[Weekly Compilation of Presidential Documents Volume 33, Number 47 (Monday, November 24, 1997)]
[Pages 1875-1877]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
Remarks on Signing the Food and Drug Administration Modernization Act of 
1997

November 21, 1997

    Thank you very much. After Secretary Shalala made you all laugh, she 
reminded me that she has to go catch a plane. She's going on a trip to 
Asia, and she's winding up in Butung. She said, ``You know, some people 
think Butung is the most beautiful place in the world, and the King is 
there, and he's got four wives, and they're all sisters.'' And she said, 
``I wonder if he'd like four and a half.'' [Laughter] I thought the 
private joke was even better than the public one, so I thought I'd give 
credit.
    Let me, first of all, thank the Vice President and his reinventing 
Government staff for the work that they have done on the FDA and 
Secretary Shalala and all the people at HHS and Sally Katzen and the 
people at OMB and folks in the White House, the industry leaders who are 
here. But let me especially thank the Members of Congress, all those who 
are here and at least two who are not, Congressman Bliley and 
Congressman Dingell, for the work that--this really astonishing work.
    It was a 2-year process. This bill passed by a voice vote in both 
Houses. And yet it is a very significant overhaul in the work of the 
Food and Drug Administration. It also, it seems to me, is symbolic of 
what we should be doing as a country.
    The FDA, which was created under Theodore Roosevelt, as the Vice 
President said, is really, I think, one of the signal achievements of 
the Progressive Era. Why was it necessary? Because more and more people 
were moving from the farm to the city and making a living in factories, 
and instead of consuming the food that they raised on their own farms, 
they had to go down and buy the food from somebody else. And more and 
more people had access to doctors, and doctors had access to medicine 
that was being discovered that they couldn't know everything about. So 
somebody needed to say, ``Hey, this medicine is okay. We've tested it. 
It's okay. You can give it to your patients in Iowa or Oregon or Arizona 
or Alabama.''
    And so a whole new world of possibility opened when people could 
move from farm to factory and when people could have access to a doctor 
when they couldn't see one before. But there needed to be someone who 
said, here's the public interest in trying to make sure the food is safe 
and the drugs are safe, and they do what they're supposed to do.

[[Page 1876]]

    And it's worked stunningly well, really. Throughout the entire 
industrial era of the 20th century, our country has continued to see its 
life expectancy increase and its economy grow and diversify. But when I 
was out there--the Vice President is right--I brought this up in our 
transition back in '92, because when I went across the country in 1992, 
everywhere I went people were complaining, on the one hand, that they 
were beginning to be concerned about some food safety issues and, on the 
other hand, that the health and welfare of the American people was 
actually being undermined by a system in the FDA that, at least the 
people who were involved in it thought, was too slow and somewhat 
arbitrary and not giving the American people the drug approvals and the 
medical device approvals in a timely fashion.
    So we set to work on it and we found there was an enormous amount of 
interest in the Congress. The Vice President's right, the FDA deserves, 
I think, a great deal of credit for the internal changes that have been 
made, that have been recognized, and particularly on the drug approvals, 
the speed of them.
    But this legislation, I think, is very, very important. And again I 
say, it is also symbolic of a larger mission we should be about. We're 
maintaining and redefining the public interest at a time when there are 
new challenges to food safety, which we've tried to meet, partly in the 
Department of Agriculture and partly with some important bipartisan 
legislation the Congress passed about a year ago, and when we have new 
possibilities in both medicine and medical devices. And what we want to 
do is get those to people as quickly as possible and still protect the 
public interest.
    And we know now we have new options for that because of the change, 
again, in the underlying nature of the society, moving from the 
industrial age to a technology/computer information dominated age in 
which we have a lot more opportunities to do things that will speed this 
approval process, and on the other hand, in the food area, we know 
because we've now gone from seeing people get their food from their 
neighbors who were farmers while they lived in the cities, that food has 
become more and more and more an international commodity. And we have an 
even higher responsibility not only through the FDA but generally 
through the government to secure the safety of our food supply.
    So I think the changes we are making are very important not only on 
their own merits but because what you have done is a model for what 
America has to do in area after area after area, clearly define the 
public interest and then change the way we pursue it consistent with the 
tools and the responsibilities and the opportunities available in this 
time. And all of you should be very, very proud of that.
    Let me say that, as everybody knows, this bill is the product of 3 
years of hard work that involves all the people I have already 
mentioned. I just think it's worth pointing out that at the beginning of 
the process, the sides stood worlds apart. I think that is an 
understatement. [Laughter] And the fact that there was a process by 
which you could think through differences and build a true consensus 
that is bipartisan and involves all the stakeholders, resulting in a 
bill--if somebody told me 2 years ago, ``Two years from now you'll be 
standing over at the Old EOB; and you'll be about to sign a bill that 
passed the Congress by a voice vote, and it will have more than two 
words in it, so it won't be an empty bill; it will, in fact, be a 
sweeping reform of FDA,'' I would have taken odds against that. And I 
think you should all be very, very proud of yourselves.
    Let me just highlight a few of the bill's provisions. First, we 
continue working with the business community to get more drugs approved 
faster. We've reauthorized the Prescription Drug User Fee Act for 5 more 
years. It ensures that the cost of reviewing and approving drugs is 
shared between industry and Government. Since 1992, these additional 
revenues have helped FDA hire some 600 more employees, cutting drug 
approval time in half already, and we want to do better.
    Second, the bill writes into law many of the reinventing Government 
measures introduced by FDA a few years ago, reducing the requirements 
and simplifying the review process for new drugs and medical devices

[[Page 1877]]

without compromising safety. And I congratulate the Vice President for 
all his work particularly on this effort.
    Third, we will offer new hope to critically ill Americans by 
expanding access to drugs and therapies whose FDA approvals are still 
pending. Anybody who's ever had a family in this situation knows what an 
important part of the legislation this is. We know that for many 
patients, experimental treatments represent their best, perhaps their 
only, chance for recovery. That's why this bill writes into law current 
FDA policies that allow doctors and patients to use new drugs before 
they are formally approved. Already, thousands of AIDS, cancer, and 
Alzheimer's patients have found new hope, even new life, with these 
experimental therapies. We will also expand the database on clinical 
trials of drugs that fight serious illnesses so that patients can keep 
track of their progress.
    It's been said that while the century we are about to leave has been 
an age of physics, the 21st century will be an age of biology, perhaps 
yielding cures to diseases we thought incurable. We are already 
witnessing the medical possibilities of the future, as the Vice 
President said. This fall alone, the FDA has approved new drugs and 
treatments for everything from HIV to breast cancer, cardiovascular 
disease to cystic fibrosis, Parkinson's to epilepsy.
    The FDA has served America well. Today, with a bill I'm about to 
sign into law, we can ensure that it will serve America well into the 21 
century, and I hope serve as a model again for how we can maintain our 
goals of pursuing the public interest and adjust our means to the 
possibilities and the challenges of a dramatically new era. The FDA has 
always set the gold standard for consumer safety. Today it wins a gold 
medal for leading the way into the future. And thank you all.
    I'd like to ask the Congressmen now to join me up here so we can 
sign the bill.
    Thank you.

Note: The President spoke at 9:50 a.m. in Room 450 of the Old Executive 
Office Building.