Using the FDA's own statement

[Guest guest]

I agree 10000%

Rogene

--- Lana Transue <lanadearest@...> wrote:

> I found this in the FDA's website yesterday. This

> letter was designed in

> order to convince people that the FDA should be

> monitoring ALL medications.

> They use these words to convince congress that

> people shouldn't be able to

> buy drugs off of the internet. I think we should

> take the part that talks

> about how important research is, keep the letter

> head and raise the name and

> signature. Let's use their own words against them!

> What do you think? Lana

>

> Remarks by:

> Jane E. Henney, M.D.

> Commissioner of Food and Drugs

> U.S. Food and Drug Administration

> for

> ASSURING SAFETY IN A RISKY WORLD

> Kansas State University

> March 9, 2000

> " This text contains Dr. Henney's prepared remarks.

> It should be used with

> the understanding that some material may have been

> added or deleted during

> actual delivery. "

>

> Good evening. Thank you for the opportunity to be

> here tonight. I appreciate

> having a chance to return to the midwest-and be

> among friends and

> colleagues. We have forged a friendship that has

> lasted for years. We've

> sweated through grant getting and celebrated success

> as we watched many post

> docs and graduate students participate in a

> multi-center project.

> Dr. Terry -- " Wizard " --has done so many things

> for this community.

> Watch him for what is coming. You had your own Harry

> Potter before Harry

> Potter was cool. Just watch out if he gets a Nimbus

> 2000 and starts zooming

> the skies.

> I was asked to share with you some of the challenges

> facing the FDA today in

> the area of product safety. It is FDA's fundamental

> responsibility to assure

> the safety of the many products it

> regulates-everything from drugs for

> humans; drugs and feed for animals--those you

> consume or those that you

> adore; biologics such as gene therapy, blood and

> vaccines; medical devices

> from tongue blades to pacemakers; to foods and food

> additives; cosmetics,

> diagnostics; and some things you may not realize,

> like microwave ovens and

> other radiation-emitting devices. In assuring the

> safety of medical

> products, the agency is always in the business of

> weighing their benefits

> against their risks. And there are inherent risks

> associated with nearly all

> of the products we regulate.

> You probably go about your day-buying and preparing

> food, undergoing medical

> diagnosis and treatment, filling a drug prescription

> or checking out the

> latest over-the-counter remedy for baldness, trying

> out a new shade of

> lipstick, or using a laser pointer in your latest

> lecture. Whether you are

> aware of it or not, your day-to-day lack of worry

> regarding the safety of

> products we regulate hopefully reflects confidence

> that the FDA is doing its

> job on your behalf.

> Throughout its nearly 100 year history, the FDA has

> enjoyed a high level of

> trust by the American people, which continues to the

> present. But trust is a

> fragile thing and we do all we can and should to

> assure that we have your

> vote of confidence in the future. For trust once

> lost is difficult to

> regain, as our counterpart regulatory bodies in

> Europe have experienced in

> recent years.

> Our uniquely American way of representative

> government has society's

> expectations--for matters ranging from national

> defense to public health and

> safety--reflected in law. A regulatory body is then

> expected to make these

> laws operative.

> The benefits of a strong regulatory agency such as

> the FDA are many. The

> most important benefits are enjoyed by patients and

> consumers who need safe

> and effective products. But benefits are also

> realized from an economic

> standpoint, for a high-quality, science-based

> regulatory agency attains

> credibility and respect on a global scale,

> stimulating innovation, enhancing

> U.S. competitiveness abroad, providing a predictable

> and level playing field

> for industry, and encouraging increased foreign

> investment in this country.

> What are some of the challenges we face? First and

> foremost are the

> tremendous advancements in science and technology.

> Both government and the

> private sector have invested enormous resources in

> biomedical research and

> biotechnology. The result of this investment is, and

> will continue to be, a

> wealth of new products and technologies that will be

> presented to the FDA

> for our review and approval before they are

> introduced into the marketplace.

> In order to make these judgements, it is essential

> that the FDA have the

> scientific talent to adequately assess the safety

> and effectiveness of these

> novel products and technologies. Our scientists must

> be current in their

> fields of expertise, quick learners in new areas,

> and have the creativity

> and ability to collaborate with other scientists in

> the FDA and outside the

> agency. When Wayne Gretzky, of ice hockey fame, was

> asked what made him a

> successful player, he said, " I skate to where the

> puck will be. " FDA is in a

> similar position. We must be able to anticipate and

> access the cutting-edge

> science that will be needed to regulate the products

> of future technology.

> Our scientists help to establish standards for

> product performance and

> potency, provide data to support regulatory

> decisions on product safety and

> information to consumers for the safe use of

> products, and provide the basis

> for science-based regulatory policies. The safety of

> vaccines, acceptable

> levels of mycotoxins such as fumonisin B1 in corn

> products, more rapid

> methods of detecting pathogens in food, better

> understanding of the

> significance of antibiotic resistance, are all

> examples of the products of

> research from within FDA laboratories. A high

> quality staff and robust

> regulatory research program are critical for

> supporting, in a scientifically

> sound fashion, the review and regulatory decisions

> we make every day.

> The interaction between our researchers and our

> regulatory, review and

> enforcement scientists is becoming increasingly

> critical given the rapid

> pace of advancements in science and medicine.

> Enhancing the agency's science base has been one of

> my highest priorities

> since I became the Commissioner almost one and a

> half years ago. We at the

> FDA continue to work tirelessly to make this

> happen-ensuring that the FDA

> has the strongest possible scientific acumen-the

> most capable scientists and

> the most current and reliable scientific information

> to support our

> decisions. Clearly, having a less than excellent

> scientific capability at

> the FDA is not an option. Our scientific component

> includes field

> investigators, laboratory researchers, reviewers in

> all areas of FDA's

> product responsibilities, and all other employees

> involved in scientific and

> policy decision-making.

> While we must be scientifically sound, consistent,

> and predictable in our

> review of products and issues that surround product

> approvals, it is equally

> vital to maintaining credibility that our

> decision-making be open and

> transparent to the lay public, health professionals,

> the regulated industry,

> and any party who depends on the outcome of FDA's

> decisions. All should have

> access and the ability to provide input and feedback

> to us.

> Let's talk just for a moment about the judgements

> that are rendered as we

> make decisions about which products are safe and

> effective and ready to move

> to the market place.

>

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