PRESIDENT CLINTON SIGNS LAW TO STRENGTHEN AND MODERNIZE THE FOOD AND DRUG ADMINISTRATION
November 21, 1997
Today, President Clinton signed into law "the FDA Modernization Act
of 1997, critical legislation that will improve the regulation of food,
medical products and cosmetics, and prepare the FDA for the 21st
century. This new law represents the culmination of several years of
effort by the Administration and Congress to reach common ground on how
to amend the drug, device, and food laws. The Act, the first major food
and medical products reform legislation in 35 years, includes numerous
initiatives championed by the Clinton Administration that will ease the
regulatory burden on industries, protect consumers, and cut red tape,
making government operations faster and more efficient.
STRENGTHENING FDA MODERNIZATION INITIATIVES. The new law builds on
FDA modernization efforts already underway which have reduced drug and
medical device approval times to record lows while maintaining consumer
protections. The new law also expands the resources available to the
FDA to carry out its mission. Key provisions of the new law include:
Reauthorizing the Prescription Drug User Fee Act. The Act
reauthorizes for five more years the Prescription Drug User Fee Act of
1992, under which the FDA uses fees from manufacturers to accelerate the
review of new drugs and biological products. This user fee program,
developed in close cooperation with the pharmaceutical industry and
Congress, has cut the average drug review time in half -- from 30 months
before user fees to 15 months today -- bringing safe and effective new
medicines to patients much more quickly than ever before.
Reinventing Government. The law enacts many FDA initiatives
undertaken in recent years under the Vice President's Reinventing
Government program. The codified initiatives include measures to
modernize and streamline the regulation of biological products; increase
patient access to experimental drugs and medical devices; and accelerate
review of important new medications.
Increasing Access to Experimental Therapies. The new law streamlines
the filing and approval for new therapies for serious or
life-threatening conditions. It also codifies current FDA regulations
and practices designed to ensure patient access to therapies for serious
and life-threatening conditions before they are approved for marketing.
At the Administration's urging, the law provides for an expanded
database on clinical trials of experimental treatments for serious and
life-threatening conditions so that patients may have access to the
results of important clinical studies.
Streamlining Medical Product Approval. The Act reduces requirements
and simplifies the review process for manufacturers of pharmaceutical
products and medical devices, while maintaining the FDA's high standards
of consumer protection. The Act also protects consumers by specifying
that the FDA may ban devices produced in a seriously deficient manner,
and by giving the agency explicit authority to take preventive action if
the technology of a device suggests that it is likely to be used
"off-label" for a potentially harmful, unapproved use.
Expanding Consumer Access to Information on Unapproved or "Off-label"
Drug Uses. This Act seeks to ensure that health care providers find out
quickly about new uses for approved products by explicitly allowing
manufacturers to distribute information about unapproved uses of drugs
and medical devices. This provision will allow manufacturers to
disseminate reliable information about off-label uses provided they
commit to conducting appropriate research and to filing a supplemental
application for approval of these uses so that this information is
available in the official product labeling.
Strengthening Risk-Based Regulation of Medical Devices. The Act
complements and builds on the FDA's recent measures to match the level
of medical device regulations to the level of risk posed by the
products. Under the Act, manufacturers are no longer required to alert
the FDA before they market certain low-risk devices. The new law also
expands a program under which low-risk products can be initially
reviewed for safety and effectiveness by FDA-accredited outside experts.
In terms of devices already on the market, the Act directs the FDA to
focus on implantable, life-supporting, life-sustaining, and other types
of high-risk devices.
Ensuring Accurate Food Labeling. The Act expands procedures under
which the FDA can authorize health and nutrient content claims -- which
link a health benefit to a particular food component -- without
weakening the current requirement that the information be truthful and
BUILDING ON PREVIOUS CLINTON ADMINISTRATION INITIATIVES. Under the
Clinton Administration, the FDA has made significant progress in
streamlining its review processes to ensure that consumers gain access
to important new drugs and medical devices as quickly as possible. At
the same time, the FDA has continued to protect consumers by working
with public and private sector partners to ensure that the foods, drugs,
cosmetics, and medical products that consumers buy are the safest
As a result of innovations led by the FDA, Americans with cancer,
AIDS, Alzheimer's disease, multiple sclerosis, and other serious
conditions now have access to major innovative drugs much sooner. To
date, the agency has cut new drug approval times nearly in half, while
the number of new drugs approved in a year has doubled.
In recognition of its innovations of the U.S. drug approval process,
the FDA was named a 1997 winner of the prestigious Innovations in
American Government Awards Program, sponsored by the Ford Foundation
and Harvard University's John F. Kennedy School of Government. In
addition, in August 1997, the FDA unveiled a new regulation that will
protect children by requiring drug manufacturers to study the safety
and appropriate dosage levels of medications for pediatric populations.
The regulation also requires proper labeling of drugs for use by