Health Hippo: FDA Modernization Act


FILE s830.


An Act To amend the Federal Food, Drug, and Cosmetic Act and
the Public Health Service Act to improve the regulation of food,
drugs, devices, and biological products, and for other purposes.


This Act may be cited as the ‘Food and Drug
Administration Modernization Act of 1997’




SEC. 101.

SEC. 102.

SEC. 103.
Authority to assess and use drug fees

SEC. 104.
Annual reports

SEC. 105.

SEC. 106.
Effective date

SEC. 107.
Termination of effectiveness



SEC. 111.
Pediatric studies of drugs

SEC. 112.
Expediting study and approval of fast track drugs

SEC. 113.
Information program on clinical trials for serious or
life-threatening diseases

SEC. 114.
Health care economic information

SEC. 115.
Clinical investigations

SEC. 116.
Manufacturing changes for drugs

SEC. 117.
Streamlining clinical research on drugs

SEC. 118.
Data requirements for drugs and biologics

SEC. 119.
Content and review of applications

SEC. 120.
Scientific advisory panels

SEC. 121.
Positron emission tomography

SEC. 122.
Requirements for radiopharmaceuticals

SEC. 123.
Modernization of regulation

SEC. 124.
Pilot and small scale manufacture

SEC. 125.
Insulin and antibiotics

SEC. 126.
Elimination of certain labeling requirements

SEC. 127.
Application of Federal law to practice of pharmacy compounding

SEC. 128.
Reauthorization of clinical pharmacology program

SEC. 129.
Regulations for sunscreen products

SEC. 130.
Reports of postmarketing approval studies

SEC. 131.
Notification of discontinuance of a life saving product


SEC. 201.
Investigational device exemptions

SEC. 202.
Special review for certain devices

SEC. 203.
Expanding humanitarian use of devices

SEC. 204.
Device standards

SEC. 205.
Scope of review; collaborative determinations of device data

SEC. 206.
Premarket notification

SEC. 207.
Evaluation of automatic class III designation

SEC. 208.
Classification panels

SEC. 209.
Certainty of review timeframes; collaborative review process

SEC. 210.
Accreditation of persons for review of premarket notification

SEC. 211.
Device tracking

SEC. 212.
Postmarket surveillance

SEC. 213.

SEC. 214.
Practice of medicine

SEC. 215.
Noninvasive blood glucose meter

SEC. 216.
Use of data relating to premarket approval; product development

SEC. 217.
Clarification of the number of required clinical investigations
for approval


SEC. 301.
Flexibility for regulations regarding claims

SEC. 302.
Petitions for claims

SEC. 303.
Health claims for food products

SEC. 304.
Nutrient content claims

SEC. 305.
Referral statements

SEC. 306.
Disclosure of irradiation

SEC. 307.
Irradiation petition

SEC. 308.
Glass and ceramic ware

SEC. 309.
Food contact substances


SEC. 401.
Dissemination of information on new uses

SEC. 402.
Expanded access to investigational therapies and diagnostics

SEC. 403.
Approval of supplemental applications for approved products

SEC. 404.
Dispute resolution

SEC. 405.
Informal agency statements

SEC. 406.
Food and Drug Administration mission and annual report

SEC. 407.
Information system

SEC. 408.
Education and training

SEC. 409.
Centers for education and research on therapeutics

SEC. 410.
Mutual recognition agreements and global harmonization

SEC. 411.
Environmental impact review

SEC. 412.
National uniformity for nonprescription drugs and cosmetics

SEC. 413.
Food and Drug Administration study of mercury compounds in drugs
and food

SEC. 414.
Interagency collaboration

SEC. 415.
Contracts for expert review

SEC. 416.
Product classification

SEC. 417.
Registration of foreign establishments

SEC. 418.
Clarification of seizure authority

SEC. 419.
Interstate commerce

SEC. 420.
Safety report disclaimers

SEC. 421.
Labeling and advertising regarding compliance with statutory

SEC. 422.
Rule of construction


. Effective date


Office of the Press Secretary

For Immediate Release

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.


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
    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.
    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
    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

  • Ensuring Accurate Food
    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
    scientifically valid.


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 available.

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 children.


Old Executive Office Building

9:50 A.M. EST

THE PRESIDENT: 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 two-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.

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 they 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
three 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 two years ago, two years from now you’ll
be standing over at the Old OEOB 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 five 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 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 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. (Applause.)


9:59 A.M. EST



Office of the Press Secretary For Immediate Release

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

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.

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


THE WHITE HOUSE, November 21, 1997


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