Five Moms urge more
parents to keep teens from abusing cough medicine
CHPA issued a
press release May 6 commemorating the one-year anniversary of the launch of
the Five Moms: Stopping Cough Medicine Abuse campaign. This ongoing
grassroots effort, launched by CHPA in May 2007, features five extraordinary mothers from across the country
who are working to bridge the communication gap between parents and teens about
the dangers of abusing cough medicine. To date, the campaign has
reached more than 23 million parents through various Internet channels including
personal blogs, an online messaging system, advertising, and a "viral" video.
"The process to address cough medicine abuse is twofold," said CHPA
President Linda Suydam. "First, we had to raise awareness among parents that teens abusing cough
medicine was a reality. Now, with our growing community of engaged parents, we
are asking our Five Moms members to engage in an open communication
with their teens to help prevent this type of substance abuse."
The mothers at the heart of the Five Moms campaign are Julie Bermant, a
pediatric nurse practitioner from Massachusetts; Blaise Brooks, an accountant
from California; Christy Crandell, a California mother of a former
cough medicine abuser; Becky Dyer, a D.A.R.E. officer and deputy sheriff from
Kansas; and Hilda Morales, an educator from Texas. The women have posted the
following steps on the web site, FiveMoms.com, to help
all parents open the door to conversations with their kids about cough medicine
Safeguard medicines at home,
Communicate with your teen,
Monitor Internet usage, and
Recognize signs your teen may be abusing cough medicine.
"Like so many parents out there, I can't help but think how different my
family's life would be had we known that cough medicine abuse was happening and
we were armed with information on how to prevent it," said Five Mom
Christy Crandell, whose son was arrested for armed robbery while high on cough
medicine and marijuana. "I can only hope that other parents understand the
importance of taking these steps to protect their teens from abusing cough
The Five Moms campaign is getting the word out to
parents that cough medicine abuse is happening in homes across the nation, and
that the Internet is a driving force.
Since the debut of the campaign in May
More than 84,000 people have visited
FiveMoms.com, a web site where parents can find information about cough
medicine abuse, read blog entries from the Five Moms, and link to
sites that have additional resources for fighting cough medicine abuse.
Site visitors have sent almost 130,000 "Tell-A-Friend" e-mails, alerting
other parents to the information available on
The Five Moms viral video has been viewed by more than 13,000 people on
YouTube, Google video, and Yahoo! video.
"Our members have worked tirelessly to educate parents about the potential for
abuse," said Suydam. "The success of the Five Moms campaign
has taken this effort to an entirely new level."
CHPA contact: Elizabeth Funderburk | Back to the top
The 2008 RSC focuses on
enhancing consumer healthcare through innovation
CHPA's annual Regulatory & Scientific Conference (RSC)
was held May 8-9 in Washington, D.C. This year's RSC explored innovations in policy,
technology, and communication that can be used to facilitate and improve
Planning Committee Chair Sue James, GlaxoSmithKline, presided over the
conference and CHPA
Scientific Affairs Committee Chair Barbara Kochanowski, The Procter & Gamble Company,
presented the status of the regulatory community
report. The event was attended
by more than 150 people and over 25 FDA representatives.
RSC Planning Committee Chair Sue James, GlaxoSmithKline, who presided over
the RSC, provided attendees
with a general overview of the conference.
Burrus reveals the
top trends in healthcare
Keynote speaker Daniel
Burrus, Burrus Research
Associates, started the RSC off on a high note by delivering a
thought-provoking presentation on strategic
leadership. He challenged attendees to think optimistically about the future and
to not dwell on existing problems, so the that challenges that lie ahead are
viewed as opportunities, not obstacles. Burrus also stressed the importance of
communicating with consumers in a two-way interaction, instead of simply
providing one-way information. According to Burrus, the current top healthcare
trends include genetic screening, prevention, remote diagnostics, the virtual
hospital, e-enabling healthcare, evidence-based medicines, and results-based
funding. He also predicted that the future of healthcare will be focused on
relationships built on trust as well as technological changes. But Burrus also
noted that motivation is the key to drive people towards technology, especially
in a multi-generational population.
Examining challenges and opportunities in the healthcare environment
In a session chaired by
John Dent, John Dent Consulting, the current consumer healthcare
environment was examined from various perspectives. That session panel featured Dr. Charles Ganley, FDA's Office of
Nonprescription Products (ONP); Ed Kuffner, McNeil Consumer Healthcare; Hubertus
Cranz, Association of the European Self-Medication Industry (AESGP); Catherine
Polley, Food Marketing Institute; and Aaron Morel, Yankelovich.
During his remarks, Ganley discussed some of FDA's challenges concerning advisory committee meetings.
Two such challenges,
he said, are the recruitment of appropriate committee members who comply with the
strict conflict of interest provisions and the timely circulation of
voluminous briefing material to all parties prior to a meeting. Ganley stated
that, in the future, the agency intends to include information on general OTC
background in briefing packages and to allow more time for the committee members
to review the material.
Kuffner recapped a
number of positive industry initiatives in 2007. At
the top of his list was FDA’s acceptance of CHPA as a sponsor at advisory
committee meetings on OTC monograph ingredients, thereby enabling the industry
to provide scientific data in a joint and coordinated manner.
Shifting the focus overseas, Cranz provided an overview
of the latest regulatory developments in the European Union (EU). He explained
that while decisions about advertising and Rx-to-OTC switches have not yet been
harmonized between EU Member States, progress has been made. OTC medicines are
now eligible for the centralized procedure and the new European Medicines Agency
guideline on invented names clarifies policies on OTC names across the EU.
Rounding out the morning session were Polley and Morel. Polley discussed the important role pharmacists can play as advisors at the
point of OTC sale, while Morel advised the industry to develop easy-to-use tools
to aid consumers in selecting the most appropriate OTC products to meet their
Following a break in the RSC program, Dr. Bill Cooley of Cooley Consulting, Inc.,
musically summons attendees into the session.
Taking novel approaches to packaging
The afternoon session on packaging innovations was chaired by
Luis Salmun, Schering-Plough
Healthcare Products. Included on the panel were Edward Bauer, Packaging & Technology Integrated
Solutions; Mike Fien, Comar; Michael Doran, Rivet Digital; Michael Levy, FDA's
Office of Compliance; and Michael Labson, Covington & Burling.
Bauer opened the session with a discussion of some of the new
developments in this area broken down by packaging categories.
Some of the examples he cited include bottles with dispensing closures
for solid-dose forms, blister cards for one day of use, and unit dose liquids.
Bauer added that more complex new packaging solutions could have integrated
audible and visual alarms or could be connected to databases.
his attention specifically to plastic liquid dosing devices.
Dosing accuracy and child resistance are well-known challenges
and Fien explained that innovative devices, such as press-in bottle
adapters or audible click oral dispensers, offer solutions to these challenges.
Michael Doran complemented both Bauer's and Fien's remarks by providing
examples of intelligent tools that allow consumers to make better decisions at
the point of sale. One such example he
showed was an interactive kiosk with a touch screen on hair colorants used to
find an individual's ideal product. This type of technology could potentially be
used for OTC products.
Levy and Labson closed the session on new packaging and
dispensing solutions. Levy reminded the
industry that dosage delivery systems must be in line with product labeling
and showed examples of poorly designed dosing devices.
Labson explained that new tools, like the kiosk Doran displayed, could potentially fall under medical device
requirements. He also described the conditions under which the secondary
packaging, as opposed to the primary packaging, can have the child-resistant
||FDA's Michael Levy provides the agency's
perspective on utilizing packaging and technology.
Understanding what all the buzz is about
Concentrics Research, introduced two speakers in the third session, who
illustrated novel marketing strategies to capture the consumer and ensure a
successful product launch. Steve
Burton, GlaxoSmithKline, and
Adam Paulisick, Neilsen Online, each discussed innovative ways of
understanding what consumers are thinking.
Burton commented on the elaborate instruction and coaching embedded in
GlaxoSmithKline's advertising program to promote the safe use of and appropriate decisionmaking
regarding the new OTC switch drug alli™.
The addition of this supplemental educational material promoted an
overall behavior change and outlook on eating and living healthy: alli™
is more than a pill; it is an entire program.
According to Burton, by "thinking outside of the box" in its advertising,
GlaxoSmithKline was able to build consumer trust before the product was even on the
Paulisick encouraged the audience to reach out to
consumers in unconventional methods. He stressed
the importance of consumer-generated media to the industry, noting that
there are currently 79 million communities and social networks on the Internet.
Many of these communities, said Paulisick, reveal consumer evaluations,
concerns, and questions regarding OTC products and product use which could be
captured as a tool for promotion and feedback collection.
Committee Member Leonard
Baum, Bayer Healthcare LLC Consumer Care, describes some
of the forthcoming challenges to the OTC industry as well as the
numerous opportunities that exist.
Looking at FDA's past and future
Participating in the FDA panel at the RSC were
Leah Christl, Joel Schiffenbauer, and M. Scott Furness, all from the
agency's Office of Nonprescription Products (ONP). They discussed some of FDA's past and future initiatives and provided an update on
anticipated changes in the agency's employee structure.
The group also highlighted some of FDA's most notable activities of the past
year and projected upcoming regulations and documents.
From right: Sue James of GlaxoSmithKline listens as FDA's
Joel Schiffenbauer, Scott Furness, and Leah Christl provide an
update on the agency's activities.
Zeroing in on the biggest consumer healthcare issue
Douglas Bierer Consulting, LLC, moderated the RSC's most diverse panel. Experts
from various fields each provided their perspectives on what they consider to be
the most important aspect of consumer health healthcare, including James
Appleby, American Pharmacists Association; Andrea Leonard-Segal, FDA; David
Spangler, CHPA; Minnie Baylor-Henry, McNeil Consumer Healthcare; and Lee Rucker,
led the discussion with an inspiring declaration for transformation and promoted
collaboration in modifying the consumer selection process of OTC products in
Leonard-Segal said that the relationships made between government,
associations, and companies were of the utmost importance for developing trust
and providing safe and effective products for our consumers.
She also spoke to the significance of educating consumers on the proper
use of OTCs.
In his comments, Spangler cited three important issues: 1) the
missing opportunities in linking self-diagnosing devices to OTCs, 2) new technology and providing consumers with
both “high-tech and
high-touch” opportunities, and 3) the movement towards electronic health
agreed with Spangler on the value of providing choice while offering
information on products in retail stores through interactive technology such as kiosks.
She added that it is necessary for the industry to “stop looking
backwards and look to ahead.”
closed out the panel session with a novel recommendation to OTC manufacturers.
She suggested that companies include medication records in OTC product packages and also to make the records available online.
Fielding audience questions (from right) were: James Appleby, APhA;
Andrea Leonard-Segal, FDA; David Spangler, CHPA;
Minnie Baylor-Henry, McNeil; and Lee Rucker, AARP.
CHPA thanks the following generous
sponsors of the
2008 Regulatory & Scientific Conference:
CHPA thanks RSC Planning
Committee Chair Sue James and the other
committee members for the excellent program.
CHPA contact: Dr, Marcia Howard | Back to the top
CHPA encourages companies to
lend assistance to China
With a death toll of over 20,000 and still rising, and with
hundreds of thousands displaced from their homes following this week’s
earthquake in the Sichuan Province in China, CHPA President Dr. Linda Suydam reached
out to the association's members to draw additional attention to the
humanitarian crisis and the need for assistance. “I know that all of your
companies seek to provide aid and support in times of crisis, both domestic and
international," wrote Suydam. "This week, many of our eyes are on China."
Suydam explained to members that friends and industry
colleagues in China helped to illuminate the magnitude of these events in the
most human of terms by pointing out that "It’s a very little village, the frail
earth. It’s a much greater power, the global industry."
"With their personal call for support," concluded Suydam, "I urge you to provide
needed medicines through such organizations as
International Federation of Red Cross and Red
Crescent Societies, or others.”
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FDA schedules meeting
to discuss pilot program on proposed proprietary names
FDA issued a notice
in the May 12 Federal Register announcing that its Center for Drug
Evaluation and Research and its Center for Biologics Evaluation and Research are
conducting a public meeting to prepare for a pilot program that will
enable pharmaceutical manufacturers to evaluate proposed proprietary names and
to submit the data generated from those evaluations for FDA's review. The
meeting will be held June 5-6 from 8:30 a.m. to 5:00 p.m. at the Crowne Plaza
Hotel in Silver Spring, Maryland.
FDA states that reducing the potential for medication errors due to proprietary
name confusion is part of the agency's ongoing product risk management effort.
As part of its performance goals, the agency agreed to publish a concept paper
and implement a pilot program that will provide a consistent, scientific
approach to the review of proprietary names data.
During the two-day meeting, the agency intends to discuss a draft concept paper
that describes the details of the pilot program, examine the proposed
recommendations for conducting a proprietary name review, and disclose its plans
for reviewing submissions from the pilot program. FDA notes that the draft
concept paper will be made available on its web site prior to the meeting. The
agency plans to formally issue the concept paper by the end of fiscal year (FY)
2008 and to begin enrollment in the pilot program sometime in FY 2009.
Requests to make oral presentations at the meeting should be sent to
FDA's Lana Pauls by May 23. Comments
on the draft concept paper and pilot program are due by July 27.
CHPA contact: David Spangler | Back to the top
FDA's Science Board to meet
FDA issued a notice
in the May 8 Federal Register announcing that its Science Board will
meet May 30 from 8:00 a.m. to 3:30 p.m. at the Washington D.C.
North/Gaithersburg Hilton in Gaithersburg, Maryland. According to FDA, the
Science Board is meeting to hear a subcommittee review of the National Center
for Toxicological Research and Office of Regulatory Affairs, discuss ways to
keep pace with technical and scientific evolutions in the fields of regulatory
science, and receive an update on the agency's science programs and
Requests to make oral presentations at the meeting should be submitted to FDA's
by May 15. Written submissions are due by May 23. FDA recommends that interested
parties check the agency's
web site for
updates and the agenda for this meeting.
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FDA seeks comments on draft
PDUFA IV drug safety plan
FDA issued a notice
in the May 5 Federal Register seeking public comments on a draft
document entitled Prescription Drug User Fee Act (PDUFA) IV Drug Safety
Five-Year Plan. The document describes FDA's strategy for meeting the
commitments for enhancing and updating the draft safety system within the PDUFA
Written requests for copies of the draft plan should be sent to FDA's Office of
Executive Programs, Center for Drug Evaluation and Research, 10903 New Hampshire
Avenue, Bldg. 51, Room 6100, Silver Spring, Maryland 20993-0002. FDA is
all interested parties to include one self-addressed adhesive label to help
Comments on the PDUFA IV drug safety plan are due by June 19.
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FDA holds annual
regulatory affairs conference in California
FDA published a
notice in the May 5 Federal Register announcing that the agency,
along with the Orange County Regulatory Affairs Discussion Group, is
cosponsoring the 11th annual regulatory affairs educational conference.The event will be held June 11-12 in
The purpose of the conference is to provide industry representatives with the
chance to meet face-to-face with FDA reviewers and compliance officers from the
agency's centers and district offices. During the two-day, interactive meeting,
speakers will focus on product approval, compliance, and risk management issues
surrounding the drug, device, and biologics industries.
Additional information and registration materials for the conference are
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Government agencies publish
semi-annual regulatory agenda
The Unified Agenda of Regulatory and Deregulatory Actions was published
in the Federal Register May 5 and posted to
www.reginfo.gov. The items listed are rough projections of what certain
government agencies, including FDA, hope to publish in the Federal Register
over the next 12 months.
The following are some issues of interest to the industry:
U.S. Food and Drug Administration
For a copy of the U.S. Department of Health and Human Services'
agenda, click here
and select the appropriate agency.
―Proposed rule on electronic data submission requirements for NDAs: 10/08
―Proposed rule on Rx and OTC combination policy: 9/08
―Proposed rule on electronic submission of postmarketing safety reports:
―Final action on changes to drug establishment listing and registration,
including NDC changes and electronic submission: 12/08
―Final action on safety reporting requirements, revisions: 4/09
―Final action on complete response letters on NDAs: 7/08
―Final action on dietary supplement good manufacturing practices and
100 percent identity testing exemptions: 6/08 (an interim final rule was
―Final action on toll-free number for adverse event reporting of NDA drugs:
12/08 (an interim final rule was issued 1/08)
―Final action on prior notice of imported food under the Bioterrorism Act: 8/08
(an interim final rule has been in place since 10/03)
―Final action on cochineal extract and carmine allergen labeling for foods
and cosmetics: 5/08
―Final action on cattle-derived materials in medical products, recordkeeping:
―Final action on good manufacturing practice amendments: 12/08 (a direct
final rule was withdrawn 4/08; a companion proposed rule remains in
―Final action on good manufacturing practices cut label controls,
amendment: to be determined
Certain Category II and III ingredients
―Proposed rule on making ingredients not
―Proposed rule on hangover claims, amendment:
―Proposed rule on food handlers: 12/08
―Final action on ephedrine single ingredient,
Cough/cold combination products
―Final action on bronchodilator/expectorant
―Final action on phenylpropanolamine, amendment: to be
―Final action on claims, amendment: 5/09
―Final action on internal analgesics: 3/09
―Final action on required warnings and other labeling: 3/09
―Proposed rule on combinations with sodium bicarbonate,
―Proposed rule on overindulgence/hangover, amendment: 4/09
―Proposed rule on miscellaneous issues, amendment: 5/09
―Proposed rule on pediatric, amendment: to be determined
Convenience size products
―Final action on labeling: 3/09
―Final action on bismuth subsalicylate: 4/09
―Final action on antacids: 4/09
―Final action of removal of epinephrine's
―Proposed rule, amendment: 5/09
―Final action on GRAS/E dosage forms for patches: 5/09
―Proposed rule on professional labeling: to be determined
―Final action: to be determined
―Final action on emergency first aid eye washes, amendment: to be
Oral healthcare products
―Proposed rule on plaque and gingivitis: to be determined
―Final action on diaper rash: 5/09
―Final action on aluminum acetate, technical amendment: 5/09
―Final action on fever blisters and cold sores: to be determined
―Proposed rule on time and extent: 5/09
―Final action on Ultraviolet A and Ultraviolet B: 5/09
―Proposed rule on insect repellent: to be determined
―Proposed rule: 5/09
Weight control products
―Final action on phenylpropanolamine: to be determined
Skin bleaching products
―Final action on hydroquinone: 5/09
―Proposed rule: to be determined
―Proposed rule on ipecac: 5/09
―Proposed rule: 5/09
―Final action on benzoyl peroxide: 5/09
U.S. Drug Enforcement Administration
For a copy of the U.S. Department of Justice's agenda, click here
and select the appropriate agency.
―Final action on ephedrine, pseudoephedrine, phenlpropanolamine chain of
distribution, importer information: 12/08
―Final action on Combat Meth Act self-certification by regulated sellers of
listed chemicals: 10/08 (an interim final rule was issued 9/06)
―Final action on Combat Meth Act transfers following import and export: 8/08
(an interim final rule was issued 4/07 with a temporary stay
provisions since 5/07)
―Final action on Combat Meth Act import quotas: 8/08 (an interim final rule
was issued 7/07)
―Final action on Combat Meth Act List I location registration: 12/08
―Final action on Combat Meth Act threshold removal: 1/09
―Final action on Combat Meth Act fee for self-certifiers: 11/08
―Final action on Combat Meth Act certification recordkeeping requirements:
―Final action on precursor chemical security requirements: to be determined
CHPA contact: David Spangler | Back to the top
Register today for CHPA's
2008 Market Exchange
are urged to register today for CHPA's 2008 Market Exchange to ensure that their
company is included on the list that table hosts may choose from in scheduling appointments. Registration materials for Market Exchange are available
CHPA's Market Exchange
September 17-18, 2008
New Brunswick, New Jersey
Questions About Market Exchange?
For appointments and sponsorship information,
contact CHPA's Phyllis Taylor
For all other inquiries, contact CHPA's
Kass Kassouf (202.429.3544)
or Maria Sarabia
. . . . . . . . . . . . . . . . . . . .
For hotel reservations, contact the Hyatt Regency New Brunswick
at 732.873.1234 or
Thank you, sponsors
CHPA thanks the following member companies that have generously agreed
to serve as Market Exchange sponsors:
you are interested in learning more about Market Exchange sponsorship
opportunities, contact CHPA's Phyllis
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CHPA comments on FDA's ANPR
for food labeling
CHPA filed a
submission with FDA April 30 on the agency's
advanced notice of
proposed rulemaking (ANPR) regarding revisions to food labeling reference
values and mandatory nutrients. In the ANPR, FDA sought comments on whether
daily values (DVs) should be set based on estimated average requirements (EARs)
for those nutrients for which an EAR has been set, or if DVs should be set based
on recommended dietary allowances (RDAs). Additionally, the agency asked for
input on whether DVs should be based on population-coverage or
population-weighted EARs or RDAs.
In its submission, CHPA strongly recommended that the DVs continue to be based
on RDAs, not on EARs. Furthermore, these DVs should be determined based on
population-coverage RDAs, as opposed to population-weighted RDAs. For those
nutrients without an EAR, the association stated that DVs should be based on
population-coverage adequate intakes.
To support its recommendations, CHPA added that this approach would:
Provide appropriate guidance on nutritional requirements to the greatest
number of consumers;
Minimize possible consumer confusion about the meaning and proper use of DVs
due to potential changes in the label values;
Lessen the need for re-education of consumers, teachers, and healthcare
professionals if the DVs were modified based on changes to standard-setting
Maintain public confidence in the ability of FDA and industry to
appropriately interpret, utilize, and convey the best scientific data on
Dr. Marcia Howard | Back to the top
AmeriCares makes an appeal for
donations for cyclone and earthquake victims
AmeriCares has responded to disasters around the world
for over 25 years to deliver critical medicines and medical supplies that
help restore health and save lives of people in crisis. The nonprofit
organization has been working around the clock to respond to the cyclone in
and the 7.9 earthquake in the Sichuan Province of China.
"AmeriCares is working to
secure all necessary approvals and flight clearances for delivery of
essential supplies, including antibiotics, multivitamins, and medicines to
treat diarrheal diseases, malaria, and dengue fever, as well as water
purification sachets," said Curt Welling, president and chief executive officer
How companies can help
AmeriCares is seeking donations of the following
medicines and medical supplies to support our emergency response efforts:
(Locally sourced from within
Analgesics and anesthetics
Skin disinfectants and dressings
Disposable splints, sutures, syringes, and gloves
Asthma and chronic pulmonary disease medicines
Oral, parental, and ophthalmic antibiotics
Companies interested in making product donations should
contact AmeriCares' Lauri
Fogarty-Swenson (203.658.9526). Financial contributions can be made at
AmeriCares to participate in CHPA's 2008 Market Exchange
Representatives from AmeriCares will be participating in CHPA's 2008
Market Exchange, scheduled for September 17-18 in New Brunswick, New Jersey (See
related article). CHPA members that would like to
set up an appointment to meet with AmeriCares to learn more about the
organization's efforts should contact CHPA's
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