, Rhode Island, November 3-4, to hear business-growing insights and network with each other and CVS/pharmacy executives. CHPA Business Development Committee Chair Adam Raczkowski, executive vice president, chief operating officer, chief financial officer, and general manager, W.F. Young, Inc., kicked off the BDC by welcoming all participants and introducing the dynamic program. Day one of the program began with a presentation on the 2004 election results by syndicated journalist and political commentator Jack Germond. Germond's remarks included a detailed analysis of the differences between the elections of 2000 and 2004.
Next up on the BDC agenda was a panel
session on OTC growth potential in the international marketplace led by
Kirk Hodgdon,
principal, growth catalyst, Bolin Fulcrum. Panelist presentations
emphasized the need to use international partners who fully understand
the laws, regulations, and culture of the desired market in order to
have a successful expansion and avoid costly and time-consuming
pitfalls. During his remarks, Hodgdon addressed issues culled from responses to a conference registrant's survey. John Keppeler, vice president, worldwide sales, CNS, Inc., discussed CNS’s experiences expanding into European markets, along side a presentation by Italian marketing partner, Antonio Braga, president, Blufarm Group. Carlos Oliva, principal, Custom Consulting Group, LLC, concluded the panel discussion by sharing his experiences with regulations, distribution, manufacturing, and trade and consumer nuances within the framework of entry into international markets, with a specific focus on Latin American countries.
“As a small CHPA member not yet a vendor of CVS, this was a great chance to hear first-hand about CVS’ strategies, policies, and practices in dealing with its current and new vendors.”
Bob Michelson, chief executive officer, Goliath Solutions, followed the international panel with a presentation on the types of in-store advertising vehicles being used in retail establishments today. He shared his insights on a number of such questions as which methods drive extra sales, what is the amount of incremental sales attributable to point-of-purchase promotions, whether co-marketing drives extra sales, whether thematic in-store advertising contributes to increased incremental sales above product brand alone, and how to measure results using radio frequency identification (RFID) technology. Michelson closed his remarks by stressing the importance of working closely with retail partners in the execution of in-store advertising to ensure all entities have the same goals.
The Second General Session began with a business overview of CVS/pharmacy which included information on the Eckerd acquisition and its go-forward strategy, details on the CVS/pharmacy targeted consumer, strategies for the CVS ExtraCare program, information on how to drive results in consumer healthcare categories at CVS, and examples of how to be a good CVS supplier. Bloom encouraged companies to use the CVS web site, noting that “everything you ever wanted to know about being a CVS supplier” is contained on its supplier web site: www.cvssuppliers.com. In another CVS overview, Kevin Smith, senior vice president, supply chain and logistics, CVS/pharmacy, briefed attendees on logistics operations at CVS—where it is now and where technology is heading. He included details on CVS' more efficient distribution centers. Jack DeAlmo, vice president, store replenishment and inventory management, then shared CVS's plans to ensure smooth adoption of RFID technologies along all product lines in the store.
BDC Chair Adam Raczkowski of W.F.Young, Inc. (far right) moderated the first CVS/pharmacy panel at the Second General Session. CVS panelists from left: Ted Williams, divisional merchandise manager; Helena Foulkes, senior vice president, advertising and marketing; Mike Bloom, senior vice president, merchandising.
“What a terrific program! This year's BDC allowed us to network with top management at CHPA member companies and CVS. I especially appreciated the generous corporate sponsorships of W.F. Young, Humco Holding, NUMARK, and Mentholatum that made this conference possible."
From left: CVS's Steve Ortleib and Ted Williams spent some time with Lynda Farrington Wilson and Dr. Rich Wildnauer of NeoStrata Company during the networking dinner.
CHPA contacts: Ted Peterson and Phyllis Taylor |
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Fourteen new members elected by CHPA board The CHPA Board of Directors elected three new Active and 11 Associate members at its November 16 meeting: Active members: GIULIANA S.P.A.,
Milan, Italy; Germano
Giuliani, president and chief executive officer, will be the
Official Representative (OR). A well-known pharmaceutical company in
Europe, Giuliani S.p.A., is preparing to launch an oral hair loss
retardant product in the United States. The company also produces
several digestive aid products which are sold outside the United States. LORNAMEAD BRANDS,
INC., Tonawanda, New York;
James A. Nass, president and chief executive officer, will be the
OR. OTC brands are Lypsyl lip balms and Natural White toothpastes. THOMAS PHARMACEUTICALS LTD., New York, New York; Tom Thomas, president, will be the OR. The company sells vitamin and OTC antacid products through specialty and national retail outlets. Associate Members: 3D COMMUNICATIONS,
Bethesda, Maryland, [individual consultant];
James DiBiasi, partner,
will be the OR. 3D is a strategic communications training and production
firm made up of award-winning journalists, producers, writers, speakers,
marketers, and business and communications strategists. The company
tailors its work to suit clients’ specific needs to create and deliver
clear and compelling media messages, inspiring presentations, and
high-quality productions that generate winning results. BARR LABORATORIES,
Woodcliff Lake, New Jersey, [non-OTC/non-DS manufacturer];
Jake Hansen, vice president
of government affairs, will be the OR. Barr manufactures generic
prescription medicines. CATALINA HEALTH
RESOURCE, Blue Bell, Pennsylvania, [print media];
Lawrence R. Blum,
general manager, will be the OR. For over 10 years, the Catalina Health
Resource Newsletter has delivered meaningful, targeted messages directly
to pharmacy customers through a national network of pharmacies. The
health information targets current prescription needs, and also
preserves patient privacy. CHR’s clients include the pharmaceutical
industry, consumer packaged goods, and government agencies. COMPETITIVE
PROMOTION REPORT, Ambler, Pennsylvania, [individual consultant];
Larry Kagel,
president, will be the OR. The company provides competitive intelligence
and consulting services to manufacturers and others regarding trade pricing, promotion,
allowances, terms, and new product introductions in the health and
beauty care, general merchandise, and private
label categories. New product flash provides
key information on competitive new products prior to shipment to retail
that includes images, pricing, ingredients, and more. CPR maintains a
database with past information on trade pricing and promotion for five
years, and new product introductions for three years. DISNEY PUBLISHING
WORLDWIDE, New York, New York, [print media];
Ron Balasco, senior
account manager, will be the OR. Disney represents Family Fun,
Discover, Disney, and Disney Adventures magazines. DKM, INC., Philadelphia, Pennsylvania, [individual consultant]; Diane K. Manwaring, president, will be the OR. Consultancy provides brand and business strategy development and execution specializing in the consumer healthcare industry. DKM, Inc., offers customized marketing support that addresses a client’s specific needs including strategy development, brand planning, consumer target development, advertising test markets, and national rollout. Acquisition and divestiture evaluations also are a specialty. MARS OTC/DTC,
New York, New York, [specialized services, market research];
Hugh J. White,
managing director, will be the OR. MARS (Multimedia Audience Research
Systems) is a powerful marketing research tool designed to measure
specific market categories in-depth. Targeting the pharmaceutical
advertising industry, MARS conducts annual syndicated studies that
provide an up-to-the-minute database to DTC and OTC product marketers
about consumers and their media habits, attitudes, and opinions. NIVA INC.,
Ottawa, Ontario, Canada, [specialized service];
John Nihmey, president, will be
the OR. Since 1978, NIVA has provided unparalleled documentation
services and solutions to government and industry sectors both
nationally and abroad. Offering specialized services ranging from
document analysis and communications planning to end-to-end document
development and web repository design, NIVA has a dynamic group of
diverse, innovative documentation professionals supported by a proven
process of standards. From technical writing to web development, the
integrated teams have the talents and skills necessary to help clients
manage their knowledge assets more effectively. PPD, INC.,
Wilmington, North Carolina, [clinical research service];
Alan Johnson,
manager-marketing communications, will be the OR. PPD is a leading
global provider of discovery and development services and products for
pharmaceutical, biotechnology, and medical device companies. PPD applies
innovative technologies, therapeutic expertise, and a commitment to
quality to help clients maximize the return on their R&D investments.
With proven discovery through post-market resources, the company also
offers compound partnering opportunities. PPD has more than 6,300
professionals in 27 countries around the world. UPSTREAM, Fargo,
North Dakota, [specialized service];
Jerome Johnson, president
and chief executive officer, will be the OR. UpStream delivers inspired
customer care through the integration of people, process, and
technology. VELOSEL CORPORATION,
Santa Clara, California, [specialized service, strategic
business/marketing consulting];
Russ Henry, senior vice president, marketing, will be the OR.
Velosel provides collaborative product information management solutions
to the consumer goods and retail industries by delivering accurate,
enriched product information that improves value chain business
performance. CHPA contacts: Ted Peterson and Phyllis Taylor |
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CHPA explains the U.S. switch process at DIA meeting in Canada CHPA's Douglas Ws. Bierer, Ph.D., vice president, regulatory and scientific affairs, was among the featured speakers at the Second Annual Canadian Drug Information Association (DIA) meeting in Ottawa, Canada, November 8. One of the topics discussed during the meeting was the current and future status of Rx-to-OTC switch in the United States and Canada. During his remarks, Bierer discussed the overall U.S. market valuation of OTC products pointing out that switch was the growth engine of the U.S. OTC market, accounting for more than half of the top 18 brands. He also explained how products are switched to OTC status in the United States and illustrated the two processes that are not present in the Canadian system: 1) consumer behavior studies and 2) advisory committee review. Bierer went on to explain that some switch products in the United States are afforded three years of exclusivity from generic competition when manufacturers supply FDA with information from new data in clinical studies that the Agency finds essential for approval. He also noted that FDA is now providing helpful information to companies about the hurdles that must be overcome in order for a product to be switched. Looking into the future, he projected a proposed greater reliance on FDA's Division of OTC Drug Products to manage the switch process, evolving roles of pharmacists in terms of consumer education, greater use of diagnostics to support appropriate consumer selection, and a greater emphasis on OTC switch products to curb the rising cost of healthcare. Robert White, director of government relations for NDMAC (formerly Nonprescription Drug Manufacturers Association of Canada, see related article), discussed the advantages of switch in Canada which included lower costs of publicly funded drug benefits plans, a reduction in physician visits for minor ailments, and a reduction in total healthcare costs. White opined that there is a need for the Canadian government to recognize investments and innovation by granting a minimum of three years of data exclusivity for innovators for novel indications on existing self-care health products and on products switched from Rx to self-care health products status. He also noted that future switches will focus on long-term management of more significant disease conditions such as heart disease, gastrointestinal conditions, skin conditions, asthma, pain management, and eye infections. White agreed with Bierer's opinion that switching products for long-term management conditions will require a significant investment in research and time which will produce a substantial reduction in healthcare costs and increase the vital role of OTC/self-care products in the healthcare system. CHPA contact: Dr. Doug Bierer |
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Meth Watch debuts in Iowa Iowa officially launched its Meth Watch program November 9 at Scott’s Foods in Norwalk, making it the ninth state to adopt the national program. CHPA has worked with states interested in adopting Meth Watch, a voluntary program which creates partnerships among retailers, law enforcement, and the community. Travis Acheson, Iowa Meth Watch director, noted, “This initiative provides a mechanism for every part of the community to come together and take the problem head on.” Partners in the Iowa program include the Iowa Grocery Industry Association, Iowa Retail Federation, Iowa Pharmacy Association, Iowa Department of Public Health, the Iowa Division of Narcotics Enforcement, and the Midwest High Intensity Drug Trafficking Area. Iowa was among the 20 states represented at CHPA’s State Leadership Training Session in July 2004, and has worked diligently to establish the program statewide. CHPA was pleased to work with the state and provide resources through its Meth Watch grant program for this public and private partnership. For more information on Iowa's Meth Watch program visit www.iowamethwatch.com. CHPA contact: Elizabeth Assey |
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FDA takes steps to further implement DSHEA FDA recently announced that the Agency is undertaking three major regulatory initiatives in order to further implement the Dietary Supplement Health and Education Act of 1994 (DSHEA). According to a November 4 FDA news release, the Agency intends to improve the transparency, predictability, and consistency of its scientific evaluations and regulatory actions to protect consumers from unsafe dietary supplement products and those products that make unauthorized, false, or misleading claims. The first step FDA has taken is to release a document that discusses the Agency's strategy to further implement DSHEA. Announced in the November 9 Federal Register, the document, entitled Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994, lays out a number of specific, integrated measures the Agency will employ, including guidance, regulations, and science-based compliance and enforcement mechanisms. According to FDA, the Agency hopes that the implementation of these measures will improve transparency, thereby helping to engage stakeholders in the development of further measures to implement DSHEA. Comments on the strategy document will be accepted by FDA at any time. The second FDA initiative is the release of a draft guidance entitled Guidance for Industry: Substantiation for Dietary Supplement Claims Make Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act. The draft guidance seeks to describe what evidence FDA recommends that a dietary supplement manufacturer have in order to substantiate a structure/function claim. In a November 9 Federal Register notice, the Agency stated that it intends to apply a standard for substantiating dietary supplement claims that is consistent with the Federal Trade Commission's standard of "competent and reliable scientific evidence." FDA notes that it does not intend to issue a guidance on the types of claims involved, pointing instead to the January 6, 2000, preamble for the final structure/function versus disease claim rule (See January 7, 2000, XNL). Comments on the draft guidance are due by January 10, 2005. The third initiative was a public meeting FDA held November 15 to solicit comments on the 75-day premarket notification program for new dietary ingredients (NDIs). (See October 22 XNL). Nine speakers made oral presentations to several FDA representatives and the general audience. Public input will be considered to address the need to clarify the requirements of the NDI 75-day notification portion of the law. FDA has identified omissions and other problems in previous notices submitted by companies to comply with the NDI notification requirement of DSHEA. These problems have suggested to the Agency that it may need to consider ways to assist companies to know what information is needed in NDI notifications. A likely benefit to industry would be clarification of statutory requirements. At the request of CHPA and the Council for Responsible Nutrition (CRN), attorney Peter Barton Hutt of Covington and Burling submitted written comments at the meeting. The final deadline for submitting written or electronic comments is December 3; however, CHPA and the other leading dietary supplement trade associations submitted a request November 3 to extend the comment period until February 10, 2005 (See November 5 XNL). FDA has not decided yet about an extension. CHPA contact: Dr. Marcia Howard |
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FDA revises compliance policy guides concerning Bioterrorism Act FDA issued two separate notices in the November 9 Federal Register announcing that the Agency has revised two of its compliance policy guides (CPGs) relating to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The first notice announces the availability of a fourth revision of a CPG for FDA and U.S. Customs and Border Protection (CBP) staff entitled Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This revised guide provides FDA and CBP staff broader enforcement discretion on details that are required but not provided on specific facilities where a food is manufactured. The CPG became effective November 8, but FDA will accept comments at any time. The second notice announces the availability of a revised CPG entitled Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. FDA revised the guide to clarify that the introductory phase for enforcement of the Agency's food facility registration rule is over (See December 23, 2003, XNL). Further, enforcement policies under the rule and the CPG will be fully implemented for domestic, as well as foreign, food facilities. The CPG is final November 9, but FDA will accept comments at any time. CHPA contact: Paul Larsen |
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Comment period reopened for certain food claims The November 18 Federal Register includes a notice from FDA reopening the comment period for 60 days for the 1995 proposed rule entitled 'Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims." According to the notice, FDA is seeking comments on the proposed amendments to allow unqualified health claims on certain foods containing less than 10 percent of certain nutrients, criteria on exemptions from disqualifying nutrient levels, and how the terms "may" or "might" are used. This is the second time since May that FDA has reopened the 1995 proposed rule (See May 6 XNL). Comments are now due January 18, 2005. CHPA contact: Dr. Marcia Howard |
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Acting Commissioner Crawford moves to beef up FDA's drug safety program FDA Acting Commissioner Lester M. Crawford, Ph.D., D.V.M., issued a statement November 5 that authorized the Center for Drug Evaluation and Research (CDER) to take measures to strengthen the Agency's safety program for marketed drugs. According to the FDA news release, this move is being made to circumvent serious adverse event problems such as those recently identified with Rx anti-depressants and a COX-2 selective non-steroidal anti-inflammatory drug.
To that end, CDER has been instructed to take the following actions:
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New FDA initiative uses RFID technology to protect U.S. drug supply FDA announced in a November 15 news release that it has enhanced its efforts to improve the safety and security of the nation's drug supply through the use of radio frequency identification (RFID) technology. RFID technology uses electronic tags on product packaging to help manufacturers and distributors keep track of drug products as they move throughout the supply chain. As part of FDA's effort to thwart counterfeit and diverted Rx drugs, the Agency published a compliance policy guide in the November 17 Federal Register for implementing RFID feasibility studies and pilot programs. Additionally, FDA announced that it is creating an internal RFID workgroup that will monitor the implementation of RFID in the pharmaceutical supply chain. |
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Chief Counsel Troy resigns from FDA FDA announced November 16, the resignation of Daniel E. Troy, associate general counsel/chief counsel of the Food and Drug Division of the Office of the General Counsel. Troy served as FDA's senior legal advisor since August 2001. His resignation is effective November 28. "In my estimation, Dan's principal legacy is having instilled in the Agency a deep and abiding respect for the rule of the law," said FDA's Acting Commissioner Lester M. Crawford, Ph.D., D.V.M., in an Agency news release. "I am deeply sorry to lose his wise counsel and steadfast support." Jerry Masoudi, the current deputy associate general counsel of FDA's Food and Drug Division, has been named acting associate general counsel/chief counsel until a permanent replacement for Troy is selected. |
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CHPA staff travel inside the Beltway and beyond CHPA President Linda A. Suydam, D.P.A., Senior Vice President, General Counsel and Secretary Eve Bachrach, Vice President, Regulatory and Scientific Affairs, Doug Bierer, Ph.D., and Vice President of Government Relations Kevin Kraushaar, met with Centers for Medicare & Medicaid Services Administrator Mark McClellan, M.D., Ph.D., November 10, to discuss the benefits of OTCs as an integral part of the U.S. healthcare system. McClellan, who served as FDA commissioner from 2002 to 2004, continues to be a self-described champion of and vocal advocate for OTCs as a "great and important component of the healthcare delivery system." CHPA Vice President, Regulatory and Scientific Affairs Doug Bierer, served as a committee member at the November 4 United States Pharmacoepial Convention, Inc., (USP), Nominating Committee meeting which developed a list of potential chairpersons to head the various USP expert committees. The chairs, along with their committees, will set the standards that go into the USP national formulary for 2005-2010... CHPA's Senior Director of Scientific Affairs and Toxicology Lorna Totman, Ph.D., and Associate Director, Scientific Affairs Marcia Howard, Ph.D., went to College Park, Maryland, November 15, to attend FDA's public meeting on premarket notification for new dietary ingredients (See related article)... |
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Freestorefoodbank helps distribute OTCs to the needy The Health & Hygience Program of the Freestorefoodbank in Cincinnati, Ohio, is now in its fourth year of operation donating close-dated and surplus OTCs and other consumer healthcare products to the needy and working, poor families of Ohio, Kentucky, and Indiana. One of only a dozen foodbanks with the necessary licenses and permits—including Drug Enforcement Administration certification—to distribute these medicines, already Freestorefoodbank has distributed more than 500,000 pounds of these items to more than 175,000 people in need. To donate products or receive additional information about potential involvement, please contact Jan Boldt, program manager, at (513) 482-4528 or jboldt@freestorefoodbank.org. |
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New publication explains how FDA advisory committees operate A new book from FDANews spells out the right and wrong ways to approach FDA's advisory committees during the lengthy and complex drug approval process. FDA Advisory Committees: Perils and Profits offers a wealth of information on such drug approval topics as what advisory committees look for in drug applications, what questions committee members are likely to ask, what kind of evidence committee members find most persuasive, and what the next steps are if the advisory committee rejects your proposal. The book is co-authored by Wayne Pines, former FDA associate commissioner for public affairs, and John Kamp, former legal and policy advisor to the Federal Communications Commission. For more information or to order a copy of the publication, visit the FDANews web site. |
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NDMAC assumes a new identity
Effective immediately, the association will be known simply as "NDMAC" (pronounced "en-dee-mac". The web site address is the same: www.ndmac.org. However, the site now has a brand new look, new and updated content, and new functionality. |
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2005 Regulatory & Scientific Conference |
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| Executive Newsletter is published every other week by the Consumer Healthcare Products Association |
| 900 19th Street, NW, Suite 700, Washington, DC 20006 |
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| Forward contact information changes to CHPA's Membership Department. |
| Forward editorial comments or questions to CHPA's Communications Department. |
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| Copyright © 2004 by the Consumer Healthcare Products Association (CHPA). CHPA's Executive Newsletter is for general information purposes only. Information reported in this newsletter is compiled from various sources. All efforts are made to assure the accuracy of the content, but CHPA cannot guarantee the information. | |
| http://www.chpa-info.org | |
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