Information Resources sponsors Second General Session at the AEC
CHPA senior leadership, CVS executive, and Harvard academic are featured 

Information Resources, Inc. (IRI), is hosting the Second General Session of CHPA's Annual Executive Conference (AEC), March 17-19, at the Grand Hyatt in Washington, D.C. 

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Register for the AEC during January and receive an early-bird discount. 
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The session will include updates on the state of the Association and priorities for the coming year from CHPA President Linda A. Suydam, D.P.A.; Chairman Richard K. Green (Blistex Inc.); and Chairman-elect Timothy G. Hayes (Bayer Corporation). 

A conversation with Chris Bodine, CVS executive vice president for merchandising and marketing, will add a retailer perspective to the session, including thoughts on supply chain initiatives and trade views on healthcare policy hot spots. Craig Fuller, the president of the National Association of Chain Drug Stores, will moderate the session. 

Rounding out the IRI program will be Harvard Business School professor of business administration, Clayton Christensen. Christensen focuses on management issues in development and commercialization of technological and business-model innovation. His books include The Innovator’s Dilemma and The Innovator’s Solution, penned with Michael Raynor. Both books look at sustaining innovations and biases toward incumbent competitors, but more importantly for future growth potential, the works also delve into what Christensen terms "disruptive technologies" that enable new entrants to a marketplace to achieve success. 

Christensen holds degrees from Brigham Young University, Oxford University, and Harvard Business School. In addition to his teaching and research work, he has consulted widely, co-founded a firm that develops products and processes using high-tech metals and ceramics, and served as an assistant to two different secretaries of transportation.

More information on the conference is available in the Members Only section of the CHPA web site, or by contacting CHPA’s Kass Kassouf or Maria Sarabia.

CHPA contact: Kass Kassouf

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CHPA requests contributions for AEC “favor bags”  With the 2004 Annual Executive Conference (AEC) business program taking shape (See preceding story), the time has come for CHPA to turn its attention to another AEC highlight, the conference "favor bags." A perennial favorite at CHPA’s annual meeting, favor bags are filled with Association member company products and distributed to conference attendees, guests, and speakers. The favor bags are CHPA's way to tangibly demonstrate "who we are and what we do" to our conference participants.  DPT Laboratories has already generously donated the actual tote bags for the 2004 AEC. If you would like your company's products included in this year's tote bags, please contact Maria Sarabia in CHPA's Meetings department.    Back to the top

CHPA participates in NCPO symposium with other national healthcare-related associations

CHPA joined other members of the National Conference of Pharmaceutical Organizations (NCPO) at its 91st annual meeting January 8-10 to discuss issues of interest to the pharmaceutical and pharmacy sectors. The symposium, held in Puerto Rico and chaired by Pharmaceutical Research and Manufacturers of America (PhRMA) President Alan Holmer, specifically focused on the impact of the recent Medicare prescription drug bill and the effects on Canada and the United States of the growing practice of drug importation from Canada. CHPA was represented at the meeting by Association Chairman Richard K. Green; President Linda A. Suydam, D.P.A.; and Senior Vice President, General Counsel, and Secretary Eve E. Bachrach.

Experts from Capitol Hill and industry described the newly minted prescription drug benefit for seniors as a “work in progress,” which will undergo re-analysis and likely amendments as it is implemented. An interim benefit card will become available in June 2004, with the full program slated to kick in January 2006. The new Medicare law also will make OTCs eligible for individuals’ health savings accounts. 

Experts from Canada discussed the phenomenon of drug importation, or “cross border drug trade” with NCPO participants, describing the varying responses from different Canadian provincial governments.  The speakers asserted that Manitoba supports the practice, seeing it as a profit center and creating jobs for its citizens. Other groups, including many Canadian pharmacies and pharmacy associations, have cautioned that selling drugs to Americans diverts both important drug products and pharmacist services from Canadian citizens.

NCPO consists of 10 national pharmaceutical associations, including CHPA; PhRMA; the Cosmetic, Toiletry, and Fragrance Association; the National Association of Chain Drug Stores; the Healthcare Distribution Management Association; and the National Community Pharmacy Association. 

CHPA contact: Eve Bachrach

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Save the date for the 2004 CHPA Business Exchange

Mark your calendars now to attend the September 23 CHPA Business Exchange in the Hilton East Brunswick in East Brunswick, New Jersey. 

The 2004 Business Exchange will be the second edition of this new annual event for the Association. Attendees of the inaugural conference last year were enthusiastic in their praise of this innovative business opportunity:

“Energetic”  
“Sensational”  
“Great conference”
“Great exposure”
“The right people"
“Looking forward to next year!”

Keep reading the Executive Newsletter for registration materials for the 2004 conference.

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CHPA requests additional time to respond to food labeling health claims ANPR

The Association sent a letter January 13 requesting an additional 60 days to respond to FDA's request for comments on its advance notice of proposed rulemaking (ANPR) for food labeling health claims "due to the breadth and extent of the comments requested by the Agency." 

Published November 25, 2003, the ANPR set a two-month deadline for interested parties to respond to three regulatory alternatives outlined by FDA for qualified health claims for foods and dietary supplements, and to provide comments on the strengths and weaknesses of each option. In addition, the Agency asked for suggestions for additional options that may exist for regulating qualified health claims and for perspectives on the many issues raised by the Task Force on Consumer Health Information for Better Nutrition. 

"Given the complexity and implications of the proposed options," CHPA maintained in its letter, "we need additional time in order to adequately assess the implications of each of the proposed regulatory alternatives." The Association hopes FDA will accept comments on the ANPR through March 26.

CHPA contact: Dr. Doug Bierer

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FDA plans to act against ephedra

FDA announced December 30, 2003, that it plans to issue a final rule effectively banning the sale of dietary supplements containing ephedra on the grounds that they pose an "unreasonable risk of illness or injury." On the same day, the Agency issued a consumer alert advising Americans to stop using ephedra products and notified 62 dietary supplement firms of its forthcoming rule. 

"We are going to issue a rule that clarifies and applies a legal standard that that [sic] has never been used before," FDA Commissioner Mark B. McClellan, M.D., Ph.D., stated in press materials that accompanied the announcement. The Agency's final rule on ephedra will assert that dietary supplements containing ephedrine alkaloids "present an unreasonable risk of illness or injury under conditions of use in the labeling" and therefore should be considered adulterated under the Food, Drug, and Cosmetic Act. 

FDA anticipates issuing the rule shortly, and making it effective 60 days after publication. 

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Agency calls for data on certain OTCs

The Agency has requested information on a number of OTC drug products that, until now, have not been reviewed by FDA. Categories included in the call for data are:

• Nasal moisturizer drug products that contain sodium chloride, normal saline, buffered isotonic saline solution, saline phosphate buffer solution, glycerin, or similar ingredients
• Urinary analgesic/antiseptic drug products, including those with phenazopyridine hydrochloride
• Urinary acidifiers and alkalinizers, including those containing ammonium chloride or ascorbic acid, and sodium bicarbonate, respectively
• Aloe vera (for OTC topical antimicrobial and external analgesic drug products) and urea (as an external analgesic drug product or for other OTC drug uses)
• Wrinkle remover products, including products containing alpha hydroxy and beta hydroxy acids
• Lubricants and vaginal moisturizers
• Breast creams (for use when nursing)

The December 31, 2003, Federal Register notice includes a number of additional categories of unreviewed drug products for which FDA would like data. The list is available online, but is not intended to be all-inclusive. The Agency also requests input on identifying additional categories of OTC drug products marketed before the start of the OTC Review on May 11, 1972, or prior to December 4, 1975. 

CHPA contact: Dr. Lorna Totman

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FDA amends pediculicide final monograph

The Agency has revised pediculicide labeling statements as part of its ongoing review of OTC drug products. Announced December 31, 2003, FDA instructs industry to make a number of labeling changes to affected products by June 30, 2005. (The compliance deadline for products with annual sales under $25,000 is January 3, 2006.)

Included in this final rule amending the final monograph is FDA's determination that the term "pediculicide" should be removed from the statement of identity and replaced to read "lice treatment." In addition, FDA has determined that "warnings" should be in the standardized Drug Facts format, and has made a number of other changes to the "directions" and "other information" sections of product labels. 

CHPA submitted comments in August 2002 supporting some of the changes, which had been proposed by FDA on May 10, 2002. In issuing the final rule, the Agency agreed with CHPA that, although essential treatment directions should be on the outer label, detailed directions for environmental control and additional statements described as “other information” could be provided in a package insert.

CHPA contact: Dr. Lorna Totman

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Agency white paper outlines consumer health and safety achievements in 2003

Major industry regulations and risk communications, facing potential terrorist and disease threats, aggressive enforcement against products making false claims, reducing preventable medical errors, speeding consumer access to medicines, and focusing on improving health literacy were all cited in a January 13 FDA white paper as the Agency's major consumer-oriented achievements of 2003. "Protecting and Advancing Consumer Health and Safety" details many of the major programs undertaken by FDA in 2003 and outlines how the Agency plans to expand on these successes in 2004.

Included in the list of FDA accomplishments for 2003 are:

• The proposed rule on dietary supplement good manufacturing practices
• New regulations implementing various parts of the Bioterrorism Act
• Proposal to amend the safety reporting requirements for drugs
• Enforcement initiatives against dietary supplement manufacturers making false claims
• Bar code rule to reduce medical errors in hospitals

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FDA sets its advisory committee calendar 

The Agency published its yearly tentative calendar of upcoming advisory committee meetings December 31, 2003. According to the Federal Register notice, tentative meeting dates in 2004 for the Nonprescription Drugs Advisory Committee (NDAC) will be:

• March (day to be announced)
• June (day to be announced)

FDA has a telephone hotline for the latest information about its advisory committees. For information about NDAC specifically, call (800) 741-8138, and use code 3014512541.  

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Government agencies publish their semi-annual unified agenda

The Government Printing Office has once again published its Unified Agenda of Federal Regulatory and Deregulatory Actions. The agenda is intended to provide a projection of what actions various government agencies anticipate accomplishing over the next 12 months. 

Following below are a number of items that may be of interest to the OTC and dietary supplement industries. 

FDA

OTC Review related:

Antidiarrheal products—travelers diarrhea—final action (amendment): 4/04

Cough/cold (antihistamine) products—final action (amendment): 4/04

Cough/cold (bronchodilator) products—proposed rule (amendment): 6/04

Cough/cold (combination) products—proposed rule (amendment): 6/04

Cough/cold (decongestant) products—proposed rule (phenylephrine): 4/04

—proposed rule (sinusitis claim amendment): 6/04

Internal analgesic products—proposed rule (labeling amendment): 4/04

—proposed rule (pediatric): 4/04

Labeling of OTC drugs—proposed rule (convenience sizes): 2/04

—proposed rule (sodium labeling): 2/04

—final action (sodium labeling): 2/04

—final action (cation labeling): 2/04

Pediculicide products—final action (labeling amendment): 2/04 [See related story.]

Skin protectant products—final action (technical amendment): 12/03

Sunscreen products—advance notice of proposed rulemaking (insect repellant combinations): 4/04

Sunscreen products—proposed rule (UVA/UVB): 4/04

Vaginal contraceptives—final action (warnings): 6/04

Food Good Manufacturing Practices (GMPs) in Part 110—end review: 12/03

Health claims (qualified health claim approaches)—next action undetermined 

Establishment registration and listing for drugs—proposed rule: 3/04

Complete response letters rather than approval/not approvable letters for new drug applications (NDAs)—proposed rule: 5/04

Use of materials from bovine and ovine animals—proposed rule: 3/04

Toll-free number for reporting adverse events in NDA drug labeling—proposed rule: 3/04

Safety reporting requirements for drugs—end of comment review on proposed rule: 9/04

Supplements and other changes to an approved application (for chemistry and manufacturing changes) —final action: 1/04

Dietary supplement GMPs—end of comment review on proposed rule: 1/04

Bar coding for drugs—final rule: 1/04

Administrative detention of food under Bioterrorism Act—final action: 3/04

Record establishment and maintenance under Bioterrorism Act—interim final rule comment period reopened: 3/04

Prior notice of food imports under Bioterrorism Act—interim final rule comment period reopened: 3/04

Drug GMP cut labeling controls—final action: 9/04

Drug Enforcement Administration

Security requirements for handlers of pseudoephedrine, ephedrine, and PPA—proposed rule: 2/04

Definition and registration of reverse distributors—final action: 3/04

Consumer Product Safety Commission

Test method for determining applicability of cautionary labeling and child resistant packaging to hydrocarbon-containing sprays—staff briefing package to commission: to be determined

Petition to amend child-resistant testing pass/fail criterion for unit dose packaging—staff briefing package to commission: to be determined

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CPSC provides refresher on the Poison Prevention Packaging Act

The U.S. Consumer Product Safety Commission (CPSC) will be holding a one-day seminar March 24 in Bethesda, Maryland, on "Understanding the Poison Prevention Packaging Act." CPSC staff will discuss the act, the effectiveness of child-resistant packaging, packaging issues, and the regulation development process. There also will be breakout sessions that will cover areas of interest to participants. Topics may be selected by registrants, and may include such issues as unit packaging and child-resistant and senior adult use effectiveness testing. The seminar will conclude with a Q&A session.

The event is open to the public and free of charge. Contact John Boja or Suzanne Barone at the commission for more details or to register.  

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Netherlands considers allowing all OTCs in any outlet

As part of an update of its Medicines Law, the Dutch Ministry of Health in December 2003 proposed allowing all nonprescription medicines to be available in all retail outlets. Prior to this, the Netherlands had restricted the sale of such medicines to pharmacies only. “These medicines are available without a doctor’s prescription, do not require medical surveillance, and are safe under normal conditions of use,” said a ministry statement. “The obligatory intervention of a druggist is not required. The government finds it no longer appropriate to grant druggists a legal monopoly on the sale of self-medication medicines as this is a normal economic activity.”

Commenting on proposals, the Dutch OTC association, Neprofarm, noted that “expert advice is important to many consumers to make a sensible choice. However, it is up to the individual consumer to decide whether or not advice is needed. This is one of the factors determining his/her choice of outlet in which to buy a self-medication medicine.”

CHPA contact: David Spangler

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2004 CHPA member dues deadline reminder 

CHPA member dues statements for the year 2004 were sent out November 20, 2003. Dues for Active members should be calculated on total net sales of OTC and dietary supplement products. For advertising agency members, dues should be calculated on total billings for these products. All Active and Associate member dues payments are due by January 31. Payments not received by February 29 are subject to a one percent per month late fee. Please note: Annual Executive Conference registration confirmations will be provisional until member dues are paid.

If you have not received your statement or if have questions, please contact CHPA’s Roman Blazauskas or Hyacinth Fray via e-mail or at (202) 429-9260.

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

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

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