FDA to change regulations regarding side-effect information in drug ads

May 2 2005

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.

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