[Congressional Record Volume 143, Number 117 (Monday, September 8, 1997)]
[Senate]
[Pages S8878-S8898]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF
1997--MOTION TO PROCEED
The PRESIDING OFFICER (Mr. DeWine). The clerk will report.
The assistant legislative clerk read as follows:
A bill (S. 830) 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.
The Senate resumed the consideration of the motion to proceed.
Mr. JEFFORDS addressed the Chair.
The PRESIDING OFFICER. The Senator from Vermont is recognized.
Mr. JEFFORDS. First, I want to thank the majority leader for, I think
very aptly and appropriately and eloquently, expressing our thoughts
about Mother Teresa. All of us were moved by her life, and all feel
similarly as to his feelings about what she did for all the people of
the world.
Mr. President, today, we move forward again on the motion to proceed
with respect to the reform of the FDA bill, S. 830.
Under the Federal Food, Drug, and Cosmetic Act, Food and Drug
Administration commonly known as FDA, has two important functions:
First, the review and approval of important new products that can
improve the public health, such as lifesaving drugs, biological
products, and medical devices; and second, the prevention of harm to
the public from marketed products that are unsafe or ineffective. Since
1938, the Federal Food, Drug, and Cosmetic Act has been amended
numerous times to expand the FDA's mission to ensure that only safe or
ineffective products are marketed.
But the act has been changed only once, by the Prescription Drug User
Fee Act of 1992, commonly called PDUFA, to strengthen the FDA's ability
to review and approve expeditiously important new products that can
improve the public health.
Food and Drug Administration Modernization and Accountability Act of
1997, S. 830, is designed to ensure the timely availability of safe and
effective new products that will benefit the public and to ensure that
our Nation continues to lead the world in new product innovation and
development.
The legislation accomplishes three major objectives: It builds upon
recent administrative reforms that both streamline FDA's procedures and
strengthen the agency's ability to accomplish its mandate in an era of
limited Federal resources; it requires a greater degree of
accountability from the agency in how it pursues its mandate; and
third, it provides for the reauthorization of PDUFA.
The FDA acknowledges that its mandate requires it to regulate over
one-third of our Nation's products. Within its purview the FDA
regulates nearly all of the food and all of the cosmetics, medical
devices, and drugs made available to our citizens.
This legislation identifies areas where improvements can be made that
will strengthen the agency's ability to approve safe and effective
products more expeditiously. It builds upon the numerous investigations
by Congress, the FDA, the General Accounting Office, and other
organizations that have identified problems with the current FDA
product approval system and have recommended reasonable reforms to
streamline and strengthen that system. The major provisions of S. 830
accomplishes, among others, the following purposes. The legislation:
First, establishes a clearly defined, balanced mission for the FDA;
Second, it improves patient access to needed therapies and provides
expedited humanitarian access to medical devices;
Third, creates new incentives for determining better pharmaceuticals
for children;
Fourth, gives patients access to new therapies more quickly through a
new fast-track drug approval process;
Fifth, increases access to information by health professionals and
patients;
Next, increases agency access to expertise and resources;
Also, improves the certainty and clarity of rules;
And further, improves agency accountability and provides for better
resources allocation by setting priorities;
It also, simplifies the approval process for indirect food contact
substances and provides a more reasonable standard for some health
claims; and,
The legislation reauthorizes the PDUFA Program thus ensuring
additional resource availability for the agency to conform with its
necessary missions.
Mr. President, let us explore these objectives in greater detail.
First, the legislation establishes a clearly defined, balanced mission
for the FDA. Congress has never established a mission statement for the
FDA. This bill does.
The FDA in March 1993 adopted a formal statement declaring that the
agency ``is a team of dedicated professionals working to protect and
promote the health of the American people.'' Although this statement
defines the agency's mission in terms of ensuring that the products it
regulates comply with the law, there is no reference to the importance
of approving new products that benefit the public.
The legislation amends the Food Drug and Cosmetic Act by adding an
agency mission statement focused on: First, protecting the public
health by ensuring that the products it regulates meet the appropriate
FDA regulatory standards; second, promptly and efficiently reviewing
clinical research and taking appropriate action on the marketing of
regulated products in a manner which does not unduly impede innovation
or product availability; and, third, participating with other countries
to reduce regulatory burdens, harmonize regulatory requirements, and
achieve appropriate reciprocal arrangements with other countries.
The legislation improves patient access to needed therapies and
provides expedited humanitarian access to medical devices. The FDA has
no crosscutting program that ensures access by patients with serious or
life-threatening diseases to drugs or devices in clinical trials--even
when that unapproved therapy may be the only way to save the patient's
life.
The legislation would create new law whereby manufacturers may
provide, under strictly controlled circumstances and in response to a
patient's request, an investigational product for those patients
needing treatment for a serious or life-threatening disease. The
legislation also improves the existing program for the humanitarian use
of medical devices for patient populations of fewer than 4,000.
[[Page S8879]]
The legislation creates new incentives for determining better
pharmaceuticals for children. Children have for years been wrongly
considered small adults when estimating the effect of prescription
drugs on their overall health. Currently there is no systematic means
for testing the safety and efficacy of drugs on the pediatric
population.
The legislation gives the Secretary authority to request pediatric
clinical trials for new drug applications and provides 6 extra months
of market exclusivity to drugs when the manufacturer voluntarily meet
certain conditions under the program. The Secretary must determine in
writing that information relating to the use of a drug in the pediatric
population is needed. In addition, the FDA may establish time frames
for completing such pediatric studies before additional exclusivity is
granted.
The legislation gives patients access to new therapies more quickly
through a new fast-track drug approval process. I think this is
important.
For several years the FDA has allowed the expedited review and
approval of drugs but such review has been largely confined to
treatments for HIV/AIDS or cancer. This provision facilitates
development and expedites approval of new drugs for the treatment of
any serious or life-threatening diseases.
The legislation increases access to information by health
professionals and patients. For years, sophisticated users of health
related economic information, like health maintenance organizations,
have had constrained from access to important information that could
help them reduce health care costs.
The legislation would apply the Federal Trade Commission's
``competent and reliable scientific evidence'' standard for FDA review
of health care economic statements distributed by manufacturers to
sophisticated purchasers. In the past, only a few patient groups have
had access to information about ongoing clinical trials for lifesaving
therapies. The legislation expands patient access to information by
requiring the creation of data bases on ongoing research related to the
treatment, detection, and prevention of serious of life-threatening
diseases.
The legislation increases agency access to expertise and resources.
Current law contains no provisions to assure that the FDA can access
expertise housed at the National Institutes of Health [NIH] and other
science-based Federal agencies to enhance the scientific and technical
expertise available to FDA's product reviewers. The legislation
requires FDA to develop programs and policies to foster such
collaboration. The legislation also authorizes the agency to contract
with outside experts to review all or parts of applications when it
will add to the timeliness or quality of a product review, and provides
for the use of accredited outside organizations for the review of
medical devices.
The legislation improves the certainty and clarity of rules. The
legislation makes a series of changes related to the classification,
review and approval of FDA regulated products designed to ensure that
sponsors of new products face consistent and equitable regulatory
requirements. In addition, the legislation gives FDA 2 years to
evaluate the success of its recently issued ``Good Guidance Practices''
guidance after which FDA is required to implement this policy as a
regulation, making any modifications necessary to reflect experience
during the 2-year trial period. The legislation provides medical device
manufacturers with the ability to make recommendations to the FDA
respecting initial product classifications.
It facilitates the reclassification and/or approval of device
applications by allowing FDA to consider historical data in making its
determinations, and the legislation more clearly states the
relationship of labeling claims to approval and clearance of medical
devices. It increases the certainty of review time frames by providing
a definition of a day with respect to the agency's review timeclock and
by requiring the agency to approve or disapprove a device application
within 180 days.
The legislation also prohibits FDA from withholding the initial
classification of a device because of a failure to comply with any
provision of the unrelated to making a determination of substantial
equivalence, and it clarifies that FDA has discretion in determining
the number of clinical trials required for the approval of a drug or
device. FDA would retain total discretion to require a sufficient
number of trials to show safety and efficacy. The provision introduces
the concept that two trials are not always necessary, establishes the
primacy of quality data over quantity of data, and requires the FDA to
consider the number and type of trials on a product-by-product basis.
The legislation improves agency accountability and provides for
better resource allocation by setting priorities. Except as required
under PDUFA, the FD&C Act provides no form of public accountability by
the FDA for its performance of its statutory obligations.
The legislation requires FDA to develop a plan designed to: First,
minimize deaths and injuries suffered by persons who may use products
regulated by the FDA; second, maximize the clarity and availability of
information about the product review process; third, implement all
inspection and post-market monitoring provisions of the act by 1999;
fourth, ensure access to the scientific and technical expertise
necessary to properly review products; fifth, establish a schedule to
bring the FDA into compliance by 1999 with the product review times in
the act for products submitted after the date of enactment of this
section; and sixth, eliminate the backlog of products awaiting final
action by the year 2000.
The legislation also requires FDA to submit an annual report to
assist Congress in assessing the agency's performance in accomplishing
the objectives laid out in the agency plan.
The legislation streamlines several FDA functions with respect to
certain review and inspection processes thus allowing the agency to
focus its limited resources on areas of greatest need. The legislation
establishes reasonable data requirements for new product approval
applications, petitions, or other submissions. The legislation provides
FDA with the discretion to approve drugs and biologics on the basis of
products manufactured in pilot and small-scale facilities.
FDA is also directed to establish policies to facilitate the approval
of supplemental applications for new uses for an approved product.
Further, the legislation establishes procedures and policies to foster
a collaborative review process between the agency and the sponsors of
medical device applications. Finally, the legislation streamlines the
review of minor modifications to medical devices.
The legislation simplifies the approval process for indirect food
contact substances and provides a more reasonable standard for some
health claims. Current law requires the agency to preapprove food
contact substances, most of which pose little if any risk to human
health.
The legislation replaces the preapproval process for these
substances, primarily packaging materials, with a simple notification
requirement. The legislation also provides for health claims for foods,
with premarket notification, when the claims are based on authoritative
recommendations by an authoritative scientific body of the U.S.
Government such as the National Institutes of Health, the Centers for
Disease Control and Prevention, or the National Academy of Sciences--
very reliable agencies.
The legislation reauthorizes the PDUFA Program thus ensuring
additional resource availability for the agency. PDUFA is reauthorized
for 5 years. Performance goals beyond those set for the 1992 act will
be identified in side letters between the FDA and the Senate Committee
on Labor and Human Resources. The bill assumes that FDA will receive
for fiscal year 1998 the 1997 level of appropriated funds for the
agency.
This is important to keep in mind. For fiscal year 1999 through 2002,
the bill assumes an annual inflation adjustment. I mention this because
there in the present proposal by the administration is a request to cut
back on the use of PDUFA.
Mr. President, I think after all of us have had time in this body to
go through this legislation, Members will understand why there is so
little dispute over almost all of the bill. We will be talking again
today, as we did last Friday, about two areas in the bill for
[[Page S8880]]
which there has not been agreement, but the disagreements are not very
complicated to understand.
First of all, we had a vote of 89-5 on Friday to allow us to end the
filibuster under the circumstances we faced. That approval indicates
what I am saying now, that for almost all of this bill there is no
dispute between us and the minority or Senator Kennedy or the Office of
the President or the Secretary of HHS.
What we do have are two problems in which there is dispute. This
makes up 6 pages out of a 152-page bill. Keep in mind, because we will
have some vigorous arguments in those two areas, everyone agrees with
the rest of the bill--almost. There will always be somebody, but there
is hardly any disagreement on the matters I discussed in my statement.
The two remaining matters refer, first of all, to cosmetics. There is
an increasing need, at least felt by especially some States and also by
the FDA and others, that there has to be more work done in approving
cosmetics or ensuring that cosmetics that are injurious to health do
not get on the market. At present, most of that has been left sort of
ambiguous whether the FDA should do it or not.
On the other hand, because of the realization that uniformity would
be helpful, it would be useful if we could have uniformity throughout
the States on cosmetics so that the people all over the country do not
have to worry about going from place to place. And thus the bill does
establish the FDA predominance in the field with respect to the use of
cosmetics.
Now, this is met with some difficulties because some States,
California in particular, had voted and had passed laws on cosmetics.
Let me go through the present authority.
The FDA now has substantial authority to ensure the safety of
cosmetic products. It can ban or restrict ingredients for safety
reasons, mandate warning labels, inspect manufacturing facilities,
issues regulatory letters, seize illegal products, enjoin unlawful
activities, and prosecute violators of the adulteration and misbranding
provisions of the Federal Food, Drug, and Cosmetic Act.
In addition, cosmetic products are subject to one of the most
comprehensive set of Federal labeling requirements for consumer
products. A cosmetic label must include the name and address of the
manufacturer, packager, or distributor; a statement of product
identity; net quantity of contents; a list of all ingredients in the
products; adequate directions for use; and mandated warnings for
specific products.
In addition to this substantial Federal regulatory authority, the
cosmetic industry supports a variety of programs to ensure the safety
of cosmetic ingredients. Most important is the Cosmetic Ingredient
Review, a 20-year program that has reviewed the safety of almost 620
cosmetic ingredients.
The safety evaluations are conducted by an independent expert panel
of seven leading academic scientists and physicians. The panel also
includes three liaison representatives from the FDA, the Consumer
Federation of America, and private industry.
Along with this regulatory authority, the agency has sufficient
resources to police the safety of cosmetics. This year, Congress
appears ready to approve nearly a billion dollars for the agency. Yet
of that amount, the FDA will likely spend no more than about $6\1/2\
million on cosmetics safety and labeling. Why? Why would the agency
devote less than 1 percent of its budget? Because of the outstanding
safety record of cosmetic products. Numerous FDA Commissioners--
including David Kessler, have stated that cosmetics are among the
safest products under the FDA's jurisdiction.
Let me turn now to the language of the national uniformity provision
for cosmetics included in the latest version of S. 830. First, let me
emphasize that this provision in no way affects State enforcement
powers, such as seizure, embargo, or judicial proceedings, that the
States can now use to guard against adulterated, misbranded, or
otherwise unsafe products. Let me repeat this point: The national
uniformity provision would not block any State from exercising its
police powers against unsafe cosmetic products.
Second, the national uniformity provision provides only limited
preemption of State safety standards. Preemption would apply only when
the FDA has an applicable safety standard affecting cosmetic already in
place. If the FDA has not acted in a safety area, the States would
still be free to impose their own particular safety regulations
affecting cosmetic products. For example, individual States could ban
particular ingredients or could set specified concentrations levels for
ingredients used in cosmetic products when the FDA has not acted.
Preemption does apply to State labeling and packaging for cosmetic
products that are in addition to or not identical with Federal
standards.
This is designed to ensure a single, nationwide system for regulating
the labeling for cosmetic products. This will promote efficient product
distribution in interstate commerce, assure the ready availability of
products in all States, and hold down costs for consumers.
Third, under this provision States and localities are clearly
permitted to petition to impose a State-specific requirement if they
have a situation where an important public interest is at stake, and
the requirement would not violate a Federal law or unduly burden
interstate commerce.
Fourth, the existing right of States, or entity or person is
preserved to petition the FDA to make an certain regulation on over-
the-counter drugs or cosmetics a national requirement.
And finally, the regulation of the practices of pharmacy and
medicine, areas traditionally and appropriately the responsibility of
the States is not modified or preempted by this provision.
This is a sensible compromise that guards against the possibility of
50 different labels in 50 different States but at the same time
preserves the ability of States to protect the public against any
problems that may arise over the safety of cosmetic products.
Mr. President, we will go forward with another lengthy dissertation
on this aspect of this. I hope people will keep in mind that there is
broad, broad agreement among all of us--Senator Kennedy and those who
support it--that this bill has come a long way. It has gone a great
distance toward bringing together what we can pass and be very proud
of. There are just two areas where there is disagreement, which we will
hear about, I am sure, now. But I hope that everybody will keep in mind
that this is in the area of 6 pages of a 152-page bill.
Mr. President, I yield the floor.
Mr. KENNEDY addressed the Chair.
The PRESIDING OFFICER (Mr. Gregg). The Senator from Massachusetts is
recognized.
Mr. KENNEDY. First of all, I want to just comment about the devotion
and duty of our friend and colleague from Vermont. I am sure there may
be those who are watching the proceedings this morning who may not
know, as many of us know, the Senator and his daughter were rear-ended
last Friday morning. Nonetheless, he came in here during the course of
the consideration of this legislation, and now he is here doing his
duty in spite of the inconvenience and discomfort he is feeling. So I
think all of us have great respect for Senator Jeffords. His devotion
to duty is again reflected in his presence here this morning and his
commitment in moving ahead this legislative process.
Mr. President, I also want to, as I did at the opening of the
discussion and debate, congratulate Senator Jeffords on his efforts in
the consideration of this legislation. We considered this legislation--
FDA reform--in the last Congress. We reported legislation out of the
committee. It did not move toward a successful resolution. There were a
number of features there that were extremely troublesome in terms of
the protection of the public. There were areas of strong difference.
Although the process did move forward, it was not successful.
Senator Jeffords has built upon a strong record and made every effort
to try to work through an important public policy area, reform of the
Food and Drug Administration, in ways that recognize its primary
responsibility, which is to protect the public. As we go forward with
this debate, FDA reform should serve the public interest and also take
into consideration the innovation of the pharmaceutical industry and
the medical device industry in bringing new products onto the market
[[Page S8881]]
in ways that can improve the health care of the American people. That
is always a balance.
Men and women of good judgment can differ. There are two important
provisions in this legislation, which eventually will be subject to
further debate and discussion, dealing with what we call sections 404
and 406, labeling and manufacturing. I will come back to those measures
a little later in the course of the debate. We heard references to
those items by our friends and colleagues, Senator Reed and Senator
Durbin, on Friday last. We will have a chance to outline at least some
of the concerns about those measures, and, ultimately, the Senate and
the conference will have an opportunity to deal with those.
I personally feel that they pose important public health issues that
need to be addressed. But I agree with what Senator Jeffords has
outlined, which is the broad sweep of this legislation, and the areas
of broad agreement that have been an impressive legislative
achievement. Senator Jeffords should receive commendation for that
because all of us who were part of that process feel that there are
many features in here that should move forward.
Some of us are hopeful that we can address the medical device
legislation and also address what I consider to be one of the important
amendments that was passed in the consideration of the legislation in
one of the last markups--passed with a strong vote, after some
discussion, but nonetheless, poses what I consider to be an important
and unnecessary health hazard to the American people. That is, the
provisions which are known as the cosmetic preemption provisions, which
were added to this legislation, not included in the original mark of
the chair, not included in the original mark of Senator Kassebaum a
year ago, but added at the behest of the industry. As a matter of fact,
the language itself was drafted by the industry. It was advanced in the
committee considerations and now is part of the legislation.
As I mentioned last week, I am absolutely convinced that if this had
been introduced as a separate bill, it would be far back in the
recesses of the Labor and Human Resources Committee, in terms of its
consideration. But nonetheless, action was taken by the committee and
that action has resulted in the inclusion of the cosmetic preemption
provision. If this legislation is passed, it will effectively say to
the 50 States that you virtually have no rights or opportunities for
protecting your consumers from unsafe or dangerous cosmetics.
Now, I listened with interest to what the Senator outlined in regards
to the powers of the FDA, in terms of protecting the public. But the
fact is, as we know, the food and drug law has 126 pages that relate to
drugs or prescription drugs and medical devices, it has 55 pages
dealing with labeling and nutrition labeling, it has 8 pages dealing
with definitions in the food and drug law, and it has a page and a half
on cosmetics.
There are only two members of the Food and Drug Administration who
oversee cosmetic packaging, labeling and warning. We have seen where
the various studies that have been done by governmental agencies, like
the General Accounting Office, have stated that what is necessary to
give assurance and protection to the American people regarding
cosmetics is more significant regulatory authorities for FDA to make
sure that the ingredients that are going into cosmetics are going to be
safe. We do that with the pharmaceutical industry; we do it with the
medical device industry. We do not do that with cosmetics.
The American people go into their drugstore and get a prescription
drug or an over-the-counter drug. They know that, in effect, there is a
warranty from the FDA that bears the gold standard for safety in the
world, that those products are going to be safe. They get a medical
device and they know it is going to be safe. But the fact of the matter
is, Mr. President, we are not so sure when it comes to cosmetics. For
example, when we consider the safety of our cosmetics, we know that,
the Consumer Product Safety Commission, more than 10 years ago--and the
utilization of cosmetics has grown exponentially since that time--
reports 47,000 emergency room visits as a result of the use of
cosmetics and cosmetic products in one single year. Does that sound
very safe to all of you? What is the record? Where is the testimony to
say how safe it was? You do not have it. You do not have it because we
have not had any hearings. It would have been a good hearing if we had
two or three former heads of FDA that appeared before the committee and
said this is what the safety issues are, these are what the health
issues are, these are why either we agree or we differ on the issues of
preemption. But we didn't have them in the Senate. And you have not had
them in the House. You didn't have them in this Congress. You didn't
have them in the last Congress. You have not had them in the Congress
before. You have not had them for 20 years. The only documents you have
are from the GAO. And they don't talk about how safe everything is.
They have a series of recommendations, which I have read into the
Record, that say what we ought to be doing in order to guarantee safety
and security.
That is what the GAO said. That isn't the Senator from Massachusetts.
That isn't the four other Senators that said let's stop, look, and
listen. But we are going to go ahead pell-mell with this particular
provision. We have looked at the results of the GAO study. They have
not been refuted, and we have not had any hearings providing evidence
that can refute the GAO.
Mr. President, is this something that just now a single Senator, or
three, or four, or five Senators should be concerned about?
It is interesting that the administration has targeted this
provision, as well as the two to three other provisions that I
mentioned earlier, as matters that have to be addressed.
The National Governors' Association: This is what they say about this
provision.
When the Senate Labor and Human Resources Committee
considered reauthorization of the Food and Drug
Administration, the committee adopted an amendment proposed
by Senator Gregg that preempts State regulations, disclosure
requirements, labeling, and warning requirements as they
apply to nonprescription drugs and cosmetics. The National
Conference of State Legislatures and the National Governors'
Association, vigorously oppose this provision and hope that
it will not be part of the bill when it is reported by the
Senate.
All the Governors are saying virtually the same thing. Let us, in the
50 States, be able to take actions with regard to cosmetics, allow us
to protect our people. That is what all the Governors are saying. But
oh, no. ``Washington knows best.'' Remember those old statements that
we used to hear all across the country by many of our colleagues. Let's
not have a one-solution-fits all. Let's not have that. Let's not have
``Government knows best.'' Well, here you have Government knows best.
They don't know best. They can't handle and protect their people in
California, or Ohio, or Massachusetts. Absolutely not, even though
there have been strong efforts in each of these States to try and move
ahead and to protect their people. But we are saying not after we pass
this law.
Mr. President, as I said last Friday here on the floor of the U.S.
Senate, we are making tough decisions on matters over which reasonable
people can differ. And these are in many instances heartrending
decisions. I mentioned last Friday, the decisions that we had in our
Human Resources Committee where you have a limited amount of money. You
have to make a decision for Meals on Wheels; whether you are going to
provide all of the money to the congregate sites to feed elderly
people--and you can feed more elderly people if you put it in the
congregate sites--or are you going to take a third of that money and
feed people that are shut-ins? The money will not go as far. You are
not going to reach as many people if you take those scarce resources
and reach the shut-ins. What should be the public policy question?
Should we give the money to feed more people, or should we allocate
some to the shut-ins, or should we just leave this up to the local
community?
These are important public policy issues that affect the lives of
real people. But not on this cosmetic issue. What are the public policy
considerations on the other side? Money. Greed. Cosmetic industry.
Greed. What are the public health considerations of preemption? How are
they advanced? How are they preserved? How are the American people
further protected by a preemption? They are not. We have not heard that
[[Page S8882]]
argument made on the floor of the U.S. Senate. We have not heard it,
because it is not there.
This legislation is proposed because of what has been happening in
the area of California, and some of the other States which have been
looking at the kinds of concerns being raised by so many consumers day
in and day out--I will mention those in just a few moments--that are
really wondering whether some of these products are safe. And there is
good reason to ask whether they are safe because as we have seen from
the GAO, many of these products are potential carcinogens. What is a
carcinogen? It is a cancer-causing agent. We wouldn't permit these
products to go into processed food because the Delaney clause would
protect the American people from carcinogens in processed food. But can
you add them to cosmetics? You can add them to cosmetics. They are
added to cosmetics today.
That is another reason, Mr. President, why the Environmental Defense
Fund says no to this provision; why the Natural Resources Defense
Council says no to this provision; why the Patients Coalition Consumers
Union says no to do this provision; why the Consumer Federation of
America says no; why AIDS Action says no; why the American Public
Health Association, the association to protect the American public
health, says no to this provision. All of these organizations say no to
this provision. Why? Because it doesn't protect and advance the
interests of the public health in the States. It advances the bottom
line of the cosmetic industry, but it does not advance the interests of
the public health.
Mr. President, I will mention what the National Women's Health
Network says in a letter that I will include.
I ask unanimous consent that this letter be printed at an appropriate
place in the Record.
There being no objection, the letter was ordered to be printed in the
Record, as follows:
National Women's Health Network,
September 8, 1997.
Hon. Edward M. Kennedy,
U.S. Senate,
Washington, DC.
Dear Senator Kennedy: On behalf of the 13,000 individual
and 300 organizational members of the National Women's Health
Network, I am writing to express our opposition to damaging
provisions in S. 830, the FDA Modernization and
Accountability Act of 1997 which would preempt state
regulation of cosmetics. I commend you for speaking out about
this potential threat to women's health.
The spectrum of the cosmetic industry is broad and not
simply limited to lipstick, mascara, or eyeshadow. Hair gels
and dyes, soap, toothpaste, baby powder, and lotions also
fall under the umbrella of this $20 billion dollar industry.
Most women use one or more of these products everyday, and
assume that they are safe for themselves and their families.
Sadly, this is not the case. There is virtually no federal
oversight of cosmetic products which, according to a 1987
Consumer Product Safety Commission study, led to an estimated
47,000 emergency room visits in one year. Additionally, the
General Accounting Office reported that a number of cosmetic
products marketed in the United States ``may pose a serious
hazard to the public.''
Because the FDA has virtually no authority to regulate this
very profitable industry; in fact the FDA has less than 30
employees overseeing the safety of cosmetics, states have
initiated their own efforts to protect their residents. These
state consumer protection laws have alerted women to products
containing carcinogens or the presence of ingredients which
may cause allergic reactions.
The Network believes that S. 830 puts the financial
bottomline of the cosmetics industry ahead of the health of
millions of women by banning states from regulating the
industry's products. The bill would even bar states from
establishing public communication campaigns which would
inform women of a cosmetic's safety and effectiveness. This
would mean no warning labels, no data on carcinogens, no
``keep out of reach of children'' notices.
It is absolutely crucial that provisions in S. 830
preempting states' rights to regulate cosmetics be removed
from the bill. Women and their families deserve to have
complete information about the safety and effectiveness of
these products and states who are willing to step forward to
safeguard the health of their residents must be allowed to do
so. The National Women's Health Network stands ready to work
with you to educate members of the Senate and the American
public about this very serious women's health issue.
Sincerely,
Cynthia A. Pearson,
Executive Director.
Mr. KENNEDY. They say:
The spectrum of the cosmetic industry is broad and not
simply limited to lipstick, mascara, or eye shadow. Hair gels
and dyes, soap, toothpaste, baby powder, and lotions also
fall under the umbrella of this $20 billion industry. Most
women use one or more of these products every day, and assume
that they are safe for themselves and their families.
Sadly, this is not the case. There is virtually no federal
oversight of cosmetic products which, according to a 1987
Consumer Product Safety Commission study, led to an estimated
47,000 emergency room visits in one year.
Just to depart for a minute, if you have 47,000 people going to the
emergency room, how many other thousands are going back to see their
doctors? How many other thousands have gone to their dermatologists?
How many other thousands have gone to their own doctors, and not to the
emergency room and willing to pay the other $150, $175, or $200 to just
visit the emergency room? How many others knew that? There were 47,000
emergency room visits in one year.
Additionally the General Accounting Office reported that a
number of cosmetic products marketed in the United States
``may pose a serious hazard to the public.''
That is the GAO-- `` * * * may pose a serious hazard to the public.''
It would seem to me this morning that we ought to be debating how we
are going to advance public health, and how we are going to protect
those individuals whose health may be in danger. Are we debating that?
No. To the contrary. We are going to say as a result of this
legislation that the health of the consumers of cosmetics are going to
be at greater risk. That is the only conclusion, and that the bottom
lines of the cosmetic industry are going to be higher.
I continue:
The Women's Health Network ``* * * believes that S. 830
puts the financial bottom line of the cosmetic industry ahead
of the health of millions of women by banning states from
regulating the industry's products.''
There it is. There is the heart of the argument right there by the
National Women's Health Network, one of the effective organizations
that looks out after the public health of American women. Does it get
it right here?
The Network believes that S. 830 puts the financial bottom
line of the cosmetic industry ahead of the health of millions
of women by banning states from regulating the industry's
products.
That is it. That is what we got tagged onto this bill that is dealing
with pharmaceuticals and prescription drugs, dealing with medical
devices, dealing with the extension of PDUFA, which is a source of
revenue to ensure that the FDA can be tops in the world in terms of
approving new products. We support those various provisions. But now we
have added onto this train this cosmetic preemption that the principal
organizations that are dealing with public health say to the U.S.
Senate: ``Stop. Say no. Do not move ahead with that.''
It continues, Mr. President:
It is absolutely crucial that provisions in S. 830
preempting states' rights to regulate cosmetics be removed
from the bill. Women and their families deserve to have
complete information about the safety and effectiveness of
these products and states who are willing to step forward to
safeguard the health of their residents must be allowed to do
so.
Mr. President, let me just continue on with the groups just so that
we understand the breadth of the opposition. It isn't just a few
Senators. As I mentioned, the principal public health associations,
those that are primarily concerned about women's health, the ones that
use these products to the greatest extent--the administration, the
State legislators. The State legislators were joined by the Association
of State and Territory Health Officials. They emphasized State laws
provide consumers with important protections in areas where the FDA has
insufficient resources to act and represent a legitimate exercise of
State authority.
As I mentioned before, Mr. President, if we were debating the
regulatory authority of the FDA to protect the public health, that is a
legitimate debate. But that is not where we are. We are not out here
debating what would be appropriate power for the FDA to have to ensure
protections for the American consumer on cosmetics.
If there are those that can say with a straight face with the $6
million budget that they are allocating through FDA
[[Page S8883]]
and two people that are overseeing the areas of packaging and labeling,
which is the only thing that the States can do in terms of trying to
get at these health considerations--if we were out here to say, ``Look,
they have too much power, they have been abusing that power, and they
are inefficient with that power,'' that would be one thing. But we are
not out here debating that. We are just saying we know, as the cosmetic
industry does, that the agency does not have the wherewithal in order
to protect the consumer, that the historical protections for the
consumer on health and safety have been the States and local
communities, and what we are out here now saying is that we are going
to take all of their power away. That is the issue. It isn't that we
have a strong FDA. We don't have it. It is not represented. It was
never discussed in the course of our markup. We had no hearing that
would be able to represent it.
Let me just take a few minutes to indicate how we have gotten to
where we are with regard to the FDA power on drugs, pharmaceuticals,
and on cosmetics.
As I mentioned, the FDA has less than two people to regulate the
labeling, packaging, and warning for a $20 billion a year industry. The
FDA has less than 30 people to work on cosmetics, and FDA's authorities
are grossly inadequate. The FDA regulation of cosmetics is a dinosaur,
an anachronism from the time when drugs didn't have to be effective,
when food additives didn't have to be safe, and when medical devices
didn't have to be safe or effective. Just go back with me in terms of
the times so we understand where we are.
I chaired the hearings that we had in the 1970's about medical
devices. Twenty-three women died from perforated uteruses as a result
of the Dalkon shield. And that was the beginning of the changes in our
medical device legislation--in the mid-1970's. Because of the danger
with the sophistication of medical devices, we were going to have to
make sure they were going to be safe and efficacious. And we did.
Mr. President, in 1938, the last and only time the Congress acted
specifically to regulate cosmetics--1938 is the last time--FDA was
given authority to regulate products that were misbranded or
adulterated. FDA had the burden. FDA had to find the problem. FDA had
to do the studies. FDA has to bring a court action.
The entire burden is on the agency. In the last 60 years, we have
progressed in other areas of public health and safety. In 1954, we
passed the Miller pesticides amendment. In 1958, we passed the Food
Additives Amendment requiring manufacturers of food additives to
demonstrate safety before putting potentially harmful chemicals in the
food supply. Now manufacturers have to demonstrate that their products
are safe in order to go in the food supply.
Do you have to do that with regard to cosmetics? No, you do not have
to do that with regard to cosmetics. Two years later, we passed the
color additives amendment to establish a premarket approval system for
additives used in food, drugs and cosmetics. The drug amendments of
1962 fundamentally restructured the way FDA required premarket approval
of safety and effectiveness for every new drug. Prior to that it was
not there, not necessary. They have to prove safety and effectiveness.
In 1976, we enacted the medical device amendments following long
years of study and debate. So now we have the agency requiring that
each of the products in terms of the prescription drugs and with regard
to medical devices have to be proven safe and efficacious. Do they have
to do that with regard to cosmetics? No. No, they do not have to do
that today.
Among the most recent changes in FDA's authority were the infant
formula amendments of 1980 and the 1990 Nutrition Labeling and
Education Act, and the 1990 Safe Medical Device Act. Under these laws
Congress held manufacturers responsible for safe and effective
products. We asked the manufacturers to provide data to FDA to
demonstrate safety before they could sell the products.
We went ahead again with regard to prescriptions and again with
regard to medical devices. Do we do it with cosmetics? No. Despite all
this progress and advance in public health and safety, cosmetic
regulation has lagged far behind. FDA's authority and regulation of
cosmetics is still stuck in the framework of the 1938 law that Congress
found it necessary to update in every other product area. This is not
to say that Congress has not revisited the area of cosmetic regulation.
In fact, every time that Congress has revisited cosmetic regulation it
has resulted in a call for additional protection and additional safety
measures--every single time. But here we are on this FDA
reauthorization bill, to reauthorize the FDA and bring it up into the
modern period in terms of medical devices and pharmacy. Here we are
with a change, significant change in terms of the relationship of the
protection of the American people from cosmetics.
And here we are without the hearings, using the exact language of the
cosmetic industry which is going to mean health threats to the American
consumer--at what benefit? Well, as I mentioned, the bottom line of the
cosmetic industry. So we have each and every time, with regard to
pharmaceuticals and medical devices, we see what we have done and we
have seen each time that Congress has gotten into it or the GAO studies
have gotten into it, they say it is an area which cries out of the need
for greater protection of the public.
In 1948, George Larrick, who became the Food and Drug Administrator,
said:
Real scientific appraisal of cosmetic ingredients should be
made before an ingredient is marketed.
Did we do that? No. In the 1952 hearings, James Delaney in the House
found that partial regulation of cosmetics resulted in insufficiently
tested cosmetics that are a source of discomfort and disability.
Further, the House report found that cosmetics should be subjected
essentially to the same safety requirement as applied to new drugs. Yet
today that is far from the case.
In 1978, the U.S. GAO report strongly recommended the FDA be given
adequate authority to increase safety of cosmetics. Among its findings:
Although there is increasing evidence that some cosmetic products and
ingredients may carry a significant risk of injury to consumers, the
FDA does not have an effective program for regulating cosmetics. Some
coal tar hair dyes may pose a significant risk of cancer because they
contain colors known to cause or are suspected of causing cancer in
humans or animals. However, the exemptions granted to coal tar hair
dyes in 1938 prevented FDA from effectively regulating hair dyes. The
industry was sufficiently powerful at that time to write an exemption
in the law. And there is increasing evidence that people with darker
hair who use these darker colors have higher incidence of troubles in
terms of not only their scalps but also their general health conditions
and there are increasing studies concerning the exposure these
individuals may have had to carcinogens and cancer.
Serious burns have been reported from the use of flammable cosmetics.
Among those likely to ignite at the time of application are perfumes
and colognes which usually contain a high concentration of alcohol and
nail polish removers which contain flammable ingredients such as
acetone and ethyl acetate.
In 1975 FDA sponsored a 3-month survey of 35,000 users of cosmetics.
Participants kept a diary and reported adverse reactions. These reports
were reviewed by a team of physicians to determine if the injuries were
cosmetically related. One of every 60 participants suffered an injury
confirmed by a physician as cosmetically related. One in every 450
participants suffered a severe or moderate injury.
These are studies that were done back in 1975 by the FDA. Do you
think we have updated those studies? No. Do you think we have had
hearings about that? No. And yet each and every time there is a serious
evaluation we are finding these incidents involving health hazards. We
have seen the varying degrees of the hazards in the examples and in the
pictures that are here behind us. And we could go through picture after
picture of the damage done by various kinds of products.
The GAO report concludes that cosmetics are being marketed in the
United States which may pose a serious hazard to the public.
[[Page S8884]]
That is not the Senator from Massachusetts. That is the GAO, not
Democrat, not Republican. In drawing on the best scientific
information, this is what they conclude.
Cosmetics are being marketed in the United States which may
pose a serious hazard to health. Some contain toxic
ingredients which may cause cancer, birth defects or other
chronic toxic effects and contain contaminants known to cause
cancer in animals because exposure to these ingredients can
occur through skin absorption and inhalation as well as oral
ingestion. It is important that the hazards posed by them be
carefully assessed.
I tell you, Mr. President, if this provision passes, those hazards
are not going to be assessed by the States because of the way the
language is written in the legislation. I am talking about what will be
preempted on page 119, line 8:
Shall be deemed to include--
This is the preemption--
any requirement relating to public information or any other
form of public communication relating to the safety or
effectiveness of a drug or cosmetic.
There it is. Here you have the last studies being done, nonpartisan.
Individuals are reviewing the most recent, up-to-date scientific
studies. Cosmetics which are being marketed in the United States which
may pose a serious hazard to the public.
Why are we asked to take a chance on it, Mr. President? Why are we
being asked to take this action? One reason and one reason only--the
bottom line for the cosmetic industry. There is no public health
argument that can be made on the other side--absolutely none--just the
greed of the cosmetic industry.
Every American ought to understand that. Here you have the GAO saying
cosmetics are being marketed which may cause a serious hazard to your
health. You have the several States: Texas, California, Ohio, my own
State of Massachusetts, and a number of other States that are
attempting to deal with some of these potential and real hazards to us
and they are going to be preempted. Sure, we exempted California from
this provision, but there are other health protections in California
that are going be precluded.
I have my differences with the attorney general, Dan Lundgren out
there in California, but you read through his letter about this action
and about the efforts California is making trying to protect its public
and how it is completely contrary to the interests of California. Here
is the Attorney General of California:
Regulation of health and safety matters has historically
been a matter of local concern, and the Federal Government
has been reluctant to infringe on state sovereignty in these
traditional areas.
And he says:
As noted above, S. 830 would, in the absence of specific
FDA exemption, appear to prevent the State of California from
enforcing their Sherman Food Drug and Cosmetic Law which is
there to protect the people of California. And it goes on to
make the case in opposition to this particular provision.
So now we have the GAO report and we have what this statute does.
The 1988 hearings held in the House of Representatives raised the
same issues about the FDA's lack of authority and resources in this
important area. Nothing has been done. Let me review one more time what
FDA cannot do under its current authority.
It cannot require cosmetics manufacturers to submit safety data on
their products--cannot require that. It can require it with regard to
pharmaceuticals. It cannot require cosmetic manufacturers to register
their plants or establishments or require cosmetic manufacturers to
register their products or require premarket approval of any cosmetic
or cosmetic ingredient even when such approval is necessary to protect
the public health; cannot require manufacturers to submit consumer
complaints about adverse reactions to cosmetics; cannot require
manufacturers to perform specific testing necessary to support the
safety of a cosmetic or an ingredient.
So, Mr. President, this is what we have under current law. I would
like to mention just some of the dangers associated with this limited
authority. We have talked in generalities. We talk about jurisdiction.
We talk about preemption. We talk about inspection. But here are
examples of dangerous cosmetics. These injuries took place this year,
and there are dozens and dozens of them in graphic detail. I want to
read a few of them for you.
Do any of you use Alberto Hot Oil Treatment for your hair? There was
a complaint just last month of eye dermatitis from this product. Do you
know what that means? It means blisters, chemical burns, rash, redness,
swelling, and inflammation. All that from a simple hair treatment.
Everybody in America uses toothpaste every single day. In August, a
consumer used a type of Colgate toothpaste with baking soda and
peroxide. What happened? Mouth pain and dermatitis. That's a fancy way
of describing itching, burning, and swelling of the lips, tongue and
gums.
In case you are thinking of switching brands, think again. Somebody
else used Crest Tartar Control toothpaste in January and developed the
same symptoms of burning, itching, and swelling in the mouth--not what
you would expect from brushing your teeth in the morning.
Here is another example. In August somebody used Gillette Cool Wave
clear stick deodorant. Instead of being clean and presentable, they
ended up with armpit dermatitis and bleeding. Can you imagine bleeding
from using deodorant.
How about a product called Revlon Outrageous Shampoo and Conditioner?
It is outrageous all right. The user developed scalp sores, swelling,
and inflammation from the shampoo.
Have you ever used Bath salts? You may not want to after you hear
this. In March, someone developed ``nervous system and urogenital tract
reactions'' from Essential Elements Bath Salts. Can you imagine
expecting a nice relaxing hot bath and end up with dizziness and
headaches.
These examples go on and on.
Prestigious manufacturers L'Oreal, Avon, Clairol, Neutrogena,
familiar names like Procter and Gamble, Revlon, Maybelline, Mr.
President, this list provides a dismaying parade of horrors from
products we rely on every single day.
Here are just a few examples of the injury complaints received by the
FDA. Dermatitis includes rash and redness, swelling, blisters, sores,
weeping and lumps, inflammation, chemical burns, and irritation. Pain
ranges from itching and stinging to soreness and tingling. Tissue
damage, other than thermal burn, can include dryness and peeling,
splitting, cracking, hair and nail breaking, hair and nail loss,
ulcerations, hair matting, and scars. Nervous system reactions range
from dizziness, and headache to irritability, nervousness, and
numbness.
How many people using these products have symptoms like dizziness,
headache, irritability, nervousness, or numbness, and wonder where in
the world this is all this coming from? It may very well be coming from
their cosmetics, from their shampoos and toothpastes and other types of
cosmetics.
If these examples aren't striking enough, there are respiratory
system reactions, like upset stomach, nausea, loss of appetite,
vomiting, and diarrhea. Or urogenital tract reactions: painful
urination, discharge, stopping of urination, and on and on it goes.
Mr. President, I asked for the complaints that we have gotten in just
the last few months. Here in my hand is the list of them from the FDA.
It is interesting to note that, a number of years ago, we tried to get
authority for an FDA hotline so people could call up with their
cosmetic injuries. It was struck out in the Appropriations Committee at
the behest and intervention of the cosmetic industry. We tried to get a
hotline so that at least we would be able to get more information and
the FDA would be able to act on that information about specific
products.
What is the lesson we can draw from this? The industry does not want
more information about cosmetic injuries. They don't want others to
have that information. So they eliminated funding of the cosmetic
hotline. We have successful and important hotlines in many other areas.
They have been a strong success. I have been a strong supporter of
them, because they assist people in obtaining information and, most
important, help in a timely way. But they also allow the Government to
register various complaints and gauge the seriousness of public health
problems.
We tried to get the hotline. We had it authorized, it went on to the
Appropriations Committee a few years ago,
[[Page S8885]]
but it was knocked out by intensive lobbying. So I am truly amazed that
the FDA has the kinds of reports I will describe, and the sheer number
of cases that they do. The truth is, most people who suffer injuries or
adverse reactions from cosmetics simply don't know who to tell, other
than their doctors. They in turn don't have anyone to tell or don't
know who to tell. Certainly, the companies are under no obligation to
tell the FDA--nor do they.
I will return a little later to the efforts that were made to try to
get the manufacturers to voluntarily assist the FDA in reporting
complaints. At the end of the day, only about 3 percent of the
manufacturers cooperated in that effort. When hearings were held in
1988, there appeared to be a consensus to do more to protect the
public. The industry itself said, give us an opportunity to voluntarily
provide the FDA the complaints that we receive. Well, it ended up being
about 3 percent of the companies that actually participated. I will get
to this in just a few moments.
Let's begin with the injury complaints. In August, Alberto Culver &
Co.'s hot oil treatment for color-treated and permed hair: Eye
dermatitis, including rash, redness, swelling, blisters, sores,
weeping, lumps, inflammation, sunburn, chemical burn, and irritation.
Clairol Helene Curtis, the brand was Nice N Easy Natural Lite Ash Brown
No. 114 and Degree antiperspirant; upper trunk and shoulder pain,
including burning and stinging. Clairol's Nice N Easy Medium Brown No.
118: Hair tissue damage other than thermal burns. Procter & Gamble's
Covergirl Makeup Master, facial and nose injury including dermatitis;
Revlon's Professional Nail Enamel Remover: Finger injury, including
cuticle, irritation, dermatitis. Neutro-gena's Clear Pore Facial
Treatment, facial injury; Dixie Health, Dermal KK is the brand: Face,
including nose bleeding.
In July, Maybelline's Great Lash Mascara: Face pain and dermatitis in
the nose. Realistic's, which is Roux Labs, Revlon Super Fabulayer Hair
Relaxer Conditioner: Scalp dermatitis; Shark Products' Africa Pride
Relaxer is the brand: Hair tissue damage. Procter & Gamble's Pantene
Shampoo: Upper trunk dermatitis, neck tissue damage. Vidal Sassoon
Shampoo: Upper trunk dermatitis. Clairol Hydrience Permanent Hair
Color: Permanent discoloration of the hair. I can't imagine a product
that could unintentionally make hair permanently discolored, but that
is what has been reported.
The list goes on. It lists the names of just about every major kind
of cosmetic maker in the book. Andrea International's eyelash adhesive:
Eye pain. You have perfume from Stern & Co., the product is Oscar:
Respiratory system reactions. And the list goes on. I have page after
page of these kinds of complaints.
It seems to me if the States want to bring these matters up and it
was the desire of the States to try to protect their consumers, they
should have the opportunity to do so. Just as California has done and
just as other States which are presently studying these issues will do.
These States could go and talk to the manufacturers and the
manufacturers can make changes, which they have on product after
product sold in California. Proposition 65 is the basis for this
California system, which works by inducing product improvements without
having to remove products from the market or even putting labels on
them. That is the way it has worked in California. Safer products. And
time in and time out, the manufacturer comes out and advertises that
they have upgraded their product. It is a better product now than it
ever has been--an interesting and desirable outcome.
But in this bill we say no. We just say no. We tell consumers, you
cannot have the remedy of the State and you cannot have the remedy at
the Federal Government. The result will be more individuals like the
59-year-old California woman who was almost killed by an allergic
reaction to hair dye. Or the woman who lost her hair and was horribly
scarred when her hair caught fire from a flammable hair treatment gel.
The 6-year-old daughter of an Oakland, CA, woman who used a hair
product on her child who suffered second-degree burns. Two women who
used eyelash dye, one of whom died and the other who went blind. A 16-
month-old toddler died of cyanide poisoning after swallowing artificial
nail remover, and a 2-year-old child from Utah was poisoned by the same
cosmetic. If there is a State that wants to do something about
children, like putting a warning label on these items in order to
protect children, it will never happen under this bill. We know that
children get into all kinds of products in the household and there is
the chance of them ingesting some of these items. Obviously, some may
be considerably more dangerous than others, and consumers will want to
have labeling that says if the child ingests this, take the following
steps or contact the following people. But under this bill, if the
State wants to do that, they are virtually prohibited from doing so.
They are denied the opportunity to protect their children in their own
States.
What if a review is made of the scientific information in these
States on these products if ingested by children, asking do they
present serious threats of poisoning among children that may be life-
threatening? Should warnings be placed on the labels? The result under
this bill will be: No, you are out. You can't do that. I just find it
difficult to understand why can't the States do this? Why can't they if
they want to in Massachusetts or any other State? The reason will be
because the Congress of the United States, at the request of the
cosmetic industry, says you can't do it. Congress and the industry say
you can't do it. That is what we are dealing with, Mr. President. It is
just why I think this makes absolutely no sense.
We reviewed earlier this morning some of the groups that were opposed
to this provision: The Governors and State legislatures, virtually all
of the public health and consumer groups like the National Women's
Health Network, the wide range of agencies and officials with primary
responsibility over the public health. They are virtually unanimous in
their opposition. I will happily wait to hear from public health groups
in support of the provision. We will have time during the course of the
debate for other Members who are able to get that kind of information
and place it in the Record. In the face of such unanimous opposition,
they will be few and far between.
Here is a letter from the United Food and Commercial Workers, Beth
Shulman, the international vice president.
We are appalled that the Senate is considering preempting
state cosmetic safety regulation in the almost complete
absence of any Federal protection.
Unlike all other products governed by the Food and Drug
Administration, such as food and drugs, the FDA has
essentially no authority to assure the safety of cosmetic
products prior to entry into the marketplace. The FDA has no
legal authority to require manufacturers to conduct safety
testing, submit lists of ingredients to the agency, company
data, or consumer complaints. Most consumers would be shocked
to learn that there is no Federal government regulation or
testing to assure the safety of cosmetics before they appear
on store shelves or are used by hair care professionals. It
is scandalous that the Senate is now considering stripping
states of their legal authority, so that the safety of
cosmetic products used by millions of consumers will now be
completely unregulated.
The United Food and Commercial Workers Union, which
represents barbers and cosmetologists among its 1.4 million
members, has a long history of campaigning for stronger
Federal regulation of cosmetic products. Over the past twenty
years we have testified repeatedly about the hazards of
cosmetic products and the need to protect not only the
750,000 professional cosmetologists, but the millions of
consumers that use these products daily.
They point out they take strong exception to those protections. Now,
why should they be concerned? They gave some excellent testimony
several years ago to the Congress. Let me give an example. After 2
years as a wig stylist, a cosmetologist from San Francisco began to
experience memory loss, nausea, and dizziness. She had troubles with
vision and balance. She stated, ``I can't remember things I did just a
short while ago. I have to write everything down.'' Her condition was
blamed on the ingredients in hair spray and other products she was
using in her work. She appeared as one of the witnesses where Congress
was working to regulate the largely unregulated industry.
Another example: Christy Smith enrolled in a beauty college in 1984.
Christy began to have trouble breathing, a problem that worsened over
the
[[Page S8886]]
years. She dropped out of beauty school after 10 months. She was found
to have irreversible occupational asthma. Again, her condition was
attributed to cosmetics present at her school.
A 1997 study in the Journal of Environmental Medicine found evidence
to support the claim that female hairdressers are at a higher risk of
asthma as a result of occupational exposure to chemicals found in
various hair products. This prompted a related study by the Palmer
Group, which found an increased prevalence of respiratory symptoms and
diseases among female hairdressers. These diseases included asthma,
bronchitis, emphysema, and other chronic lung diseases.
Female hairdressers face daily exposure to many harmful chemicals
that are used in a wide array of hair care products on the job. I will
give a few examples. These chemicals include persulfates, which are
used in hair bleaches and can cause allergic skin and respiratory
symptoms. Several indications of occupational asthma among hairdressers
have been reported. Polyacrylates mixed with chemicals and hydrocarbons
in hair styling agents can cause irritation of airways and adversely
affect other respiratory functions.
Ammoniac and sulfur compounds released in hair dying and permanent
waving can cause irritation of the airways.
The relative risk of asthma and chronic bronchitis among hairdressers
was measured almost twice that of a reference group between 1980 and
1995. This study found that the youngest cohort of female hairdressers
experienced the greatest occurrence of asthma, 42 percent; and chronic
bronchitis, 44. These women ranged in age from 35 to 44.
Mr. President, this is what is happening in the beauty parlors among
beauticians across the country. Why? Because they are inhaling these
products. They suffer from the higher concentrations of these toxins,
but the women of this country who use these products at home are also
inhaling them and endangering their health.
I am not here to say precisely what the extent of this problem is,
but we know now that it is happening as a result of studies that the
compounds that are being used are more toxic and there are more of them
being used every year. The health hazards have to be greater. At a time
when the health hazards have to be greater, why are we taking away the
rights of the States to render judgments to protect their citizens?
This is especially true in an area of traditional State authority.
What if the States want to take some kind of action? We are
prohibiting them from doing so. We are denying them that chance to do
so. It makes absolutely no sense--no sense at all. It does make dollars
and cents because the industry is going to benefit from it, but it
doesn't make any sense in terms of the public health. That is why
virtually every public health agency committed to protecting women and
women's health wants this provision out. It undermines their ability at
the State level to give additional protections to consumers, and for no
other reason than the financial interest of the cosmetic industry.
Mr. President, I will mention here how the United States compares
with the rest of the world. That doesn't happen to be the most
important argument made this morning, but we heard on the floor of the
Senate last Friday about how we have fallen behind other countries in
terms of the FDA's work. In reality, the United States has been
compared with the rest of the world, and impartial sources such as the
General Accounting Office have found that the United States has the
fastest and most vigorous product approvals. American consumers expect
the best and that is what they get from the FDA.
But when it comes to cosmetics, the U.S. motto should be: ``Expect
the best, but settle for less.''
Looking around the world, it is remarkable how inadequately the
United States stacks up against other countries. The European Union
requires documented proof of good manufacturing practices and similar
proof that extensive testing be carried out on all its products. What
do they know that we don't know? What are their scientists and research
scientists finding? Are we taking the time of the Senate to go through
their various studies that point out the health hazards in their
communities? They have done it, and they are providing additional
protection.
Let us examine another major economic power: Japan regulates
cosmetics likes drugs, requiring the companies to do safety tests
before marketing. Why? What is it they understand about cosmetic
safety? Is it possible they have reviewed and found the same things
that we have talked about this morning? The same things that the GAO
has found out about the dangers posed by cosmetic products?
Japan requires testing before marketing. That is exactly what the
Congress said in 1952 we should be doing in the United States. Forty-
five years later, we are still waiting for safety testing. The Japanese
are not.
Let's look at North America. Mexico adopted a regulation mandating
expiration dates on all cosmetics. To the north in Canada,
manufacturers submit data to show the product is safe under normal use
conditions.
The Scandinavian countries: Sweden and Denmark are initiating product
registration for cosmetics, something the FDA can't require.
Malaysia already requires mandatory registration of cosmetics. That
is something the cosmetics industry would fight tooth and nail.
The bottom line is that the American consumers have less protection
than consumers in any other country that I have mentioned. The United
States is a First World country with a Third World cosmetics safety
system. That is the way it is today, and this legislation is going to
make it worse. Much worse. That, Mr. President, is wholly unacceptable.
I want to mention more specifically the products of which I think
people should have some awareness. These are five common cosmetics
products with potentially devastating health effects:
Alpha-hydroxy acid, used in face cream, causes skin cancer.
Feminine hygiene products cause infertility in young women;
Talc used in baby powder that may cause cancer; and
Mascara that can cause blindness.
Alpha-hydroxy acid is one of the hottest selling cosmetics on the
market with sales of roughly $1 billion a year. This product is sold to
erase fine lines and tighten the skin, but has devastating health
effects that are unknown to most consumers. The agency has received 100
reports of adverse effects with alpha-hydroxy acid products ranging
from mild irritation and stinging to blistering and burns. More
importantly, these products make users more sensitive to ultraviolet
radiation from sunlight which causes skin cancer.
To find out if a cosmetic contains an alpha-hydroxy acid, the
consumer has to look for one of the following ingredients: glycolic
acid, lactic acid, malic acid, citric acid, L-alpha-hydroxy acid, mixed
fruit acid, triple fruit acid, sugar cane extract. All of these are
alpha-hydroxy acids, although you'd hardly know from their names.
The cosmetics industry sponsored a study linking alpha-hydroxy acids
to increased ultraviolet sensitively and, most likely, skin cancer. An
industry panel concluded that alpha-hydroxy acid cosmetics are safe at
concentrations less than equal to 10 percent at a pH of greater than or
equal to 3.5 percent when directions for use include daily use of Sun
protection.
Equal to less than 10 percent. This is what the cosmetic industry
says will be safe if used along with these other items.
Wouldn't it be useful for someone else or someone impartial to get a
chance to look at the basic science and research that the industry has
used to make a judgment? Wouldn't that be worthwhile? Wouldn't it be
valuable if the FDA had a chance to have that data submitted to them?
They could have their researchers look at it and see whether they come
to the same conclusion as to the safety.
But, no, there is a recognition by the industry itself that if there
is something wrong, they want to do their own study and make their own
recommendations. We, the public, don't know. We don't know whether they
are accurate. We don't even know whether there is going to be any kind
of enforcement, or by whom. By the industry? How? All we have is the
industry's
[[Page S8887]]
record and their willingness to comply voluntarily with the FDA. We
have less than 3 percent of them willing to submit adverse kinds of
reactions to the FDA. So we have no way of knowing about the true
safety of cosmetics. What we do know is that the industry itself
understands that there are health hazards with this specific product
and want to control what's on the warning label.
Don't we want researchers out in the great centers of research in
this country to say, ``Look, we'd like to try to find out if and how we
can protect people.'' Maybe States with broad exposure to the Sun, such
as the South and Southwest, should have particular interest in trying
to do this. They might want to do some studies to find out.
Would they be able to try to make some kind of a judgment under this
bill? Mr. President, the answer is no. We are preempting those States.
Let us look at alpha-hydroxy acids again. Here we have one of the most
highly advertised products on the market today. We have the industry's
own recognition of their health hazards. Again, are we doing something
on the floor of the Senate to protect the consumer from those hazards?
Absolutely not. We are undermining what protection there is out there
among the States.
Consumers should be aware that alpha-hydroxy acid concentrations and
pH are generally not noted on these products, not unless FDA's two
employees find the time and resources to initiate rulemaking to
establish such a regulation. FDA is reviewing the industry report, as
well as other data, about these products and may initiate rulemaking
sometime in the future, but do not expect the States to protect their
citizens from alpha-hydroxy because under the law, States could not
warn their citizens about alpha-hydroxy acid creams.
Feminine hygiene products are other harmful, largely unregulated
products, with roughly $100 million a year in sales. Many women who buy
these products will be surprised to find the overwhelming majority of
these feminine hygiene products are regulated only as cosmetics. These
products have been known to cause upper reproductive tract infection,
pelvic inflammatory disease, ectopic pregnancies, infertility in women.
This reduction in fertility is even greater in young women.
Researchers at the Center for Health Statistics in Seattle, WA, have
published studies regarding the risk of pelvic inflammatory disease
from the use of feminine hygiene products. These researchers have found
that the risk of ectopic pregnancy doubles in women who use feminine
hygiene products. Researchers at Brigham and Women's Hospital, Harvard
Medical School also published data regarding the adverse health effects
of feminine hygiene products. We had better hope that those two people
at FDA working on cosmetics labeling and warnings have time to work on
adequate labeling for feminine hygiene products.
The National Women's Health Network has testified before an FDA
advisory committee that more has to be done to protect the reproductive
health of women, which is clearly affected by these cosmetics. Just
look at the science. But the industry doesn't want the States to have
the authority to warn consumers. So, for the women of the State of
Washington, we should say goodbye to the research studies conducted in
Seattle and what they found out--because we are preempting what those
States can do with them.
Even in my own State, research conducted at Brigham and Women's
Hospital found that the risk of ectopic pregnancy doubles in women who
use feminine hygiene products.
It is worthwhile to inquire if there are other researchers who come
to contrary conclusions. These are studies being done. What State is
going to go out and perform studies, and which research centers, when
they know they are preempted from doing anything about it? That is why
the Women's Health Network is opposed to this provision. And for what
reason are we risking women's health? Why are we risking lives? It is
because of the cosmetic industry. It is going to be cheaper for them,
allegedly, when they don't have to deal with warnings and disclosure of
health risks. It's too much trouble for them. Talc is something widely
used in baby powder and other body powders.
In 1992, the National Toxicology Program published a study of the
effects of talc inhalation in animals and an epidemiology study on
exposure to talc and ovarian cancer risk. The researchers reported an
elevated risk of ovarian cancer associated with talc use. Workers at
Columbia University have reported the detection of talc particles in
the ovaries of patients undergoing surgery.
The Cancer Prevention Coalition has submitted a citizen's petition to
FDA addressing their concern about the possible health risks posed by
talc and requested the agency establish regulations to require
carcinogen warning labels on cosmetics containing talc as an
ingredient. FDA is reviewing the information and may respond sometime
in the future. Those two workers are going to be hard pressed with this
one, too. If the State wanted to warn its consumers about the potential
carcinogen, they would be prohibited under S. 830.
A technique that has been used to extract ovarian tumor material
found talc particles in approximately 75 percent of ovarian tumors
examined. Subsequent evaluations have appeared to support the
contention of an association between talc and ovarian carcinoma.
The most recent study reported by the American Cancer Society has
validated the claim that talc exposure increases the risk of ovarian
cancer. Since the use of talcum powder is not an unusual practice for
women, further studies need to be conducted to further understand the
effects on a woman's female reproductive system. We had hoped that
perhaps some of these research centers, some of these States would be
interested in this. They might have done some work and might have been
able to provide some health and safety recommendations in this area.
But now we are saying that if the State of Washington, that was
interested in alpha-hydroxy, or if we are going to find out from
Columbia University the work they have done with regard to the finding
of talc particles in the ovaries of patients undergoing surgery, if
they wanted to do something in warning people in the State of New York,
those would effectively be off the table. Why are we not debating how
we are going to provide greater protection for women?
We have seen important research done up in Seattle, WA. Why are we
not out here debating what we are going to do about it? How can we
provide protections? What about these kinds of recommendations in terms
of the talc? How dangerous is that to our children? Why are we not out
here debating that rather than saying, look, even though we have seen
this kind of study, we are not going to permit the States to get into
this--into this at all--because the cosmetic industry does not want it.
On mascara, the FDA had numerous reports of corneal ulceration
associated with mascara products, some of which caused partial
blindness of the infected eye. In addition, many other reports of
conjunctivitis caused by contaminated mascara were received.
In a 1969 FDA survey of hand and body lotions and creams, about 20
percent of the products sampled contained microbial contamination.
Researchers at the Medical College of Georgia demonstrated that 10
percent of eye cosmetics were contaminated when sold. Bacteria were
isolated from about 50 percent of all used eye cosmetics. Popular
brands of mascara were marketed without preservative systems and are
particularly vulnerable to contamination.
Mascara cosmetics can become easily contaminated during customary use
because human skin is not sterile, and contact between the skin and a
cosmetic leads to microbial contamination of the products. FDA
published a notice asking the industry to provide information covering
microbial testing methods and standards of performance suitable to
assure that cosmetics do not become contaminated with microorganisms
during manufacture as well as use. However, FDA's request for
information resulted in no substantive response from the industry. The
industry just said no. What can FDA do about it? Since FDA has no
authority to request the safety data from the manufacturers or look at
industry records, FDA's inquiries likely stops
[[Page S8888]]
there. Can the States perhaps do something down the line? Perhaps they
could have at some point, but not under this proposal.
Expiration dates would help remind consumers to get rid of cosmetics
before the bacterial contamination becomes dangerous. Under this
legislation, States could not act to require expiration dating on
cosmetics.
So, Mr. President, the cosmetic provision of the bill is utterly
irresponsible. It is a flagrant example of a special-interest lobby
using its back room muscle to attain unfair advantage over the public
interest.
You bring that bill out separately, Mr. President, and let us have an
opportunity to debate that on the floor of the U.S. Senate. The votes
are not there to carry that individually. And they should not be there.
But now we have seen that the cosmetics industry has added this on to
legislation that was initially devised for the extension of PDUFA, to
ensure adequate funding for FDA's drug review program so that the
United States can be first in the world in terms of approving new
products in the pharmaceutical industry.
It is time for the Senate to stand up for the health of the American
people, reject this unjustified, unwise, unacceptable provision that is
nothing more than a tribute to the greed and recklessness of the
cosmetic industry. The political power of the cosmetic industry is not
a license to ride roughshod over the rights of the States and the
health of the Nation's men, women, and children who use their products
every day.
The American people deserve safe cosmetics. They have a right to full
and fair information about the actual and potential danger of their
products. The last thing Congress should do in a bill called the FDA
reform is to give the cosmetic industry a blank check, poisoning the
American people with its products.
Mr. President, we allow States to decide whether their bottles will
be recycled or buried or whether their barbers are going to be
licensed, whether their pets will be registered, how close to a
crosswalk you can park your car, what hours the stores can be open. But
this bill prohibits the States from protecting the consumers from
cosmetics that can give you cancer, catch on fire, or cause birth
defects.
As I mentioned, the language broadly preempts any public information
or public communication. That is an ironclad guarantee that the
consumers will know less about their cosmetics. States will not be able
to require warnings to parents or children about the dangers of a
particular product. American consumers are going to know less about
their products. The cosmetic industry introduces 1,000 new ingredients
every single year into our cosmetics, everything from lipsticks, hair
creams, soap, deodorant, and hair dyes.
Do you think we will know how safe they are if this language becomes
law? Who will be looking out after the public interest under this
language? I suppose it is left to the two employees at FDA--an agency
with limited authority and resources--who are charged with regulating
$20 billion worth of cosmetic labeling and packaging. This language
that we are considering was drafted by the cosmetic industry itself so
make no mistake who it is intended to benefit.
Many challenges to State action have been rejected by the Federal
appellant courts because the courts interpret preemption narrowly. This
is because the courts cannot imagine that Congress would want to
preempt the States from protecting their citizens. So what does the
cosmetic industry do? They carefully drafted this language to give them
their broad preemption. They have admitted that they drafted this law
specifically to force the Federal judges to interpret preemption very
broadly.
Mr. President, this provision should not become law.
Mr. President, beyond this issue, I will mention two other important
items that I hope we will have a chance to debate in the form of
amendments when we move to the bill itself. Others have spoken to them,
and I will work with them or introduce legislation on these particular
provisions.
The overall legislation includes a number of provisions that will
significantly improve and streamline the regulation of prescription
drugs, biologic products, and medical devices. I am pleased that,
through a long process of negotiation both prior to and subsequent to
the markup of the legislation, many provisions that seriously threaten
public health and safety were dropped or compromised.
But despite our best efforts, this legislation includes several
Trojan horses that I think undermine important positive proposals in
this bill. I would like to discuss the changes in the regulation of
devices that put consumers at unacceptable and unnecessary risk. They
should be removed from the bill before it goes forward. The
administration has made it clear that these provisions put the whole
bill at risk.
A great deal of negotiation has taken place on the medical device
provisions of this bill. I compliment Senator Jeffords and Senator
Coats and other colleagues in the committee for resolving most of the
divisive provisions in a way that is consistent with the protection of
the public health. I see in the chair Senator Gregg. We worked with
Senator Gregg on the health claims issues in a constructive manner.
But there are at least two medical device provisions in the bill
which still raise substantial concerns that could be corrected very
simply with negligible effect on the basic purpose and intent of the
bill. Yet these corrections have not been made. My colleagues deserve a
clear description of the hazards they pose. A brief explanation of how
the FDA regulates and clears the medical devices for marketing may be
first in order.
Under the current law, manufacturers of new class I and class II
devices can get their products onto the market by showing that they are
substantially equivalent to devices already on the market. For example,
the manufacturer of a new laser can get that laser onto the market if
they can show the FDA that the laser is substantially equivalent to a
laser that is already on the market.
Similarly, the manufacturer of a new biopsy needle can get that
biopsy needle onto the market by showing that it is substantially
equivalent to a biopsy needle already on the market. And the
manufacturer of new patient examination gloves can get those gloves
onto the market by showing that they are substantially equivalent to
patient gloves already on the market.
Mr. President, these manufacturers are obliged to demonstrate
substantial equivalence to the FDA by showing that the new product has
the same intended use as the old product and that the new product has
the same technological characteristics as the old product. If the new
product has different technological characteristics, these
characteristics must not raise new types of safety and effectiveness
questions in order for the product to still be substantially equivalent
to the older product.
The logic of this process for bringing medical devices onto the
market is quite simple: If a product is very much like an existing
product, it can get to market quickly. If it raises new safety or
effectiveness questions, those questions should be answered before the
product can be marketed.
This process for getting new medical devices on the market, commonly
known as 510(k), is considered by most to be the easier route to the
market. Devices that are not substantially equivalent to a class I or
class II device already on the market must go through a full premarket
review. Thus, device manufacturers have an incentive to get new
products on the market through the 510(k) process. In effect, well over
90 percent of all new devices get on the market through the submission
of a 510(k) application.
This legislation seriously compromises the FDA's ability to protect
the public health through its regulation of medical devices that are
marketed through the 510(k) process. Of the dozens of provisions that
we have negotiated and discussed which affect medical devices in this
bill, these two still raise fundamental public health
problems. Although few in number, these provisions raise substantial
risks to public health which simply cannot be ignored.
The first problem raised by the bill relating to medical devices is a
prohibition on the FDA from considering how a new device will be used
if the manufacturer has not included that use in its proposed labeling.
[[Page S8889]]
You may think this approach makes sense. Why should the agency
consider the use of a device if the manufacturer has not specified the
use on the label? I'll tell you why--because that proposed label may be
false or misleading. How would the FDA know that? Because the design of
the new device may make it perfectly clear that the new device is
intended for a different use.
Let me provide my colleagues with a few examples. Let's talk about
the biopsy needle I mentioned before used on breast lesions. Most
biopsy needles for breast lesions currently on the market take a tissue
sample the size of a tip of a lead pencil. Assume the manufacturer of a
new biopsy needle comes to the FDA with a 510(k) submission. But the
new biopsy needle takes a tissue sample 50 times as big, the size of a
1-inch stack of checkers.
The manufacturer of this new needle has proposed labeling that says
that the needle will be used like the old, marketed needles to biopsy
breast lesions. But FDA knows the chunk of tissue being ``biopsied''
will exceed the size of the lesion. This makes it clear to FDA--and any
impartial observer--that the needle in most cases will be used to
remove the lesion.
Under these circumstances the FDA should be able to ask the
manufacturer to provide information on this use. Is it safe to remove
lesions? Does it really work? The bill, however, categorically bars FDA
from asking these essential questions. This means the FDA would be
unable to make a complete review of the device and the public would be
deprived of existing assurances that devices are truly safe and
effective.
The proponents of this provision have argued that the FDA could
simply say that the change in device design or technology--such as the
change and size of the biopsy needle--renders the new product not
equivalent to the old product. But that is not always true. The
manufacturer could argue that there are no new questions of safety or
effectiveness for the purpose claimed on the label. In the case of the
biopsy needle there are times when a large sample is needed--a sample
larger than a pencil tip.
So long as the larger needle is safe and effective for removing a
sample, FDA could be barred from obtaining data about the new use of
removing lesions and to the extent the needle is used for the new use,
women could be put at risk for effective or unsafe treatment of breast
cancer.
Another example is surgical lasers that have been used for decades to
remove tissue. Several years ago, a manufacturer added a side-firing
mechanism to their laser to improve its use in prostate patients. While
the manufacturer did not include this specific use in its proposed
labeling, it was transparently clear that the new side-firing design
was intended solely for this purpose of treating prostate patients.
As a result, FDA required the manufacturer to submit data
demonstrating the laser's safety and effectiveness in treating prostate
patients. This is precisely how the device review process should work.
Manufacturers must prove their devices live up to their claims, while
patients and doctors receive all of the information needed to make the
best possible treatment choices.
Under this bill, FDA would be prohibited from getting adequate safety
data on the laser's use on prostate patients, even though that would be
the product's primary use. This defies common sense, yet this is the
result of one troubling and indefensible provision. Other examples in
the way this provision could allow unsafe and ineffective devices onto
the market abound. A stent designed to open the bile duct for
gallstones could be modified in a way clearly designed for treatment of
blockages in the carotid artery. Without adequate testing, it could put
patients at risk for stroke or death. But under this bill, the
FDA would be prohibited from looking behind the label to the actual
intended use of the device. A laser for use in excising warts could
have its power raised so it was also possible for use in smoothing
facial wrinkles, but without FDA's ability to assure adequate testing,
the use of the laser for this purpose could lead to irreversible
scarring.
Most companies, of course, will not try to bypass the process in this
pay. But some bad actors will. This legislation should not force the
FDA to fight these bad actors with one hand tied behind it. This
provision is like asking a policemen to accept a known armed robber's
assurance that the only reason he is wearing a mask and carrying a gun
is that he is going to a costume party.
The second way this bill undercuts the FDA's ability to protect the
public's health and adequately regulate medical devices is the way it
forces the FDA to clear a new device for marketing even if the agency
knows that the manufacturer cannot manufacture a safe device.
Let me repeat that. It sounds, frankly, preposterous but it is true.
One of the bill's provisions actually requires the FDA to allow a new
device on to the market even if the manufacturer is producing defective
devices. Surprisingly, the proponents of this provision freely admit
that this is true.
Under the current law, let's assume that a maker of a new examination
glove submits a 510(k) to the Food and Drug Administration and claims
that the new gloves are substantially equivalent to gloves already on
the market. If the FDA knows for a fact from its inspectors that the
company uses a manufacturing process that often results in the gloves
having holes, FDA would simply not clear the gloves for marketing. FDA
would find that these gloves are not substantially equivalent to gloves
on the market because gloves on the market don't have holes. That is
common sense, and fortunately that is also the law.
In contrast, this bill would force FDA to clear the gloves for
marketing. These defective gloves would be sold to hospitals, clinics,
and HMO's where they would be used routinely by doctors, nurses,
paramedics, and other health professionals every single day. Every
single glove would expose these professionals needlessly to AIDS and
hepatitis.
Here is the response of the provision's supporters. They argue that
once these defective gloves are in the market and being used by health
professionals, FDA can simply institute an enforcement action to remove
them from the market. But when hundreds or thousands of defective
devices have been distributed, and when dozens or hundreds of
facilities may be using these devices, an enforcement action entails
more than blowing a whistle or picking up the phone to place a simple
call.
In reality, FDA must coordinate with the U.S. Attorney's Office, U.S.
Marshal's Office, and persuade the court of jurisdiction to issue
appropriate papers. As any attorney or law enforcement professional can
tell you, that takes precious time. In the case of a defective device
which is exposing people to unnecessary risk, time is absolutely
critical. The sooner a defective glove is pulled from the market the
sooner the public is protected.
All this makes no sense when the FDA can prevent this from arising.
If this provision becomes law, the debater's point distinguishing
between different forms of FDA authority will be paid for in the health
and safety of American consumers, placed at needless risk of death and
injury. In fact, even the regulated industry is willing to compromise
on this provision because they recognize it is so unreasonable and
should be removed from this bill.
In the end, there is simply no justification for these troubling
medical device provisions. Our overriding priority in regulating
medical devices should be distinguishing between reforms which preserve
the public health and protections and those which endanger the public
health.
Mr. President, we have had arguments on the other side of
that provision which say, well, on the labeling provision are we going
to have to require the manufacturer to dream up every possible use and
be able to answer the charges that some nameless person at FDA can
possibly imagine that a particular medical device would be used for?
We say, no, that is not what we are looking for. We are looking for
what would generally be defined as the predominant or dominant use of
the device as a criteria. That ought to be the key. We know many
devices are used in different kinds of ways. We are looking here at the
predominant or dominant use for the device. That is what we are
concerned with.
You might have a pacemaker which can speed up the activities of the
heart
[[Page S8890]]
and some treatment might require that you slow down the beat of the
heart. You might have one pacemaker that has already been approved, and
someone else wanted to get on stream and say that they have a pacemaker
that speeds up the heart but also may slow it down. So they come in and
say, ``We want this approved because it will speed up the heart but it
also has the possibility of slowing it down,'' in order to circumvent
the safety requirements.
It seems to me we ought to be able to work that out. We are looking,
as I said, as a criterium of the predominant and dominant device use as
the key. We are not looking for these other, incidental uses. It seems
to me we ought to be able to work that through. For the reasons I
outlined in discussing the good manufacturing practices provision, it
seems to me we also ought to be able to find some common ground in that
area, as well, but we are not there yet.
I suggest the absence of a quorum.
The PRESIDING OFFICER (Mr. Brownback). The clerk will call the roll.
The bill clerk proceeded to call the roll.
Mr. GREGG. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. GREGG. Mr. President, I ask unanimous consent to consume as much
time as I may require under the pending debate.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. GREGG. Mr. President, today, we are debating, in part, the FDA
Modernization Act, which is a very important piece of legislation
because it goes to the issue of the health and safety of the Nation. I
congratulate the Senator from Vermont for having the foresight,
ability, and acumen to bring this bill to the floor after a
considerable amount of negotiations and debate and discussion and
activity within the committee. In fact, we have been working on this
ever since I have been on the committee. I believe that would be almost
5 years now.
The need to modernize the FDA is obvious. I think it is obvious to
anybody who represents any group of people, as we hear constantly from
folks in our States about problems that they have had with getting
drugs, getting devices in a prompt way and in a manner that will help
them live better lives. I, for example, had an instance where Helen
Zarnowski came to my office fairly regularly over the years as she
sought to get approval, or wanted to be able to use various Alzheimer's
drugs, drugs being developed that were experimental, in order to help
her husband, who, unfortunately, had Alzheimer's. She would come and
talk about how terrible this disease is--and it is a horrible disease--
and how much she would like to be able to try this drug she had heard
about, or that drug which she knew was having positive effects. She had
heard about some in Europe that had positive effects, which had been
approved there. Yet, unfortunately, the process of approval in the FDA
involved considerable delay, delay really well beyond what one would
consider to be common sense. Regrettably, her husband died in 1995.
Some of the drugs that might have been able to be helpful were not
approved by then.
Of course, we all, I suspect, have friends or people we know who have
contracted the AIDS disease and have had problems with AIDS. They are
historic. The FDA has started to address that more aggressively in the
last few years. In the latter part of the 1980's, that was not the
case. Approval was delayed for an extended period of time in a variety
of other areas, especially the device area, where people's lives could
be improved dramatically by getting a medical device that would assist
in their rehabilitation. Or the testimony which was so heart rending
and stark, given within our own committee by our own committee member,
Senator Frist, a nationally prominent heart surgeon prior to becoming a
U.S. Senator. He made it so clear that if he had simply had a device
that was available in Europe, he could have possibly saved some of his
patients. But he could not get it because the FDA would not approve it
in a manner that was timely enough to have it available for those
patients.
So this is a very personal issue. It is brought up in the context of
the bureaucracy and the question of this huge institution called the
FDA, but when you get right down to it, like most Government, this is a
very, very personal issue of people being impacted by their need to
obtain care, by their belief that certain types of care that are
available maybe in other countries would help them, and their inability
to get it in a timely manner in the United States. The FDA has had some
real problems. There has been, without question, an attitude that ran
well into the early part of this decade that caused FDA to be
ponderously bureaucratic in the manner in which it dealt with drug
approvals and especially device approvals. That has changed. It has
changed for the better. It hasn't gone as far as it needs to go, no.
But that is what this bill is about--to give the FDA the capacity to go
even further down the road toward being a positive force for the
approval of drugs that may help people live longer, live better lives,
and for the approval of devices that would help people live better
lives. So especially for those individuals who are going to be
impacted, this is a very significant piece of legislation.
In addition, of course, it has the PDUFA language in it, which is
critical because PDUFA is the manner in which we fund the expedited
approval process for all intents and purposes. And we need to have that
fee system reauthorized so that we can keep on board the 600 or so
people who are employed through the PDUFA fee process to help us
expedite approvals. So that is one approval. In addition, it deals with
the question of a variety of questions such as health plans and what
can be said. And we approve that language in the bill. The issue of
uniformity and how we deal with that--we have improved that language in
the bill for a variety of areas. But, most importantly, it is a piece
of legislation which will--to use a nice term-- ``modernize'' the FDA
and help us move more promptly to the approval of drugs and devices
which will cause for better caring for Americans.
There has been a lot of discussion on this floor about the question
of national uniformity in the area of over-the-counter drugs, and
national uniformity in the area of cosmetics. Certainly the Senator
from Massachusetts has expanded considerably on this topic. I must say
that at an entry point I do find it ironic that this bill would be
filibustered because when this bill is filibustered it slows down the
approval process for people who have problems, for people who confront
diseases and who need new drugs and new devices. And the filibuster by
very definition when it was initiated on this floor in opposition to
this bill means people are going to have further delays--delays beyond
just the bureaucratic delays, which are bad enough --delays which are
created by the politics of the process. That is just not right. If the
Senator from Massachusetts has a serious concern, which he, obviously,
does about one or two items in this bill, he shouldn't be filibustering
this bill. He should be offering amendments to the bill letting us vote
them up or down and decide whether or not his position has the support
of the body, or the bill as it was reported has the support of the
body. Clearly a filibuster is totally inappropriate and tremendously
ironic in the context of an issue which we are trying to expedite the
approval of. And we run into a filibuster. It is bad enough, as I said,
to have a bureaucratic slowdown of the approval process. But to have a
political slowdown of the approval process is really, I think,
unconscionable.
Independent of that point, let's go to some of the specifics here of
the concerns. The issue of uniformity is an issue which has been
addressed and discussed at dramatic depths and lengths over the last
decade, at least--probably prior to that. That is the only time I
recall over the last decade. There have been commissions of very
thoughtful people who are extraordinarily expert on the issue of how we
deal with the approval process and management of the drug and device
delivery system in this country, and who have looked at this. In fact,
there was a study, a group, a commission put together headed up by Carl
Edwards, who was at one time head of the FDA, and the conclusion of
that commission, which was
[[Page S8891]]
put together at the request of the Congress as early as 1991, was that
Congress should enact legislation that preempts additional and
conflicting State requirements for all products--not a few, all
products--subject to the FDA jurisdiction. States should be permitted
to seek a preemption in areas where the FDA has acted based on
convincing local needs. States should in addition be allowed to
petition for the adoption of national standards.
That is exactly what is proposed in this bill relative to the two
items that the Senator from Massachusetts appears to have problems
with--over-the-counter drugs and cosmetics. It should, also, according
to this language, have been proposed for food. We should have done
uniformity for food if you follow the presentation of this commission
proposal. And maybe there will be an amendment coming as we move
forward on FDA reform which addresses the issue because I know there is
a lot of support on both sides of the aisle for the issue of uniformity
on food regulation as well as drugs--over-the-counter drugs and
cosmetics.
But the point here is that an independent, thoughtful,
congressionally supported commission headed up by the former head of
FDA concluded that this type of uniformity is exactly what we need in
order to effectively administer and protect--administer the issue of
food and drugs and protect the public. In their 1-year review of their
report--1 year later. That was a unanimous agreement, I should have
mentioned, reached by the commission, and 14 of the 17 people on this
commission said, ``We reaffirm our original recommendation that
Congress should enact legislation preempting conflicting or additional
requirements for products subject to FDA regulation with provisions for
the States to be able to demonstrate a genuine need for distinctive
requirements to seek an exemption. Failing action by Congress, FDA
should adopt regulations to accomplish the same rules for national
uniformity.''
They went a step further. They said even, ``If the Congress doesn't
go the uniformity route, the FDA ought to do it unilaterally with
regulation.''
I don't agree with that. I think it is the prerogative of the
Congress to decide this type of issue. But the fact is they felt so
strongly about this as a group of commissioners who had expertise in
this area that they asked for that type of an extraordinary action.
That would have meant uniformity for drugs, food, over-the-counter
drugs, and uniformity for cosmetics.
Then Commissioner Edwards reaffirmed this point in a letter that he
sent to Chairman Jeffords by saying ``national uniformity should play a
greater role in FDA-State relations. If not, the agency's ability to
protect''--this is the issue; how do you protect? --``to protect
consumers will be further eroded and unnecessary concerns will be
imposed on the national Congress.''
Former Commissioner Arthur Paul Hayes wrote in July 1997, ``I write
in strong support of the national uniformity provisions in S. 830 for
the nonprescriptive drugs and cosmetics, I have long believed that a
single national system for regulations for these FDA-regulated products
is essential and now overdue.''
So you have a commission which was the brainchild of the Congress to
determine what FDA should do and how they should manage the issue of
drugs, cosmetics, over-the-counter drugs, and food; a commission
saying: Use uniformity. Why did they say that? They said it because
they believe that to have 51 FDA's running around the countryside--50
States plus the Federal FDA--would create chaos. It would confuse the
consumer and create a situation where a consumer in one State was to be
given one piece of advice and the consumer in the next State was being
given another piece of advice, and as a result, rather than having an
encouragement of a comprehensive, thoughtful approach to health
protection, you would have confusion and anarchy in the public's mind
as to what was correct in the area of health care and protection.
It is a pretty logical position. I have to say as someone who comes
from the States' rights viewpoint, and who has spent most of my life
defending States' rights, that it runs against my grain to want one
Federal agency to run the country on one issue but, when you think
about it, to do it any other way would be to undermine the health, and
certainly the veracity and the confidence of the public on the issue of
health care provided.
This is especially true in the area of FDA because even though the
FDA has been excessively bureaucratic, nobody would argue that they
haven't been extremely professional. They are an agency which has and
maintains the view that they are the world's premier reviewer and
protector of public health. And I think they have credibility in taking
that position.
That is why I think as a States' rights advocate I am willing--or one
of the reasons I am willing--to say yes in this area. The role of the
FDA is unique, and to undermine the role of the FDA--that is what you
would be doing--to undermine the role of the FDA by allowing the 50
States to basically pursue arbitrary independent views in areas where
the FDA has the authority to regulate would be a big mistake. It would
run counter to the basic goals of having a strong system of health
protection in this country.
So we are talking here about how you protect the public health. And
what we have is a commission set up with the support of the Congress
which concluded--we have experts; they weren't Members of Congress on
this--concluding that the way to protect the public health is to have
uniformity.
So let's give that a fair amount of credibility. Let's not just
discard that. I think that is a fairly persuasive point in favor of the
language in this bill which tracks the proposal of the commission, the
Edwards Commission, for all intents and purposes, and which was brought
forward out of committee with a vote of something like 14 to 4--
overwhelming support because the people on the committee who have taken
a long time looking at this sort of thing understand that the
commission made sense when it came to these conclusions.
Before I get into the specific responses to some of the points made
here, there is another general theme that comes out which is that if
you take the argument coming in opposition to the uniformity standards
in this bill you are essentially taking an argument that says the FDA
can't do its job; the FDA isn't competent; that the States are more
competent than the FDA. The corollary to that is you are saying the FDA
doesn't care; the FDA isn't really interested in health and safety;
that there are areas of health and safety under its regulatory
responsibility, under its portfolio, that it has no responsibility, and
that it is going to walk away from it. Those are heavy charges to make
against the FDA.
But that is essentially the subtlety of the position in opposition to
uniformity: It is that the FDA isn't capable of administering its
portfolio and it doesn't care about safety. I personally disagree with
that. If anything, the FDA consistently errs in favor of safety, which
is probably the right way to do it. We are asking in this bill that
they streamline their efforts, that they expedite their procedures, but
we are not asking that they do it at the expense of safety. And to
imply that they aren't going to fulfill their obligations--which is not
an implication but basically a statement made here on numerous
occasions--citing that only two people are doing this, three people are
doing that, to imply that they are not going to fulfill their
obligations is I think incorrect. I think the track record shows that
the FDA does fulfill its obligations in many ways, and it maybe is a
little slow in doing it sometimes. But it sure does get into the issue
of safety. And to presume that it would not is I think inappropriate or
inaccurate. ``Inappropriate'' is not correct. Obviously, you can
presume anything you want. So that is another point.
First, we have the commissions' support for this proposal.
Second, we have the logic of the committees' support for this
proposal.
Third, we have the fact that the FDA is perfectly capable of pursuing
this proposal and should be pursuing this approach because a single
uniform approach is what makes sense for the health and safety of the
American citizenry.
There were a number of specific points made in representations
relative specifically to cosmetics. But you have
[[Page S8892]]
to remember that cosmetics isn't any different here than over-the-
counter drugs for all intents and purposes. Thus, I am surprised with
the intensity of opposition of the colleagues; that we don't have the
same intensity of opposition to over-the-counter drugs. It seems to be
inconsistent to me. And it may just be that the photographs are better
for cosmetics than over-the-counter drugs. I doubt that. You can
probably find some pretty heinous photographs that relate to over-the-
counter drugs. But the fact is that, I think, that is inconsistent.
In specific, the statement was made that the States will no longer be
able to regulate, or to paraphrase it, the States will no longer be
able to regulate the packaging and labeling of cosmetics. That isn't
really accurate. Nothing preempts State enforcement powers. States may
seize, embargo, or pursue judicial proceedings whenever necessary to
enforce the law; Federal law; the FDA law.
(Ms. COLLINS assumed the chair.)
Mr. GREGG. States are also free to publicize any information or
warning they deem necessary. They simply cannot force the manufacturers
to post warnings unless they can get the FDA to agree that that warning
is legitimate.
What is wrong with that? Nothing. FDA is certainly going to want a
warning on a bottle if it is proven to cause cancer. It is absurd to
think they will let the bottle or whatever it is out on the market. If
there is some threat that is created by something, the FDA is going to
step forward.
States will have two specific options under this legislation. The
States may use the existing authority provided under 21 CFR 10.30 to
petition the FDA to make any requirement a national requirement. So
they can ask that their proposals, their ideas, be moved up to the
national level. Under this provision, States may seek an exemption. If
you have a law or requirement that is different from the FDA's, the
States can come to the FDA and say we think there should be a national
protection.
For example, the Senator from Massachusetts was talking about the
studies in the State of Alaska and what the State of Massachusetts was
doing in the area of caring for women. If they feel strongly about
that, they can go to the FDA and ask that those types of disclosures
which they think are appropriate in the State of Washington and the
State of Massachusetts be national. Why shouldn't they?
The other side of that argument is that, well, women in Washington
and women in Massachusetts should get a different warning label than
women in New York State or women in Oregon. Why? If it is that serious,
why would you want the people in Washington to know something different
than the people in Oregon? Obviously, you would not. The logic is that
the FDA should make the determination as to whether or not it is
serious enough to require national disclosure or to make a
determination whether it isn't so that you don't arbitrarily scare the
people in one State versus another State. It really makes no sense to
have a hodgepodge of disclosures on these over-the-counter drugs and
cosmetics, requiring that over-the-counter drugs and cosmetics are not
drugs in the traditional sense that they are defined by the statute.
Drugs are clearly something that the FDA is going to be involved in.
So it is just an inconsistency here to this argument that the FDA
should not be making the decisions but that the States should be making
decisions because you end up with inconsistency from State to State by
definition. So I don't think that argument really applies.
Now, there was another representation that I believe 47,000 injuries
resulted last year from cosmetics use. This calculation was not
analyzed in its representation, the specifics of it. I think it should
be.
The Consumer Product Safety Commission's National Electronic
Emergency Injury Surveillance System came up with this figure in a 1988
House hearing. I believe that is what is being referred to here. Their
calculation included things such as slipping on soap in the shower,
suicide attempts, injuries from broken bottles, plus in the context of
total usage 47,000 injuries, some of which clearly weren't involved in
the character of a cosmetics, represents .00044 percent, which I
believe is less than five ten-thousandths--five ten-thousandths--of the
number of products sold in the country; 10.5 billion products sold in
the country and 47,000 potentially caused injuries, some of which
involved slipping on soap or broken bottles or possibly ingesting
things intentionally to cause harm, and that represented .00044 percent
or less than five ten-thousandths of the products sold.
You have to put that in a little bit of context here because, as
studied by the same group, injuries caused by couches and sofas were
70,000. Almost twice as many injuries were caused by couches and sofas
as were caused by cosmetics. And 117,000 were caused by drinking
glasses. Are we going to have that be State regulated--drinking
glasses? And 253,000 were caused by pillows, mattresses, and beds. What
is that, almost six times the number caused by cosmetics studied by the
same group. So when that number is thrown out here, I think it has to
be put in context, and I think that puts it in the context of ``less
than persuasive'' would be the adequate term to put to that statement.
Now, also, the point was made that cosmetics pose an inherent threat
to a person's health and safety. I think we just saw from the numbers
it is not very inherent if it is less than five ten-thousandths of a
percent that are impacted.
But cosmetics by definition are inherently the safest products FDA
regulates. Cosmetics, as defined by the Federal Food, Drug and
Cosmetics Act, section 201(I), means:
Articles intended to be rubbed, poured, sprinkled, or
sprayed on, introduced into, or otherwise applied to the
human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance, and (2)
articles intended for use as a component of any such
articles; except that such term shall not include soap.
We are not talking about products that affect the structure of any
function of the body. Such products are viewed as drugs. So if it
affects structure, if it affects function of the body, it is a drug; it
is not a cosmetic.
In fact, former Commissioner Kessler stated in a hearing in the
House, again in 1991:
People can take comfort from the fact that the cosmetics
industry is as safe as they come.
So cosmetics are not inherently dangerous, which would be what you
would think if you listened to the debate here for the last couple of
days.
There are problems with cosmetics. Nobody is going to deny that. And
that is what we have the FDA for. When there is a problem, that is what
the FDA is there for.
Now, there was another statement, I believe, made that 884 cosmetic
ingredients have been found to be toxic. That is a pretty strong
statement. Of course, we all know that things that are toxic are things
that we deal with every day. Salt is toxic if you take too much of it.
In fact, that list included chemicals such as water, salt, and vinegar.
This was a list derived from a list published by the National Institute
of Occupational Safety and Health Registry of Toxic Effects of Chemical
Substances, which list, as I mentioned, included such things as water,
salt, and vinegar.
So toxicity depends on the manner in which it is used and the manner
of application as versus by definition that the substance is toxic.
``Many substances that are common in everyday life are obviously
toxic.''
Mr. President, 884 ingredients were evaluated by the Cosmetic
Ingredient Review Expert Panel to determine if they were toxic. This
was not mentioned, I don't think, during the debate. They found no
significant health effects with the cosmetic use of any of them. So,
again, I don't think that argument is persuasive.
Then there is the GAO report on which a considerable amount of
discussion has been spent. I believe the Senator from Massachusetts was
referring to the 1978 GAO report that listed 125 ingredients which were
then available for use in cosmetic products that were suspected of
causing cancer, 25 that were suspected of causing birth defects, and 20
that were suspected of adversely affecting the nervous system.
The GAO report goes on to state that:
Neither we nor NIOSH--
Which is the other Federal agency that would have responsibility
here; I just quoted their numbers--
[[Page S8893]]
has reviewed the adequacy of the tests performed or the
applicability of the tests performed or the applicability of
the results to exposure to the ingredients through the use of
cosmetics.
They haven't reviewed that. In fact, much of the limited scientific
work done before this list was first compiled by NIOSH was done at
extremely high exposure levels, rather than against a relative
baseline.
Anytime the FDA would like the Cosmetics Review Panel, in its
capacity as an independent expert panel meeting the same criteria as
any FDA review board, to review the data, to review the safety data on
anything that can be used as a cosmetic ingredient, they may request
that it be done. But the FDA has never asked them to do that. The CIR
has never denied such a request. The FDA may have asked, but the CIR
has never denied the request. The fact is that if something causes
cancer and if it were being used in some sort of cosmetic and as a
result cancer was being generated, you would have FDA action.
What do we think the FDA is, a potted plant? They are not going to
sit around if there were any cancer-causing substances that were being
generated by any cosmetic that were a threat. The idea that a State is
going to step up and do a better job of evaluating whether or not there
is a carcinogenic effect to anything is, I think, a bit of an affront
to the FDA. The fact is the FDA takes cancer pretty darned serious. And
they aren't about to walk away from anything or not get involved in
anything that has a cancer issue, a serious cancer issue. So bandying
around numbers like that may create headlines, but I don't think it is
persuasive if you look at the substance of this.
Now, there has been some representation that FDA doesn't have a whole
lot of regulatory authority here. It has a lot of regulatory authority,
as was shown again by the Edwards Commission. FDA is the regulatory
agency, and that's why there should be uniformity.
Just let me read a few of these.
Section 301 prohibits the introduction into, or receipt of, any
cosmetic that is adulterated or misbranded in interstate commerce.
Section 303 lists the penalties for violating section 301, starting
at imprisonment for up to 1 year and a $1,000 fine.
Section 601 defines ``adulterated''--if it contains a poisonous or
deleterious substance; contains a filthy or decomposed substance--we
are not even talking about things that are going to cause you cancer
here; we are talking about a filthy or decomposed substance--if it was
prepared, packaged or stored under unsanitary conditions; its container
is made of an adulterated substance; or if it contains a color additive
not approved by the FDA.
We heard a lot about color additives earlier.
Section 706 requires FDA to approve color additives as safe before
they can be used in cosmetics.
Again, we heard a lot about color additives, but the FDA has
authority here.
Section 602 defines ``misbranded'' as: False or misleading labeling;
if the package is not labeled with the name and place of business of
the manufacturer, packer, or distributor, and with accurate quantity;
if any word required by Federal law or regulation to appear on the
label is not prominently displayed in a readable and understandable
manner; if the container is misbranded; if the color additives don't
conform with requirements; or if the packaging or labeling violates the
Poison Prevention Packaging Act.
Section 201(n) states that misbranding must also calculate the extent
to which the required facts are not revealed.
The FDA has broad authority--broad authority--here. And they will use
that authority.
The FDA can ban or restrict ingredients for safety reasons, mandate
warning labels, inspect manufacturing facilities, issue warning
letters, obtain court orders to seize illegal products, obtain court
orders to enjoin activities, prosecute any violators, publicize public
health issues, and work with manufacturers to implement nationwide
recalls.
There are 41 pages--41 pages--in the FDA, in the Federal Food, Drug
and Cosmetic Act applying to cosmetics--41 pages. There are 32 pages of
FDA regulations of cosmetics in the Code of Federal Regulations. The
fact is that the FDA knows this issue and has the capacity to deal with
this issue. The idea that the States are going to do a better job--
well, I suppose that if they are they can come to the FDA, under the
law as proposed in this bill and say, ``We have done a better job.
Change the Federal rule.'' And the FDA will do that, because that is
what the law gives them the authority to do. Or if they think it is a
unique situation, then the States can come and say we want special
treatment for this, and the FDA will give them that authority.
But the point here is that you should not have--and my colleague uses
the term women or children a great deal. I think it is just about
anybody who would be impacted. But you should not have women in
Washington State getting a different instruction from women in the
State of Oregon, because it is going to confuse people. Who is going to
know who is getting the better instruction, the people in New York
versus the people in Massachusetts? Let's have it done consistently,
across the country. That is why the commission decided in favor of
uniformity. Uniformity on over-the-counter drugs, uniformity for
cosmetics, uniformity for food. We don't have food in this bill. Maybe
we will. Maybe there will be an amendment.
There is some representation--I couldn't get it clear but I think
there was a representation relative to California's status. Let's
define California's status. This law is prospective. It doesn't affect
the California situation at all. Prop 65 remains effective in
California. So that bit of red herring should be put to bed.
There has been this representation there are only two people over at
the FDA doing this or that. The FDA regulates cosmetics. It has the
financial capability--and we will give it the financial capability if
it feels it doesn't have it--to have the personnel to do the job right.
And I believe that, as part of its portfolio, the leadership of the FDA
will do the job right. To say they will not or imply they will not,
which is the representation, I think, as I said earlier--the subtle
undercurrent of these representations in opposition to this language
that the FDA cannot do its job is, I think, incorrect. I think the FDA
has shown its capacity. So, resources, here, is not really an issue at
all. Resources may be an issue for us as the Congress. But I can assure
you that, as a member of the Appropriations Committee--sitting not on
the FDA subcommittee but on the overall committee--I would have no
problem funding whatever is needed in this area. I suspect none of my
colleagues would either. In fact, this bill is about that, with the
PDUFA language. It is about funding the FDA in a more effective way. In
fact, I put an adjustment in this bill so we would not end up cutting
FDA, as a result of the PDUFA funding from base funding, which is
critical.
There was also, I believe, a representation that this prevents the
States from providing public information. No, it does not. Under this
provision, the States remain free to publicize any information or
warning they deem necessary. They simply cannot force manufacturers to
post the warning unless the FDA says they agree with it. As I said
earlier, what's wrong with that? If a State decides that something
needs to be put on a warning label, they can come to the FDA, say,
``This is important.'' The FDA will evaluate it and tell them, ``Yes,
it works,'' or, ``No, it doesn't work.'' If you do it another way, you
get into this confusing, anarchic situation I spoke about earlier. This
is a transient society. People coming from different States are going
to see different statements, different warnings. They are not going to
know what to think, and that undermines health because it undermines
confidence. It's better to have a single agency making that decision
because, when you are dealing with health, you have to have confidence.
There are a couple of specific claims--lead in hair dye was one, I
believe. In 1980 the FDA approved the use of lead acetate as a color
additive, ``safe for use in cosmetics that color the hair.'' That
approval was based on extensive testing that showed there was no
toxicological risk of lead absorption through the skin from lead
acetate in hair dye. Hair dye is one of the most stringently tested
products on
[[Page S8894]]
the market today. The FDA has the authority to impose any warning it
chooses to promote the continued safety use of hair dye. The fact is,
the FDA is engaged in the issue and has made the decisions which it
deems appropriate for safety. We should have a consistency across this
country, based on what they have decided.
Mercury in lipstick and nail polish was also cited as an example.
Mercury, through the Code of Federal Regulations, has been
affirmatively banned for use in all cosmetic products except eye area
preservatives, so I am not sure why this idea was thrown out. Maybe it
was a red herring.
``Alpha-hydroxy in face creams causes cancer.'' That was, I believe,
the representation. Certainly it has been discussed at considerable
length as a concern. In 1995, the Office of Cosmetics and Colors'
Director stated that appropriate actions can be taken in product
characterization or through proper label warning statements in regards
to reactions to alpha-hydroxy. So the FDA stepped up to this issue. He
noted that the adverse reactions reported--often allergy-type
symptoms--could be due to the pH factor in the product and not the
actual concentration. He did not raise any concerns about it causing
cancer.
If the FDA is concerned that this type of product is causing cancer,
it already is investigating such products generally and why would it
leave this product on the market? Obviously, it would not. Alpha-
hydroxy has been used literally for 3,000 years, in hundreds of
different ways. Just this past June the Cosmetic Ingredient Review of
this independent group I mentioned before, unanimously confirmed after
public debate that alpha-hydroxy is safe for use in a variety of
products. However, if there is evidence now, or that comes to light
later to the contrary, I am certain that the decision would be reversed
and these products would be prohibited nationally. And they should be
prohibited nationally if they are that much of a problem. Why should
they be prohibited in just one State? Obviously, they should not be.
Why would you protect one State over another State? If the legitimacy
of the science is such that it is determined that the product is a
problem, then obviously the FDA is going to sign on to that debate at
that point, and you are going to have a national ban or national
warning.
But to have the people in the State of Washington told one thing and
the people in the State of Oregon told another thing and the people in
the State of Nevada told another thing--six States in New England that
sit right on top of each other such that you can't go shopping without
going to one of the other States. At least that is what we hope. We
hope that everybody from Massachusetts goes to New Hampshire to go
shopping. The fact is, What are you going to do? Are you going to tell
them they are going to get a different labeling than they get in
Massachusetts? Foolish, worse than foolish, because it undermines
confidence in the health care delivery system and the safety and
efficacy of it, which has always been the core, always been the core,
really, of one of the great strengths of our health care system in this
country, which is that we have public confidence in its safety,
primarily as a result of the work of the FDA.
If you have a lot of different States moving into this area you have
confusion, and confusion leads to lack of confidence and that is why,
again--it was not my idea. It was not the committee's idea to go to
uniformity. It was a commission, set up by the Congress, with
professionals, who said uniformity makes sense. It not only makes
sense, it's essential--essential. So the alpha-hydroxy, I think is,
again, a matter of hyperbole, maybe, in this debate. Certainly the
photographs have been aggressively used. But is it substantively an
issue? No. Because the FDA is already involved in that debate, has made
initial decisions on that debate, and if it were determined that there
were further decisions that had to be made on that product, it would
make them.
A side point--I believe there was a statement there is no cosmetic
hotline. There is a cosmetic hotline. It's at the FDA. In fact I'll
give it to people, 1-800-270-8869. Call it up if you have a question.
As I mentioned, Prop 65 has been addressed.
So, overall this goes, not only to uniformity of cosmetics, that's
just one, the uniformity of over-the-counter drugs, uniformity of
management of our health care system in the area of drug protection and
quality of the drug delivery system in our country is something that
has been concluded to be essential. This bill tries to accomplish that
and pursues that course.
I am not sure what energizes the opposition with such enthusiasm,
except the leader of the opposition is an enthusiastic individual. But
I do not feel the facts or the substance support any of the--or even a
marginal amount of the presentation made from the other side. The facts
and the substance support the position of the committee; the position
of the committee, which it passed out 14 to 4, which is that uniformity
protects the public. It protects the public health, maintains
confidence in the public system, and allows us as a nation to deliver
better health care.
I yield the floor to the Senator from Vermont.
Mr. JEFFORDS. Madam President, I commend the Senator. His expertise
in this area has helped us greatly and I am sure will lead us to a
final conclusion here.
I would also like to point out as another member of a small State,
how we would suffer if we had to rely upon others, since we have no
resources to do any of this investigation ourself. We would be placed
in a position without uniformity to have to rely on some big State or
something to tell us what we should or should not do. We really have no
ability in ourselves to protect our citizens, that we would like to. I
wonder if you would agree with that as well?
Mr. GREGG. I agree 100 percent with what the Senator from Vermont is
saying, being from New Hampshire, an equally small State, and knowing
it would be confusing to our consumers who cross the borders all the
time to purchase products, if they were not able to rely on a
nationally regarded, highly expert agency to evaluate their health care
products instead of a hodgepodge from the States.
The PRESIDING OFFICER (Mr. Roberts). Who yields time?
Mr. JEFFORDS. Mr. President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
The Senator from Vermont is recognized.
Mr. JEFFORDS. Mr. President, I only anticipate speaking for a few
minutes. I know Senator Coats will follow me.
This legislation to modernize the Food and Drug Administration and
reauthorize the Prescription Drug User Fee Act will, upon enactment,
streamline the FDA's regulatory procedures. This modernizing will help
the agency review medical devices and drugs more expeditiously and will
let the American public have access sooner to newer, safer, and more
effective therapeutic products.
I am disappointed that some of my Democratic colleagues are still
attempting to block this bill.
I am especially chagrined given the months of bipartisan negotiating
that have led to this bill. Each major provision--every drug issue and
all but one medical device provision of this measure, represents long-
sought agreements with the minority and with the FDA itself. We have
made significant concessions on the uniformity provision objected to by
the Senator from Massachusetts to ensure that a State may act on
cosmetic safety issues in the absence of FDA action. I do not
understand this continued objection and delay. In particular, I am
disappointed that after countless hours and many concessions to his
point of view, the ranking minority member is opposing progress in
passage. And I must add that I wish to applaud his willingness--and his
tenacity--in working through several difficult issues to reach a
consensus on 99 percent of this legislation. In addition Secretary
Shalala and the FDA itself, has worked diligently, to reach reasonable,
sensible agreements.
[[Page S8895]]
This is a good, bipartisan measure that represents moderate, yet real
reforms. There is no reason for further delay.
On June 11, prior to the committee markup of S. 830, I received a
letter from Secretary Shalala outlining the Department's key concerns.
In her letter the Secretary stated:
I am concerned that the inclusion of non consensus issues
in the committee's bill will result in a protracted and
contentious debate.
Before and since our committee markup, we have worked hard to achieve
a consensus bill. And the measure before us today accomplishes that
goal. Bipartisan staff have worked diligently with the agency to
address each of the significant nonconsensus provisions raised by the
Secretary.
The American people will hardly believe that anyone would suggest
that disagreement over 6 pages out of a total of 152 is grounds for
holding up consideration of this important bill. A little over a month
ago, we all joined together to further the economic health of the
country by voting for an historic budget bill, despite our many
misgivings, on each of our part, on far more than 6 pages of that
legislation. We must do no less here to promote the physical health of
our citizens by moving forward to approve S. 830.
In her letter, Secretary Shalala felt the legislation would lower the
review standard for marketing approval. Key changes have been made to
the substitute to address these concerns. With respect to the number of
clinical investigations required for approval, changes were made to
assure that there is not a presumption of less than two well controlled
and adequate investigations--while guarding against the rote
requirement of two studies. The measure clarifies that substantial
evidence may, when the Secretary determines that such data and evidence
are sufficient to establish effectiveness, consist of data from one
adequate and well-controlled clinical investigation and confirmatory
evidence, totally under the control of the FDA.
Concerns were raised also about allowing distribution of experimental
therapies without adequate safeguards to assure patient safety or
completion of research on efficacy. Changes to accommodate those
concerns were made. We tightened the definition of who may provide
unapproved therapies and gave the FDA more control over the expanded
access process.
Other changes will ensure that use of products outside of clinical
trials will not interfere with adequate enrollment of patients in those
trials and also give the FDA authority to terminate expanded access if
patient safeguard protections are not met. The provision allowing
manufacturers to charge for products covered under the expedited access
provision was deleted also.
In mid-June, the Secretary argued that S. 830 would allow health
claims for foods and economic claims for drugs and biologic products
without adequate scientific proof.
In response, Senator Gregg agreed to changes that would allow the FDA
120 days to review a health claim and provide the agency with the
authority to prevent the claim from being used in the market place by
issuing an interim final regulation. In addition, the provision
allowing pharmaceutical manufacturers to distribute economic
information was modified to clarify that the information must be based
on competent and reliable scientific evidence and limited the scope to
claims directly related to an indication for which the drug was
approved. That problem is taken care of.
This bill was further changed to accommodate the Secretary's
opposition to the provision that would allow third party review for
devices.
Products now excluded from third party review include class III
products, products that are implantable for more than 1 year, those
that are life-sustaining or life-supporting, and products that are of
substantial importance in the prevention of impairment to human health.
In addition, a provision advocated by Senator Harkin has been
incorporated that clarifies the statutory right of the FDA to review
records related to compensation agreements between accredited reviewers
and device sponsors. I would add that FDA's existing stringent
regulations which protect against conflicts of interest in today's
third-party review program would apply to the expanded program created
by this bill.
Finally, the Secretary was concerned about provisions that she felt
would burden the Agency with extensive new regulatory requirements that
would detract resources from critical agency functions without
commensurate enhancement of the public health. This legislation now
gives FDA new powers to make enforcement activity more efficient, adds
important new patient benefits and protections, and makes the review
process more efficient.
First, we give FDA new powers and clarify existing authority,
including mandatory foreign facility registration, seizure authority
for certain imported goods, and a presumption of interstate commerce
for FDA regulated products.
Second, to assist patients with finding out about promising new
clinical trials, we establish a clinical trials database registry
accessed by an 800 number. Patients will also benefit from a new
requirement that companies report annually on their compliance with
agreements to conduct post-approval studies on drugs.
Third, FDA's burden will be eased by provisions to make the review
process more collaborative. Collaborative review will improve the
quality of applications for new products and reduce the length of time
and effort required to review products. We also expressly allow FDA to
access expertise at other science based agencies and contract with
experts to help with product reviews.
Lastly, by expanding the third-party review pilot program for medical
devices, we build on an important tool for the agency to use in
managing an increasing workload in an era of declining Federal
resources.
In closing, I would echo another part of Secretary Shalala's June 11
letter:
I want to commend you and members of the Committee on both
sides of the aisle on the progress we have made together to
develop a package of sensible, consensus reform provisions
that are ready for consideration with reauthorization of the
Prescription Drug User Fee Act . . .
. . . a protracted and contentious debate . . . would not
serve our mutual goal of timely reauthorization of PDUFA and
passage of constructive, consensus bipartisan FDA reform.
From the beginning of this process, all of the stakeholders have been
committed to producing a consensus measure--and we have accomplished
that goal. There is overwhelming agreement on this bill. For those who
still oppose a few pages of this bill I can only say that we will
continue to bend over backward to accommodate their concerns and to
bring about an even closer consensus. Dozens and dozens of changes have
been made. The Secretary of Health and Human Services knows that we
will continue to work with her--this is not the end of the line. But at
some point, the Senate must move on, and we have reached that point,
Mr. President.
Mr. COATS addressed the Chair.
The PRESIDING OFFICER. Who yields time?
Mr. JEFFORDS. Mr. President, I yield the Senator such time as he may
consume.
The PRESIDING OFFICER. The Senator from Indiana is recognized.
Mr. COATS. Mr. President, I know this debate today doesn't have the
fireworks that the debate on Friday had about FDA reform. I know we are
today detailing some of the specifics of the reform legislation that is
before us, but I think it is important for us to lay out this record as
to why it is important to go forward with FDA reform and what the FDA
reform bill that is before this Congress actually proposes.
On Friday, I laid out the why of the need for reform, but I didn't
lay out the what it is that we are actually doing to bring about this
reform and what is included in this bill. I think it is important for
our colleagues and Members to focus on the constructive things that we
have done through our exhaustive process in the Labor and Human
Resources Committee to conduct an FDA reform bill that can truly bring
greater efficiency to this agency.
On Friday, I indicated how much many of us resent the charge that we
are somehow gutting the FDA. FDA is an important agency. It is an
agency that does protect the health and safety of Americans, and we
want to do all that we can to give that agency the kind of resources
and the necessary support that it needs to continue that effort. Yet,
clearly, I think the case
[[Page S8896]]
that was laid out Friday indicates the need for substantial reform of
the agency on how it does its business, how it is going to proceed in
the future.
Senator Kennedy from Massachusetts has stated the agency has improved
so much in the last few years--and others have said the same thing,
including a former commissioner--that it doesn't need congressional
reform. I think the facts indicate otherwise. As I outlined on Friday,
the agency can't come close to meeting its statutory deadlines for
approval of either drugs or devices. There have been egregious examples
of delays that have affected people's safety and health, and we want to
do everything we can to minimize those delays and to make the agency a
more constructive force in terms of dealing with these questions.
The President's latest budget is outlined in this publication I have
entitled ``Department of Health and Human Services Food and Drug
Administration, Justification of Estimates for Appropriations
Committee.'' This is a backup document, material facts in terms of the
President's budget decision, as to how much we should fund FDA for the
next fiscal year.
Having outlined all of these problems that exist at FDA in approving
drugs, in approving devices and expediting the process and even
beginning to attempt to meet their statutory requirements, it is
astounding that the President's budget for next year does not only not
strengthen the agency, it diminishes its effectiveness.
The proposal here plans to cut the agency's total appropriated budget
by 8 percent and cut the device center budget--that is the center that
reviews and approves medical devices--by 27 percent. This is at a time
when, if we need to do anything, we need to increase the funding for
the agency or at least find ways to help the agency with outside
sources to try to do its job more effectively and more efficiently.
So that alone--I guess this was designed to meet some budget numbers,
but it certainly doesn't square with the assertions that the agency is
well on the way to solving its problems and, given a little more time
and few more resources, those problems will be solved. It also flies in
the face, I think, of the facts that have been presented on this floor
in terms of the agency's inability to meet its statutory requirements
for review and approval of devices.
In just a couple of areas, with respect to the 510(k) submissions,
the agency itself predicts that it will complete 6 percent fewer
applications in fiscal year 1998 over fiscal year 1997 because it has
fewer resources. It also predicts that it will review them 20 percent
slower than it did in fiscal year 1996. In fiscal year 1996, it took
them an average of 110 agency days for review; in fiscal year 1997, 120
days; for fiscal year 1998 it is predicted to be 130 days and will only
complete 40 percent of the submissions in the statutory 90-day period
compared with 60 percent last year.
So it makes no sense whatsoever to assert that the agency is well on
the way to reforming itself and this legislation isn't needed when the
agency's own predictions, own plan for what it is able to do with the
resources it has for next year, indicates that it is going in the other
direction, not toward reform, not toward more efficiency, not toward
meeting their statutory requirements, but in the opposite direction.
With respect to PMA applications, the agency has said, while it
expects to receive slightly more PMA applications than in recent years,
it will complete 27 percent fewer applications. In fiscal year 1997,
they completed 75. But for fiscal year 1998, they predict they will
only complete 55, and that they will review those applications 15
percent slower than last year, 250 days of review as opposed to 220
days, that they will complete only 35 percent within the first 180
days--that is the statutory limitation--as compared with 53 percent
last year, and they will have a 17 percent increase in the backlog.
If there has ever been justification for reform of FDA, it is in
looking at their own estimates of what they will be able to do next
year as compared to previous years. And so they are certainly not
reforming themselves, certainly not going in the right direction. They
are going in exactly the opposite direction.
What we are trying to do here with this legislation that Senator
Jeffords is leading the effort on--I might add with a lot of bipartisan
support, both Republicans and Democrats, as indicated by the cloture
vote last week with I think only five votes in support of Senator
Kennedy's support of a filibuster. People want to move forward here. We
know that hanging in the balance are decisions that can affect people's
health and safety and their very lives. We want to do this in a more
efficient and effective manner. So I think there is certainly
justification for going forward with this reform bill.
I just point out, for the benefit of my colleagues, that even after
extensive debate and markup in the committee, which produced a vote of
14 in favor and only 4 against on the legislation that we are
discussing today, there has been considerable negotiation. I have in my
hand here a list of 33 separately negotiated compromises to try to
accommodate the Senator from Massachusetts, four pages of single-spaced
negotiations on 33 separate items to try to address the concern of the
Senator from Massachusetts and a couple of other Senators on the
committee who thought that perhaps we should have addressed these in
committee.
In good faith, we sat down with them and attempted to address their
concerns. I know that Senator Harkin had a particular concern during
the markup, and we were very close to getting an agreement on that. And
I take responsibility for not accepting it at the time. In retrospect,
I think Senator Harkin was correct. I think what he was suggesting in
terms of how we classify medical devices and what devices will be
eligible for outside third-party review was correct. And so we notified
him of that. We worked with his staff, and we made the change.
So the bill before us incorporates the change that he thought we
should have made in committee. In retrospect, I wish I had made that
change in committee. I think it probably would have changed the
Senator's vote. And I think it would have been wise for us. We would
have then had a 15 to 3 vote or maybe even a 16 to 2 vote if that was
the case. In review of that action, that was one of the compromises or
one of the negotiations that were made.
But to say that, you know, we are standing here on the floor
unwilling to look at reasonable requests for some of the concerns and
objections of the Senator from Massachusetts, or from others, I think
this undermines that assertion. Mr. President, 33 changes have been
made to address the concerns raised by the Senator from Massachusetts
and from others.
Mr. President, I sincerely hope that we do not have to engage in
another filibuster effort as we move to the bill itself and open the
bill up for amendment and consideration. With that vote on Friday, only
five votes in favor of proceeding with discussion of the bill, I think
it would be a disservice to the American people, a disservice to the
FDA, and to this body for us to engage in additional lengthy
filibusters of this where we have to go to another cloture vote.
So I hope that as soon as we finish the Labor-Health and Human
Services appropriations bill, we can move with a definitive timetable
which will allow amendments to be offered, hopefully debated with some
kind of limitation on the time so we can move and then vote on, and
then move forward with this. It makes no sense to continue to delay it.
Mr. President, let me just talk a little bit about what the bill
includes--we talked about why we need it--about what the bill includes.
Back in 1990, I authored legislation which would allow some expedited
provisions within FDA for review of what is called humanitarian
devices. These are devices that affect only a small class of people and
really are not in the manufacturer's financial interest to proceed with
these devices because there is not a broad enough market for them. But
yet there are individuals that can benefit from these devices, and it
makes no sense to have the same convoluted, time-consuming process, and
particularly some of the specifics of what the FDA requires for
approval of these devices, if the sum total of all of that discourages
the manufacturer from going ahead because there is such a limited class
for whom these devices
[[Page S8897]]
are applicable. Then the only losers in this are the people for whom
the devices could have improved their quality of life or perhaps have
been of great benefit to their health.
And so in 1990 we enacted some humanitarian device provisions. But
since that time, as a result of I think what can only be described as
bureaucratic delay and inefficiency, since that time only one company
has been able to take advantage of this provision. The bill that we
have before us expedites certain agency procedures. It allows a waiver
of prior hospital review committee approval if the patient would suffer
harm or death while waiting for supervised approval. So if a patient is
in a position where waiting for approval could result in their death,
it allows for the provision for a waiver of the agency procedures.
In addition, the agency is ordered under this legislation to review
the application in 75 days, and that is one of those compromises. We
originally had 60 days. The agency thought they needed a little more
time. We agreed to allow them to have 75 days. And the agency was no
longer allowed to arbitrarily force the manufacturer to seek reapproval
of the product. In the past legislation the approval was only good for
a limited period of time and then they had to go through the whole
procedure again to get reapproval. We are saying once the agency
approves it, absent evidence to the contrary, that approval sticks.
In addition, the humanitarian device provision is made permanent
whereas before it had a sunset. Now, perhaps one of the most important
parts of this legislation is the increased access to expertise, outside
expertise, to allow the agency to accomplish its reviews and approval
process in a much more expeditious timeframe.
We, in the bill, require the FDA to enter into contracts with
nongovernmental experts--non-FDA scientists and reviewers--to assist in
product approvals. We are still talking about medical devices here to
assist in product approvals if the agency determines that doing so
would improve the timeliness or the quality of the review.
It is important to understand that the agency is going to retain
final approval authority over the review, but for the first time we are
requiring them to utilize outside experts, outside resources to help
them with that review. They are saying, ``We're overwhelmed. We have
all these applications. We don't have enough employees to review it.
And that's why we have the delay.'' We are saying, ``There are
organizations, institutions, agencies outside of the FDA that can help
provide these reviews. We are asking you to look to these to provide
some assistance. But you, the FDA, have approval authority.'' In other
words, it does not automatically go to an outside reviewing group, but
it can go to a group that the FDA approves of.
I do not see what the problem is with that. I mean, final authority
rests within the FDA. But if there is an organization outside the FDA
that the FDA can contract with or that the manufacturer can contract
with, to expedite it, as long as FDA retains approval authority, then
why not utilize this? It is going to expedite the process.
The agency currently has a pilot program in place with which it is
testing out this concept. We want to expand that pilot program. We
would like to require that 60 percent of the nonexempt 510(k)
submissions be included in the pilot. We also have language in here
which limits the agency's ability to write all the guidance documents
for these organizations. Sometimes the writing of the guidance
documents takes months, if not years, and in a sense is unnecessary
because the agency can allow the outside organization to go forward
without that as long as it retains authority.
We are concerned about a manufacturer contracting with an outside
agency just to seek approval. And if the manufacturer were allowed the
contract with that outside agency, and they just said, ``OK, we
reviewed it. Here is the approval. You have to take it,'' there would
be legitimate grounds for objection to that. But we have built in total
oversight authority and control into the FDA so that they really are
not giving up jurisdiction here, they are just utilizing that outside
source to help them do their work. It is not like somebody
subcontracting work out if they do not have the capacity to do it
within their factory or within their business.
But because public safety and public health is at risk here, we want
to make sure that FDA retains sufficient authority to oversee all of
this. FDA is given the authority in the bill to establish conflict of
interest protections because we do not want to get into a situation
where there is a conflict of interest between the manufacturer and the
review authority. FDA decides what those protections are. FDA accredits
the pool of qualified organizations. In other words, a manufacturer
cannot go to any organization unless FDA has preapproved that
organization, that outside agency for review. They have to get FDA's
stamp of approval, good seal of approval, before they are even eligible
to do the work to assist FDA.
FDA selects from a pool of two or more accredited parties from whom
the product sponsor may select. In other words, FDA says these agencies
are certified to do this work; the company selects one or two or a pool
of accredited parties, and FDA then makes that selection. FDA has
authority to revoke the accreditation if it feels that it is not
proceeding according to the way they want it to go. It has the ability
to investigate any kind of conflict of interest and it has final
approval authority.
Now, this is important, this final approval authority. At one point,
I threw up my hands and said the FDA has so much authority why are we
going outside? Are we not just defeating the purpose? But in order to
get the legislation addressed, we built in all these protections,
additional protections, and of course the best protection of all for
FDA is that it has final approval authority.
If it does not like what comes back from the outside agency despite
all these other steps where it accredits and so forth it can say we do
not approve because we do not think the agency did such and such. So it
has preapproval authority. It has process approval authority. It has
final approval authority. That is plenty of protection.
All of what you hear about how risky it is to American health and so
forth, some agency which is not part of the Federal Government is
involved in approving a particular product, that is not the case,
because we have built into the legislation approval authority for FDA
all up and down the line.
Title III improves the collaboration and communication between FDA
and the various drug and device companies. There is a list of items
that I will not take time to detail.
Title IV clarifies a lot of the rules currently in place and improves
the certainty of the process. We address the whole question of policy
statements. In recent years, FDA has increasingly developed informal
policy statements without involving the public and has failed to make
the policies available to the public. In response to a petition from
citizens in my State, a group of Indiana manufacturers, the agency
published guidance that radically changed these practices. The bill
requires the FDA to make this ``Good Guidance Practices" document
permanent by promulgating it as a final regulation in 2 years.
In the area of labeling claims for medical devices, in the past the
agency has looked beyond a manufacturers' legitimate labeling claims
and requires that the company making the product provide extensive data
on a variety of claims for which the company never intended the product
to address. The product was designed for a specific purpose. The FDA
said we want you to conduct all kinds of trials and provide extensive
data for what other things it might be used for, not for what the
company is marketing it for, not for what the company has designed it
for, but what it might be used for. That has clearly delayed the
ability to review products and to get them approved.
The bill clarifies the relationship of labeling claims to approval
and clearance of products, and it further limits FDA's review of device
submissions to the intended use of the device set forth in labeling.
We tried to build in certainty of review timeframes. I will not go
through the details of that, but that is extensive and brings some
certainty to the process.
We have placed some limitations on initial classification
determinations.
[[Page S8898]]
Recently the agency denied due process of law to manufacturers by
withholding a substantial equivalence determination even when the
product was in fact substantially equivalent whenever the manufacturer
was determined to have even a technical defect in the GMP inspection.
The bill prohibits the FDA from withholding the initial classification
of a device based on failure to comply with unrelated provisions of the
act, including good manufacturing practices. The agency is directed to
use its ample existing enforcement authority to ensure that products
that have the GMP violations at the time of classification do not reach
the market.
Title V, improving the accountability. It sets an agency plan for
statutory compliance in an annual report so we have a better handle on
what is going on within the FDA.
Title VI, better allocation of resources by setting priorities. We
exempt certain classes of devices from premarket notification
requirements. This really expands on the administration's reinventing
Government initiative that exempts class I and class II medical devices
that pose little risk by exempting all class I devices, the least risk
devices, except those that are important in preventing impairment of
human health or presents potential unreasonable risk of illness or
injury.
We had extensive discussion on this. This is an area where Senator
Harkin raised what I believe are legitimate concerns and we have tried
to address those concerns in this legislation.
We have evaluation of automatic class III designations. Current law
requires that all new devices not substantially equivalent to a device
already on the market must be automatically classified in a highest-
risk category. This does not make sense. If a very simple device that
would otherwise be a class I or class II device is not substantially
equivalent to a device already on the market, it has to be
automatically classified as the riskiest of all devices and therefore
falls into class III for the review process, and the approval process,
which takes an extraordinary amount of time and requires
an extraordinary amount of data, clinical trials and so forth. That is
not necessary. So we have changed that so that it does not
automatically fall into class III.
It says ``if it is not substantially equivalent,'' what we have done
here is allow the agency to make a determination as to which category
it would fall in rather than automatically go to class III. So the
agencies could look at it and say we think this is class I or class II
and is subject to those review procedures rather than automatically
moving into class III. It is a sensible change in the current status of
how this is handled.
We made changes regarding health care economic information, health
claims for food products, and pediatric studies of drugs.
Title VII, we have extended, and of course this is the engine that
drives the train here, and another reason why it is so necessary to
move forward with this legislation. We have reauthorized the
Prescription Drug User Fee Act for 5 years. That is the so-called PDUFA
legislation which the prescription drug companies have agreed to
support. It is a tax on those companies for the specific purpose of
providing extra funds for FDA to hire personnel to expedite the reviews
of drugs which are submitted for review and approval to the FDA.
It has worked out very, very well in response to an overwhelmed FDA
who could not begin to meet their statutory requirements for review of
drugs. A proposal was made that we would enact a tax against the
companies submitting the product and the proceeds of that tax will be
used to hire personnel and establish procedures whereby we could
expedite the approval drugs. It was needed. It was supported. It has
worked. We need to reauthorize it because it expires October 1 this
year. That is why it is so important to move forward with this
legislation.
There are other things in the bill, Mr. President, but in the
interests of time I will not detail them unless the President wants me
to go through them point by point, but I do not think we have the time
still allotted. I know the majority leader is anxious to move back to
the Labor-Health and Human Services appropriations bill.
Again, I thank the Senator from Vermont for his leadership on this
issue. It has been a cooperative effort that has reached across the
aisle and involved Members from both parties in a very substantial
number. Hopefully, we can move forward now in getting to the bill
itself and the amendments and move this very needed legislation
forward. I will be involved in this. I know there are a number of
discussions coming up with some of these amendments.
I appreciate the leadership and support of the Senator from Vermont,
who is not testing but actually utilizing a medical device to address
an unfortunate accident he had just last week.
I yield the floor.
Mr. JEFFORDS. I commend the Senator from Indiana who has been
extremely helpful on this whole bill in helping us bring it to
conclusion. He made many offers, very reasonable, and I hope we can
find the magic one to bring us to fruition very quickly.
I yield the floor and I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk called the roll.
Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. JEFFORDS. I have the authority to yield back the balance of the
time for the minority, as well as the majority on this side.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. JEFFORDS. I suggest the absence of a quorum.
The PRESIDING OFFICER (Ms. Collins). The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. WELLSTONE. Madam President, I ask unanimous consent that the
order for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________