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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.
Back to the top


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...
Back to the top


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.
Back to the top


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.
Back
to the top


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.
Back to the top


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