FDA to Change Regulations Regarding
Side-Effect Information in Drug Ads

Goodbye Fine Print?
          

    BRIDGEWATER, N.J., April 29 /PRNewswire/ -- The Food and Drug
Administration is about to make it easier for you to understand both the
benefits and risks of a prescription medication, it was revealed at the Second
Annual Medical Liaison Seminar sponsored here by Scientific Advantage LLC.

    "Consumers ignore the presentation of adverse effects in print
advertisements and TV commercials," said Thomas W. Abrams, RPh, MBA, Director
of the Division of Drug Marketing and Communications of the FDA. "We have got
to get people to pay attention and one way to do that is to have headlines and
a question and answer format so that it is more appealing. We want to present
the most common risks."

    Abrams said that the FDA's objective is to protect and promote public
health and to ensure that prescription drug promotion is not false or
misleading.

    "We have to ensure that the complete picture of a drug is conveyed and get
more useful information about drugs and diseases to the American public."  He
said medical liaisons can play an important role by providing new information
to health care professionals about developments in pharmaceuticals and disease
awareness.

    Robin Winter-Sperry, MD, president of Scientific Advantage, a
Bernardsville, NJ company pointed out that medical liaisons (MLs), are a
rapidly growing specialty in the pharmaceutical industry. They are often the
ones who build the first bridges from the pharmaceutical companies to the
health care communities. "They blaze trails through the uncharted territory of
early clinical trials, answering physicians' questions long before the package
inserts are written."

    Michael Pucci, Vice President of External Advocacy for GlaxoSmithKline
gave a rousing defense of the pharmaceutical industry which he said now is
being wrongly perceived by many in the same negative light as big tobacco.

    He said the public complains about the costs of their medications but
today's pharmaceuticals pay for tomorrow's miracle drugs. Pharmaceutical
companies from other countries are moving to the United States because of the
scientific environment and the ability to support their research.

    "Within five years, for example," he said, "there will be a vaccine to
prevent cervical cancer; a kinase inhibitor that will allow patients with
cancerous tumors to take a pill instead of having to go through chemotherapy
and there are 21 different projects underway to treat Alzheimer's disease."
    He said the message has to get out to the public about the true worth of
medications: "A bottle of Lipitor may cost $90 a month but isn't it worth $3 a
day to prevent having a heart attack?"

    The politicians talk about importing medications, Pucci said, but
countries with socialized medicine such as Canada and Great Britain that
require generics be used support their price: "What Americans don't realize is
that if they import a generic drug from Canada or Great Britain, they will pay
more for it than if they purchased the same drug in the United States."

    He also pointed out that many people don't know a lot of the big drug
companies provide medications free or at reduced cost to patients who cannot
afford them.  The toll-free number to call to find out more information about
the program is 1-888-477-2669.

    Scientific Advantage, LLC is the industry leader in creating medical
liaison departments and clinical operations.  For more information about this
company and the Annual Scientific Advantage Liaison Seminar, please contact
them at http://www.ScientificAdvantage.com or (908) 204-0995, e-mail:
info@scientificadvantage.com

     Contact Information:

     Xio Curry
     908-204-0995 ext. 6
     FAX: 908-292-1114
          

PRESS RELEASE March 17, 2005

TO BUSINESS, LEGAL AFFAIRS AND MEDICAL EDITORS:

Pharma Under Fire: Industry and Government Leaders Look to the Future, Says Scientific Advantage

BRIDGEWATER, N.J., March 17 PRNewswire -- As the pharmaceutical industry comes under unprecedented scrutiny, influential leaders in industry, government and law will discuss the future at "The Second Annual Medical Liaison Seminar: Partnering for Product Success" April 27-28, 2005, sponsored by Scientific Advantage LLC.

Thomas W. Abrams, RPh, MBA, Director of the Division of Drug Marketing, Advertising and Communications (DDMAC) of the US Food and Drug Administration (FDA) will give a keynote address on new regulatory developments and Peter O. Safir, Esq., of the Washington law firm, Covington & Burling, which has major pharmaceutical companies as clients, will present a keynote on dealing with risk management and product liability.

Other panelists include Scott Gottlieb, MD, Editor of the Forbes/Gottlieb Medical Technology Investor, formerly the Senior Advisor to the Administrator, Centers for Medicare/Medicaid Services (CMS) who will discuss Washington's health care agenda for the next 18 months. John M. O'Brien, Pharm D, Director of State Policy, PhRMA, and a former medical science liaison for Sankyo Pharma, will present his perspective on the importance of medical science liaisons to the industry's future.

Robin Winter-Sperry, MD, founder of Scientific Advantage LLC, points out that the program is designed for the healthcare industry's rapidly evolving area of specialization, the medical scientific liaison.

"Medical liaisons -- usually advanced-degree scientists -- provide leaders in the medical community with fair, balanced, data driven clinical information about their company's products. Medical liaisons are on the leading-edge of scientific research and medical education."

For more information about attending or covering "The Second Annual Medical Liaison Seminar: Partnering For Product Success" go to ScientificAdvantage.com.

SOURCE Scientific Advantage LLC

CONTACT: Marie Tartaglio, MEd, 610-647-3444 Marie.Tartaglio@scientificadvantage.com, for Scientific Advantage LLC

www.ScientificAdvantage.com

KPMG Health Care Insider

Are Medical Science Liaisons Just What the Doctor Ordered?