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Peter Pitts
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. announced the appointment of Frank M. Torti, M.D., M.P.H. as the FDA's Principal Deputy Commissioner and first Chief Scientist.
The newly created Chief Scientist position stems from the Food and Drug Administration Amendments Act of 2007.
"Dr. Torti's impressive clinical and scientific credentials are an excellent match for the work we do on a daily basis to promote and protect the nation's health as a science-based and science-led agency," said Dr. von Eschenbach. "FDA's Chief Scientist will ensure that the foundation of the FDA's regulatory structure will always be state-of-the-art science."
As Chief Scientist and a member of the agency's senior leadership team, Dr. Torti will support the launch of the FDA Fellowship Program, which has the potential to attract up to 2,000 professionals of varying disciplines for a two year training program. As well, the new office will work to ensure the quality and regulatory focus of the intramural research programs of the agency, and place special emphasis on the importance of clinical research trials that are a part of the foundation of the FDA's regulatory structure.
“I appreciate the confidence and trust that Secretary Leavitt and Commissioner von Eschenbach have placed in me," said Dr. Torti. “I look forward to beginning this work at this important moment for the FDA."
A prominent clinician, scientist and researcher in molecular oncology, Dr. Torti is currently serving as Charles L. Spurr Professor of Medicine, Chair of the Department of Cancer Biology, and Director of the Comprehensive Cancer Center at Wake Forest University School of Medicine in Winston-Salem, N.C.
Dr. Torti received his bachelor's and master's from Johns Hopkins University, his medical degree from Harvard Medical School, and his Master of Public Health from Harvard School of Public Health. He served as an intern and resident at Beth Israel Hospital in Boston, and a fellow of medical oncology at Stanford University where he subsequently joined the faculty and was tenured. He has written extensively on prostate and bladder cancer, designed and executed a number of cancer clinical trials, and has substantially contributed to the understanding of the molecular mechanisms that underlie inflammatory diseases and cancer.
Throughout his career, Dr. Torti has served on and chaired a number of national health and medical committees. He currently serves on the National Institutes of Health's National Advisory Council for Complementary and Alternative Medicine. He also founded and serves as President of the Cancer Biology Training Consortium, a national society of cancer biology department chairs and program directors. He is the recipient of a National Institutes of Health MERIT Award.
Dr. Torti will join the FDA in May.
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. announced the appointment of Frank M. Torti, M.D., M.P.H. as the FDA's Principal Deputy Commissioner and first Chief Scientist.
The newly created Chief Scientist position stems from the Food and Drug Administration Amendments Act of 2007.
"Dr. Torti's impressive clinical and scientific credentials are an excellent match for the work we do on a daily basis to promote and protect the nation's health as a science-based and science-led agency," said Dr. von Eschenbach. "FDA's Chief Scientist will ensure that the foundation of the FDA's regulatory structure will always be state-of-the-art science."
As Chief Scientist and a member of the agency's senior leadership team, Dr. Torti will support the launch of the FDA Fellowship Program, which has the potential to attract up to 2,000 professionals of varying disciplines for a two year training program. As well, the new office will work to ensure the quality and regulatory focus of the intramural research programs of the agency, and place special emphasis on the importance of clinical research trials that are a part of the foundation of the FDA's regulatory structure.
“I appreciate the confidence and trust that Secretary Leavitt and Commissioner von Eschenbach have placed in me," said Dr. Torti. “I look forward to beginning this work at this important moment for the FDA."
A prominent clinician, scientist and researcher in molecular oncology, Dr. Torti is currently serving as Charles L. Spurr Professor of Medicine, Chair of the Department of Cancer Biology, and Director of the Comprehensive Cancer Center at Wake Forest University School of Medicine in Winston-Salem, N.C.
Dr. Torti received his bachelor's and master's from Johns Hopkins University, his medical degree from Harvard Medical School, and his Master of Public Health from Harvard School of Public Health. He served as an intern and resident at Beth Israel Hospital in Boston, and a fellow of medical oncology at Stanford University where he subsequently joined the faculty and was tenured. He has written extensively on prostate and bladder cancer, designed and executed a number of cancer clinical trials, and has substantially contributed to the understanding of the molecular mechanisms that underlie inflammatory diseases and cancer.
Throughout his career, Dr. Torti has served on and chaired a number of national health and medical committees. He currently serves on the National Institutes of Health's National Advisory Council for Complementary and Alternative Medicine. He also founded and serves as President of the Cancer Biology Training Consortium, a national society of cancer biology department chairs and program directors. He is the recipient of a National Institutes of Health MERIT Award.
Dr. Torti will join the FDA in May.
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BrandweekNRX
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Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
Alliance for Patient Access
Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
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As the Intergovernmental Working Group (IGWG) of the WHO prepares to meet and discuss how to best facilitate the expropriation of intellectual property rights (in this case the IPR of pharmaceutical patents) it's important to consider the unintended consequences -- the death of medical innovation.
The global purloiners of patents -- led by Jamie Love -- are thrilled to point out all of the new and important medicines that are the low hanging fruit of their property theft proposals -- but are far less keen to explain how the fruit tree got there in the first place -- or how they are nurtured. In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death” in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all. In other words, the elimination of patent rights doesn’t produce greater access to medicines. There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive.
Intellectual property rights are the fertile soil that allowed the tree to grow in the first place -- and to thrive. To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation. Jamie Love and Company may very well say, "A world without patents, amen." And they're right, because minus pharmaceutical IPR we'd all better start saying our prayers -- because that's the only way we're going to battle disease and improve the health of our global fraternity. If the IGWG succeeds, pharmaceutical innovation dies. And that's a Silent Spring we cannot afford.
The global purloiners of patents -- led by Jamie Love -- are thrilled to point out all of the new and important medicines that are the low hanging fruit of their property theft proposals -- but are far less keen to explain how the fruit tree got there in the first place -- or how they are nurtured. In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death” in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all. In other words, the elimination of patent rights doesn’t produce greater access to medicines. There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive.
Intellectual property rights are the fertile soil that allowed the tree to grow in the first place -- and to thrive. To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation. Jamie Love and Company may very well say, "A world without patents, amen." And they're right, because minus pharmaceutical IPR we'd all better start saying our prayers -- because that's the only way we're going to battle disease and improve the health of our global fraternity. If the IGWG succeeds, pharmaceutical innovation dies. And that's a Silent Spring we cannot afford.
Some people will do anything to shove price controlled drugs from parts unknown down the the throats of unsuspecting Americans...that includes the editors at the San Jose Mercury News (there goes my chances for an oped placement)
From that august body:
"The Food and Drug Administration should be embarrassed by its lack of attention to the ingredients in prescription drugs.
The latest evidence is the 19 deaths and hundreds of allergic reactions reported by Americans using a bad batch of the drug thinner heparin. Some ingredients were contaminated, and the FDA admitted violating its own rules by not inspecting the Chinese factory where they were made.
This at the same time the FDA stubbornly refuses to allow cheaper prescription drugs to be imported. What hypocrisy."
http://www.hollandsentinel.com/stories/040808/opinion_20080408035.shtml
Some truth is in order by way of Andy von Eschenbach, FDA Commish:
"Our records at FDA indicated that we had inspected that facility in China, but that was incorrect. The inspection records we reviewed were on a facility with a very similar name. But having done the inspection in 2004 probably wouldn’t have prevented this problem, because this chemical contaminant cannot be detected using the standard testing methods for heparin. We have now developed new test methods to screen heparin for this new contaminant and regulators around the world are using those tests to protect their citizens. "
http://www.fda.gov/oc/vonEschenbach/andys_take/lifecycle.html
So much for the canard that the FDA "lied". What do you call a paper that calls someone else a liar when it knows that the very statement is not factual?
Now as to "hypocrisy", why would the FDA allow the importation of drugs from companies that are not producing for the US market when it's first priority is to improve the monitoring of the supply and production chain of products that are approved for US sale and distribution? Why indeed given the fact that counterfeit products are a growing problem worldwide and given the fact that importation will, according to the Congressional Budget Office and the Commerce Department hardly make a dent in health care spending?
Because some people can't understand that there are benefits to having a free and global market for medicines and that such conditions are not inconsistent with a bi-partisan effort to improve the FDA's ability to track and trace the production of such goods.
Now that's hypocrisy for you.
From that august body:
"The Food and Drug Administration should be embarrassed by its lack of attention to the ingredients in prescription drugs.
The latest evidence is the 19 deaths and hundreds of allergic reactions reported by Americans using a bad batch of the drug thinner heparin. Some ingredients were contaminated, and the FDA admitted violating its own rules by not inspecting the Chinese factory where they were made.
This at the same time the FDA stubbornly refuses to allow cheaper prescription drugs to be imported. What hypocrisy."
http://www.hollandsentinel.com/stories/040808/opinion_20080408035.shtml
Some truth is in order by way of Andy von Eschenbach, FDA Commish:
"Our records at FDA indicated that we had inspected that facility in China, but that was incorrect. The inspection records we reviewed were on a facility with a very similar name. But having done the inspection in 2004 probably wouldn’t have prevented this problem, because this chemical contaminant cannot be detected using the standard testing methods for heparin. We have now developed new test methods to screen heparin for this new contaminant and regulators around the world are using those tests to protect their citizens. "
http://www.fda.gov/oc/vonEschenbach/andys_take/lifecycle.html
So much for the canard that the FDA "lied". What do you call a paper that calls someone else a liar when it knows that the very statement is not factual?
Now as to "hypocrisy", why would the FDA allow the importation of drugs from companies that are not producing for the US market when it's first priority is to improve the monitoring of the supply and production chain of products that are approved for US sale and distribution? Why indeed given the fact that counterfeit products are a growing problem worldwide and given the fact that importation will, according to the Congressional Budget Office and the Commerce Department hardly make a dent in health care spending?
Because some people can't understand that there are benefits to having a free and global market for medicines and that such conditions are not inconsistent with a bi-partisan effort to improve the FDA's ability to track and trace the production of such goods.
Now that's hypocrisy for you.
According to Congressional Quarterly, Chairman Dingell is aggressively pursuing efforts to require the FDA to take a much more aggressive role in monitoring food and drug production and safety abroad, with stiff penalties for companies that import tainted products. The article says: “Dingell’s plan would also crack down on companies that violate drug import regulations. Manufacturers and importers could be fined as much as $500,000 for bringing contaminated or adulterated food or drugs into the country, and individuals could be subject to fines as high as $100,000 for similar offenses.â€
You may ask, How is that statement compatible with legislators’ calls for liberalized prescription drug importation? Good question.
Hopefully Mr. Dingell will point this out when his colleagues raise the subject.
You may ask, How is that statement compatible with legislators’ calls for liberalized prescription drug importation? Good question.
Hopefully Mr. Dingell will point this out when his colleagues raise the subject.
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