CHPA wants your Market Exchange "top prospects"

Now in its second year, CHPA Market Exchange is shaping up to be one of the most popular and highly anticipated Association meetings of the year. The inaugural 2003 conference sold out, and CHPA Active members already are registering for the 2004 event to ensure their companies are represented. The popularity of CHPA Market Exchange stems from the full day of direct and focused interaction between Active and Associate members it provides. It's a business-building conference designed by and for CHPA members exclusively.

With Active member participation promising to be excellent, Associate members are urged to register immediately for a table. Associates also must return their Top Prospects Form to CHPA by May 1 in order for the Association to pre-arrange appointments with Active members.

Following the timeline below will ensure members can take full advantage of the 2004 CHPA Market Exchange:

May 1:              Top Prospects Form due to CHPA

May 25:            CHPA will send table hosts and Active Official Representatives appointment schedules and a list of topics to be discussed

June 15:            Point-person contacts for appointment assignments due to CHPA from Active members

August 18:        Registration cut-off date for inclusion in printed registration booklet

August 27:        Hotel room block cut-off date

September 2:    Registration refund cut-off date (substitutions permitted)

Visit the Members Only section of www.chpa-info.org for more information about this important, members-only conference or to register online. For hotel reservations, contact the Hilton East Brunswick directly at (732) 828-2000 or (800) 445-8667.

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Larsen joins CHPA as assistant general counsel

Paul Larsen joined the CHPA Legal department staff as assistant general counsel April 1. He will be working on a broad range of CHPA legal and policy issues, including adverse event reporting for monograph OTCs; providing contracting, legal, and regulatory support for many of the Association’s task groups and conferences; working with the CHPA Government Affairs Committee; and preparing CHPA comments on regulatory proposals from FDA and other agencies. Larsen also will provide legal support to the Association’s Logistics Steering Committee and Business Development Committee.

“Paul is a welcome addition to CHPA’s Legal department,” said CHPA President Linda A. Suydam, D.P.A. “His background as a food and drug lawyer will allow him to hit the ground running in his work for CHPA’s membership.”

A practicing food and drug lawyer for several years at Washington, D.C., law firms, Larsen was most recently with McDermott, Will & Emery. Larsen also served in the general counsel’s office of then Governor (now U.S. Senator) Zell Miller of Georgia, and as a judicial law clerk in the U.S. District Court for the Northern District of Texas. Larsen is a graduate of Harvard University and Vanderbilt University School of Law.

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CHPA offers comments on TEA guidance

“We are encouraged that the Agency is seeking to provide guidance on how to utilize the [time and extent application, or TEA,] process,” wrote CHPA in comments to FDA March 31. “We are also encouraged by the fact that the Agency has acted on TEAs and has published notices of eligibility for ingredients and conditions based on TEA submissions.” However, the Association repeated previous statements reproving the “lengthy, difficult, and unnecessary steps” required by the TEA approach.

TEAs provide a two-step process for interested parties to add a new condition to an OTC drug monograph. First, applicants must submit data to demonstrate to FDA that a product has been marketed "to a material extent" and "for a material time," either under a new drug application or abroad. Second, following verification of those criteria, FDA then would follow its call for data, and proposed and final rule process to amend an affected monograph to include the new condition or to create a new monograph. To date, only two Federal Register notices have been published calling for data following successful TEA determinations: The first was on July 11, 2003, in which FDA published a notice in response to three separate TEAs on three sunscreen ingredients and the second was on February 18 for data on a dandruff-control ingredient. No ingredient that has been the subject of a TEA has yet made it to the proposed or final rule stage.

According to CHPA, “A less complicated, less unwieldy approach to TEAs would allow a more vibrant and more readily used mechanism to incorporate new conditions into the OTC Review. A threshold review of eligibility for foreign-marketed OTC drugs . . . would have provided such a mechanism.” The Association continued that “there is no need for FDA to make a material time/extent determination separately from its consideration of safety and effectiveness.” CHPA issued its comments in response to a draft guidance from the Agency published February 10.

CHPA contact: David Spangler

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IOM publishes framework for dietary supplement safety evaluation

The Institute of Medicine (IOM) and the National Research Council of the National Academies released a report April 1 on a framework for evaluating the safety of dietary supplements. The report, prepared in a study requested and sponsored by FDA, describes a process for the Agency to identify ingredients that may be unsafe, prioritize them according to the level of risk they may pose, and evaluate them for safety. The recommended process has three major components: signal detection, initial review of the signal, and integrative evaluation. Four categories of data were specified for evaluations determining potential for serious harm: human data, animal studies, in vitro experiments, and information on related substances. The expert committee that wrote the report devised guiding principles for evaluating those data to determine unreasonable risk. The committee also prepared six prototype monographs as examples of integrative evaluations.

Copies of the report are available for purchase from the National Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313; or www.nap.edu. An electronic copy can be viewed at http://www.nap.edu/books/0309091101/html/.

CHPA contacts: Dr. Doug Bierer and Dr. Lorna Totman

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Legislation against steroid-like products moves forward

A measure that would broaden the federal classification of anabolic steroids is quickly moving through the legislative process, fueled by recent media attention surrounding the use of supplements by professional athletes. The House of Representatives' bill, H.R.3866, was approved unanimously by the House Judiciary Committee March 31 and could be on the House floor as early as the week of April 19. A companion Senate bill, S.2195, is expected to be considered by the Senate Judiciary Committee by the end of the month. Both bills broaden the definition of “anabolic steroid” to include any supplement that is “chemically and pharmacologically related to testosterone.” The bill specifically names 50 substances, including androstenedione. CHPA, along with four other dietary supplement trade associations, has publicly expressed support for the legislation.

CHPA contacts: Kevin Kraushaar and Amber Thyson

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Republicans fail to push tort reform forward in the Senate

Senate Republicans were once again unsuccessful this week in moving their tort reform agenda forward, failing to secure the 60 votes necessary to require a floor vote on legislation that would limit medical liability. The bill, the Pregnancy and Trauma Care Access Protection Act of 2004 (S. 2207), spearheaded by Senators Judd Gregg (R-N.H.), John Ensign (R-Nev.), and Majority Leader Bill Frist (R-Tenn.), includes a Government Standards Defense for FDA-regulated products supported by CHPA. If enacted, the bill would disallow punitive damages against a manufacturer, distributor, supplier, or seller of a medical product used in direct connection with obstetrical or gynecological services as well as emergency or trauma care services, when such a medical product was subject to pre-market approval or clearance by FDA, or when it is generally recognized as safe and effective pursuant to conditions established by FDA.

Republicans indicate they plan to try to force a vote on the issue every few months.

CHPA contacts: Kevin Kraushaar and Amber Thyson

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FDA announces public meeting on Part 11

FDA announced April 8 that it will host a public meeting in Washington, D.C., June 11 to discuss various topics relating to the regulations on electronic records and signatures in Part 11. The meeting is to solicit information to help the Agency in its re-evaluation of Part 11. FDA is reviewing the regulations in order to:

• Prevent unnecessary controls and costs
• Clarify the scope of the rule
• Ensure that Part 11 provides an adequate level of record security, authenticity and integrity, while encouraging innovation.

Specifically, the Agency is looking for industry input on the scope of the rule, risk-based approaches, validation, audit trails, record retention, record copying, and legacy systems.

CHPA contact: Fred Razzaghi

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NCCAM plans strategic planning stakeholder forum

The National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health will host a Strategic Planning Stakeholder Forum on its second five-year strategic plan. NCCAM is seeking public input on opportunities, challenges, and areas to research. The meeting will take place in Seattle, Washington, April 19, from 1:00 to 5:00 p.m. To learn more about NCCAM’s strategic planning or to register for the forum, visit NCCAM online.

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CHPA to address consumer access at WSMI Beijing conference

CHPA President Linda A. Suydam, D.P.A., will chair a session on access to self-medication at the upcoming World Self-Medication Industry (WSMI) Asia Pacific Regional Conference. The conference, scheduled for October 26-29 in Beijing, China, will have the theme “From the past to the future: opportunities in responsible self-medication.”

With a special but not exclusive focus on the host country, China, the conference will include a number of sessions to examine some of the social, public health, political, and economic forces that encourage people to take more responsibility for their own healthcare and increase the status of self-medication. More specifically, sessions will look at the regional drivers of change in self-medication in the Asia Pacific; key recent and prospective developments in the regulation of nonprescription medicines in the region; an overview of insights and attitudes among consumers in the region, and China specifically; exploring better opportunities for access to self-medication; communication and education; and alternative healthcare approaches.

Still in development are optional business appointment opportunities and side trips to Shanghai or Yunnan, areas with a strong pharmaceutical presence.

WSMI's regional conference is a must-attend opportunity for companies with business interests in China or those looking to explore the possibilities there. More information about the conference is available online.

CHPA contact: David Spangler

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Associate science director and regulatory affairs manager sought

A West Chester County, New York, CHPA member is seeking applicants for two open positions:

• Associate Director, Scientific Affairs: Candidates for this position should possess a doctorate and be an experienced researcher in the areas of diabetes, cardiovascular disease, obesity, or other metabolic diseases. This position will be responsible for reviewing scientific publications, medical editing of abstracts and other materials, writing articles for publication in peer-review medical journals, analyzing clinical study results to support marketing, and presenting and appearing at scientific conventions and national trade shows. Candidates must have a minimum of five years of experience in the field, and possess excellent presentation skills, a network of industry and academic contacts, have published in peer-reviewed journals, and great verbal and written skills.
• Regulatory Affairs Manager: Candidates must have at least three years of regulatory experience, including knowledge of and experience with FDA and the Federal Trade Commission. Overall responsibilities for this position include managing regulatory aspects of projects and products, including the preparation of regulatory submissions such as new dietary ingredient applications, health claim petitions, and labeling claim submissions for both domestic and international regulatory agencies; acting as a direct liaison with regulatory authorities to facilitate the prompt review and approval of applications; and, if desired, serving in a lobbying capacity in Washington. The regulatory affairs manager will help assure that the company is in compliance with all U.S. and international regulatory requirements, and will interface directly with governmental regulatory personnel including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications and conduct presentations as required; interpret existing or new regulatory requirements as they relate to company products and clinical trials; and review and advise on labeling, product claims, or marketing programs. Requirements include the minimum of a B.S. or M.S. in a science-related field or a J.D. specializing in regulatory or food law. European Marketing Authorization experience is a plus, as is experience in nutrition and dietary supplements. Candidates must possess excellent presentation, communication, and analytical skills, and be able to travel when necessary.

For more information, visit CHPA’s members-only Job Board in the Members Only section of www.chpa-info.org or e-mail Nancy Hutter.

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NACDS readies for annual meeting

The National Association of Chain Drug Stores (NACDS) is gearing up for its 2004 annual meeting, April 17-21, in Scottsdale, Arizona. More than 2,200 business leaders from the drug, food and mass merchandising companies and their suppliers are expected, including CHPA President Linda A. Suydam, D.P.A.; CHPA Vice President of Corporate Development Ted Peterson; and CHPA Vice President for Communications and Strategic Initiatives Virginia A. Cox. The meeting will offer a format that enables attendees to strengthen relationships, discuss strategic issues, and identify enhanced business opportunities. NACDS has more information about its conference on its web site.

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University of Wisconsin offers GMP course in Vegas

The Department of Engineering Professional Development of the University of Wisconsin-Madison is offering a course on “Good Manufacturing Practice (GMP) for Regulated Consumer Products” April 19-20. The workshop will cover the quality system, the quality control unit, facilities and equipment, material controls, production systems, packaging and labeling, and laboratory control systems. The course will take place in Las Vegas, Nevada, and will focus on OTCs, cosmetics, sunscreens and other skin treatments, and dietary supplements. More information on this course is available online.

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

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