What the co-chairs of the
Congressional Caucus to Fight and Control Methamphetamine are saying...

“[Meth] is a problem that cannot be solved by the government alone. It will take the combined effort of law enforcement, retailers, industry, and others to bring an end to the meth epidemic. A program like Meth Watch creates just that sort of partnership. Counties in Washington state have begun to implement Meth Watch programs, and I urge other states and counties to take part in the Meth Watch program.”

—Representative Larsen

“Methamphetamine is one of our nation’s fastest growing drug threats. Unfortunately, Utah is not immune to this menace. . . Utah’s participation in CHPA’s Meth Watch Program is an opportunity to demonstrate that local involvement and commitment is the difference between prevention and abuse. I am a strong supporter of Meth Watch and I am glad to see that Utah has decided to participate in this program.”

—Representative Cannon

"We know that it works."

Those were the words of the head of NACDS at the press conference about Meth Watch. NACDS members and others in the retail community are a vital component of the Meth Watch program. NACDS, which represents chain pharmacies nationwide, is a partner in the effort and has provided funding to implement it. “NACDS members are in a unique position to help law enforcement on this issue,” said NACDS’s Fuller. “NACDS and our members are committed to helping their communities in the fight against meth by participating in Meth Watch.”

Meth Watch is modeled after a successful program begun locally in Kansas in 2002. As news of its success spread, several states began looking for ways to implement the innovative model, but were deterred by limited resources and lack of expertise. Over the past several months, CHPA has been working in partnership with Kansas to design the uniform Meth Watch program for those states interested in participating.

CHPA’s Meth Watch program is available to all interested states. To date, 15 have registered for the Meth Watch implementation training, scheduled for July 8-9 in Washington, D.C. At the training, participants will be briefed on the diversion of household products to meth production and will be provided with information on best practices for implementing a local program. In addition, participants will receive copies of all the Meth Watch materials located on www.MethWatch.com, including the retailer brochure, decals and shelf tags, a training video, and consumer information sheets.

CHPA contacts: Elizabeth Assey and Virginia Cox

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FDA/industry summer workshops focus on the timely issue of cGMPs

The 2004 FDA/industry summer workshops will explore in-depth FDA’s evolving systems approach to drug quality. These workshops will take an intensive look at the area of current Good Manufacturing Practices (cGMPs) and show that FDA recognizes the need for the Agency to work in a collaborative manner with primary stakeholders to develop new ways to ensure product quality. CHPA and FDA developed the workshop program through a co-sponsoring arrangement. 

FDA Summer Workshops

July 12 Parsippany Hilton Hotel Parsippany, NJ

August 9 Hyatt Regency Chicago Chicago, IL

Online registration available

cGMPs currently are under a risk-based review by FDA. This analysis will come to a close at the end of the summer with an FDA announcement, so industry input at this stage may help in determining the direction the Agency takes.

Among the areas being emphasized at the workshops are:

• Development of institutional knowledge on manufacturing science and technology
• The regulatory chemistry and manufacturing controls processes for specifications and other post-approval changes
• Application of recognized risk management methods to realize tangible endpoints for a variety of product quality issues
• Training
• Dispute resolution on scientific issues
• Examination by academic institutions of industry and FDA GMP and operational decision-making and compliance

The new cGMPs will have potential program management and logistical benefits for both FDA and the pharmaceutical industry as they are intended to embrace continuous improvement and allow for the use of new technologies. To be effective, however, the industry and the Agency need to fully understand the process and work together toward the common goal of safe and effective drug products of consistently high quality.

FDA officials engaged in the development of the cGMP initiative will be on hand at the workshops to describe their current thinking on the drug quality system. Industry experts will provide their practical experience and will discuss how cGMPs can be mutually productive for both industry and government. Reservations for both workshops are still available.

CHPA contact: Fred Razzaghi

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CHPA distributes 2004 Market Exchange appointment schedules

_______________________ September 23 Hilton East Brunswick East Brunswick, New Jersey ________________________

The 2004 Market Exchange has exceeded the registration totals of the inaugural event last year. Already 75 tables have been reserved and 200 CHPA members have registered for the September 23 event. CHPA has completed the pre-arranged appointment schedules and sent them to all table hosts and attendees via e-mail, as well as to Official Representatives of those companies with which appointments were requested but which have not yet registered for the conference. Table hosts and attendees with unreserved time during the conference are encouraged to use the advance registration list online in the Members Only section of www.chpa-info.org to schedule additional appointments. The web site list is updated as registrations are processed, so CHPA Market Exchange participants are encouraged to check back frequently to keep track of additional attendees.

Active member companies are asked to submit their registrations as soon as possible. Online registration is available in the Members Only section of the Association's web site. For assistance in using this section, contact CHPA's Susan DiBartolo.

Guidelines for Market Exchange table hosts will be sent in mid-July via e-mail, and will be posted on the CHPA web site.

Sponsorship opportunities are still available

Several companies have expressed interest in providing extra support for this valuable CHPA event by offering to sponsor various activities. We are thankful for the continued generosity of our member companies in helping to make CHPA events among the best in the association community. If you are interested in sponsoring a portion of the CHPA 2004 Market Exchange, contact CHPA’s Ted Peterson.

CHPA contacts: Ted Peterson and Phyllis Taylor

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Mark your calendars for CHPA's Business Development Conference

CHPA's members-only Business Development Conference will be held November 3-4 in Providence, Rhode Island. The conference will feature a CVS immersion day with input from a variety of CVS executives. Other sessions will focus on international aspects of the OTC business.

Conference registration materials will be available soon.

CHPA contacts: Ted Peterson and Phyllis Taylor

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House moves against steroid precursors

The U.S. House of Representatives overwhelmingly passed the Anabolic Steroid Control Act of 2004 (H.R. 3866) June 3. The bill bans the open sale of precursors, such as androstenedione, or andro, which act like steroids in the human body. The bill also doubles the penalties for manufacturing or distributing anabolic steroids at or near a sports facility. Similar legislation (S.2195) sponsored by Senator Joseph Biden (D-Dela.) is pending in the Senate. CHPA has no members that manufacture affected products.

CHPA contacts: Kevin Kraushaar and Amber Thyson

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Senate and House subcommittees hold hearings on dietary supplements

Senate and House subcommittees recently held separate hearings on FDA and Federal Trade Commission (FTC) oversight of the dietary supplement industry. Both hearings focused on delays in promulgating dietary supplement Good Manufacturing Practices (GMPs), adverse event reporting, and the need for additional resources at both agencies.

The Senate Government Affairs Subcommittee on Oversight of Government Management held a hearing June 8 on the status of the Dietary Supplement Health and Education Act (DSHEA) 10 years after its enactment. Witnesses included Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Applied Nutrition, as well as representatives from consumer groups, industry, and medicine. Senators expressed concerns about the length of time it took FDA to publish proposed GMPs and to remove ephedra from the market. Senators heard several recommendations from witnesses on the need to amend DSHEA by mandating premarket approval for dietary supplement products and requiring adverse event reporting. One witness also expressed frustration that FDA was not adequately funded.

In the House, the Energy and Commerce Subcommittee on Oversight and Investigations held a hearing June 16 on dietary supplements marketed to parents of overweight children. The FTC testified about recent cases that it has brought against companies and individuals marketing supplements for weight loss in children and its authority and responsibility to enforce the law against companies that make false or unsubstantiated claims. Another panel of witnesses included representatives of companies that manufacture and distribute the products. Members of the subcommittee expressed their concerns about the “junk science” being used to market these products and the lack of premarket approval to keep the products from entering the market in the first place.

CHPA contact: Kevin Kraushaar

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FDA considers revising its export notification and recordkeeping regulations

In response to a petition from the Grocery Manufacturers of America (GMA) and the Cosmetic, Toiletry, and Fragrance Association (CTFA), FDA is considering whether to revise its export notification and recordkeeping regulations as they apply to foods (including dietary supplements) and cosmetics. The regulations were originally scheduled to become effective March 19, 2002. However, CHPA, CTFA, and others asked the Agency to delay the effective date by 180 days. FDA complied. CTFA and GMA subsequently petitioned FDA to reconsider the rule, arguing that FDA had over-stepped its inspection authority regarding access to food and cosmetics records and that the Agency's requirement to demonstrate that an export product does not conflict with a foreign country's laws shifts the burden of proof from FDA to companies.

FDA has issued an Advance Notice of Proposed Rulemaking on these two points, and requests comments by August 16.

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FDA's pharmaceutical science advisory panel meets in July

The Agency announced the next meeting of its Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science. The committee will meet July 20-21, in Rockville, Maryland. The agenda includes examinations of quality by design; a Good Manufacturing Practices risk model under development; and risk-based questions for chemistry, manufacturing, and controls review processes. The FDA/industry summer workshop series scheduled for July 12 in New Jersey and August 9 in Illinois will explore these issues in-depth. For more information, see the related story in this issue of the Executive Newsletter.

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AESGP hosts 40th annual meeting

The Association of the European Self-Medication Industry (AESGP) held its 40th annual meeting in Madrid, Spain, June 2-4. CHPA President Linda A. Suydam, D.P.A.; Vice President of Regulatory and Scientific Affairs Douglas Ws. Bierer, Ph.D.; and Vice President-International and Assistant General Counsel David C. Spangler represented CHPA at the meeting, which included discussions about switch, two industry panels on a host of issues, EU pharmaceutical legislation implementation, and the economic and public health value of self-medication.

Switch

There was a great deal of attention to the prescription-to-nonprescription switch of simvastatin 10 mg (McNeil Europe’s Zocor Heart-Pro) in the United Kingdom, and what that could mean for both the switch environment in other EU Member States and for the switch of products for chronic conditions in general. Professor Kent Woods, chief executive of the regulatory body for drugs in the UK, the Medicines and Healthcare products Regulatory Agency, addressed the importance of switch in the UK’s three-part approach to widening access to medicines. In addition to switch, the UK also is focusing on expanding the role of pharmacists and broadening prescribing authority to nurses or others.

Industry panels

A panel discussion with Albert Esteve, Esteve Group (and elected to head of AESGP); Brian Perkins, Johnson & Johnson; Paul Stoneham, Boots Healthcare International; Hans Van Zoonen, Procter & Gamble; and Ulf Wiinberg, Wyeth Consumer Healthcare, covered a range of subjects on what industry achieved and what remains to be done. The importance of building brands and momentum for switch was of particular emphasis. The topics of branding and advertising were the specific focus of a second panel, which included CHPA’s Bierer. Bierer noted the differing roles of advertising and labeling as pieces in a product’s communication plan, and reviewed advertising’s effectiveness in communicating product and benefit information to consumers, as well as government and self-regulatory controls surrounding advertising.

EU pharmaceutical legislation implementation

AESGP speakers commented on a variety of issues that have arisen concerning the EU’s pharmaceutical legislation implementation. Three areas of emphasis include:

1. Collaborating with the EU authorities on an update of the switch guideline, which European Commissioner for Enterprise and Innovation Erkki Liikanen indicated likely would be complete within a few months;
2. Working on a guideline on “serious risk to public health” in the mutual recognition procedure, the trigger for a Member State objection in that procedure; and
3. Gaining European Medicine Evaluation Agency support for the new herbal medicinal products committee.

Economic and public health value of self-medication

The meeting also presented an opportunity for the launch of a new AESGP publication, The Economic and Public Health Value of Self-Medication. Based on modeling, a study in the publication estimates that over 16 billion Euros could be saved annually if seven EU member states switched five percent of their prescribed products to self-medication. The study provides further support for overall OTC industry goals in Europe, including:

• Allowing better communication on nonprescription medicines through labeling improvements, permitting advertising of OTC medicines in all media, and ensuring appropriate flexibility in the use of trade names;
• Providing incentives for the scientific work necessary to support Rx-to-OTC switch; and
• Supporting free pricing to ensure a competitive environment.

CHPA contact: David Spangler

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CHPA staff travel inside the Beltway and beyond

CHPA Director of Technical Affairs Fred Razzaghi and Vice President-International and Assistant General Counsel David Spangler took part in International Conference on Harmonization (ICH) steering and expert working group committee meetings June 7-10 in the Washington, D.C., area as part of the World Self-Medication Industry team. Use of risk management tools in the quality process is of growing importance among the ICH topics for both prescription and nonprescription products...

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Update your address books: CHPA is moving

After nearly two decades, CHPA is preparing to move to a new address. Starting Monday, June 28, the Association can be found at:

900 19th Street, NW
Suite 700
Washington, DC 20006

Staff e-mail addresses, as well as phone and fax numbers, will remain the same.

To facilitate the move, CHPA will be closed Friday, June 25.

CHPA contact: Roman Blazauskas

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CHPA, others sponsor unsaleables conference

CHPA, the Food Marketing Institute, Grocery Manufacturers of America, and the National Association of Chain Drug Stores are co-sponsoring an event that promises to be the largest gathering of executives responsible for unsaleables merchandise: the 2004 Joint Industry Unsaleables Management Conference, “Making a Dent.”

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July 20-22, 2004
Loews Miami Beach Hotel
Miami Beach, Florida
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Conference highlights will include informative business sessions, workshops, and the opportunity to meet with industry vendors in the exhibit hall. There will also be ample opportunity for one-on-one interaction between trading partners and peers. CHPA members should be sure to take advantage of the special CHPA member rate for this conference. 

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Start-up seeks CEO

A publicly traded start-up OTC company in Boston, Massachusetts, is seeking a chief executive officer to direct and coordinate all activities. The CEO will be responsible for developing a strategic plan, coordinating annual and quarterly filings with the SEC; identifying acquisition and merger opportunities, and overseeing financing strategy. In addition, the CEO will represent the company before the media and present the company report at the annual stockholder and board of directors meetings. At least five years of experience in public company reporting and compliance is required for this position. Direct experience with OTC and consumer product marketing, as well as a working knowledge of direct-to-consumer marketing programs, are a plus. Visit the job board in the Members Only section of CHPA's web site for more information.

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FDA/CHPA Summer Workshop
July 12, 2004
Hilton Parsippany
Parsippany, NJ

FDA/CHPA Summer Workshop
August 9, 2004
Hyatt Regency Chicago
Chicago, IL

CHPA Market Exchange
September 23, 2004
Hilton East Brunswick
East Brunswick, NJ

Manufacturing Controls Seminar
October 7-8, 2004
Hilton Parsippany
Parsippany, NJ

Business Development Conference
November 3-4, 2004
The Westin
Providence, RI

2005 CHPA Annual Executive Conference
March 10-12, 2005
Fairmont Turnberry Isle Resort & Club
Aventura, FL

2005 Regulatory & Scientific Conference
May 5-6, 2005
Mandarin Oriental Hotel
Washington, DC
[meeting date and hotel tentative]

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