FDA Cheif now takes to the road

[Guest guest]

Who says that his townhall meetings should only be on drugs?

He says that they are a CONSUMER PROTECTION AGENCY...ok, label cosmetics

as they are not food and nutrition!

FDA chief takes show on the road

Crawford to hear consumer concerns

By Diedtra , Globe Staff | August 16, 2005

WASHINGTON -- The new head of the Food and Drug Administration will hit

the road, Oprah-style.

To find out what is on the minds of American consumers, FDA commissioner

Lester Crawford will walk through smallish audiences, fielding questions.

Crawford picked the talk show format for ''Vision 2006 " public hearings

the agency will hold in Massachusetts, Arizona, and Florida. The hearings

will be Crawford's highest-profile event since his Senate confirmation.

The first will be held Sept. 13 in Miami, followed by a Nov. 2 hearing at

the Boston Marriott, in Cambridge, and a Nov. 30 session in Phoenix,

according to an eight-page notice published in today's Federal Register.

People interested in attending may register at www.grad.usda.gov/vision.

Suzanne Trevino, an FDA spokeswoman, said the sessions will not be idle

chatter.

''This is an opportunity for Dr. Crawford to shape his leadership ad set

the tone that we are very interested in what consumers have to say and

will be responsive to what they have to say, " Trevino said.

Trevino said public comments will influence FDA actions as the regulatory

agency celebrates its 100th anniversary in 2006. Each 10 a.m. to 4 p.m.

session will include at least 150 people, with time devoted to such

hot-button topics as drug advertising, conflicts of interest among federal

advisers, and drug safety.

The events lift a page from the playbook of Dr. A. Kessler, who held

similar information exchanges with the public while serving as FDA

commissioner from 1990 to 1997.

Such sessions can serve triple duty, said Vodra, a former FDA

associate chief counsel for drugs. They balance the sessions the FDA holds

with the drug industry, give a chance to hear what a large number of

consumers have on their minds, and make the agency's top leaders and

scientists accessible.

''This is a consumer-protection agency, " said Vodra, a partner at Arnold &

Porter in Washington, D.C. ''If the consumers think they've bagged out to

industry, that's a very bad thing. They've got to be open and available. "

This fall's meetings come as the FDA faces unprecedented scrutiny from

Congress and the public, as well as criticism from the drug industry. Last

fall's withdrawal of the painkiller Vioxx due to heart risks triggered

congressional hearings and fueled calls for major changes at the FDA. To

fend off congressionally mandated changes, the drug industry has initiated

voluntary restrictions on advertising to consumers.

''The FDA needs to step in to not only vet these drugs for safety, but

also make them not so susceptible to consumer whim, " said Lori Ehrlich,

42, a certified public accountant who lives in Marblehead with her husband

and two daughters.

Ehrlich said television ads for erectile dysfunction drugs prompted her 9-

and 13-year-old daughters to ask ''a lot of questions. " The conversaions

that followed were age appropriate, but remained uncomfortable. And the

episode piqued her curiosity. A quick family survey showed nine of 13

advertisements during the evening news were for pharmaceuticals.

''They're just so in-your-face now, " Ehrlich said.

In addition to drug advertising qualms, the FDA expects drug safety

concerns to be on consumer's minds.

Few consumers balance the risks and benefits of prescription drugs, said

Alan Sager, a professor of health services at Boston University.

''Most of us listen to our doctors and do what our doctor says because our

doctor has actually been to medical school, " Sager said. ''Most of us

haven't the time, ability, or willingness to make these complicated

trade-offs. "

The FDA chose locations around the nation to gauge consumer interest that

can vary by region. Cambridge has a high concentration of drug and medical

device companies whose profits are affected by the speed of FDA drug

approvals. Arizona and Florida have high numbers of elderly residents, who

use more prescription drugs than younger consumers. Trevino said Florida

was selected for the diversity of its aging population, and Arizona

because many seniors travel to Mexico to buy inexpensive prescription

drugs.

The FDA has warned that prescription drugs purchased in Canada or Mexico

could be made in far-flung countries aand could be unsafe.

But elderly residents also hear from doctors that they should take

prescription drugs to improve or lengthen their lives.

''Half the time, it's bad advice. But that's what they hear, " said Arthur

Levin, director of the Center for Medical Consumers. ''The question is

what message are you going to hear louder? "

Those who can't afford life-saving drugs trek across the border, despite

the FDA warnings, he said.

Diedtra can be reached at dhenderson@....

" Toliet water is to be FLUSHED, not WORN! "

Angel

" If having endured much, we at last asserted our 'right to know' and if,

knowing, we have concluded that we are being asked to take senseless and

frightening risks, then we should no longer accept the counsel of those

who tell us that we must fill our world with poisonous chemicals, we

should look around and see what other course is open to us. "

Carson

" My toxicasa (world) is your toxicasa (world). "

Judith Goode