Association News

CHPA weighs in on proposed "behind-the-counter" nonprescription drugs
Association says current laws offer flexibility for Rx-to-OTC switches

CHPA presented at FDA's November 14 public meeting to solicit public views and input on proposed  "behind-the-counter" nonprescription drugs. The association also issued a statement that summarized its comments at the meeting.

In the statement, CHPA President Linda A. Suydam, D.P.A., pointed out that the association has been a longtime advocate for expanded access to nonprescription medicines and has made every effort to empower consumers with tools and information so that they may make appropriate decisions for OTC use. On the topic of Rx-to-OTC switch, Suydam noted that there has been a significant increase in the number of successful switches across a wide range of therapeutic categories which has benefitted millions of patients. "In itself, this is ample evidence that our current regulatory system allows for safe, expanded consumer access to medicines," she said.

Suydam explained that because flexibility is built into the existing framework, sponsors are provided with the opportunity to work with FDA to design the appropriate tools to address any challenges to a particular medicine. She cited the informational and support strategies for the Rx-to-OTC switches of nicotine replacement therapy (NRT), orlistat, and levonorgestrel as examples of how these tools add value and provide safeguards in the selection or use of these switched medicines. "Like all things, the switch from prescription drug to over-the-counter status has its share of challenges," she acknowledged, "but based on these switches, we have concrete examples of success."

Finally, Suydam reiterated CHPA's belief that existing statutory and regulatory laws offer sufficient flexibility for companies and FDA to explore new or different approaches to moving Rx products to OTC status. "We are committed to providing innovative solutions to enhance consumer access to OTC medicines," she said.

CHPA's slide presentation by David Spangler, senior vice president, policy & international affairs, from the November 14 FDA meeting is available online.

FDA's written comment period on the meeting remains open until November 28.

CHPA contacts: David Spangler and Elizabeth Funderburk | Back to the top


Fifteen new members are elected to CHPA

CHPA is pleased to announce that a record 33 companies have joined the association this year. Fifteen of these members―five Active and 10 Associate―were elected by the board of directors at its November 15 meeting in New York City:

Active members:

Alaven Pharmaceutical LLC, Marietta, Georgia; Connie Swanson, vice president, sales & marketing, will be the primary contact. Alaven Pharmaceutical is a privately-held specialty pharmaceutical company that develops and markets Rx and OTC products that treat women's health issues, as well as gastroenterological and anemia conditions. The company's OTC products are UniFiber and CystoProtek.

Carma Laboratories, Inc., Franklin, Wisconsin; Michael R. Pietsch, vice president, sales & marketing, will be the primary contact. Incorporated for 70 years, Carma Laboratories manufactures Carmex Lip Balm, Lanex Ointment, and Am-Ren Ointment, which are sold through retail, C-stores, and alternative channels. Carma products are available nationwide at major retail outlets and web sites.

G.H.C. Group, LLC, San Antonio, Texas; Sonya Dawson, vice president, will be the primary contact. G.H.C. owns Blue Star Ointment, a topical analgesic designed for the temporary relief of symptoms associated with jock itch, ringworm, psoriasis, and tetter. The company formerly held membership as Quaker House Products, Inc.

NextWave Pharmaceuticals Inc.; Vernon Hills, Illinois; Mahendra G. Shah, chief executive officer, will be the primary contact. NextWave produces MyKidz Iron, MyKidz Iron with Fluoride, and MyKidz Iron-10. NextWave Pharmaceuticals is currently developing a broad line of products across several therapeutic areas.

Dr. Reddy's Laboratories, Inc., Charlotte, North Carolina; John R. Segura, senior director marketing OTC, will be the primary contact. Dr. Reddy’s produces naproxen sodium, ranitidine, famotidine, and certirizine on a contract-manufacturing basis. Dr. Reddy’s is a vertically integrated pharmaceutical company with a presence in over 100 countries and is one of the leading global generic pharmaceutical companies by revenue.

Associate members:

About.com, New York, New York, [online/Internet service provider]; Kim Huey-Steiner, strategic sales director, will be the primary contact. About.com is one of the 15 most visited web sites in the United States. The site is created by a network of guides who have expertise and credentials in their respective fields. About.com:Health is one of the top health resources on the Internet and a destination for consumers who are seeking information on managing all aspects of their health.

BusinessWeek, New York, New York, [print media]; Cindy Pabst, account manager, will be the primary contact. BusinessWeek, a McGraw-Hill publication, was established in 1929. Since that time, the magazine has strived to produce a publication of the highest caliber and integrity and to present journalism based on accurate information which is honestly gathered and fairly presented.

Dragon Rouge, New York, New York, [media service bureau]; Eric Zeitoun, president, will be the primary contact. The company was founded in 1984 with the mission of establishing a design firm that would balance strategic discipline with inspired creativity. Over its 20 year history, Dragon Rouge has become the world's largest independent branding and design consultancy, with links to professional teams in Paris, London, Warsaw, and Hamburg. The firm previously held membership from 2004-2006 with a different management team.

Evincii, Inc., Mountain View, California, [specialized service]; Roger Bertman, vice president marketing, will the the primary contact. Evincii PharmAssist™ is an in-store advisory search engine that helps consumers locate OTC medicines and dietary supplement products that meet their precise needs. The service includes cross-selling of products to enhance treatment of consumers' symptoms and conditions.

GTL Sales & Marketing, Chicago, Illinois, [sales, marketing, & retail merchandising]; Gary Longstein, president, will be the primary contact. GTL Sales & Marketing provides focused solutions for small brands in the areas of sales, trade, and consumer marketing. Positioned against healthcare, the company launched and managed a variety of small brands in food, drug, and mass market retails outlets. GTL's integrated approach at each step ensures a product launch culminates in a successful and profitable end result for both the retailer and the manufacturer.

Linkwell Communications, Dover, Massachusetts, [marketing & strategic business services]; Ben Gardner, president, will be the primary contact. Linkwell Communications is a marketing services company that sells condition-specific advertising. Linkwell partners with health plans to create unique and efficient access to consumers with targeted chronic conditions.

MedVantx, Inc., San Diego, California, [specialized services]; Patrick P. Woo, vice president, business development, will be the primary contact. Established in 2002, MedVantx has created a national network of more than 18 health plans and over 2,500 physicians to provide patients with free, first-line drug therapy samples. The MedVantx network, which has been active in eight states since November 2006, encourages the use of generic and OTC medications. It provides payors and physicians an integrated and sustainable solution to the rising cost of healthcare.

Persuadable Research Corporation, Overland Park, Kansas, [specialized services; marketing, market research, and strategic information]; Charles Miller, senior vice president, will be the primary contact. Persuadable Research Company (PRC) has been in business for 12 years. Since 2001, the company has concentrated on online research, fielding quantitative primary consumer and B2B research through e-mail invitation. PRC offers online focus groups for a qualitative approach, as well as telephone "call-out" research.

The Swanson Group, Buffalo Grove, Illinois, [strategic sales and marketing consulting]; Richard T. Durr, principal, will be the primary contact. Swanson provides strategic sales and marketing consulting services commensurate with client and market needs in traditional and mass market retail, with a focus on health and wellness, diagnostics, beauty, and personal care.

Lorna Totman Consulting, LLC, Annandale, Virginia, [individual consultant, regulatory affairs]; Lorna C. Totman, Ph.D., DABT, principal, will be the primary contact. Dr. Totman consults on regulatory affairs and safety evaluations for nonprescription medicines and other consumer products.

CHPA contacts: Ted Peterson and Phyllis Taylor | Back to the top


Members are encouraged to register soon for the 2008 AEC

The holidays are fast approaching and CHPA members are asked to add one more item on their "to do" lists: register for the 2008 Annual Executive Conference (AEC). Specific details, including this year's registration brochure, will be available in early December. In the meantime, members may reserve a place at the AEC by registering online or downloading a registration form in the members-only section of CHPA's web site.

Sponsors make it all happen

CHPA thanks all of the companies that are supporting the association for the 2008 meeting.

Sponsorship for AEC tote bag available

CHPA is currently seeking a sponsor for the AEC tote bag that will be filled with donated member company products and distributed at the conference. Interested persons should e-mail Kass Kassouf or call at 202.429.3544.

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


Early Associate member renewal deadline is fast approaching

CHPA recognizes the value of Associate member participation in the association's many events and meetings held each year. In an effort to make participation easier and more affordable, CHPA again is offering an early membership renewal offer for Associate members.  

Associate member companies that renew membership and pay 2008 dues by December 1 will be eligible to choose between the following options:

• One free attendance with a single-paid registration to any one 2008 CHPA meeting, or
• 50 percent off a single-paid registration to any one 2008 CHPA meeting (offer not applicable to the Market Exchange table host fee).

Associate members are strongly encouraged to take advantage of this opportunity. Mail in your dues payment today or contact Rong Xu at 202.429.3550 to pay by credit card.

CHPA contact: Phyllis Taylor |  Back to the top

CHPA's 2007 annual report is now available

Members stand united under CHPA's leadership

 

CHPA's 2007 annual report  is hot off the presses. As always, the association took time this year to reflect upon its many achievements that are only made possible through its members' support. Some of CHPA's most important efforts of the past 12 months include continuing the fight against medicine abuse, promoting the safe and effective use of OTCs to parents of young children and to older adults, enhancing consumer confidence and empowerment, and creating opportunities to bring the industry together as a whole.

Copies of the 2007 annual report are being mailed to CHPA's membership, along with the association's 2008 annual dues letter. 

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CHPA on the Road

CHPA staff travel inside the Beltway and beyond

Senior Vice President, Policy & International Affairs David Spangler presented the association's views to FDA during the agency's November 14 meeting concerning proposed behind-the-counter nonprescription drugs. President Linda A. Suydam, D.P.A., Vice President, Communications & Strategic Initiatives Virginia Cox, and Director, Communications & Media Relations Elizabeth Funderburk also attended the meeting (See related story)...
 

Associate Director, Regulatory & Scientific Affairs Rachael Carlisle attended the National Chamber Foundation's meeting on nanotechnology which was held November 13 in Washington, D.C...

Director, State Government Relations Mandy Hagan traveled to La Quinta, California, November 7-10 to participate in the Food Industry Association Executives' Annual Convention. Hagan also went to Oklahoma City, Oklahoma, November 11-14 for the Council of State Governments meeting...

President Linda A. Suydam, D.P.A., and Vice President, Corporate Development Ted Peterson attended Yahoo! Summit Series November 7-8 in Washington, D.C...

Director, Communications & Outreach Mimi Pappas participated in the National Alliance for Hispanic Health's annual meeting November 14 in Washington, D.C. CHPA is an organizational member of the alliance...

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Industry News

OTC Issues

FDA approves Zyrtec-D for nonprescription use

FDA issued a press release November 9 announcing the agency has approved the allergy drug Zyrtec-D (cetirizine HCI mg and pseudoephedrine HCI 120 mg) for nonprescription use in adults and children 12 and older. Manufactured by Johnson & Johnson, Zyrtec-D has been used as a prescription drug since 2001 for the treatment of symptoms due to hay fever and other respiratory allergies including runny nose, sneezing, itchy and watery eyes, itching of the nose or throat, and nasal congestion.

Because Zyrtec-D contains the active ingredient pseudoephedrine, the nonprescription version of the product will be sold behind the counter as required by the Combat Methamphetamine Epidemic Act.

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On Capitol Hill

New legislation seeks to alter FDA's oversight of OTCs

The Non-Prescription Drug Modernization Act of 2007 (NPDMA), H.R. 4083/
S. 2311, was introduced November 6 by U.S. Representative Henry Waxman, (D-Calif.), chairman of the U.S. House Committee on Oversight and Government Reform, and U.S. Senator Ted Kennedy (D.-Mass.), chairman of the U.S. Senate Committee on Health, Education, Labor and Pensions.

According to the bill sponsors, this legislation was introduced to expand FDA's authority over OTCs in light of recent recommendations brought forth by at a recent FDA advisory committee meeting on children's over-the-counter oral cough and cold medicines (See November 2 XNL). Responding to the introduction of this initiative, CHPA President Linda A. Suydam, D.P.A., commented, "We feel that any process to reevaluate data is best addressed through a clearly defined and transparent process. We fully support efforts to achieve this goal in a more streamlined fashion and remain committed to ensuring that the best science is applied to all of our medicines."

This legislation is pending consideration before Chairman Kennedy's Senate Committee on Health, Education, Labor, and Pensions, as well as the U.S. House of Representatives' Committee on Energy and Commerce.

CHPA contact: Andy Fish |  Back to the top


Federal Agency Update

FDA takes steps to strengthen advisory committee processes

FDA issued a press release November 15 announcing several initiatives the agency is taking in its advisory committee processes. These efforts include publishing a new draft guidance entitled Voting Procedures for Advisory Committee Meetings. According to FDA, the draft guidance recommends that during advisory committee meetings, committee members should all vote at once. The results of the vote would be announced immediately and each individual member vote would become part of the public record. Comments on the draft guidance are due January 18, 2008.

A second draft guidance, entitled Public Availability of Advisory Committee Members' Financial Interest Information and Waivers, which was issued October 31, recommends that all advisory committee members publicly disclose financial interests for which a waiver is granted. The draft document also includes redesigned disclosure and waiver templates that are easier to understand. Comments on the draft guidance are due December 31.

FDA states that it also has formalized operating procedures concerning security measures and appropriate public conduct at advisory committee meetings. In addition, the agency says that it has improved its advisory committee web page to provide better access to information about waivers granted for conflicts of interest.

Finally, FDA notes that an outside consulting group retained by the agency has completed a report that highlights the difficulty of finding highly qualified experts, who are free of conflicts of interest, to serve on advisory committees. FDA has made the full report available online.

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FDA schedules meeting, extends comment deadline for proposed rule on "essential use" designation for OTC inhalers

FDA issued a notice in the November 8 Federal Register announcing a public meeting will be held to solicit comments on the agency's September 20 proposed rule to amend its regulation on the use of ozone-depleting substances in self-pressurized containers to remove the "essential use" designation for OTC epinephrine metered-dose inhalers (See September 21 XNL). The meeting will be held December 5 from 9:00 a.m. to 3:30 p.m. at FDA's Center for Drug Evaluation and Research in Rockville, Maryland.

FDA states that information gathered at the meeting will be considered by the agency in its final rulemaking. The Federal Register notice includes a list of topics that will discussed at the meeting, including impediments to developing non-ozone depleting formulations, the impact of having no OTC product in the class, and whether or not the risks of self-treatment of asthma outweigh the public health benefits that OTC epinephrine inhalers may provide.

Written or electronic comments for consideration at the public meeting and requests for oral presentations must be submitted by November 23.

In addition to scheduling the public meeting, FDA also has extended the comment period for the proposed rule to December 19.

CHPA contact: Dr. Heinz Schneider |  Back to the top


Members selected for FDA's Risk Communication Advisory Committee

FDA issued a press release November 5 announcing that it has chosen 15 voting members to serve on its Risk Communication Advisory Committee. Established in June, this new advisory committee is charged with helping FDA to better understand the communication needs and priorities of the general public, advising the agency on the development of strategic plans to communicate product risks and benefits, and making recommendations on crafting appropriate risk and benefit messages.

According to FDA, the 15 advisory committee experts were selected from the fields of risk communication, risk perception, decision analysis, communication, social marketing, health literacy, journalism, and other behavioral and social sciences. They have been assigned to serve on the committee for periods ranging from one to four years. The committee roster is available on FDA's web site.

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FDA holds workshop on adolescent use of OTCs

FDA published a notice in the November 5 Federal Register announcing the public workshop entitled "Adolescent Over-the-Counter (OTC) Drug Product Use" will be held December 6-7. CHPA is sponsoring this event in conjunction with FDA. The purpose of the workshop is to:

• Gain a better understanding of how adolescents currently use OTC drug products,

• Examine factors that influence adolescent OTC drug product use, and

• Compare adolescent decision making skills with those of adults.

FDA states that the workshop also is aimed at designing efforts to encourage appropriate OTC drug product use by adolescents that will foster appropriate use when the adolescents become adults. Adolescent use of dietary supplements will not be discussed at the workshop. FDA has included a list of topics that will be addressed in its Federal Register notice. 

The workshop is scheduled for 8:30 a.m. to 5:30 p.m. on December 6 and from 8:30 a.m. to 3:30 p.m. on December 7 at the National Institutes of Health's Natcher Conference Center in Bethesda, Maryland. Requests to make oral presentations must be submitted to FDA's Faith Dugan by November 21. Written or electronic comments are due by January 31, 2008.

CHPA contact: Dr. Rachael Carlisle | Back to the top


In Brief

FDLI offers course on food and drug law regulation

The Food and Drug Law Institute (FDLI) is hosting a workshop December 10-11 on the fundamentals of the laws and regulations that affect such FDA-regulated products as food, drugs, biologics, medical devices, veterinary products, dietary supplements, and cosmetics. During the two-day course, experts will provide a broad overview of FDA; explain the history and details of specific areas of regulations; and discuss how other government agencies, such as the U.S. Department of Agriculture and the Federal Trade Commission, implement and enforce the regulation of foods, drugs, and other products. This course is recommended for individuals who are new to the food and drug regulatory community. Additional information is available online.

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