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Stories
A Message
from CHPA President and CEO Scott Melville:
Game Change in the U.S. Healthcare Arena
 It’s
the busiest time of year here at CHPA. The association is fully engaged in
advocacy efforts before Congress, the 50 states, and our regulatory agencies. At
the same time, we’re preparing for our Annual Executive Conference (AEC), taking
place next week in Bonita Springs, Fla.
The theme of this year’s meeting—Game Change—is a fitting description of the
dynamic events underway in today’s U.S. healthcare arena. As always, there is an
outstanding roster of speakers for this year’s meeting including Presidential Historian Doris Kearns Goodwin, former Mississippi Governor Haley Barbour, a
high level broadcast/print/digital media panel, and NYU Business School
Professor Luke Williams. In addition, this year we are offering two concurrent
business sessions--one focusing on retail trends featuring Walgreens and
Nielsen executives, and the other providing insights into the implementation of
healthcare reform with noted policy and legal experts. Of course, there will be
plenty of time for networking and we’ll be sure to add a high degree of fun,
too. So I hope to see many of you there—it's not too late to register—and I
look forward to catching up.
Click here to read the full story.
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CHPA participates in the Community Anti-Drug Coalition’s (CADCA) National
Leadership Forum
CHPA’s Emily Skor and Tammy Walsh, the newest “mom” to join the Stop Medicine
Abuse Five Moms campaign, discussed how to engage communities to stop cough
medicine abuse during a joint CHPA and Community Anti-Drug Coalition’s (CADCA)
workshop on February 7 during CADCA’s National Leadership Forum. This year’s
forum took place February 6-9 in National Harbor, Md.
The forum brought together more than 2,500 participants representing community
anti-drug coalitions from all regions of the country, government leaders, youth,
addiction treatment professionals, researchers, educators, law enforcement
professionals and faith-based leaders.
In addition to the workshop, CHPA staff also hosted a booth on the exhibit floor
throughout the conference to share information and resources from the
StopMedicineAbuse campaign to give attendees tools to spread awareness about
cough medicine abuse in communities across the country.
Emily Skor presents at CADCA's National Leadership Forum.
Photo by Nobile Photo
Tammy Walsh presents at CADCA's National Leadership Forum.
Photo by Nobile Photo
Meetings on Capitol Hill with our newest Five Mom
On February 8, Tammy Walsh and CHPA staff traveled to Capitol Hill to meet with
members of her Congressional delegation in support of federal legislation to
enact sales restrictions on DXM products to minors.
A native of Northport, N.Y., Tammy met with staff from the offices of Senators
Schumer (D-NY) and Gillibrand (D-NY) and with Congressman Israel (D-NY-2).
Tammy Walsh meets with Congressman Israel.
Dose of Prevention Award
CHPA President and CEO Scott Melville presented the annual Dose of Prevention
award, which recognizes CADCA-member coalitions that have helped raise awareness
about the dangers of over-the-counter cough medicine abuse in their community,
during CADCA’s Awards Luncheon on February 9. This year’s winner was the Youth
Community Coalition (YC2) from Columbia, Mo. YC2 works toward decreasing
substance abuse and promoting healthy behaviors among Columbia’s youth to foster
their positive development.
CHPA President and CEO Scott
Melville and CADCA Chairman & CEO Maj. Gen. Arthur Dean present the Dose of
Prevention Award to YC2 representatives.
Photo by Nobile Photo
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Federal
Register Update
Public Hearing on
FDA Using Innovative Technologies to Expand Which Drug Products Can Be
Considered Nonprescription
In the Feb. 28
Federal
Register, FDA announced a public hearing on March 22-23 at FDA's White
Oak Campus in Silver Spring, Md. to obtain input on a new paradigm where the
Agency would approve certain drugs that would otherwise require a prescription
for nonprescription use (OTC) under conditions of safe use. These conditions of
safe use would be specific to the drug product and might require sale in certain
pre-defined health care settings, such as a pharmacy. Request to speak due to
FDA by March 9. Written comments due to FDA by May 7.
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Available Guidance on Postmarketing Adverse Event Reporting During an Influenza
Pandemic
FDA announced in the Feb. 24
Federal Register the availability of a guidance for industry titled “Postmarketing Adverse
Event Reporting for Medical Products and Dietary Supplements During an Influenza
Pandemic.” The guidance discusses FDA’s intended approach to enforcement of
adverse event reporting requirements for drugs, biologics, medical devices, and
dietary supplements during an influenza pandemic. Comments may be submitted to
FDA at any time.
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Available Draft Guidance for Industry on Drug Interaction Studies
FDA announced in the Feb. 21
Federal Register the availability of a revised draft guidance for
industry titled “Drug Interaction Studies--Study Design, Data Analysis,
Implications for Dosing, and Labeling Recommendations.” The revised draft
guidance is intended to provide recommendations for sponsors of new drug
applications and biologics license applications for therapeutic biologics
regarding in vitro and in vivo studies of drug metabolism, drug transport, and
drug-drug, or drug-therapeutic protein interactions. Comments are due to FDA by
May 21, 2012.
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Meetings
2012 Annual Executive Conference is Next Week!
Members can
still register for CHPA’s Annual Executive Conference (AEC), March 8-10 at The
Hyatt Regency Coconut Point Resort & Spa in Bonita Springs, Fla. Healthcare
executives from across the nation will participate in high-level education
sessions focused on emerging markets, evolving new media, industry trends, and
the pivotal political landscape.
Conference
Highlights
• Keynote
Address: Lessons in Leadership with Pulitzer Prize-Winning Author and
Presidential Historian Doris Kearns Goodwin
• Changing Your Media Game: Platform Integration in a
Hybrid World with panelists Jack Haire, Parade Publications Inc.; Tim
Spengler, Initiative; and Michelle Schumaker, Google, Inc.
• Health Policy Game Changers with panelist Gerald Masoudi, Covington &
Burling LLP; Christopher Jennings, Jennings Policy Strategies; and Ginger Loper,
Loper Consulting.
• OTCs of the Future: The Retail Picture with Rob Wengel, Nielsen; Joe
Magnacca, Walgreens Co.; and John Burbank, Nielsen.
• Conversations with Power: The New Political Landscape with former
Mississippi Governor Haley Barbour
• Mastering Change for Business Success with Luke Williams, NYU's Stern
School of Business.
Networking
Events - Don't Miss Out!
• 3D Communications & Edelman Casino Night event, Thursday, March 8;
7:00-10:00pm
• Grey Group Reception, Friday, March 9; 6:00-7:30pm
• NEW! Catalina & Nielsen "After-Glow" Party, Friday, March 9;
9:00pm-12:00 midnight
• CHPA Golf Tournament (additional fee), Saturday, March 10; 12:30-5:00pm
• Hyatt Regency Coconut Point Resort & CHPA Closing Dinner, Saturday,
March 10; 6:00-8:00pm
Register online or fill out the
registration form.
Learn more at
chpa-info.org/AEC.
Thank You Sponsors
CHPA thanks
the following generous sponsors of the 2012 Annual Executive Conference.
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Take Advantage of 2012 RSC Early-Bird Registration Rates Until March 30
Now is the time to
take advantage of
early-bird registration rates for the 2012 CHPA Regulatory & Scientific
Conference (RSC), May 10-11 in Washington, D.C. Members can save $100 by
registering before March 30.
This conference will focus on regulatory issues and scientific advances that
enable innovative approaches in the self-care space, maximizing the essential
connections between manufacturers, regulators, and consumers of over-the-counter
(OTC) products.
Featured speakers
and sessions include:
May 10
Opening Session
A Dialogue with CDER’s Dr. Janet Woodcock
Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
Keynote Address
The Future of Self-Care: Trends and Innovation
Michael Rogers, Principal, Practical Futurist
Afternoon Panel 1
Exploring a Benefit/Risk Model for OTC Products
Eric P. Brass, M.D., Ph.D., Professor of Medicine, UCLA; and Director,
Harbor-UCLA Center for Clinical Pharmacology
Afternoon Panel 2
Best Practices in Safety Surveillance
Rick Kingston, Pharm.D., President, Regulatory & Scientific Affairs,
SafetyCall International; and Senior Clinical Toxicologist & Clinical Professor
of Pharmacy, University of Minnesota
May 11
Morning Session
Baby Boomers and Self-Care Product Innovation
James C. Appleby, R.Ph., M.P.H., Executive Director & CEO, The Gerontological
Society of America
Closing Session
U.S. FDA Update Panel
Fill out the
registration form
or
register online now.
View the
registration
brochure.
Thank You Sponsors
CHPA thanks the
following generous sponsors of the 2012 Regulatory & Scientific Conference.
If you're interested in sponsorship opportunities, contact
Marcia Howard.
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Register Now for 2012 Market Exchange
Registration
is now open for the 2012 Market Exchange, Sept. 12-13 at the Sheraton Parsippany
Hotel in Parsippany, N.J.—new
hotel and location!
Developed by CHPA
members for CHPA members, the CHPA Market Exchange is focused exclusively around
opportunities, connections, and face time with consumer healthcare executives.
Touted as the most comprehensive, face-to-face business meeting of the year,
Market Exchange features a convenient and time-efficient networking forum, with
up to 24 pre-scheduled appointments with existing and prospective customers.
No other venue in the consumer healthcare industry brings together so many key
decision-makers for the specific purpose of exploring opportunities to work
together. Save your company time and money by meeting with your most valued
business contacts in one place, at one time.
For more information, view the new
registration brochure
and register today.
Thank You Sponsors
CHPA thanks the
following generous sponsors of 2012's Market Exchange.
If you're interested in sponsorship opportunities, contact
Phyllis Taylor.
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CHPA News
CHPA Job Board Posts
Industry Job Openings
Find the talent
that's right for your company on CHPA's members-only
job board.
The job board
allows members to post openings in their companies and view career opportunities
in other companies. Take advantage of this valuable resource to search for
consumer healthcare opportunities across the industry. For assistance in
accessing the members-only section of the website or in creating a new account,
contact CHPA's Susan DiBartolo and
Phyllis Taylor.
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CHPA Submits Comments to CMS' Proposed Rule to Medicare, Medicaid, Children’s
Health Insurance Programs
On Feb. 16, CHPA submitted comments to the Centers for Medicare and Medicaid
Services (CMS) regarding the proposed rule that would require applicable
manufacturers of drugs, devices, biologicals, or medical supplies covered by
Medicare, Medicaid or the Children’s Health Insurance Program to report annually
to the Secretary certain payments or transfers of value provided to physicians
or teaching hospitals.
In the comments, CHPA supported the agency’s decision to limit the disclosure
trigger definition of “covered drug, device, biological, or medical supply” to
only those drugs and biologicals that require a prescription by law in order to
be dispensed, thus excluding drugs and biologicals that are available to
consumers over the counter. CHPA further urged CMS to change the proposed rule
to exclude payments or transfers of value related to OTC drugs altogether,
including for manufacturers who produce both covered products and OTC drugs.
CHPA also requested a change in the proposed rule to exclude payments or
transfers of value related to OTC medicines for manufacturers, including for
manufacturers who produce both covered products and OTC medicines. This change
would assure that an undue burden would not be placed on manufacturers of OTC
products that is not currently required by law, would reduce unintended
consequences, and would avoid an inefficient burden on OTC manufacturers
yielding minimal if any value to CMS.
To view the submitted comments,
click here.
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Industry
News
New
Survey Released by the Center for Medicine in the Public Interest
A
new survey released by the Center for Medicine in the Public Interest (CMPI)
on Feb. 17 reported that the majority of adult consumers and parents in the
United States rely on accessible, affordable over-the-counter (OTC) cough
medicines to treat themselves and their families’ cough symptoms.
The survey illustrates consumers’ reliance upon OTC cough medicines as a
first-response to relieve cough symptoms for themselves and their children in
order to go about their daily lives:
-
61 million
consumers in the past 12 months have avoided missing work, school, or other
scheduled appointments because they had access to OTC cough medicines to
treat their symptoms (extrapolated from survey findings, based on U.S.
Census data).
-
8.5 million
households in the past 12 months have children ages four or older who have
avoided missing school or daycare due to illness because their parents had
access to OTC cough medicines to manage their symptoms (extrapolated from
survey findings, based on Census data).
-
Two-thirds (66
percent) of surveyed adults and 70 percent of surveyed parents rely on OTC
cough medicines to treat their own and their children’s symptoms.
-
If using OTC
cough medicines required a prescription, 78 percent of consumers believe
that it would place a burden on them and their family because they would
need to visit a doctor.
The survey was
conducted by StrategyOne in partnership with CMPI through a grant from CHPA.
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CHPA, IPEC-Americas
and SOCMA Co-Sponsor ICH Q3D Metal Impurities Workshop
The Consumer Healthcare Products Association, the
International Pharmaceutical Excipients Council - Americas, and the Society of
Chemical Manufacturers and Affiliates are co-sponsoring a workshop titled "ICH
Q3D Metal Impurities Workshop: Impact of Excipients," April 4-5 in Bethesda, Md.
The workshop will provide a confidential method for providing data on actual
levels of metal impurities that exist in commonly used excipients, including
what levels this may create in various dosage forms and how it impacts the
implementation of the Q3D guideline and the associated compendial chapters.
Participants will include the International Congress on Harmonization (ICH) Q3D
Expert Working Group in addition to expert representatives from the excipient
and pharmaceutical industries who are directly involved in the assessment of the
Q3D requirements and their impact on drug products.
To register, visit www.ipec-events.com.
For more information and to view the program,
click here.
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Stericycle ExpertRECALL 4th Quarter Recall
Stericycle's
ExpertRECALL 4th Quarter Recall Report is
now available. This report highlights recall trends among five product
categories, including medical devices, pharmaceuticals, food, consumer products,
and children's products. This free resource is produced on a quarterly basis.
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