[Public Papers of the Presidents of the United States: William J. Clinton (1997, Book II)]
[November 21, 1997]
[Pages 1624-1626]
[From the U.S. Government Publishing Office www.gpo.gov]

Remarks on Signing the Food and Drug Administration Modernization Act of 
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 Bhutan. She said, ``You know, some people 
think Bhutan 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 
    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

[[Page 1625]]

the food is safe and the drugs are safe and they do what they're 
supposed to do.
    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 
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

[[Page 1626]]

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 the bill I'm about to 
sign into law, we can ensure that it will serve America well into the 
21st 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. S. 830, approved November 21, was assigned Public Law 
No. 105-115.