FDA Speech before National Press Club, Feb. 29th, 2008

[niecy]

http://www.fda.gov/oc/speeches/2008/fdaworld022908.html

Speech before
National Press Club
Washington, D.C.
Remarks by
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
on
“FDA at a Turning Point:
Meeting the Challenge of a Rapidly Changing World”
February 29 , 2008

I have just taken a few excerpts out for the forum, please take the time to read the full article. I am seeing the number "22" again............

Niecy

This text contains Dr. von Eschenbach's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.


Just as with the atom and its nucleus, revolutionary progress in science and technology enables us to study the cell and its nucleus thereby leading to our understanding of genes, molecules and DNA that control life processes and disease. We can clone animals, genetically modify crops, and create X-ray devices that see living biology.
We are now creating medicines that don’t just treat the manifestations of disease, but actually alter the biology of the living cell.

Exponential advances in science and technology are again coupled with changes in how we live.

Urbanization has given way to globalization, and the industrial age now embraces the information age. As with the past these changes are filled with promise but also peril as they impact on our health. Society must respond and, I believe, recreate the FDA.

And our responsibility extends to products not just for humans but also animals: we regulate "genetically engineered animals" and products from pet food and pet turtles to feed and drugs for livestock.

FDA was created one hundred years ago because change had created peril along with promise, and today FDA must be re-created because the peril and promise from these products is now even greater.

Consider food safety and nutrition. The perils are many. In processed food, we have recently witnessed the risk of botulism in canned chili sauce, and E.coli and salmonella contamination in ready-to-eat fresh cut produce.

We can do more to prevent disease such as genetically engineering crops to improve nutrition and promote health.

Consider drugs and medical devices:
The perils are many with sophisticated and miniaturized devices such as cardiac pacemakers susceptible to breakdown or failure simply because of their complexity. New materials such as nanoparticles and devices that present new unknowns. Drugs and vaccines containing ingredients obtained from sources around the world and manufactured and distributed through complex supply chains as in the recent case of heparin.

We have embarked on an aggressive recruitment and retention effort with a target of hiring an additional 700 new employees in 2008. This has primarily been made possible by the passage of the Food and Drug Administration Amendments Act of 2007 and incremental increases provided in our appropriations.

In addition we will shortly be launching plans for an FDA Fellowship Program which has the potential to attract up to two thousand professionals of varying disciplines for a two year training program.

Other assessments demonstrated a need for renovation and modernization of our information technology infrastructure, and this year we will spend approximately 250 million dollars on employing modern high performance servers and new software systems that facilitate interoperability across the Agency and expansion of our electronic data bases.

Monitoring and detection must be accompanied by enhancing our response to mitigate adverse outcomes. We must enhance our capability for intervention by increasing risk based inspections now using modern scientific tools of detection and expanding our network.

This emphasizes the need for FDA to enhance its collaborations. We are forging multiple partnerships with Federal agencies like Customs and Border Protection, the Centers for Disease Control and Prevention, and the U. S. Department of Agriculture, as well as State agriculture and health colleagues, private sector organizations, and our international counterparts.

As demonstrated by our recent agreements with our counterpart agencies in China, the globalized economy demands nothing less than interoperability, information exchange, and cooperation especially on enforcement matters.

***In an age when a border is not a barrier, we have embarked on our initiative: "FDA beyond our Borders." It is an effort to establish an FDA presence overseas and to build capacity at foreign sites – in at least five regions, beginning with China. We must also expand our work with foreign regulators, to share information more fully.***

Earlier this week, our experts discussed with 62 representatives of 48 embassies our food and feed protection efforts and our commitment to international collaboration, truly taking FDA beyond our borders.

***This requires us to regulate products where they are produced, before they arrive at our borders.***

As FDA Commissioner I am aware of the need for these changes to avoid the peril of failing in our mission to protect your health.

As a physician and researcher, I am aware of the need for change for the FDA to achieve the promise of being the bridge and not the barrier to delivering life-saving solutions to eradicate and prevent diseases that threaten you, now and in the future.

***But most of all, as a grandfather concerned about the future of his six grandchildren, I am aware of the need for radical and rapid change.***

About a month ago, I traveled with Secretary Leavitt to India to meet with our counterpart government officials as well as leaders of the food and drug industries to discuss how to best assure the quality of products produced there for export to you here in the U.S.A.
While there in Delhi I had the opportunity to visit a neighborhood and to vaccinate babies and small children for polio. Afterwards I handed out lollipops to some of the children, and suddenly I was faced with a mob of grasping hands and squealing voices that grew more rapidly than my ability to dispense the lollipops -- until that moment came when there was nothing more to give to them.

I will never forget the out stretched hands and those big eyes and little faces whose smiles turned to sad stares because I had nothing more to give them.

As I look at the faces of my grandchildren. I know that their expectations will go beyond our past that developed a vaccine for polio to their future in which food and drugs will be a personal prescription for health, and I know that FDA must radically and rapidly change so that their smiles of expectation will not turn to stares of sadness -- because without the FDA of the 21st century protecting and promoting their health, there will be nothing more we can give them. Thank you.

[Kritters]

Wow Niecy..... what great stuff.

Wouldn't it be great if Dr. von Eschenbach would be taken seriously? If he could actually make a difference?

He has it down. Can he implement his vision? I certainly hope so.

xoxo
Kritts

[jonsi]

Thank you for finding this niecy.

With tears running down my cheeks, I hope it is not too late. The last paragraph got me. "As I look at the faces of my grandchildren. I know that their expectations will go beyond our past that developed a vaccine for polio to their future in which food and drugs will be a personal prescription for health, and I know that FDA must radically and rapidly change so that their smiles of expectation will not turn to stares of sadness -- because without the FDA of the 21st century protecting and promoting their health, there will be nothing more we can give them."

ItWL,
~jonsi

[niecy]

News Article about the FDA and China:


http://www.slate.com/id/2189673?wpisrc=newsletter

today's papers: A summary of what's in the major U.S. newspapers.
The Drug Wars
By Daniel Politi
Posted Tuesday, April 22, 2008, at 6:15 AM ET
The New York Times leads with the Food and Drug Administration announcing that contaminated heparin from 12 Chinese companies has been found in 11 countries and is linked to 81 deaths in the United States. But Chinese Embassy officials strongly disputed the claims, saying that the man-made contaminant can't be the real cause of the deaths and suggested the problem may have originated in the United States.

Before the FDA made its announcement about Heparin, the Chinese government began what the WSJ characterizes as a "pushback" against the conclusions. At a press conference, Chinese officials said they want to look into whether the problem was caused in the end stage of the production process. The FDA disputes the Chinese assertion that severe adverse reactions have not been observed in any other countries, although it's unclear whether contaminated heparin is linked to deaths anywhere else.

The NYT and WSJ highlight how this is the latest example of the growing rift between the United States and China over safety issues. Meanwhile, it's becoming clearer just how little oversight there is of imported products. A new government audit says the FDA would have to invest an additional $56 million next year simply to begin full inspections of foreign plants. At the current pace, "the F.D.A. would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant," reports the NYT.


I was told by my gp when he found a nodule in one of my lungs that it very common for people in the south to have the fungus "histoplasmosis" in their lungs. He never said another word about it............ bs


In other news, the WP fronts a look at a new study that says life expectancy for women in nearly 1,000 counties is shorter now than what it was in the 1980s. The women who saw the sharpest drops in their life spans live mainly in the Deep South and Appalachia. Researchers say lung cancer, diabetes, and obesity have contributed to this "distinctly American" trend.


Niecy
XOXOXO

[niecy]

I don't mean to be annoying, but did you guys pay particular interest to the words highlighted in red in my last post?

SOMETHING HAS TO BE DONE!!!

Niecy
xxxxxx

[Jo]

Hi Niecy,

Its worrying stuff.

It all comes back to the money yet again. Whose's commissioning and buying the Chinese manufactured pharmaceuticals? Governments and big companies, looking to cut costs and make profits.

You would have thought that all items being imported would be strictly tested....I thought they were, especially in the States and especially with medicines??

A wannabe anti capitalist Jo
xxx

[jonsi]

Hi niecy & jo,

What would happen if the FDA got their controlling hands on vitamins, minerals and herbs, making these illegal unless they are tested and approved by the FDA. Then, to keep us safe from self-abuse, we would need a prescription from an MD. I know we've discussed this before, but this a reminder to keep our eyes wide open...

...especially after learning how good of a job the pharmaceutical companies and FDA are doing now.

Itwl,
~jonsi

[Kritters]

Jonsi,

That is exactly what they are trying to do. They want to control it all and they have no idea what they are dealing with.

xoxo
Kritts

[jonsi]

Here's a link about how the FDA is (protecting us by ???) pushing vaccines:
www.healthfreedomusa.org/?page_id=676

It also discusses organic and "GM free" labeling, constitutional rights, etc...

Itwl,
~jonsi

[carla]

This is so obvious . Why can't everyone see it .
Does anyone really believe this is all by accident or lack of sense.
Or that they love us really ,enough to make sure we are all vaccinated against any nasty diseases.

They don't care that they are leaving evidence anywhere.

What you worked all your life for is going to be stolen from you. They plan on ditching the dollar and having a global currency.
carla
xx