    [Public Papers of the Presidents of the United States: William J. Clinton (1997, Book II)]
    [November 21, 1997]
    [Pages 1626-1627]
    [From the U.S. Government Publishing Office www.gpo.gov]

    Statement on Signing the Food and Drug Administration Modernization Act
    of 1997
    November 21, 1997

        I am pleased to sign into law S. 830, the ``Food and Drug
    Administration Modernization Act of 1997.'' This bipartisan legislation
    culminates several years of work by my Administration and the Congress
    on steps to streamline and rationalize the process by which the Food and
    Drug Administration (FDA) approves new drugs and medical devices, while
    ensuring that these products, on which the American people rely, are
    safe and effective. The Act represents the most comprehensive reform of
    our Nation's drug, medical device, and food laws in decades. I believe
    that it is a good compromise on a difficult set of issues and am pleased
    that the Congress and my Administration were able to work through these
    issues and enact a bipartisan bill. Most importantly, I am pleased that
    S. 830 addresses my key concern that any FDA legislation maintain our
    high standards to protect the American people from dangerous drugs,
    devices, and foods.
        This legislation will extend through Fiscal Year 2002, the
    Prescription Drug User Fee Act, which requires drug companies to help
    underwrite the cost of FDA reviews of their products' safety and
    efficacy. This measure has enabled the FDA to eliminate backlogs and
    significantly shorten the review time of new human drug applications
    without compromising quality standards. Supported by the drug industry,
    the Prescription Drug User Fee Act illustrates the true benefits of a
    public-private partnership.
        Certainly, FDA reform did not start with this bill. The Vice
    President has been working on reforming and reinventing the FDA since
    1993. This bill codifies many of the reforms proposed by the Vice
    President's Reinventing Government Initiative. For example, it
    modernizes the regulations of biological products, eliminates the batch
    certification and monograph requirements for insulin and antibiotics,
    and streamlines the approval process for drug manufacturing changes.
    This Act also codifies reforms proposed by the FDA's Center for Devices
    and Radiological Health that will significantly improve both the rigor
    and timeliness of its premarket review of medical devices.

    [[Page 1627]]

        Notably, S. 830 will expand FDA's current program to streamline the
    filing and approval of new therapies for serious or life-threatening
    conditions. It will also codify FDA regulations and practices designed
    to ensure that patients will have access to therapies for serious and
    life-threatening conditions before they are approved for marketing. The
    Act requires the Department of Health and Human Services to establish a
    databank, providing information to the public on clinical trials of
    experimental treatments for serious and life-threatening conditions.
        In addition, S. 830 includes a provision that eliminates certain
    health information dissemination restrictions, while maintaining public
    health protections. For example, product sponsors, manufacturers, or
    distributors will now be permitted to furnish to health professionals,
    providers, and others, peer-reviewed journal articles on an ``off-
    label'' use of an approved or cleared drug or device, so long as the
    manufacturers commit to completing the research needed to approve such
    use and meet other specified conditions. Drug manufacturers will also be
    able to give cost data to health maintenance organizations and other
    institutional purchasers of prescription drugs, so long as it is based
    on competent and reliable scientific evidence. The Act will also resolve
    the issue of pharmacy compounding--the process of making customized
    medicines--so that legitimate pharmacy compounding is allowed, while the
    manufacture of unapproved drugs is not.
        While I am satisfied with the resolution of the issues in this
    legislation, I am also pleased that the Congress included sunsets to
    certain of the Act's provisions so that, at the appropriate time, we can
    evaluate whether the proper compromises were reached. As FDA reform did
    not start with this bill, it will not end with this bill. Even with the
    streamlining provided in S. 830, the FDA will continue to face the
    challenge of fulfilling its many responsibilities and requirements
    within available resources. The Vice President and I look forward to
    continuing our work with patient groups, industry, and the Congress to
    make sure that the FDA is meeting the challenges of the future and
    providing safe and effective products to all Americans.

                                                          William J. Clinton

    The White House,

    November 21, 1997.

    Note: S. 830, approved November 21, was assigned Public Law No. 105-115.