CHPA, grocers, and food processors ask OEHHA to keep Proposition 65 status quo

CHPA joined forces with the Grocery Manufacturers of America and the National Food Processors Association in recommending that California's Office of Environmental Health Hazard Assessment (OEHHA) not adopt May 28 proposed revisions to its prioritization procedure for the state's Proposition 65 statute.

In June 28 comments to OEHHA, the coalition cited the following seven reasons why OEHHA should withdraw or take no action on the proposed revisions to its Procedure for Prioritizing Candidate Chemicals for Consideration Under Proposition 65 by the "State's Qualified Experts":

1. They are less scientific. The existing prioritization procedure, adopted in May 1997, contains 45 lines of appropriate scientific guidance concerning the determinations that govern whether a chemical will be assigned a "high" priority for committee review. In contrast, the proposed revisions contain only 12 lines concerning these determinations.
2. They are less open and transparent. The proposed revisions are much shorter, less specific, and provide for less public input, thereby undermining an important aspect of OEHHA operations. Furthermore, OEHHA does not have to adhere to the proposed revisions if adopted which would potentially allow for modifications "when necessary." The existing procedure may be modified only in limited circumstances.
3. They depart from the statute's "clearly shown" standard. The proposed revisions would remove the "clearly shown" standard from the procedure. No purpose is served by having the Proposition 65 Identification Committee's review chemicals that do not have a reasonably strong chance of meeting the statute's "clearly shown" standard.
4. They wrongly disregard authoritative body analyses. While the existing procedure provides that OEHAA will address the evaluations of bodies considered to be authoritative, the proposed revisions disregard such evaluations.
5. They are not an effective use of resources. The existing procedure provides that OEHHA will spend less time on the prioritization of chemicals with straightforward toxicological evidence and more time on the chemicals that present more complicated issues.
6. They are unnecessary. The chemicals that remain for possible evaluation warrant the more rigorous evaluation called for by the existing procedure.
7. They contradict prior expert panel input. The proposed revisions contemplate review of draft prioritization decisions by the Carcinogen Identification Committee, with public comment. The committee unanimously rejected this same proposal in 1996.

Finally, the coalition asked OEHAA to withdraw or take no action on the draft prioritization procedure, but rather to maintain the May 1997 prioritization procedure.

CHPA contact: Eve Bachrach

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CHPA calls on FDA to establish an OTC monograph for urinary analgesic products

To acknowledge the long and safe marketing of specific OTC urinary analgesics, CHPA recently recommended that FDA create an OTC monograph for which those drugs would be generally recognized as safe and effective (GRAS/E) and not misbranded. The Association presented this recommendation to the Agency in June 28 comments that were in response to a request for information in the December 31, 2003, Federal Register (see January 15 XNL).

In its submission, CHPA stressed that OTC urinary analgesics containing either the ingredients methenamine-sodium salicylate (in combination) or phenazopyridine hydrochloride have been in widespread use without a prescription for decades. These ingredients have long histories of helping consumers who are not yet able to obtain professional medical attention to relieve pain and discomfort associated with urinary tract infections.

The Association stated that, while these drugs were identified as eligible for the OTC Drug Review, the category has not yet undergone an evaluation. CHPA pointed out, however, that FDA has nevertheless reviewed individual OTC urinary analgesic ingredients either for a monograph under another drug category or as part of the drug efficacy study implementation process.

Finally, CHPA encouraged the Agency to closely review the information submitted by individual companies that market OTC urinary analgesics. The Association explained that this information would further prove the extensive history of safe use of these ingredients and that an OTC monograph should be established accordingly.

CHPA contact: Dr. Lorna Totman

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Association supports FHWA's rule on pharmacy signage

CHPA recently conveyed its strong approval of the U.S. Department of Transportation's Federal Highway Administration's (FHWA's) interim final rule permitting pharmacy signs on federal-aid highways. In a June 23 submission to the FHWA, the Association commended the agency for carrying out the rulemaking in line with demographic trends that will make highway travel safer for the American public.

Further to the point, the Association stated that '"the criteria established for eligible pharmacies – that they be open 24 hours a day, have a licensed pharmacist on duty, and be located relatively near to an interchange – are appropriate and serve the best interests of those travelers who are in need of pharmacy services while on the road."

CHPA added that it would encourage all states to take advantage of the new guidance in order to create a nationwide uniformity of such signs.

CHPA contact: David Spangler

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New members elected to CHPA

The CHPA Board of Directors elected one Active and seven Associate members at its June 18 meeting:

Active Member:

POLYMEDICA MEDICA HEALTHCARE INC., Woburn, Massachusetts; Peter Etzel, vice president & general manager, will be the Official Representative (OR). Eligible products, under the Azo brand, include urinary discomfort relief, menopausal hot flash relief, vaginal yeast infection relief, and a cranberry-based dietary supplement to help maintain a healthy urinary tract. 

Associate Members:

THE CAREGIVERS GROUP, INC., Charlestown, Rhode Island, [individual consultant market research, strategic business market consulting]; Paul Alper, president, will be the OR. The Caregivers Advisory Panel is a full-service market research practice with business development consulting services. The Caregivers Marketplace is involved with promotion, advertising, and marketing. 

GMR MEDICAL MARKETING, New Albany, Ohio, [individual consultant, specialized services];  Richard Bauer, managing director, will be the OR. GMR's specialty is design and implementation of proprietary health screenings, wellness programs, and consumer life events in the healthcare arena. 

KLINE & COMPANY, Little Falls, New Jersey, [market research, strategic business market consulting, and specialized services]; Laura Mahecha, industry manager, Healthcare, will be the OR. Kline is an international business consulting firm which also publishes syndicated market analyses. Serving the pharmaceutical industry as well as consumer products, chemicals and other businesses, the company has published a report entitled Nonprescription Drugs USA annually since the 1960s, as well as numerous reports on Rx-to-OTC switch. In addition, Kline has completed many custom consulting engagements for both the Rx and OTC industries. 

THE MARKETING SWOT TEAM, New York City, New York, [individual consultant, market research, strategic business market consulting]; Peggy B. Masterson, chairman, president & chief operating officer, will be the OR. A strategic marketing resource for marketers, planners, and market researchers, the SWOT Team has developed a range of proprietary investigative and analytical methodologies to find differentiating and effective solutions to tough marketing challenges. 

NCI CONSULTING, Lawrenceville, New Jersey, [individual consultant, strategic business marketing consulting]; Susan Lavine-Coleman, president, will be the OR. NCI Consulting helps pharmaceutical and healthcare-oriented consumer product companies maximize sales and profit growth, utilizing proprietary tools in such areas as: competitive strategy development, life cycle planning, business opportunity analysis, decision analysis/optimization, market impact modeling, and market entry maximization. NCI also is a leader in OTC switch strategy development.  

PROVISOR MARKETING, Basking Ridge, New Jersey, [individual consultant, new business development]; Jacqui Green, president, chief executive officer, will be the OR. Provisor specializes in new business development—creating new revenue streams for clients via channels, markets, and business models. From concept to commercialization, the company works with manufacturers and retailers across the consumer goods and services industries to explore, qualify, and open new business. 

CHPA contacts: Ted Peterson and Phyllis Taylor

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The 2004 Market Exchange will be here before you know it

CHPA staff are working diligently to process the registrations pouring in for the 2004 Market Exchange. Because the attendance list is updated online as soon as registrations are processed, members should make it a habit to log in frequently to the Members Only section of www.chpa-info.org to check for the most recent listing. Please remember that in order to be included in the Market Exchange printed attendance book, CHPA must receive registration forms by August 18. 

Table host guidelines

Table host guidelines for the Market Exchange will be sent to attendees in July. These guidelines will include important information such as hosting "do's" and "don'ts," shipping information, a company description form, and a special services order form. The deadline for returning the company description form will be August 18. This 50-word (maximum) description will be included in the attendance book (see information below).

Attendance book

The CHPA Market Exchange Attendance Book, which will include contact information of companies and table hosts, will be handed out to participants at the September 23 event. This information-loaded resource will come in handy not only at the 2004 Market Exchange—recipients will find it useful all year long.
 

_______________________

September 23
Hilton East Brunswick
East Brunswick, New Jersey
________________________

Sponsorship opportunities

Sponsorship opportunities are still available. Contact CHPA's Ted Peterson or Phyllis Taylor for details on potential sponsorships or other issues concerning the 2004 Market Exchange.

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Members use NACDS Marketplace Conference as an opportunity to discuss FSAs, other business

Company reps meet on the future of FSAs

CHPA held several meetings in conjunction with the National Association of Chain Drug Stores (NACDS) Marketplace Conference held June 21-24 in San Diego, California. Representatives from several member companies met the morning of June 23 to discuss current and future initiatives to promote greater use of flexible spending accounts (FSAs) by consumers and employees, as well as the potential of partnering with retail groups.

CHPA members mull over new ideas to further promote FSAs during
 NACDS'  Marketplace Conference in San Diego.

BDC Subcommittee begins program development for November conference

Other Association business during the NACDS event included a June 23 evening meeting of CHPA's Business Development Committee (BDC). BDC subcommittee chairs convened to discuss program plans for this year's Business Development Conference slated to take place November 3-4 in Providence, Rhode Island. BDC Chair Adam D. Raczkowski, executive vice president, chief operating officer, chief financial officer, and general manager, W.F. Young, Inc., worked to develop a vision for the upcoming conference, along with input from International Initiatives Subcommittee Chair Kirk Hodgdon, president/growth catalyst, Bolin Fulcrum; Flex Spending Account Initiatives Subcommittee Chair David Wendland, vice president, Hamacher Resource Group; Marketing Initiatives Subcommittee Chair Randy M. Sloan, senior vice president, Marketing, Del Pharmaceuticals, Inc.; and BDC Immediate Past Chair Gregory C. Pulido, chairman & chief executive officer, Humco Holding Group, Inc.

CHPA strongly represented at NACDS Marketplace

The 2004 NACDS Marketplace Conference held June 21-24 in San Diego, California, brought together drug, food, mass, club, and value retailers which consisted of more than 200 retail companies representing approximately 70,000 stores and 900 manufacturing companies across 13 major categories. The NACDS "Meet the Market" program, specifically designed to give first-time and new product-launch exhibitors the opportunity to meet with retailers, received high-praise from attendees.

CHPA staff Ted Peterson, vice president for corporate development, and Phyllis Taylor, membership and corporate development manager, also participated in the NACDS event in order to meet with numerous CHPA member company executives, as well as with prospective members.

CHPA Board member Dean M. DiMaria, vice president and general manager,
Consumer HealthCare, Boehringer Ingelheim Pharmaceuticals, Inc., meets with clients
 in the conference area of Boehringer's exhibit booth.

CHPA Associate member ACNeilsen sponsored several "Cyber Cafés," scattered throughout the NACDS exhibit hall, so that attendees were able to check their e-mail.

Pharmaceutical Formulations, Inc., the company of CHPA Board member Michael A. Zeher, president, had a high-volume of traffic at its exhibit booth.

CHPA contacts: Ted Peterson and Phyllis Taylor

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CHPA has entered the building

With little more than the typical moving aches and pains, CHPA officially took over its new office residence June 28.

The staff may be contacted via the same e-mail addresses and fax and telephone numbers for the old location.

Stop by and visit us soon at our new location:

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

CHPA contact: Roman Blazauskas

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CFSAN seeks input on its program priorities for '05

FDA announced in the June 24 Federal Register that it is seeking comments for its Center for Food Safety and Applied Nutrition's (CFSAN's) program priorities for fiscal year (FY) 2005. Specifically, the Agency stated that it is looking for input on new program areas or activities to include as high priorities for CFSAN's workplan for FY 2005 (October 1, 2004, through September 30, 2005).

According to FDA, the format of CFSAN's FY 2005 workplan will be similar to that of the 2004 workplan which emphasized eight specific program areas including nutrition, health claims, and labeling. In addition, the FY 2004 workplan separated its planned activities into two lists–the "A-list" and the "B-list"–to further indicate the level of activity's priority.

Comments are due to FDA by August 9. The Agency plans to make the FY 2005 workplan available some time in the fall of 2004.

CHPA contact: Dr. Doug Bierer

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FDA releases revised compliance guide for Bioterrorism Act

FDA announced in the June 29 Federal Register that it has published a revised compliance policy guide entitled Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness Response Act of 2002. The original guide, published December 15, 2003, (see December 23, 2003, XNL), provided guidance to FDA's and Customs and Border Protection's staff on the enforcement of section 307 of the Bioterrorism Act and the Agency's implementing regulations, which require prior notice for all food (including dietary supplements) imported or offered for import into the United States. The guide has been revised to provide staff with additional guidance on how to address such food that is imported or offered for import for noncommercial purposes with a noncommercial shipper.

While the revised guidance is in final form, FDA indicated that it will accept comments on the document at any time.

CHPA contact: Paul Larsen

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It's semi-annual regulatory agenda time again

The Government Printing Office published its Unified Agenda of Federal Regulatory and Deregulatory Actions June 28. The purpose of the agenda is to provide a look at some of the activities government agencies hope to tackle in the next 12 months.

Following are a number of items that concern the OTC and dietary supplement industries:

FDA

Drug safety reporting amendments—comment review on proposed rule ends: 9/04

Drug establishment registration and drug listing amendments—proposed rule: 11/04

Complete response letters for new drug applications (NDAs)—proposed rule: 7/04

Definition of "serious adverse health consequences" under Bioterrorism Act—proposed rule: 7/04

Qualified health claims—proposed rule: 1/05

OTC Review related:

Cough/cold (bronchodilator)—proposed rule (amendment): 9/04

Cough/cold (combination)—proposed rule (amendment): 9/04

Cough/cold (nasal decongestant)

—proposed rule (phenylephrine): 9/04

—proposed rule (phenylpropanolamine): 9/04

—proposed rule (sinusitis claim amendment): 10/04

Internal analgesics

—proposed rule (labeling amendment): 8/04

—proposed rule (pediatric amendment): 9/04

Labeling of OTC drugs—proposed rule (convenience sizes): 8/04

Weight control products—proposed rule (phenylpropanolamine): 9/04

Antiperspirants—final action (partial stay): 9/04

Cough/cold (antihistamines)—final action (common cold amendment): 10/04

Ophthalmics (emergency first aid eyewashes)—final action: 11/04

Skin protectants—final action (technical amendments): 12/04

Vaginal contraceptives—final action (warnings): 11/04

External analgesics—next action undetermined

Laxatives—next action undetermined

Oral health care products—next action undetermined

Dietary supplement Good Manufacturing Practices (GMPs)—final action: 11/04

Records establishment and maintenance under the Bioterrorism Act—final action: 7/04

Food facility registration—final rule: 3/05 (*Note: there is already an interim final rule)

Food import prior notice—final rule: 3/05 (*Note: there is already an interim final rule)

Toll-free number for NDA'd drug adverse event reporting—final action: to be determined

Drug GMP cut labeling requirements—final action: to be determined

Drug Enforcement Administration

Security requirements for handlers of pseudoephedrine, ephedrine, and phenylpropanolomine
     —proposed rule: 6/04

Revision of reporting requirements for imports and exports of Lists I and List II chemicals (to reflect
     exact amounts shipped/received)—proposed rule: 12/04

Definition and registration of reverse distributors—final action: 10/04 (*Note: there is already an interim final rule)

Exemption of chemical mixtures under the DCDCA—final action: 12/04

Consumer Product Safety Commission

Unit dose packaging child-resistant product testing pass/fail criterion—staff briefing package to commission: to be determined

CHPA contact: Dr. Doug Beirer

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WHO publishes guidelines to promote the proper use of alternative medicines

The World Health Organization (WHO) announced that it has released a new set of guidelines to help national health authorities develop specific and reliable information for consumer use of alternative medicines. In a June 22 news release, the organization stated that up to 80 percent of developing country populations rely solely on traditional medicine for their primary healthcare and that all consumers around the globe should be provided with access to appropriate, safe, and effective treatment.

"WHO supports traditional and alternative medicines when these have demonstrated benefits for the patient and minimal risks," said WHO Director-General Dr. Lee Jong-wook. "But as more people use these medicines, governments should have the tools to ensure all stakeholders have the best information about their benefits and their risks," he added.

According to WHO, the new guidelines are not meant to compensate for poor complementary and alternative medicine products or inappropriate practices, but rather, they are intended to help government officials educate consumers on maximizing the benefits and minimizing the risks.

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CHPA staff travel inside the Beltway and beyond

CHPA President Linda Suydam, D.P.A., along with Senior Vice President, General Counsel, and Secretary Eve Bachrach, Vice President, Scientific and Regulatory Affairs Dr. Doug Beirer, Vice President of Government Relations Kevin Kraushaar, and Vice President for Corporate Development Ted Peterson, met at Church & Dwight headquarters in New Jersey June 16 to brief Brad Casper, president, Consumer Care, and members of his senior marketing team, on CHPA's priorities and to discuss ongoing industry issues...

Vice President for Corporate Development Ted Peterson and Membership and Corporate Development Manager Phyllis Taylor attended the NACDS Marketplace Conference June 21-24 in San Diego, California, to meet with current and prospective members (see related story above)...

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FDA offers training materials for GMPs

FDA has developed a series of audio CDs and transcripts to help companies improve internal training programs for good manufacturing practices (GMPs). Effective GMP Training Made Easy is a three-part audio alert series based on an Agency training conference that took place in the spring. The sessions will teach companies how to upgrade internal GMP training programs by establishing realistic objectives and outcomes, determine when retraining is necessary, and provide proven strategies to ensure employees remember and apply what they have learned. More information on the training materials is available at FDANews.com.

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Winston-Salem State University conference to explore health disparities

Winston-Salem State University will present Faces of a Healthy Future: National Conference to End Health Disparities September 27-29 in Winston-Salem, North Carolina. The purpose of the conference is to help create a vision for a healthy future in which all Americans, regardless of race, gender, age, or socioeconomic status, receive quality healthcare. Included in the roster of speakers are U.S. Department of Health and Human Services Secretary Tommy Thompson and National Center on Minority Health and Health Disparities Director John Ruffin. Session topics include cultural competency training, the current state of health disparities at the national, state, and local levels, and cross-cultural education in healthcare professions. For more information, log onto www.fhfconference.com.

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IIR summit to address drug supply chain integrity

The Institute for International Research (IIR) is sponsoring a meeting entitled TRAX 2004 - Pharmaceutical Supply Chain Summit. To be held July 20-22 in Washington, DC, the summit will focus on specific strategies to maintain the efficiency, competency, and integrity of the drug supply chain cycle. The conference will feature a number of speakers from the pharmaceutical manufacturing industry, the retail community, and related healthcare associations. Some of the topics to be discussed include the impact of FDA's barcode mandate, cargo and border security, and the important role of packaging in the supply chain process. For more information, click here.

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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

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