Return to Transcripts main page

Live From...

Interview with Dennis Goldberg

Aired December 10, 2002 - 13:33   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: Now, it's our guardian and gate keeper when it comes to our food, our drugs, even our deodorant. And guess what? No one is in charge. We are talking about the FDA, the Food and Drug Administration. Its mission is to regulate high drug prices and cloning research. It is supposed to protect you and your food supply from terrorism. So why is there no FDA leader since President Bush took office?
Joining us now with his perspective on whether his vacancy is helping or hurting the nation, Dennis Goldberg. He is the president of Phaedrus Pharmaceuticals in Massachusetts -- good to see you, Dennis.

DENNIS GOLDBERG, PHAEDRUS PHARMACEUTICALS: Thank you. Good to be here.

PHILLIPS: All right. So what's going on here? Why hasn't this been made a priority?

GOLDBERG: Well, there's a big battle here. This has been a political football. The -- a number of people have wanted an activist FDA, and the industry, pharmaceutical and biotech industry has wanted someone who would be a little more comfortable for the industry, and so there's been a battle to see who could get the appointee in place.

PHILLIPS: But meanwhile -- meanwhile Dennis, we face this new era of terrorism. So how do we know that our food supply and our medication is not being tampered with, and that we are safe from terrorist activity?

GOLDBERG: Well, the FDA has some very basic functions that they've performed, and they're performing this with or without the FDA commissioner. They go in and inspect very rigorously the drugs that are manufactured. They inspect the manufacturing process, have very strong quality control standards.

If you remember some years ago, we had an issue with Tylenol that was tainted, and we put in place tamper proof packages to try to prevent that, because those pills were tampered with in the warehouse, after they had been manufactured.

I don't believe that the commissioner of the FDA will be getting involved in that level of detail. Where the commissioner can have an impact is by adding additional resources to the FDA, allow them to provide stronger scrutiny of the things that are being added to the drug supply and to the food supply. The problem that you have there is that you then add additional burden to the manufacturers, and they're not going to be very happy about that.

PHILLIPS: All right. You mentioned scrutiny. Let's talk about bioterrorism. Should food and drugs with bioengineered ingredients definitely have more scrutiny?

GOLDBERG: Well, the FDA has a great deal of scrutiny over that right now, and the amount of work that goes through to ensure that a bioengineered product is indeed the product you have is very extensive. It costs a great deal of money to produce a cloned product.

It costs a great deal of money to manufacture it, and the FDA has been, to date, more concerned with the fact of introducing what we call (UNINTELLIGIBLE), which is a virus or bacteria from an animal or an animal cell that would then get into the human body and mutate to create a disease which the human immune system is not prepared to respond.

That has been what has held back or has created the great scrutiny that's presently in place. I think that same system would work very well against a -- any type of terrorist activity, if, for example, you wanted to put in a vaccine that was a live virus instead of an attenuated virus, that would show up in the process that is put in place to examine (UNINTELLIGIBLE) that is being made. So I think processes are in place, I think they need to be rigorously enforced, and the standards have to be upheld.

PHILLIPS: Well, public health is definitely at stake here in this new era, and we're also hoping soon that we will see a new head of the FDA. Dennis Goldberg, president of Phaedrus Pharmaceuticals, thanks for joining us with your insight.

GOLDBERG: My pleasure.

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 10, 2002 - 13:33   ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
KYRA PHILLIPS, CNN ANCHOR: Now, it's our guardian and gate keeper when it comes to our food, our drugs, even our deodorant. And guess what? No one is in charge. We are talking about the FDA, the Food and Drug Administration. Its mission is to regulate high drug prices and cloning research. It is supposed to protect you and your food supply from terrorism. So why is there no FDA leader since President Bush took office?
Joining us now with his perspective on whether his vacancy is helping or hurting the nation, Dennis Goldberg. He is the president of Phaedrus Pharmaceuticals in Massachusetts -- good to see you, Dennis.

DENNIS GOLDBERG, PHAEDRUS PHARMACEUTICALS: Thank you. Good to be here.

PHILLIPS: All right. So what's going on here? Why hasn't this been made a priority?

GOLDBERG: Well, there's a big battle here. This has been a political football. The -- a number of people have wanted an activist FDA, and the industry, pharmaceutical and biotech industry has wanted someone who would be a little more comfortable for the industry, and so there's been a battle to see who could get the appointee in place.

PHILLIPS: But meanwhile -- meanwhile Dennis, we face this new era of terrorism. So how do we know that our food supply and our medication is not being tampered with, and that we are safe from terrorist activity?

GOLDBERG: Well, the FDA has some very basic functions that they've performed, and they're performing this with or without the FDA commissioner. They go in and inspect very rigorously the drugs that are manufactured. They inspect the manufacturing process, have very strong quality control standards.

If you remember some years ago, we had an issue with Tylenol that was tainted, and we put in place tamper proof packages to try to prevent that, because those pills were tampered with in the warehouse, after they had been manufactured.

I don't believe that the commissioner of the FDA will be getting involved in that level of detail. Where the commissioner can have an impact is by adding additional resources to the FDA, allow them to provide stronger scrutiny of the things that are being added to the drug supply and to the food supply. The problem that you have there is that you then add additional burden to the manufacturers, and they're not going to be very happy about that.

PHILLIPS: All right. You mentioned scrutiny. Let's talk about bioterrorism. Should food and drugs with bioengineered ingredients definitely have more scrutiny?

GOLDBERG: Well, the FDA has a great deal of scrutiny over that right now, and the amount of work that goes through to ensure that a bioengineered product is indeed the product you have is very extensive. It costs a great deal of money to produce a cloned product.

It costs a great deal of money to manufacture it, and the FDA has been, to date, more concerned with the fact of introducing what we call (UNINTELLIGIBLE), which is a virus or bacteria from an animal or an animal cell that would then get into the human body and mutate to create a disease which the human immune system is not prepared to respond.

That has been what has held back or has created the great scrutiny that's presently in place. I think that same system would work very well against a -- any type of terrorist activity, if, for example, you wanted to put in a vaccine that was a live virus instead of an attenuated virus, that would show up in the process that is put in place to examine (UNINTELLIGIBLE) that is being made. So I think processes are in place, I think they need to be rigorously enforced, and the standards have to be upheld.

PHILLIPS: Well, public health is definitely at stake here in this new era, and we're also hoping soon that we will see a new head of the FDA. Dennis Goldberg, president of Phaedrus Pharmaceuticals, thanks for joining us with your insight.

GOLDBERG: My pleasure.

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