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Association News
CHPA presents the "Top 10"
reasons to attend the 2006 AEC
Although the ball has not yet dropped to signify the beginning of 2006, CHPA
staff already is counting down the days until its Annual Executive Conference (AEC).
There are many reasons members should attend this premier event, set
for March 16-18 at The Fairmont Turnberry Isle Resort & Club in Aventura,
Florida. To help put it into perspective, the Association has developed the
following "Top 10" list:
Number ten: Cap off the opening night with friends and colleagues by
celebrating CHPA’s 125th
anniversary, complete with fireworks, compliments of The Emerson Group.
Number nine: Mingle
with key contacts at the ACNielsen opening night dinner, featuring a must-see
performance from Cirque.
Number eight:
Get plugged into the techniques behind what Ad Age terms the "tactics du
jour"—word-of-mouth and mobile marketing—at
the March 17 session entitled
“Politics-to-Go: What Political Campaigns and Evolving Technologies Can Teach
Us About Consumer Product Marketing.”
Number seven:
Revisit CHPA’s industry accomplishments and learn about
future initiatives in presentations by CHPA Chair Tim Hayes, Chair-elect
John
Hendrickson, and President Linda A. Suydam, D.P.A.
Number six: Take part in a thought-provoking
discussion with Newt Gingrich, Judy Feder, and Gail Wilensky,
on the future of healthcare, presented by Cargill Health & Food Technologies.
Number five: Watch
Sam
Donaldson lead a panel of senior business leaders on
“The Consumer As Sovereign,” brought to you by Information Resources, Inc.
Number four: Hear
Dan Pink
explain why the era of “left brain” dominance is over,
and “right brain” thinking is ascending, thanks to
Information Resources, Inc.
Number three:
On Friday morning, attend the Heart Magazines breakfast session to listen to demographer
Neil Howe talk about generational shifts and cycles. Then on Saturday
morning, eat and listen some more at the Reader’s Digest breakfast
session where Pulitzer Prize winner David Halberstam will discuss “Who We
Are: America Then
and Now.”
Number two: Spend quality networking time with
colleagues and contacts at: the Grey Worldwide reception, before and after the
Prevention Magazine fun run, during
the sports events, and at the final evening picnic.
Number one:
Be instrumental in shaping the direction in which CHPA is headed for 2006 and beyond.
Register for the AEC online or by
downloading the conference brochure and returning it to CHPA. Both options are
available in the members-only section of
www.chpa-info.org.
CHPA contacts: Kass Kassouf and
Maria Sarbia | Back to the top
CHPA nominates Goldstein to
serve as industry rep to NDAC
CHPA recently nominated George S. Goldstein, M.D.,
F.A.A.P., as the industry representative to FDA's Nonprescription Drugs
Advisory Committee (NDAC). In a November 28
letter to to the Agency, the Association highlighted Goldstein's extensive medical career history, which includes 14 years in
private practice as a pediatrician. He also spent 15 years at Sterling Drug Inc.
where he served as chief medical officer to the company's OTC drug division and
prescription drug division. According to his
résumé,
Goldstein has made appearances before the United Nations, the World Health
Organization, the UN Commission on Narcotic Drugs, and the International
Federation of Pharmaceutical Manufacturers and Associations. He received his medical
degree from SUNY Upstate Medical Center.
CHPA informed FDA that it has consulted with other interested
industry organizations concerning its nomination of Goldstein and that it would
work to reach consensus in the selection process for the NDAC representative.
CHPA contact: Dr. Lorna Totman | Back to the top
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CHPA holiday schedule |
|
CHPA's
staff will observe the following schedule
during the
upcoming holidays:
Office closed: December
26-January 2
Office reopens: January 3,
2006
|
Back to the top
Industry News
On Capitol
Hill
U.S. House approves FSA
rollover provision
The U.S. House of Representatives approved legislation December 15 to
overhaul the nation’s pension system; require employers to enhance funding of
pension plans offered to employees; and to improve the financial
health of the Pension Benefit Guarantee Corporation (PBGC), the federal agency
that insures private pensions. The pension reform bill also includes a provision that
would allow employees who have Flexible Spending Accounts (FSAs) to carry
forward up to $500 in unused benefits to the next calendar year or to contribute
the funds to a health savings account (HSA). The $500 per year “rollover”
provision is intended to encourage more employees to enroll in FSA programs by
eliminating the requirement that they must “use or lose” all monies in the
account at the end of the year. The Internal Revenue Service has ruled that the
out-of-pocket costs of OTC drugs can be reimbursed from FSAs or HSAs.
The debate on pension reform legislation now moves to a
House-Senate conference committee to resolve differences between the House and
Senate versions of the bill. The Senate passed its version of the bill November
16, but did not include the FSA rollover provision.
CHPA contact: Kevin Kraushaar | Back to the top
Senate fails to adopt anti-meth
initiative
Last week, the U.S. House of Representatives passed legislation to reauthorize
the Patriot Act. Included within this initiative was a measure aimed at
addressing methamphetamine abuse by placing medicines containing pseudoephedrine
behind the counter, implementing a sales limit of nine grams per month, and
requiring customers to show identification and sign a log book. Because
negotiations on this legislation broke down in the U.S. Senate, the
Senate-passed version did not include the anti-meth provision. However, Senate
leaders have assured legislators that the measure will be taken up in early
2006.
CHPA contact: Kevin Kraushaar | Back to the top
OTC Issues
NDAC to consider OTC use of
tetrahydrolipstatin
FDA issued a notice
in the December 16 Federal Register announcing that its Nonprescription
Drugs Advisory Committee (NDAC) will meet jointly with its Endocrinologic and
Metabolic Drugs Advisory Committee January 23, 2006, from 8:00 a.m. to 5:00 p.m.
in Bethesda, Maryland. The purpose of the meeting is for committee members to
consider the safety and efficacy of a new drug application submitted by
GlaxoSmithKline (GSK) that proposes the OTC use of Orlistat
(tetrahydrolipstatin) capsules. In its application, GSK recommends a 60-milligram dosage to promote weight loss in adults when used along with a
reduced-calorie, low-fat diet.
According to FDA, the background materials will be posted to its
web site no later than one day prior to the
meeting. Persons wishing to submit written comments on the subject matter or to
present orally during the meeting should contact
Darrell Lyons by January 13, 2006.
CHPA contact: Dr. Lorna Totman |
Back to the top
FDA proposes amendment to OTC
dandruff monograph
FDA published a
proposed rule in the December 9 Federal Register that would amend the
final monograph for OTC dandruff, seborrheic dermatitis, and psoriasis drug
products to include the combination of 1.8 percent coal tar and 1.5 percent
menthol in shampoo. The Agency issued the proposed rule after considering a
study submitted in a citizen petition. Based on FDA's review of the information,
the Agency believes that the specific concentrations of 1.8 percent coal tar
and 1.5 percent menthol combined in a shampoo should be generally recognized as
safe and effective to control dandruff and relieve itching associated with
dandruff. FDA points out that no data for a range of concentrations for coal tar
and menthol have been submitted, so the final monograph should include
only the concentration of each active ingredient used in the study.
FDA is proposing that a final rule on this proposal become effective 30 days
after publication. Comments are due by March 9, 2006.
CHPA contact: Dr. Lorna Totman | Back to the top
Nutritional Supplement Activities
New allergen labeling for the
new year
The Food
Allergen Labeling and Consumer Protection Act of 2004 labeling
requirements will take effect January 1, 2006. This act addresses,
among other issues, the labeling of foods, including dietary supplements, that
contain certain food allergens.
FDA's Center for Food Safety and Applied Nutrition recently posted the following updates to its
web site on the law:
The Agency
notes that “it is not unlikely” that FDA may consider threshold levels
for allergens in the future in the context of exemption petitions or
notifications.
CHPA contact: Dr. Marcia Howard | Back to the top
In Brief
Germany approves switch of
a triptan
Government officials in Germany recently approved the
prescription-to-nonprescription switch of naratriptan hydrochloride (2.5 mg
tablets) for relief of migraine symptoms. Naratriptan will be available in
Germany beginning April 1, 2006, in maximum package sizes of two tablets, or
five mg. It was expected that the switch would have gone into effect January 1,
2006, but the parliamentary order includes an extra phase for manufacturers
to alter labeling and product information.
Back to the top
ASMI
holds its fourth annual corporate communications summit
The American Strategic Management Institute (ASMI) is holding its fourth annual
corporate communications summit February 28-March 2, 2006, in San Diego,
California. The program, which will focus on both internal and external
communications, features leading business communicators who will address such
issues as brand identity, crisis response, corporate strategy, internal
alignment, message building, and performance management. For more information on
this event, visit ASMI online.
Back to the top
Industry-related meetings of
interest for 2006
Following is a listing of association meeting dates and locations for 2006—including CHPA's—that are of
interest to the industry:
|
Date
|
Meeting
|
Location
|
| March 1-4 |
Cosmetic, Toiletry and Fragrance Association Annual Meeting |
Boca Raton, FL |
| March 16-17 |
Pharmaceutical
Research and Manufacturers of America Annual Meeting |
Washington, DC |
March 16-18
|
2006 CHPA
Annual Executive Conference
|
The Fairmont Turnberry Isle Resort & Club
Aventura, FL |
| March 17-21 |
American Pharmacists Association Annual Meeting and Exposition |
San Francisco, CA |
March 22-24 |
Nutracon |
Anaheim, CA |
March 23-24 |
Natural Products
Expo West |
Anaheim, CA |
| April 29-May 3 |
National Association of Chain Drug Stores Annual Meeting |
Palm Beach, FL |
| May 1-3 |
Supply Side East International Trade Show and and Conference |
Secaucus, NJ |
| May 2-3 |
CHPA Regulatory
and Scientific Conference |
The Fairmont Hotel
Washington, DC |
| June 9-12 |
Grocery Manufacturers Association Executive Conference |
White Sulphur Springs, WV |
| October 4-6 |
Healthcare Distribution Management Association Annual Leadership Forum |
Orlando, FL |
| October 4-7 |
Natural Products
Expo East |
Baltimore, MD |
| October 7-11 |
National Community Pharmacists Association Annual Convention & Trade
Exposition |
Las Vegas, NV |
| October 18-20 |
Supply
Side West International Trade Show and Conference |
Las Vegas, NV |
Back to the top
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