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Coalition calls on
U.S. Congress to repeal the cough and cold tax
CHPA, as part of a
coalition, sent a
letter and issued a
news release on November 18 calling on the U.S. Congress to repeal the
requirement that prevents consumers from using their flexible spending accounts
(FSAs) to purchase OTC medicines without a prescription. The coalition is
seeking a repeal or a delay of the provision, enacted into law as part of the
Patient Protection and Affordable Care Act, removing OTC medications from the
list of eligible medical expenses for FSAs and health savings accounts (HSAs),
effective January 1, 2011. The coalition includes CHPA, the National Association
of Chain Drug Stores, the National Grocers Association, the Food
Marketing Institute, the American Pharmacists Association, and the National
Community Pharmacists Association.
“This new restriction
will eliminate a tool that 35 million Americans have come to depend on to
cost-effectively purchase medicines they need, when they need them,” said CHPA
President and CEO Scott Melville. “As Congress considers extensions of current tax cut
policy, they should also be mindful of the middle-class working families who
will see their FSA benefits slashed if this provision is not repealed."
CHPA contacts:
Elizabeth Funderburk and
Allen Segal | Back to the top
CHPA issues statement
outlining measuring and dosing improvements already made for liquid OTC
medicines for children
On November 30, CHPA
issued a
statement
on the progress that has been made over the past year to help caregivers
correctly measure and dose OTC liquid medications for children. The statement
was issued in response to one- to two-year-old survey data published in the
November 30 online edition of the Journal of the American Medical
Association.
In the statement, the
association reiterated the industry's commitment to helping parents and
caregivers safely and correctly administer OTC pediatric oral medicines to
children and outlined the steps industry has taken to voluntarily address the
problem:
“In November 2009, CHPA approved
voluntary guidelines with respect to liquid OTC medicines. The guidelines
address two important components. The first involves the inclusion of an
appropriate dosing device for OTC pediatric medications. CHPA members are in
compliance with this guideline. The second component involves dosing directions
for children under age 12 for OTC liquid medications.
While the guideline includes such improvements as utilizing charts versus
running text for labeled dosing directions and user-friendly formats regarding
fractions and decimals, it also suggests use of milliliters as the preferred
unit for dosing with an abbreviation to read 'mL.' It is our goal that all OTC
medicines will fully follow the guidelines by the end of 2011."
CHPA contact:
Elizabeth Funderburk | Back to the top
CPSC rejects changes
to consumer product safety information database rule
At a November 24
hearing, the Consumer Product Safety Commission rejected proposed changes to its
consumer product safety information database rule. CHPA asked the commission in a November 16
letter and a July 20
submission to revise the rule to exclude OTC and dietary supplement
product incident reports from the CPSC safety information
database. The association also questioned the value of including incident reports
related to Poison Prevention Packaging Act regulated packaging of OTCs and
dietary supplements. While the commission did not revise the rule, it noted that the incident report form
states “CPSC does not have jurisdiction over automobiles, trucks, and
motorcycles, car seats protecting children in on-road vehicles, foods,
medicines, cosmetics, and medical devices, or dissatisfaction with business
practices.”
CHPA contact:
David Spangler | Back to the top
Federal
Register Update
Guidance issued for
use of noninferiority trials to support approval of antibacterial drug products
FDA issued a
notice in the November 29 Federal Register announcing the
availability of a
guidance providing information on FDA’s current thinking on the appropriate
use of noninferiority clinical trial designs to evaluate antibacterial drug
products.
Back to the top
FDA issues guidance
on abbreviated new drug applications (ANDAs): impurities in drug products
FDA issued a
notice in the November 29 Federal Register announcing the
availability of a
guidance updating recommendations regarding degradation products and
updating the December 1998 draft guidance, ‘‘ANDAs: Impurities in Drug
Products,’’ to conform with International Conference on Harmonization guidances.
Back to the top
FDA issues draft
guidance on "Dear Health Care Provider" letters
FDA issued a
notice in the November 12 Federal Register announcing the
availability of a
draft guidance providing recommendations on when to use a "Dear Health Care
Provider" letter, the type of information to include in the letter, how
to organize that information, and formatting techniques to make the information
more accessible. Comments are due January 11.
Back to the top
Report on the
performance of drug and biologics firms in conducting postmarketing requirements
and commitments
FDA issued a
notice in the November 9 Federal Register reporting on the status of
clinical trials and studies that holders of approved drug and biological
products have agreed to conduct or are required to conduct. This notice was
accompanied by an FDA
news release affirming that "most makers of approved drug and biological
products are meeting their regulatory obligations and meeting targets for
postmarketing studies/clinical trials in a timely manner," with 40 percent
having been closed (either fulfilled or released) by FDA and 60 percent in
progress and on schedule or with the final report having been submitted for FDA
review.
Back to the top
Meetings
CHPA's Annual
Executive Conference: Your Health at Hand
Each year, millions
of people rely on trusted over-the-counter medicines to get well, stay well, and
feel well. This industry’s products provide Your Health at Hand—an effective
tool in family healthcare, especially in today’s healthcare environment. Your
Health at Hand is not only the theme of the March 2011 Annual Executive
Conference (AEC), but the theme of a new association initiative to be launched in the
first quarter of 2011.
Kicking off this year’s conference will be a breakfast hosted by Hearst
Magazines, where attendees will get a broad view of the overall mindset of
Americans in a turbulent economy from Ambassador Jim Glassman. Glassman’s career
has spanned business, politics, media, and government, and he currently
moderates Ideas in Action on PBS. Glassman is also the
founding executive director of the George W. Bush Institute, served as Under
Secretary of State for Diplomacy and Public Affairs, was president of the
Atlantic Monthly Co., and authored columns on economics and business in a
variety of publications.
Registration brochure now available
Take a look at what’s
in store at the upcoming conference and download the
registration brochure
or
register online! Be sure to register for the conference by January 31, 2011,
and receive the $200 discounted early bird rate.
Hotel reservations can be made online at The Fairmont Turnberry Isle Resort
& Club. Make your reservations immediately to take advantage of the $349 CHPA
group rate.
2011 AEC Sponsors
We greatly appreciate
the generosity of the 2011 AEC sponsors.
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3D Communications—Thursday
evening opening event co-sponsor
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Catalina
Marketing Corporation—Saturday morning business session
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Edelman—Thursday
evening opening event co-sponsor
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The Emerson Group—General AEC
open sponsor
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The Fairmont
Turnberry Isle Resort & Club—Saturday evening dinner co-sponsor (with CHPA)
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Grey Group—Friday
evening reception
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Hearst Magazines—Friday
breakfast session
speaker
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The Nielsen
Company—Friday afternoon business session
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Parade
Publications Inc.—Saturday breakfast session speaker
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Pharma Tech
Industries—Photographer and post-conference photo gallery
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Salvatori-Scott,
Inc.—Sports tournament prizes
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SymphonyIRI Group—Friday
morning business session
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Time Incorporated—General AEC
open sponsor
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WebMD—Welcome tote
Favor bag
contributions needed for CHPA’s 2011 AEC
The holiday spirit is
stirring and what better time to start thinking about providing a
contribution for the upcoming conference. Year after year, members have
graciously contributed products to be included in the Annual Executive
Conference favor bags. Contributing to the favor bag provides another
opportunity to build awareness of the products and services that CHPA members
represent.
We are pleased to
thank WebMD for once again sponsoring the actual “tote” for the favor bag
products.
If you would like to
participate, please complete the
favor bag participation form and fax the form to Maria Sarabia at 978.719.6333.
CHPA contacts:
Kass Kassouf and
Maria Sarabia | Back to the top
Don’t miss the 2011
CHPA RSC on "Designing a Blueprint for Success"
Whether you work in
the public or private sector, you should plan to attend the 2011 Regulatory &
Scientific Conference (RSC) at the Hyatt Regency Bethesda, Maryland, on May 5-6
to hear about “Designing a Blueprint for Success.” FDA’s Chief Scientist Dr.
Jesse Goodman will join keynote speaker Biotechonomy's Juan Enriquez as they
address how science and consumer self-care intersect. Check CHPA's
website for program updates as speakers are confirmed.
Join your colleagues
at the 2011 RSC to learn about innovative ideas impacting OTC medicines and
dietary supplement products as well as regulatory issues affecting the industry. Online registration will be available
in early 2011.
Special thanks to RSC sponsors
Special thanks are
being extended to the 2011 CHPA RSC sponsors:
CHPA contact:
Dr. Marcia Howard | Back to the top
CHPA News
CHPA office holiday
schedule
The CHPA office will
be closed December 24-January 2 for the holidays.
Back to the top
CHPA Board names
Sturman chair-elect; elects new board members
CHPA's Board of
Directors named Paul L. Sturman, president and general manager, Pfizer Consumer
Healthcare, chair-elect at its November 18 meeting. Sturman will assume the
chair position at the March 2011 Annual Executive Conference when the term
expires for current Chair Christopher D. DeWolf (president & chief executive
officer, Lil’ Drug Store Products,
Inc.).
Three new board
members were also elected at the meeting:
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Briain de
Buitleir, vice president, NA Personal Health Care and Global Brand Franchise
Leader Digestive Wellness, The Procter & Gamble Company; *
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Gary R. Downing,
chief executive officer, Insight Pharmaceuticals Corp.; and
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Brian J.
McNamara, president and region head, OTC Americas, Novartis Consumer Health,
Inc. *
* denotes appointment
to CHPA's Executive Committee.
CHPA contact:
Roman Blazauskas | Back to the top
16 new companies join
CHPA
CHPA’s Board of
Directors elected four Active and 12 Associate member companies to membership at
its November 18 meeting:
Active members:
Heel Inc.,
Albuquerque, New Mexico;
Thierry Montfort, president & chief executive officer, will be the primary
contact. The company, in business for more than 30 years, produces numerous
homeopathy products sold through brokers, wholesale distributors, healthcare
practitioners, and retail outlets.
Hisamitsu Pharmaceutical Co., Inc.,
Torrance, California;
Takehiko Noda, executive officer, will be the primary contact. Eligible
products are external pain relieving patches, gel, and spray under the Salonpas
and Salonsip brand names.
Insight Pharmaceuticals Corp.,
Langhorne, Pennsylvania;
Gary Downing, chief executive officer, will be the primary contact.
Insight’s portfolio of products spans pain, cold, sore throat, allergy, skin,
head lice, dietary supplement, and other categories and includes products such
as Allerest, Anacin, Bonine, Chooze, N’Ice, Sucrets, Vitron C, and others.
Insight also produces some private label products.
Welmedix Consumer Healthcare,
Princeton, New Jersey;
Avani V. Kanubaddi, president and chief executive officer, will be the
primary contact. Their homeopathic products are First Degree Therapeutic Burn
Cream and SunBurnt Therapeutic After-Sun Gel, sold through food, drug, and mass
merchandiser outlets.
Associate members:
Benchmark Research,
Austin, Texas [clinical research organization];
Mark Lacy, president &
chief executive officer, will be the primary contact. Benchmark owns and
operates six multi-therapeutic research site locations. Their experienced staff of
physicians and coordinators has extensive experience with trials on consumer
healthcare products, nutritional supplements, specialty products, Rx-to-OTC
switch products, and more. Benchmark has a database of more than 50,000 active
volunteers as well as an in-house call center which allows rapid access to a
diverse population of individuals. Additionally, their experienced team of
physicians, coordinators, and staff help ensure that trials are handled in the
best and most efficient manner possible.
The Chestnut
Partnership, Tampa, Florida [individual consultant];
Robin Chestnut,
partner, will be the primary contact. The Chestnut Partnership (TCP) is a
consumer research consultancy. For over 20 years, it has designed and conducted
qualitative and quantitative studies for healthcare industries. Its expertise is
in the area of innovative custom approaches to business and product objectives.
Fesnak and
Associates, LLP, Blue Bell, Pennsylvania [accounting, audit, taxes,
financial management];
James J. Caruso, CPA, partner-Financial Management
Outsourcing/M&A, will be the primary contact. Fesnak’s mission is to provide
high quality, sophisticated audit, accounting, tax, financial management, and
transaction services that are relevant to their clients’ business needs to
enable them to achieve their business objectives. Their service team has the
ability to provide technical skills in these areas as well as in the areas of
valuation and mergers/acquisitions that you would expect from a national
accounting firm. The company was founded on a tripartite value proposition:
provide world-class quality services at reasonable rates and with significant
partner/manager time on engagements, and that’s a credo that has served the
company well. Fesnak and Associates' clients range from large, privately-held,
multi-generational companies, to emerging growth businesses and multi-national
public corporations.
The Goldstein
Group, New York, New York [individual consultant];
Terri Goldstein,
principal/founder, will be the primary contact. A mid-sized consultancy firm
based in Manhattan, The Goldstein Group specializes in restaging iconic brands
for today’s ever-changing market. Led by shopper marketing strategist Terri
Goldstein and creative director Darcy Bolker, The Goldstein Group’s designers,
writers, and production specialists draw upon a combined 30 years of knowledge
and experience to navigate every phase of the branding process, from strategy
to design to interactive.
Grifcon
Enterprises, Inc., Lincoln, California [insurance services];
Dick
Griffin, president, will be the primary contact. Grifcon Enterprises has been a
leading provider of consultative and other services to the natural products and
OTC industries for over 15 years, and has been a commercial lines insurance
broker for more than 45 years. Grifcon specializes in product liability
insurance and has worked extensively with trade associations and industry
leaders, with programs developed for manufacturers, importers, exporters,
distributors, wholesalers, and multi-level marketers of both raw and finished
products. They also have expertise in commercial general liability, product
recall expense coverage, professional liability for clinical trials, and general
liability. Endorsed by the American Herbal Products Association, Natural
Products Association, United Natural Products Alliance, and the American
Botanical Council, Grifcon also holds associate membership with the Council for
Responsible Nutrition.
Charles N. Jolly,
Esq., Galena, Maryland [legal and regulatory consulting];
Charles N. Jolly, will be the primary contact.
Charles N. Jolly provides general
business and legal consulting services for FDA-regulated companies.
Pharma Packaging
Solutions, Norris, Tennessee [packager, contract packager];
Reid Lederer, president, will be the primary contact. Pharma Packaging Solutions (PPS)
is a contract packager for Rx, OTC, private label, and dietary supplements
industries. PPS delivers primary and secondary packaging in the forms of bottle
filling, blister packaging (including cold form), pouching, secondary packaging,
re-packaging, re-work, folding carton production, and compliance packaging
design/production.
Quality Assured
Label, Minneapolis, Minnesota [packager, labeling services];
Harley Haase, president, will be the primary contact. Quality Assured Label (QAL) has
been an industry leader in producing quality packaging for over 25 years. The
company has printed more than 50 billion packaged products, and holds more than
15 patented products and innovative processes in use on leading global brands.
QAL leads through innovation in six specific product categories: pressure
sensitive labels, roll-fed labels, extended content labels (ECLs), blister
cards, cartons, and coupons—all produced 100 percent in-line which offers cost
efficiency and quick turn-around times. They have a fully equipped R&D and
materials testing lab, with engineers who continually challenge both the science
and art of future printing technology. QAL’s capabilities include: up to
12-color line and process printing; UV letterpress, filmography and/or screen
printing; foil application; embossing; adhesive application; lamination;
folding, gluing, die-cutting; and application of Q-vations (QAL’s specialty
coatings, techniques, and links which deliver experiential packaging that
brings products to life—engaging and interacting with customers through sensory
experience).
Roush Fenway
Racing, Concord, North Carolina [specialized marketing];
John Bauersfeld,
vice president
Business Development, will be the primary contact. Roush Fenway Racing provides
access, through sponsorship, to more than 75 million consumers who are NASCAR
fans. Roush is the
largest and most successful NASCAR team with 30+ years of motorsports experience
and over 400 victories. Sponsorships can include partial or full season,
affiliate sponsorship, team sponsorship, hospitality, and show car activation.
The Roush Fenway team helps sponsors achieve their marketing goals with years of
experience in creating a positive ROI involvement in this unique area of
product marketing. Current partners include 3M, Aflac, UPS, Ford, Coca-Cola,
Kellogg’s, and others.
RSVP Group US,
Inc., Ewing, New Jersey [human resource management, executive search];
Michael
Klinger, president, will be the primary contact; also contact
Rich Morford, principal. RSVP is an international human
resources and management consultancy firm, specializing in the life science,
chemicals, healthcare, consumer healthcare, and fast moving consumer goods
industries.
Starlite Media LLC,
New York, New York [media services];
Baret Upham,
executive vice president, head
of Sales, will be the primary contact. A full-service, place-based, at-store
advertising company that specializes in reaching consumers across 15 top
markets in the U.S. The company’s “necessity” media locations are those places
that consumers must go to on a daily and weekly basis; media displays are
positioned at the entrances and exits of high-end retail centers, reaching
consumers on their way to purchase groceries, fill prescriptions, take care of
banking, purchase/rent movies, etc. Companies that want to reach and influence
consumers before they reach the medley of products and messages inside the
stores, should contact Starlite Media.
Taratunio
Consulting Associates, LLC, Staten Island, New York [marketing and strategic
planning];
James Taratunio,
principal, will be the primary contact. Taratunio
provides go-to-market strategic planning, program development, and execution
services to drive increasing value, using customized sales strategies,
organization effectiveness, and execution at headquarters and retail for large
and niche brands. Taratunio has worked with senior management at retail,
pharmacists, front-end/back-end programs, and has developed OTC/HBC marketing
guides to help new marketing managers and sales strategy managers implement
training of retail personnel for client programs. Program development and
execution services include expertise in shopper marketing and in-store
marketing in the OTC environment, pharmacy programs from development to
execution, client and retailer training and implementation programs, pilot test
programs (controlled store testing), and in-store research.
CHPA contacts:
Ted Peterson and
Phyllis Taylor | Back to the top
CHPA's Roehrig to
serve as chair of the PQRI Steering Committee
CHPA's Dr. Rachael
Roehrig was recently named chair-elect to the
Product Quality Research Institute's (PQRI) Steering Committee. PQRI is a
nonprofit consortium of organizations working together to generate and share
timely, relevant, and impactful information that advances drug product quality
and development. CHPA is a founding member of PQRI and has been an active member
since 1996.
As PQRI Steering
Committee chair-elect,
Roehrig is looking to develop a more robust mechanism for soliciting project
proposals and providing members added opportunities to interact with FDA and the
U.S. Pharmacopeia (USP) on technical issues. One recent project was
related to nanomaterials for pharmaceuticals and their components where a grant
was awarded to produce a comprehensive technology landscape and review of the
state-of-the-art and state-of-the-science relevant to nanobiotechnology.
Roehrig continues to
look for additional project proposals from the pharmaceutical industry that
will improve product quality and the safety and efficacy of medicines. To
provide suggestions for project proposals or for additional information on PQRI,
please contact CHPA's
Roehrig.
CHPA contact:
Dr. Rachael Roehrig | Back to the top
In Brief
PQRI/FDA to hold
December workshop on process drift
The Product Quality
Research Institute (PQRI) and FDA will offer a December 1-3 workshop entitled "PQRI-FDA
Workshop on Process Drift: Detection, Measurement, and Control in the
Manufacture of Pharmaceuticals." The workshop will focus on:
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The lifecycle
approach to monitoring manufacturing performance that assures prompt
detection and correction of meaningful variation;
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Technological and
management system approaches to better control process variation and
mitigate product variability; and
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The impact of
process drift on product performance, safety, and efficacy.
The workshop will
give attendees the opportunity to ask the agency, academics, and peers questions
regarding systematic approaches, experiences, and inspection findings.
Program information and
registration are available online.
CHPA contact:
Dr. Rachael Roehrig | Back to the top
Agape International
appealing for donations for Haiti
Agape International is providing logistics (flights of supplies) to missions
in Haiti and is asking for donations of powder to mix oral rehydration solution
or electrolyte mixes such as Gatorade. To donate such items, please contact
Agape International at 978.443.8501 or
kim@agapeintl.org.
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