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Bioterrorism Changes FDA's Role

Aired December 18, 2002 - 14:07   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


KYRA PHILLIPS, CNN ANCHOR: The Food and Drug Administration hits home with every American from our food to our medication to the deodorant we use. The FDA is our guardian and gate keeper. Now the threat of terrorism, so eerily evident in all of our lives, what is being done to make sure our food and drugs are not tampered with.
Recently appointed FDA Commissioner Dr. Mark McClellan joins us today from Washington.

Sir, thanks for being with us.

DR. MAR MCCLELLAN, FDA COMMISSIONER: Kyra, thank you for having me.

PHILLIPS: Well, a number of topics we want to address, mainly bioterrorism.

Is this a concern of yours?

MCCLELLAN: Absolutely, it's a concern for the entire administration. Secretary Thompson and the president have directed the FDA as well as all other federal agencies to take a range of new steps to help protect the American public from the new threat.

PHILLIPS: Well, lets talk about the steps. What are you working on? what are you envisioning?

MCCLELLAN: The role of the FDA is to help make new treatments available to the public and to address public health threats, to prevent diseases and, I'm sorry to say in this case to help prevent deliberate complications of deliberate -- deliberately introduced types of terrorist activities. And so we are working on a whole host of new initiatives, ranging from bioterrorism prevention initiatives, to developing new treatments for chemical attacks, and radiation attacks. Developing new technologies to help identify these attacks when they occur.

PHILLIPS: This is something that you probably never thought you'd have to think about a number of years ago. Now, it's a brand new world. Who would ever have imagined that terrorism could infiltrate our food, our drugs. That's everyday life.

MCCLELLAN: It is everyday life, and there has been a change in the language that we use at FDA to describe many of our activities in response to preparedness for the new threats.

For example, FDA used to talk about food safety, about protecting our food supply from infections, from contaminants (UNINTELLIGIBLE) and the like. Now, we talk about the need for a food security strategy. New steps resulting from new legislation and new enforcement action to make sure that the food supply that Americans use is protected not only from naturally occurring contaminations, infection, but also from deliberately introduced pathogens.

PHILLIPS: And so how do you bring in the right people? Are you bringing in different types of scientists or inspectors?

MCCLELLAN: We have already brought in a lot of new people to FDA. This past year saw legislation enacted that resulted in the biggest expansion of the agency in more than a generation. We've hired more than 800 new inspectors to help at our borders, to help with outreach to industry and outreach to the public, and to help internationally with making our food supply safe. We're also starting a number of new programs to take new approaches for bringing medical treatment to the market, to American public, to help prevent the consequences of a bioterrorist attack and other forms of terrorism.

PHILLIPS: Well, Dr. McClellan, I want to ask you about this which we got from our medical folks at CNN. I understand you're taking a bigger role, rather, in regulating dietary supplements. I mean, This is something we've been talking about a for a while. Tell us what the new initiative is.

MCCLELLAN: We've started a new initiative that we announced today to get better information to consumers to help them improve their health. One part of this is announcing a new commitment to enforcing the current law which says that dietary supplements cannot make claims about their health effects that are not based on good science.

Earlier this week, we seized a large supply of Echinacea product called Everclear that was making claims about its effects on preventing viral infections. Those claims are not substantiated and American consumers who now more than ever want to take actions to improve their health need to have good information out there to base their health choices on. And so we are going to -- we are putting manufacturers on notice that misleading claims about health effects of dietary supplements will result in FDA enforcement action.

There was a second part to the initiative as well. That was to provide new steps to make it easier for consumers to get information about the health consequences of the food they eat. We are setting up a new program through a task force in FDA to review and allow new claims about the health benefits of foods if there is scientific evidence to support them. So, that's a second part of the initiative on better information to better health.

PHILLIPS: FDA Commissioner Dr. Mark McClellan. Definitely check out your website. And sir, welcome to the post. Thanks for being with us.

MCCLELLAN: Thank you very much, Kyra.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com







Aired December 18, 2002 - 14:07   ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
KYRA PHILLIPS, CNN ANCHOR: The Food and Drug Administration hits home with every American from our food to our medication to the deodorant we use. The FDA is our guardian and gate keeper. Now the threat of terrorism, so eerily evident in all of our lives, what is being done to make sure our food and drugs are not tampered with.
Recently appointed FDA Commissioner Dr. Mark McClellan joins us today from Washington.

Sir, thanks for being with us.

DR. MAR MCCLELLAN, FDA COMMISSIONER: Kyra, thank you for having me.

PHILLIPS: Well, a number of topics we want to address, mainly bioterrorism.

Is this a concern of yours?

MCCLELLAN: Absolutely, it's a concern for the entire administration. Secretary Thompson and the president have directed the FDA as well as all other federal agencies to take a range of new steps to help protect the American public from the new threat.

PHILLIPS: Well, lets talk about the steps. What are you working on? what are you envisioning?

MCCLELLAN: The role of the FDA is to help make new treatments available to the public and to address public health threats, to prevent diseases and, I'm sorry to say in this case to help prevent deliberate complications of deliberate -- deliberately introduced types of terrorist activities. And so we are working on a whole host of new initiatives, ranging from bioterrorism prevention initiatives, to developing new treatments for chemical attacks, and radiation attacks. Developing new technologies to help identify these attacks when they occur.

PHILLIPS: This is something that you probably never thought you'd have to think about a number of years ago. Now, it's a brand new world. Who would ever have imagined that terrorism could infiltrate our food, our drugs. That's everyday life.

MCCLELLAN: It is everyday life, and there has been a change in the language that we use at FDA to describe many of our activities in response to preparedness for the new threats.

For example, FDA used to talk about food safety, about protecting our food supply from infections, from contaminants (UNINTELLIGIBLE) and the like. Now, we talk about the need for a food security strategy. New steps resulting from new legislation and new enforcement action to make sure that the food supply that Americans use is protected not only from naturally occurring contaminations, infection, but also from deliberately introduced pathogens.

PHILLIPS: And so how do you bring in the right people? Are you bringing in different types of scientists or inspectors?

MCCLELLAN: We have already brought in a lot of new people to FDA. This past year saw legislation enacted that resulted in the biggest expansion of the agency in more than a generation. We've hired more than 800 new inspectors to help at our borders, to help with outreach to industry and outreach to the public, and to help internationally with making our food supply safe. We're also starting a number of new programs to take new approaches for bringing medical treatment to the market, to American public, to help prevent the consequences of a bioterrorist attack and other forms of terrorism.

PHILLIPS: Well, Dr. McClellan, I want to ask you about this which we got from our medical folks at CNN. I understand you're taking a bigger role, rather, in regulating dietary supplements. I mean, This is something we've been talking about a for a while. Tell us what the new initiative is.

MCCLELLAN: We've started a new initiative that we announced today to get better information to consumers to help them improve their health. One part of this is announcing a new commitment to enforcing the current law which says that dietary supplements cannot make claims about their health effects that are not based on good science.

Earlier this week, we seized a large supply of Echinacea product called Everclear that was making claims about its effects on preventing viral infections. Those claims are not substantiated and American consumers who now more than ever want to take actions to improve their health need to have good information out there to base their health choices on. And so we are going to -- we are putting manufacturers on notice that misleading claims about health effects of dietary supplements will result in FDA enforcement action.

There was a second part to the initiative as well. That was to provide new steps to make it easier for consumers to get information about the health consequences of the food they eat. We are setting up a new program through a task force in FDA to review and allow new claims about the health benefits of foods if there is scientific evidence to support them. So, that's a second part of the initiative on better information to better health.

PHILLIPS: FDA Commissioner Dr. Mark McClellan. Definitely check out your website. And sir, welcome to the post. Thanks for being with us.

MCCLELLAN: Thank you very much, Kyra.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com