    [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
    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 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
    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

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    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

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    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.