Association News

CHPA and CADCA host Capitol Hill reception

CHPA and the Community Anti-Drug Coalitions of America (CADCA) hosted a reception January 12 on Capitol Hill in conjunction with CADCA's National Leadership Forum. The event, part of CADCA’s Capitol Hill day, provided CHPA and CADCA members with an opportunity to meet with congressional representatives and staff to discuss policy and legislation that promotes community anti-drug abuse measures. The reception was attended by 400 CADCA volunteers and also included representatives of the Bush Administration.

During his remarks at the reception, CHPA’s Vice President of Government Relations Kevin Kraushaar thanked CADCA for its leadership on Capitol Hill and acknowledged the Kansas Meth Watch program for its work in educating retailers about the diversion of chemicals used in the illicit manufacture of methamphetamine. 

CHPA and CADCA will continue theirjoint efforts to lobby Congress in support of additional funding for demand reduction, education, and treatment of substance abuse. 

CHPA contact: Kevin Kraushaar |  Back to the top


AEC concurrent sessions focus on obesity and the retail delivery of healthcare solutions

CHPA's Annual Executive Conference (AEC), set for March 10-12 at the Fairmont Turnberry Isle Resort & Club in Aventura, Florida, promises to provide something of interest to all Association members. In the AEC spotlight this week are the meeting's March 11 concurrent sessions.

The cause and effect of obesity in the United States

According to the U.S. Centers for Disease Control and Prevention (CDC), there has been a dramatic increase in obesity in the United States over the past 20 years. The CDC emphasizes that this alarming rise also heightens the risk for such diseases or conditions as high blood pressure, high cholesterol, diabetes, and a number of heart diseases, among others. An AEC concurrent session will explore what government and the business community can do to help address the causes and consequences of obesity.

During the session, a panel of experts will lend its perspectives on this important topic. Among the panelists is Lisa Katic, a registered dietitian and spokesperson with the American Council for Fitness and Nutrition. Katic specializes in food policy, communications, and education with her firm K Consulting.

Juliet Seifert, executive director, Australia Self-Medication Industry, will moderate the session. Seifert has a wealth of association and industry experience and focuses on fostering the acceptance and understanding of the role of nonprescription medicines in community health. 

Retail pharmacies' role in healthcare delivery solutions

Running concurrently with the obesity session will be a panel discussion on innovations in the retail delivery of healthcare solutions. How can retail pharmacies better position themselves as places that deliver healthcare more than places where medicines are dispensed and sold? Anthony Civello, Kerr Drug, Inc., and chair-elect of the National Association of Chain Drug Stores, will discuss how Kerr is working to translate this question into concrete action.

Joining Civello on the panel is Linda Whitman, CEO, MinuteClinic. Staffed by nurse practitioners or physician assistants, MinuteClinics are located in mass merchandisers or large groceries and offer services at a low-set cost without an appointment.

Moderating the panel is Wendy Liebmann, president, WSL Strategic Retail, who provides marketing and retail advice to clients on marketing strategies that impact the consumer at retail.

AEC first and second general session sponsors—Information Resources, Inc. (IRI), and Cargill Health & Food Technologies (Cargill)—met with CHPA staff January 19 to finalize the business program for the meeting. Front row from left: Stephen C. Johnson, IRI; Ted Ziemann, Cargill; and Linda Suydam, CHPA. Back row from left: Ted Peterson, CHPA; and David Spangler, CHPA.

For more information on AEC 2005, download a copy of the AEC program brochure and registration information. Members also may register online in the Members Only section of CHPA's web site. For hotel reservations, visit www.fairmont.com/tir/chpa.

CHPA contacts: Kass Kassouf and Maria Sarabia |  Back to the top


FDA helps consumers get through cold and flu season

There’s no doubt about it. It’s cold and flu season. With children getting an average of six to 10 colds a year, FDA has drafted a quick primer for parents. “Spotlight on Consumer Health: Getting Through Cold and Flu Season” provides information to help parents:

• Tell the difference between a cold and the flu,

• Take precautions to keep their children health this winter, and

• Understand a few pointers regarding treatment options.

According to FDA Public Affairs Specialist Patrick E. Clarke, M.Ed., the flu generally is “worse than the common cold, and symptoms such as fever, body aches, extreme tiredness, and dry cough are more common and intense,” while “people with colds are more likely to have a runny or stuffy nose.” Clarke specifically cautions parents that antibiotics are ineffective when treating colds.

The “Spotlight on Consumer Health” is available on CHPA’s web site in the consumer section. More information about children and medicines also is available in Kids Aren’t Just Small Adults, a publication developed by CHPA and FDA. A Spanish-language version of the brochure is available online for download, as well.

CHPA contact: Mimi Pappas |  Back to the top


Meth Watch Program Update

CHPA holds Meth Watch workshop at CADCA's National Leadership Forum

Responding to an ever-growing interest among states that would like to implement a Meth Watch program, CHPA was pleased to provide an overview of Meth Watch during a pre-conference workshop at the Community Anti-Drug Coalitions of America's (CADCA's) National Leadership Forum January 10 in Washington, D.C. Virginia Cox, CHPA's vice president of communications and strategic initiatives, was joined by Cristi Cain, project coordinator for the Kansas Methamphetamine Prevention Project, and Steve Bundy, sheriff of Rice County, Kansas, to provide insight and lessons learned from Kansas' creation and implementation of the program.

The workshop, which featured an overview on the scope of the methamphetamine problem in the United States, as well as a framework for implementing a Meth Watch program, was attended by over 40 individuals representing 23 states. During a question and answer period, participants were provided with additional recommendations on how to become effective leaders in the fight against meth. Cain emphasized this theme throughout her discussion, pointing out that one of the keys to success is having people dedicated to addressing the methamphetamine issue in their community.

CHPA launched the national Meth Watch program in June 2004. The program is based on the Kansas model and provides interested states with the resources and know-how to implement Meth Watch in their communities. More information can be found at www.MethWatch.com.

CHPA contact: Elizabeth Assey |  Back to the top


CHPA on the Road

CHPA staff travel inside the Beltway and beyond

CHPA Vice President of Government Relations Kevin Kraushaar attended a congressional policy retreat January 14-15, sponsored by the Ripon Society, where he participated in healthcare policy discussions with Senator Orrin Hatch (R-Utah), Senator Chuck Grassley (R-Iowa), and Congresswoman Nancy Johnson (R-Conn.), among others...

CHPA Vice President of Corporate Development Ted Peterson and CHPA Vice President–International and Assistant General Counsel David Spangler traveled to Durham, North Carolina, January 13 to visit with Anthony N. Civello, chairman, president, and CEO, Kerr Drug, Inc., and a team of six senior Kerr executives, to discuss the company's innovations in healthcare and its participation in CHPA's Annual Executive Conference March 11... 

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Industry News

OTC Issues

FDA advisory committees recommend against the switch of lovastatin

A January 13-14 joint meeting of FDA's Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolism Drugs Advisory Committee culminated in a recommendation to FDA against the Rx-to-OTC switch of 20 mg. lovastatin to help lower low density lipoproteins (LDL), or "bad" cholesterol. In a 20-to-three vote, committee members expressed concern that the large actual use study did not support the premise that consumers can self-select whether the product is appropriate for them to use without first consulting a qualified healthcare professional.

During the two-day meeting, the advisory committees unanimously agreed that 20 mg. lovastatin is effective in lowering cholesterol in the proposed OTC target population, that no liver function testing is necessary either before or during use, and that the risk of potential muscle toxicity is acceptable for an OTC drug. Because lovastatin is considered "Category X" for pregnancy, however, committee members expressed concern about its potential for use in women of child-bearing age and called for further improvements in labeling.  
Had the advisory committees voted in favor switching lovastatin to OTC status, it would have been the first such switch of an OTC medicine for the treatment of a chronic, asymptomatic condition.

CHPA contact: Dr. Doug Bierer |  Back to the top


Draft guidance explains OTC labeling requirements

FDA announced in the January 13 Federal Register the availability of a new draft guidance entitled Labeling OTC Human Drug Products—Questions and Answers. According to the Agency, this new draft document was created to help manufacturers, packers, and distributors of OTC medicines comply with FDA's standardized content and format requirements for OTC labeling. The draft guidance includes several examples of labeling with various format and content features and suggests how the information should be finalized before it is converted to the new format. Comments on the draft guidance are due to FDA by March 14.

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Dietary Supplement Activities

IOM holds public briefing on CAM in the United States

The Institute of Medicine (IOM) held a public report briefing January 12 on complementary and alternative medicine (CAM) in the United States. One of the IOM's findings is that dietary supplements are among the most widely used and increasingly used forms of CAM. The IOM committee advocated that the same general research methods and principles should be applied to conventional and CAM treatments in the evaluation of efficacy. Furthermore, although the committee acknowledged that the Dietary Supplement Health and Education Act of 1994 (DSHEA) has yet to be fully implemented, it recommended that Congress and interested parties, including industry, amend the act to implement manufacturing quality-controls standards, to improve consumer protection, and to create incentives for research on product efficacy. Implementation of any of the recommendations listed in the IOM report will depend on the educational, legislative, and regulatory entities charged with the various tasks. 

To order a pre-publication copy of the IOM report, click here.

 CHPA contact: Dr. Marcia Howard |  Back to the top


CFSAN gives itself an "A"

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published its report card for 2004 January 18. According to center Director Robert E. Brackett, Ph.D., CFSAN completed 93 percent of its "A" list goals last year, demonstrating the center’s commitment to focus its resources on where it can “provide the most benefit to American consumers.” Of particular importance, according to Brackett, were CFSAN’s work on the nutrition program, product safety, and ephedrine alkaloids, as well as efforts related to food defense (formally food security).

Regarding nutritional supplements specifically, the report card highlights how CFSAN either filed or responded to nearly 100 75-Day New Dietary Ingredient Notifications last year, received almost 2,000 30-Day Nutrient Content/Health Claim Notifications, drafted a guidance for industry on “Substantiation for Dietary Supplement Claims,” and took numerous enforcement actions.

Among the 2004 goals carried over into fiscal year 2005 is the publication of a final rule on good manufacturing practices (GMP) for nutritional supplements. CHPA has urged the center to make the publication of the GMP rule one of its highest priorities. 

CHPA contact: Dr. Marcia Howard |  Back to the top

Federal Agency Update

Heuer named chief financial officer of FDA

FDA announced in a January 12 news release the appointment of Kathy Heuer as the Agency's chief financial officer and associate commissioner for management. Heuer comes to FDA from the U.S. Department of Health and Human Services, where she most recently served as the deputy assistant secretary for performance and planning in the Office of Budget, Technology, and Finance.

In her new role at FDA, Heuer will oversee the Offices of Acquisitions and Grants Services, Executive Operations, Financial Management, Human Resources, Information Resources Management, Management Programs and Real Property Services, and the White Oak consolidation program. She replaces Jeffery M. Weber, who recently announced his retirement from the Agency after 35 years of service.

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International Perspectives

UK Department of Health report supports self-care

A January 12 report released by the United Kingdom's (UK's) Department of Health highlighted self-care as a key building block for a patient-centered health service. The authors of the report, entitled Self Care – Real Choice: Self Care Support – A Practical Option, state that research shows that supporting self-care can improve health outcomes, increase patient satisfaction, and help in deploying the biggest collaborative resource available—patients and the public.

The report points to the desire for more information, choice, and control for health; the ability to successfully self-treat a number of ailments without a doctor visit; and a range of existing training or support programs as the basis for its conclusions.

CHPA contact: David Spangler |  Back to the top


In Brief
 

2005 CHPA member dues reminder CHPA member dues statements for 2005 were sent out December 1, 2004. Dues for Active members should be calculated on total net sales of OTC and nutritional 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, 2005. Payments not received by February 28, 2005, are subject to a one percent per month late fee. Please note: 2005 Annual Executive Conference registration confirmations will be provisional until member dues are paid. If you have not received your statement or have questions, please contact CHPA’s Roman Blazauskas or Hyacinth Fray via e-mail or at (202) 429-9260.

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EduQuest boot camp teaches how to comply with FDA regulations

EduQuest, in cooperation with FDANews, is hosting a compliance boot camp February 7-11 in San Diego, California. This four-and-a-half day training session features the following three courses: 1) Effectively Responding to FDA 483s, 2) Introduction to Systematic Risk Management, and 3) FDA Auditing of Computerized Systems and Part 11. Boot camp instructors will explore a number of issues such as what FDA looks for during facility inspections, how the enforcement process works, and how to perform a computerized system validation. For more information or to register, visit http://www.fdanews.com/images/ads/Compliance%20Agenda%20111604.pdf.

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IPEC Americas conference examines the marketability of excipients

The International Pharmaceutical Excipients Council of the Americas (IPEC Americas) is holding a regulatory affairs conference February 28 - March 1 in Arlington, Virginia. The meeting program focuses on regulatory issues impacting excipients in both the United States and Europe. Topics to be discussed include the expansion of FDA's inactive ingredient database, current U.S. anti-counterfeiting and bioterrorism initiatives, and the evolution of current good manufacturing practice standards in the global marketplace. For additional information on this event, visit www.ipecamericas.org.
http://www.ipecamericas.org/public/2005_regulatoryaffairsconference.html.
 

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