[Congressional Record Volume 142, Number 110 (Wednesday, July 24, 1996)]
[Senate]
[Pages S8594-S8602]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
        RELATED AGENCIES APPROPRIATIONS ACT FOR FISCAL YEAR 1997

  The Senate continued with the consideration of the bill.
  Mr. BROWN addressed the Chair.
  The PRESIDING OFFICER. The Senator from Colorado.


                    Amendment No. 5002, As Modified

  Mr. BROWN. Mr. President, in discussing the Brown amendment on the 
Agriculture appropriations bill, the junior Senator from Nebraska had 
recommended that we go with the modified version instead of the 5-year 
moratorium I suggested. He suggested a 2-month moratorium with an 
allowance for an additional time period in the event that there were 
delays in the process. So I have incorporated that aspect into my 
amendment and go from 5 years down to the 2 months, plus the additional 
time.
  In addition, the senior Senator from Nebraska has suggested that we 
modify the provision regarding funding by the Secretary of Agriculture 
so that the funding relates to an amount which he feels is appropriate. 
That is very open-ended language and not very tight. But I must say 
that I have a great deal of confidence and faith in the Secretary of 
Agriculture and in his sense of fairness.
  So I ask unanimous consent that my amendment be modified to 
incorporate those changes which I filed at the desk.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  The amendment (No. 5002), as modified, is as follows:

       At the appropriate place in the bill, insert the following 
     new section:

     ``SEC.   . INTERIM MORATORIUM ON BYPASS FLOWS.

       ``(a) Moratorium.--Section 389(a) of P.L. 104-127 is 
     amended by striking ``an 18-month'' after the word ``be'' and 
     inserting ``a 20-month''.
       ``(b) Report.--Section 389(d)(4) of P.L. 104-127 is amended 
     by striking ``1 year'' after the word ``than'' and inserting 
     ``14 months''.
       ``(c) Extension for Delay.--Section 389 of P.L. 104-127 is 
     amended by adding at the end the following new subsection:
       `` `(e) Extension for Delay.--There shall be a day-for-day 
     extension to the 20-month moratorium required by subsection 
     (a) and a day-for-day extension to the report required by 
     subsection (d)(4)--
       `` `(1) for every day of delay in implementing or 
     establishing the Water Rights Task Force caused by a failure 
     to nominate Task Force members by the Administration or by 
     the Congress; or
       `` `(2) for every day of delay caused by a failure by the 
     Secretary of Agriculture to identify adequate resources as 
     determined by the Secretary of Agriculture to carry out the 
     purposes of the Task Force.' ''

  Mr. BROWN. Mr. President, it is my understanding that, while neither 
Nebraska Senators now have concerns about the amendment--or perhaps I 
should say will not object to the amendment--the senior Senator from 
Vermont does not want it passed prior to an amendment which he will 
offer.
  So I ask unanimous consent that the yeas and nays be ordered and that 
the timing of the amendment be set at such time as the ranking Member 
and the chairman of the subcommittee would recommend to the body.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  Mr. BROWN. Mr. President, I note the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. KENNEDY. 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. KENNEDY. Mr. President, I ask unanimous consent that Pearl 
O'Rourk and Osvaldo Percira, legislative fellows, be permitted access 
to the floor during the consideration of H.R. 3603, the agriculture 
appropriations bill.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. I suggest the absence of a quroum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. KENNEDY. 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. KENNEDY. Mr. President, I would like to speak to an issue that is 
included in the agricultural appropriations bill that deals with public 
health, and address the Senate for a short time this afternoon. I would 
then like to introduce the amendment that deals with that particular 
issue and then to move on from there.
  The legislation before us includes a proposal to cripple the FDA's 
ability to protect the public against one of the most costly and deadly 
tragedies suffered by Americans. Every year millions--millions--of our 
fellow citizens are injured or killed by this silent epidemic. It 
results in over 2 million Americans being hospitalized each and every 
year. It results in 3 million Americans having to visit their doctor 
each and every year for problems that could be avoided. It costs the 
American economy an estimated $100 billion--$100 billion--a year in 
additional health costs and lost productivity.
  What is this epidemic? It is a wave of illnesses, injuries, and even 
deaths caused by prescription drugs. Millions of Americans are affected 
and billions of dollars are spent on medical problems caused by 
prescription drugs. The Nation spends as much to cure the illnesses 
caused by prescription drugs as we spend on the drugs themselves.
  The vast majority of these adverse drug reactions can be avoided if 
patients have basic information about the prescription drugs they are 
taking. That information will allow patients to understand the proper 
use of the drugs their doctors prescribe. It will alert them to the 
symptoms of adverse reactions that can occur with their medication. 
This basic information would be a written reminder of what doctors tell 
their patients when the drug is prescribed. That information is often 
hard to remember, often not followed, and often misunderstood.
  We should do all we can to end these tragic, costly, and unnecessary 
illnesses, injuries, and deaths. Who can be against providing patients 
with basic information about the prescription drugs they take? 
Unfortunately, a powerful group of special interests has been fighting 
for two decades to prevent patients from getting this basic 
information. They have been fighting for almost 20 years to prevent 
patients from getting the information that could prevent needless 
injuries, illnesses, and deaths.
  The latest battle in this long war by the special interests is this 
appropriations bill. Buried on page 58 of this 81-page bill is a 
provision that prohibits the FDA from assuring that drugstores and 
pharmaceutical companies provide their customers with the simple, basic 
information they need to protect themselves against drug-induced 
illnesses.
  This provision would forbid FDA from going forward with a proposed 
regulation, called the medication guidance regulation, which would 
require that patients receive adequate information when they fill a 
prescription. The Food and Drug Administration is America's premier 
consumer protection agency. It has been working with private industry 
for many years to implement a program to achieve this objective. Time 
and time again, for more than 17 years, private industry has promised 
to get that information to patients. It has promised to stop these 
millions of needless injuries, illness, and deaths. It has promised to 
prevent these unnecessary hospitalizations and doctors' visits.
  But, year after year, as millions of individuals are injured and 
billions of dollars are wasted, these tragedies continue. Why? Because 
all of these promises have been broken.
  So, these tragedies continue, even though it costs only a few cents 
per prescription to add this basic information. Rather than spend a few 
cents per prescription, these special interests cause billions of 
dollars in tragedies year-in and year-out. Time and again, they put 
profit and self-interest ahead of public health.
  As the result of these efforts the FDA is being muzzled by an unholy 
alliance

[[Page S8595]]

of drugstores and pharmaceutical companies. And, the patients are the 
losers. This provision is nothing more than a gag order preventing the 
FDA from making sure that patients get basic, minimal information about 
the prescription drugs they are taking. We are no longer in the dark 
ages when people mistakenly believed that patients needed to be 
protected from basic medical information.
  It is almost inconceivable, Mr. President, but going back to the 
ethical statute of the Royal College of Physicians in 1555:

       Let no physician teach the people about medicines or even 
     tell them the names of the medicines, particularly the more 
     potent ones such as purgatives, opiates, narcotics, 
     abortifacients, emetics or any other which are particularly 
     dangerous: For the people may be harmed by their improper 
     use. This under the penalty of 40 shillings.

  That used to be the old method, deny individuals and consumers 
information about the types of treatment they were receiving.
  Then as recently as 1934 a statement published in the Federal 
Register, stated that drug labeling should be written ``* * * only in 
such medical terms as are not likely to be understood by the ordinary 
individual.'' I repeat, that was in 1934.
  We have transitioned a long way. The American consumer wants to know 
what they are ingesting, what is going into their bodies. They want to 
know about the food they eat. They want to know about the air they 
breathe and the water they drink. They want to know about prescription 
drugs. They want to know about over-the-counter drugs. It is a bygone 
day when we should deny the American consumer the best information that 
we have available. That is really what this issue is all about. Are we 
going to make sure that, for each and every prescription drug, the 
individual is going to get the best information that is available. They 
need this information in order to know how take their prescription 
drugs safely and to know if they are going to interact with any other 
types of prescription or over-the-counter drugs that they may be 
taking?
  As billions of dollars are wasted each year, as millions of Americans 
are needlessly hospitalized each year, as millions of patients suffer 
adverse reactions each year, these special interests claim that their 
voluntary efforts are adequate to protect consumers. The body count 
goes up, but they claim that they have been doing all that is 
necessary.
  But, their claims are false, and they know it. The clear facts show 
that Americans do not get enough information about the prescriptions 
they are taking. We know that because the hospitalizations, the 
doctors' visits, the injuries, the illnesses, and the deaths continue. 
Those are facts that the special interests do not want to talk about.
  But the problem is even worse than that. American consumers get more 
information from a box of cereal than they do from the prescription 
drugs they buy. In fact, almost half of all consumers get no written 
information at all of the kind they need to use their prescriptions 
properly. And when the information is provided, it is too often 
inadequate or incomplete.
  Approximately half of all consumers get some form of information. 
Half of them do not. But of the 50 percent that do, much of the 
information is incomplete. We have waited for industry to present their 
plans for providing this important information to the consumer: this is 
exactly what the Food and Drug Administration had requested. Industry 
was to voluntarily create a system and be able to show that 75 percent 
of prescription drug consumers received reliable information by the 
year 2000 and, hopefully 95 percent by the year 2006.
  The Food and Drug Administration was going to make an assessment of 
the progress in the year 2000 and decide if additional steps were 
needed or if the industry should just continue with their efforts. The 
hope was that industry would provide this program voluntarily. But as 
you can see by the information presented here, the needed information 
is not forthcoming. This bill allows industry to continue as is and 
would not allow the Food and Drug Administration to meaningfully 
evaluate the process of information flow to consumers.
  The Food and Drug Administration looked at the information that was 
provided to drug stores by eight commercial vendors. Drug stores that 
want to provide information to their customers can buy information 
systems from such commercial vendors. The FDA examined the information 
that these eight vendors provided on three commonly prescribed drugs: a 
sedative, an antibiotic, and a drug used to treat high blood pressure.
  While there are a number of vendors, for this study, the FDA selected 
eight of the better ones.
  Remember, we are talking about common medications that can result in 
life-threatening complications. We are talking about providing people 
with basic information and warnings that the drug that they are about 
to take could result in serious birth defects or could cause a fatal 
allergic reaction.
  Mr. President, these drugs each have potentially dangerous side 
effects. One of these drugs can cause severe birth defects, but only 
four of the eight vendors even warned about use in pregnancy. And only 
one vendor commented on birth defects when that was the real danger.
  One drug, the antibiotic, has the potential of causing a fatal 
allergic reaction. While six of the eight vendors provided information 
on the possibility of an allergic reaction, only one told ``What to do 
if an allergic reaction occurs.''
  There were eight sources. This scorecard on this chart should have 
read ``8,8,8,8,8'' all the way down. That is the only score that should 
be acceptable. For each one of these three commonly used medications, 
they ought to provide the appropriate warnings about side effects, 
contraindications, the possibility of serious drug reactions. Anything 
less is unacceptable.
  This is one of the more recent studies done by the FDA on the 
adequacy or inadequacy of information provided on important, commonly 
used prescription drugs. I remind you, for half of the prescription 
drugs no information is provided; while information is provided for the 
other half, this is an example of what that information may be.
  Let me show you a specific example. This is a prescription for a drug 
called Macrobid, which is an antibiotic used for chronic therapy.
  On the left is an enlargement of the information that one patient 
received when she had this prescription filled. It sounds pretty simple 
and certainly safe. It says, ``Take one capsule twice a day with food 
for 30 days. Then decrease dose to one capsule once a day. Take with 
food to lessen stomach upset. Must use for full length of treatment. 
May interfere with urine glucose test in diabetics.''
  But is something missing? Is there information that is generally 
available and scientifically sound that would be of value to any 
consumer? What is missing is the fact that this drug is contraindicated 
in term pregnancies and during labor and delivery. If a baby is exposed 
to this drug during such time, there is the possibility of 
precipitating a rapid destruction of red blood cells that could be 
fatal for the baby.
  So if a pregnant woman were taking this drug, she should know that if 
she takes it in the last stages of pregnancy or during labor and 
delivery she is risking the health of her child.
  It is contraindicated in mothers who are breastfeeding infants less 
than 1 month of age. The drug gets into the breast milk and causes the 
same destruction of red blood cells.
  Here you see it is also contraindicated in people with G6PD 
deficiency. G6PD deficiency is a type of blood disorder, reasonably 
rare, but nonetheless noteworthy. If you take this medicine and you 
have this kind of blood disorder, you may experience a fatal hemolytic 
anemia which is the breakdown of red blood cells. So this would 
obviously be valuable information for a patient who knows they have 
G6PD deficiency.
  This drug can also cause lung disease. ``Should consult your 
physician in the event of pulmonary symptoms.'' Physicians suggest that 
patients who take this drug for more than 6 months should have routine 
lung examinations.

  This is the kind of information that should be available. This is the 
kind of information that could easily be available. We are not talking 
about overly extensive pages of data. We are talking

[[Page S8596]]

about the kind of information that is readily available and accessible 
to both the company and to the FDA. This is the kind of information 
that is not being routinely provided today on these prescription drugs.
  What is it that the FDA thinks is necessary? Here is a prototype 
designed by the FDA which includes the information they believe the 
consumer should be told. This one uses Cardizem, as an example. This 
provides all the information. We have it blown up here. ``What is the 
most important information that I should know about Cardizem?''
  ``Used to treat angina pectoris--chest pain. May lower blood 
pressure. If you get dizzy while using, call your doctor. Can interact 
with certain medications. Check with your doctor if using beta blocker, 
digitalis. If you notice very low heart rate, palpitations or feel very 
weak, call your doctor.''
  Then there is a description of what Cardizem is. It is a relaxant 
that dilates blood vessels in the body, increases blood flow to the 
heart and helps reduce chest plain. A drug known as calcium channel 
blockers.
  It has, ``Who should not take it?'' It indicates if you have heart 
problems, your doctor needs to know. If you have low blood pressure or 
heart block, a pacemaker, heart failure or any other heart problem; if 
you have liver or kidney problems, your doctor needs to know. If you 
are pregnant--the use of Cardizem in pregnant women has not been 
studied. Studies with animals suggest, however, that Cardizem may cause 
miscarriages.
  So it points out if you have a heart problem, if you have liver or 
kidney problems or if you are expecting you should not take this 
medication. And it also says, ``If you are nursing, Cardizem is passed 
on through the breast milk. If you take, use some form of infant 
feeding.'' Change from breast to infant feeding.
  Then it talks about how I should take Cardizem. ``Take before meal, 
if possible. If you miss a dose, take it as soon as possible. However, 
if it is almost time for your next dose, skip the missed dose and take 
your medicine as scheduled. Do not take double your prescribed dose.''
  This is very important. Many people, when they are on prescription 
drugs, will fail to take it at the time prescribed, and they wonder 
whether they ought to double up. Maybe they forget for a day, maybe 
they forget to take a morning, noon or evening dose, and they wonder, 
``Should I take it double tomorrow because I forgot to take 
today.'' Say I forget this morning's dose? Do I take two this 
afternoon? And this tells what to do if you do miss a dose.

  ``What should I avoid taking with Cardizem?'' It interacts with other 
medications. Your doctor may need to change the dosage for the 
medicine. Check with your doctor before taking the beta blocker drugs, 
ulcer drugs, and digitalis for heart failure.
  So it mentions the types of health challenges that you might face, 
the sort of chronic problems that you might face, it gives you a 
warning and a heads up. And then it talks about other types of 
medicines that would have an adverse reaction.
  ``What are the side effects?'' It gets into the side effects. The 
swelling of the legs, headache, rash, weakness, a small number, less 
than a half-percent get heart palpitations. So it says, ask your doctor 
if you have difficulty breathing or have dizziness. This goes on. This 
is the type of information that we are talking about. This is 
scientific information presented to consumers in readable, 
understandable form that responds, by and large, to the everyday kind 
of questions that a consumer would have with regard to this particular 
medication.
  I think all of us have seen the information for over-the-counter 
drugs. You know, the insert for Tylenol, Excedrin. Very few people, 
unless you are a chemist, can really understand it. That is not what we 
are talking about here. We are talking about valuable, readable 
information that could be of such great importance to consumers.
  It is readable. It is understandable. And it is enormously valuable 
for patients. And yet, 50 percent of the American people do not get 
this kind of information. And the other 50 percent, in too many 
instances, get information that is inadequate.
  This is the type of thing that we want to encourage. We want the 
industry to do this in a voluntary way. As I say, they are doing 50 
percent now. We were hopeful to get them to 75 percent, working with 
the industry, working with the FDA to permit them to move through that 
process by the year 2000.
  So this provision of the pending bill tells patients--the provision I 
mentioned earlier--that they do not need these warnings. All they need 
is to trust the industry to take care of them. But the industry is not 
providing the warnings, is not telling the patients the drug they are 
about to take will cause a serious birth defect or fatal allergic 
reaction.
  The industry promised for years to provide the patients with the 
information. There are many, many examples of why industry cannot be 
trusted to do what is right.
  In 1992 the FDA required a box warning--those are the warnings that 
are printed on the various boxes, the most serious kinds of warnings--
on the labeling provided doctors and pharmacies for Seldane and 
Hismanal, two of the most popular prescription antihistamines for 
allergies. When taken in association with certain antibiotics or 
antifungals, which are two other classes of frequently prescribed 
drugs, there were deaths and serious cardiovascular reactions.
  Let me tell you about one 29-year-old woman who was taking Seldane 
for allergies. She went to her podiatrist for athlete's foot and was 
given a prescription for Ketoconazole. Two days later she went to an 
emergency room complaining of a blackout. They could find nothing wrong 
with her, told her to return if it happened again. The next morning she 
was found dead in bed. Apparently, the cause of death was cardiac 
arrhythmia and death. The blackout episodes were most likely caused by 
arrhythmias.
  If she was given patient labeling, she could have easily identified 
the warning against using the two drugs together. Her death was 
preventable.
  The needed warnings even appeared in FDA-approved consumer 
advertising in magazines, such as People, Newsweek and Time.
  Here in the Washington Post, on April 16, 1996 it talks about a 
warning: ``Seldane and Popular Antibiotics Equals Trouble.'' And the 
point of this chart, Mr. President, is this:

       American pharmacists fill about 2 billion prescriptions a 
     year, and the market is more complex than ever, with more 
     diseases treated by multiple drugs. Retail pharmacists 
     have more financial incentive to sell prescriptions than 
     to spend time talking to customers about possible drug 
     interactions,'' Shulke said.
       They rely increasingly on computer programs to catch 
     potentially dangerous drug interactions. Unfortunately, 
     ``these software programs are lagging behind the state of the 
     art'' and fail to keep up with [the] latest Food and Drug 
     Administration and pharmaceutical [company] warnings.

                           *   *   *   *   *

       Much of the information that doctors and patients receive 
     about drugs comes from the companies themselves. Such 
     information, while useful, tends to present ``one side of the 
     story''--emphasizing the benefits of medications more than 
     the risks.

  So, Mr. President, this is something that was pointed out. This is by 
the pharmacists themselves, the American Pharmaceutical Association. 
The Director of Policy and Regulatory Affairs made those observations.
  All of us would believe that when a prescription drug is given, that 
the patient has the best protection because he or she has the doctor. I 
think all of us understand that. We have come to rely on that doctor. 
The doctor is not going to obviously put this person at risk. But what 
we are finding out, what every indication is, particularly with elderly 
people, is that people either forget after a few days, a week, a month, 
several months, they get easily confused between various different 
kinds of information that they may have been told or that they have 
forgotten, all against a background where that kind of information is 
easily available, accessible, and understandable and should be provided 
to the consumer.
  The warnings against taking these drugs in combination did not appear 
on the information sheets that pharmacists gave to consumers. Consumers 
were given better information in magazine ads than they were given by 
the pharmacists who dispensed their prescriptions.
  Even today, after concerted efforts to educate physicians and 
pharmacists

[[Page S8597]]

about the dangers of prescribing Seldane with certain antibiotics, tens 
of thousands of patients are still given coprescriptions written in 
conjunction with one of those antibiotics.
  We have been promised that the pharmaceutical industry and retail 
pharmacies will take care of keeping the public informed. What is 
happening in the Washington, DC, area? Well, Dr. Woolsey from 
Georgetown recently completed a study. Fifty pharmacies were selected 
out of the yellow pages. An investigator was sent to each of these 
stores with a prescription of Seldane and Erythromycin. Thirty-four of 
the pharmacies either refused to fill them or warned that the two drugs 
should not be taken together. But 16, or nearly a third, filled both 
prescriptions without any comment or warning, the very kind of 
situation we are talking about here.
  A third of the pharmacies issued both of these drugs even though 
there are these extraordinary dangers. And 14 of those were asked if 
there were any problems taking the two drugs together. Nine said they 
could be taken together--that there was no problem.
  Only nine of the prescriptions were accompanied by a written note 
suggesting a patient check with a doctor if these two drugs were taken 
together or to ``report any other drugs you take or disease you have.''
  These are the warnings we have for a fatal reaction. Think of the 
information we would get for reactions that merely cause disease or 
discomfort.
  Yet the current underlying legislation will allow industry to 
independently provide this information. This is the same industry that 
has so overtly failed in just this one situation of the fatal reaction 
of Seldane and Erythromycin. I ask you, how often have you been on an 
antihistamine and an antibiotic at the same time? What about your 
children?
  So the rollcall of patients harmed or injured because they did not 
receive adequate warnings is a long one, and includes children and 
adults from every walk of life. Senior citizens, as I mentioned, are 
particularly victimized. The best estimate is 17 percent of all 
hospital admissions for senior citizens is as a result of an adverse 
drug reaction, about 5 percent for children. But no American can be 
confident that a member of their family will not be the next to suffer.
  Let me give you several examples.
  A 69-year-old man was prescribed an antibiotic called Cipro to treat 
a kidney infection. He took the pills for 10 days and failed to notice 
any improvement. When he returned to his physician, a repeat urine 
culture showed that the infection was still present. The physician 
changed it to another antibiotic.
  The problem was not the antibiotic. This man was also taking Maalox 
for indigestion, which he had not been told that Maalox or other 
antacids prevent the antibiotic Cipro from being absorbed. Even though 
he was swallowing the right dose, not enough entered the bloodstream.
  This should have been included on a drug information sheet.
  A 48-year-old man was diagnosed as having a mild form of diabetes 
which can be treated by taking pills that will lower the amount of 
sugar in the blood. He had been taking these pills for 4 months. During 
that time his physician had changed the dose in order to maintain a 
good blood sugar level. He had been stable without any change in dosage 
for 2 months.
  Then one day he twisted his ankle. To treat the pain he started 
taking Advil every 4 to 6 hours. The next morning he awoke feeling 
sweaty and light-headed and fainted as he got out of bed. He was rushed 
to the hospital where his blood sugar was measured at an extremely low 
level.
  This man should have been warned that Advil and other related drugs 
increase the effect of the diabetes medication he was taking. What had 
been a good dose of medication in the past now lowered his blood sugar 
level to a dangerous level.
  This should have been included on a drug information sheet.
  A 58-year-old man who was otherwise very healthy developed diarrhea 
and abdominal cramping. He was diagnosed as having irritable bowel 
syndrome and was placed on a strong tranquilizer medication to calm 
down his intestines. Six months after being on this medication, he 
developed the symptoms of Parkinson's disease. His doctor started him 
on a medication for Parkinson's disease.
  For 7 years, he took both drugs. Then a neurologist specializing in 
Parkinson's disease evaluated him and recognized that the real problem 
was the tranquilizer. Both drugs were discontinued.
  Four months after seeing the neurologist, this man was on no 
medication and all of the Parkinson's symptoms had disappeared.
  This man suffered from a side effect of the tranquilizer. The 
neurologist who made the correct diagnosis says that in 3 years he had 
seen 38 other patients who had drug-induced Parkinson's disease.
  A 60-year-old woman was started on a drug called propranolol to treat 
her high blood pressure. The physician had prescribed a large dose 
considering her age and her size.
  Two days after starting the drug she began feeling very weak. This 
got worse and on the third day she went to the emergency room where on 
arrival her pulse rate was only 36 beats per minute. This low heart 
rate was a result of the propranolol.
  If she had received an adequate drug information guide, she would 
have recognized that her symptoms were likely a response to the 
medication, and she could have called her physician rather than going 
to an emergency room. She was lucky. If she had any heart disease, 
lowering her heart rate to such a level could have produced severe 
heart failure.
  Mr. President, the list goes on. Leaving out critical warnings is 
unacceptable. In these types of life-and-death cases, FDA oversight is 
clearly warranted. The health and lives of too many patients is at 
stake.
  FDA has rightly decided consumers deserve more protection than the 
status quo. The medguide regulation is intended to correct this gross 
deficiency in our consumer protection laws.
  Today, we go into a supermarket to buy a loaf of bread, a carton of 
milk, or a box of cereal. Complete nutritional information is provided 
on the package. Here we have the package label for Wheaties, 
``Breakfast of Champions.'' We see that, under the Food and Labeling 
Act we passed just a few years ago, we have the calories, total fat, 
cholesterol, sodium, potassium, all of the vitamins that are listed, 
the carbohydrates. All of this is printed in an easily and 
understandable form that is welcomed by every mother, every parent, 
every child.
  When we buy over-the-counter drugs like aspirin or Tylenol, the FDA 
regulations require the drugs to have complete information, so those 
who take the pills understand what they are taking, how to take them, 
what side effects to watch out for, and what food or drugs it interacts 
with. Anyone who goes to the drugstore this afternoon will find that 
information available.
  But, if we buy a prescription drug in the pharmacy of one of these 
same grocery stores, there is no guarantee that we will get the same 
kind of information when the prescription is filled. Current laws 
require more information about breakfast cereals than about dangerous 
prescription drugs, even though the necessary information can be 
provided simply and cheaply.
  The results of this neglect are predictable and shocking. Mr. 
President, 30 to 50 percent of adult patients do not use their 
medications properly. In children, improper use exceeds 50 percent. 
Just look at this dog food label, Alpo puppy food. Friskies Alpo puppy 
food has all the information--protein, fat, fiber, moisture, calcium, 
phosphorous. It lists the various ingredients and how the minerals and 
vitamins have been added, talks about the weight and age of the dog, 
talks about recommended amounts and how many different feedings ought 
to be included. We provide it on dog food, cat foot, pet food. We 
provide it at the grocery store on the box of cereal and just about 
every other item in the grocery store under the food labeling 
provisions. We provide it for over-the-counter drugs. But the one area 
where we do not provide assurance is in the prescription drugs.
  The FDA is attempting to provide and encourage the industry to get to 
75 percent information by the year 2000--not by requiring--by working 
with them. We have seen the attempt in the

[[Page S8598]]

House of Representatives and the Senate of the United States to bar 
that type of action. That is not acceptable.
  Mr. President, in the elderly, who rely most heavily on medication, 
noncompliance is often higher. They do not often understand the 
problems of missing doses or changing doses. This is more dramatic in 
low-income elderly. There are economically induced compliance problems, 
and patients sometimes attempt to stretch their medication by cutting 
back on their required daily dose. They have not been warned such 
action endangers their health.
  You cannot have a meeting with senior citizens in any part of this 
country without, when you ask them how many spend $25 or more per month 
on prescription drugs, 80 percent of their hands going up. Ask who 
spends $50 or $75 a month, and a third of the hands go up that are 
taking prescription drugs. In many instances, there are a number of 
seniors who are dividing those prescription drugs to make them last 
over a longer period of time and who have no understanding or awareness 
of what that is doing in terms of endangering their health.
  The patients taking medications are not the only losers. Public 
health is put at risk if uncured infections are transmitted and 
resistant infections develop.
  The economic and human costs are staggering: 2 million avoidable 
hospitalizations, 3 million avoidable doctor visits, $20 billion in 
additional health care costs, and $100 billion in total costs to 
society. The need for action is clear, yet this legislation will stop 
the FDA from doing what is needed. Here it is, $20 billion, 
effectively, for avoidable hospital admissions because of adverse drug 
use--$20 billion a year. The best estimate is that it is $100 billion 
in terms of either direct or indirect costs. It has health implications 
and cost implications in terms of individuals and the community.
  The medication guidelines this legislation would block would 
establish concrete goals for industry to meet. By the end of the year 
2000, FDA seeks to ensure that at least 75 percent of patients with new 
prescriptions would obtain adequate, useful, easily understood written 
information. By the year 2006, 95 percent of patients with new 
prescriptions would receive this information. There is nothing radical 
about these targets. They are the same commonsense objectives 
established in the landmark ``Healthy People 2000'' goals developed 
under the Reagan-Bush administrations.
  Working with drug companies, pharmacists, physicians, and consumers, 
FDA was planning to establish nonbinding guidelines on such 
information. These guidelines will help pharmacies ensure that the 
written information they provide is adequate.
  If the goals in the proposed regulation are not met, FDA would have a 
choice--either institute a mandatory program or seek public comment on 
what steps to take next.
  This approach is reasonable. It gives the private sector the 
opportunity to achieve compliance without regulatory requirements over 
the next 4 years. Yet the industry still objects. It claims that 
neither the medguide regulation nor binding requirements are necessary.
  Inadvertent misuse of prescription drugs is not a new problem. FDA 
first starting tackling the problem on a broad scale in the mid-1970's.
  In 1975, after examining the issue in-depth by studying existing 
labels, interviewing consumers, conferring with experts in the 
different health care fields, FDA published a notice in the Federal 
Register asking for public comments to help formulate a policy on 
patient labeling for prescription drugs.
  In 1979, the FDA issued a proposed regulation to require drug 
manufacturers to write patient labeling for their drugs and provide it 
to pharmacists for dispensing with the drug. In comments on this 
proposal, consumers favored the proposal, while manufacturing 
pharmacists and the medical professions opposed it.
  In 1980, after considering the comments, FDA issued a final rule. It 
decided that the evidence in the rulemaking record amply demonstrated 
that labeling would improve the benefits that consumers receive from 
prescription drugs in a number of ways. The information would increase 
compliance, which would in turn decrease injuries from misuse. The 
regulation required manufacturers to provide labeling to pharmacists, 
but it also allows pharmacists to write their own labeling.
  In 1981, the incoming Reagan administration delayed the 
implementation of the FDA regulation. This is an issue that has been 
around for a long period of time. But the regulation was revoked 
altogether. Its justification was that the private sector had promised 
to implement a voluntary program to do the job. So here we are--15 
years later--and industry is saying, once again, ``We don't need 
Federal regulation. Give us a few more years and we'll do the job.''

  But the results of the industry's past 15 years of nonaction are 
crystal clear--too many deaths, too many injuries, and not enough 
patient information. Almost half of all patients receive no written 
information of the kind they need to monitor their use of medications. 
Too often, the information they receive is shockingly inadequate.
  FDA rightly concluded that consumers are not being served. They 
developed a proposal and took it to industry, before even beginning a 
rulemaking proceeding. In a letter to Senator Cochran, FDA explains:

       We originally envisioned mandating that drug manufacturers 
     develop patient leaflets which would be distributed with most 
     prescription drugs, informing patients of such things as how 
     to take the drug, what it was used for, what side effects to 
     watch for, and what to do if problems were experienced with 
     the drug.
       However, before issuing such a proposal, we met with the 
     medical and pharmacy professions, representative of the 
     nation's drug stores, drug manufacturers, consumers groups, 
     and others. Many told us that new patient information 
     systems, most using computer technology, had been developed 
     and were being implemented that could accomplish our goal at 
     little cost to pharmacies and consumers, and that by the end 
     of the decade, most patients would be getting such 
     information through these private sector mechanisms.
       We accepted their argument, and our subsequent proposal of 
     August 1995 announced that we would defer consideration of a 
     mandatory comprehensive Federal program until at least the 
     year 2000, to give the private sector time to fulfill that 
     commitment. We believe the proposed rule is very consistent 
     with the concept stated in your letter of giving the 
     marketplace a chance to meet our mutual objective. We are 
     currently reviewing the comments submitted in response to the 
     proposed rule, and recognize that revisions may be necessary 
     to respond to some of the specific concerns raised by those 
     who manufacture, prescribe, dispense prescription drugs.

  So FDA's regulation, developed after consultation with the affected 
industries, is entirely reasonable. It sets a performance standard and 
goal of 75 percent of consumers receiving accurate, complete, helpful, 
and legibly written information by the year 2000. The 75 percent goal 
takes into account the existence of the small corner drug store that 
may not be able to meet the target as readily as large firms. The 
underlying mandatory regulation will not go into effect if this goal is 
met by the year 2000. In addition, it does not apply to drugs dispensed 
in doctors' offices, or hospitals, or in an emergency. In addition, 
there is special consideration for small retail pharmacies.
  The FDA has gone the extra mile. Consumers deserve the protection. 
Fifteen years of inaction under so-called voluntary guidelines 
established by the industry is already too long. Now the industry will 
have another 5 years to show it can do the job voluntarily. But even 
that is not enough for the majority of Congress. They want to prohibit 
the FDA from implementing even this modest approach.
  The provision in the bill states that if the private sector develops 
a plan within 120 days of enactment, FDA's rulemaking is suspended. 
However, the Secretary of HHS and the Commissioner of FDA cannot review 
the voluntary program to determine if it is, in fact, adequate. The 
only action that HHS or FDA is allowed to take is to audit the program 
to see if it meets the goals set by the industry--not the goals set by 
FDA or Healthy People 2000. The bill further hamstrings FDA by 
precluding any activity, such as guidelines, that might assist the 
private sector or assure that its program is adequate.
  This provision is an abdication of Congress's responsibility to 
protect the

[[Page S8599]]

public health. Instead of responsible action by FDA, an industry with 
an unsatisfactory track record is permitted to regulate itself--without 
any FDA oversight to make sure that the industry program is adequate.
  How many more people must be injured or killed before Congress does 
the right thing? How many more billions of dollars in health care costs 
must be squandered before we decide that the public interest should 
take precedence over these special interests.
  The offensive provision in this bill is also part of the overall FDA 
reform bill reported by the Labor Committee. That legislation is the 
subject of continuing negotiations between Congress and the 
administration. The administration has identified modifying this 
provision as one of its highest priorities. We have been negotiating in 
good faith in the hope of reaching bipartisan agreement on a 
responsible FDA reform bill. Yet in the middle of these negotiations, 
this particular proposal is suddenly being rushed through Congress on 
this appropriations bill.
  This FDA gag order does not belong on the agriculture appropriations 
bill. We all know what is going on here.
  Special interests have brought and paid for this provision with 
political campaign contributions. Anti-FDA companies have contributed 
$1.3 million to the sponsors of several so-called FDA reform bills in 
the 3 years ending December 31, 1995. Of that sum, $888,000 were 
contributed by political action committees of FDA-regulated companies 
to the sponsors of these anti-FDA bills.
  And those are only the campaign contributions made through last 
December. The money hasn't stopped flowing. In fact, in 1996 the money 
has continued to pour into the Republicans: Eli Lilly & Co., gave 
$305,000 to the Republican National Committee in the first 4 months of 
1996. Bristol Myers-Squibb contributed $275,000 to the Republican 
National Committee in the first 4 months of 1996. And now they have 
their payoff.
  The American people deserve a strong and independent FDA--an FDA that 
has the authority and ability to assure that the food we eat is 
nutritious and healthy, that the medicines we take will cure, not kill, 
and that the medical devices we rely on will sustain and improve life, 
not harm it.
  By rejecting the proposal in the bill before us today, the Senate can 
send a message of reassurance to the American people. Public health is 
not negotiable. The FDA is not for sale to the highest bidder, and 
neither is Congress. No amount of campaign contributions can possibly 
justify selling out the FDA and jeopardizing the lives and health of 
the American people. The people have the right to useful and necessary 
information about the drugs they take--and FDA should have the chance 
to make sure they get it.
  I yield the floor.
  Mr. SIMON addressed the Chair.
  The PRESIDING OFFICER (Mr. Thomas). The Senator from Illinois is 
recognized.
  Mr. SIMON. Mr. President, first, I want to commend Senator Kennedy 
for all his work with the Food and Drug Administration. He has been a 
bulldog in fighting to protect the public interest.
  I stopped at the little store over in the Dirksen Building on the way 
over here. In the Dirksen Building, I saw pretzels, and I looked on the 
back of the pretzels and I saw how much sodium and everything else was 
there. A bag of pretzels gives us that information. When you pick up a 
candy bar, you have the information. But unless there is an agreement--
and I understand some negotiations are taking place, and we may have an 
agreement here shortly, and I hope we do--what is going to happen is we 
are going to continue to not give people information on prescriptions.
  Some companies do it voluntarily, but a great many do not. What the 
FDA has worked out is that, by the year 2000, 75 percent of 
prescriptions will have to provide that information. Frankly, I think 
the FDA, instead of being undermined, as this bill would do, ought to 
be criticized for not moving further than 75 percent. I cannot believe 
we would accept that 75 percent of pretzel bags is adequate. We insist 
that 100 percent of pretzels or dog food or breakfast food have this 
information. Why shouldn't people who buy prescriptions have this 
information? It just boggles the mind.
  When you take a look at the reactions that come, which Senator 
Kennedy was talking about, to people--and I can remember one of our 
colleagues just yesterday in the Democratic Caucus talking about a 
reaction that he got to drugs that were prescribed to him. Fortunately, 
he had information there, and he found out by reading the information 
that it was a reaction to the drug. By all means, we ought to protect 
the American public. What the Kennedy amendment does, and what the FDA 
is proposing, is that 75 percent of prescriptions should be covered by 
the year 2000, which is 4 years from now, and that 95 percent be 
covered by the year 2006, which is 10 years from now. If there is 
something wrong with this, it is that we are not covering everybody by 
the year 2000, all prescriptions, and, much less, by the year 2006, 10 
years from now, still having 1 out of 20 prescriptions not covered.
  I have to ask the question, Mr. President: Why do we have this here? 
Why would a pharmaceutical company want to prevent the American public 
from having this information? I assume it is that they may want to make 
a few more dollars and not have a liability here. I don't know. But, 
frankly, it seems to me that it protects them from the liability to 
have that information provided. What we do not need is an FDA gag 
order. That is what this bill is without an amendment. I am hopeful, 
from a report I just received from a staff member, that some kind of a 
compromise is being worked out. I do not know. But to say that the 
industry can set its own standards, I do not know how many 
prescriptions there are out here for various medicines. Let us say 
there are a thousand different kinds of things that could be out there. 
According to this bill right now, if each year they add one more where 
they would give the information, then it would take 1,000 years in 
order to meet that industry standard. And that would comply with this 
bill as it now is.

  Mr. President, clearly we have to protect the public. This bill 
without an amendment does just the opposite. It protects pharmaceutical 
companies and not the public. Our aim ought to be to protect the 
public. I want good pharmaceutical companies. I want companies that 
invest in research and do other things. But we cannot do that and 
jeopardize the public. We can both protect the public and encourage a 
healthy pharmaceutical industry.
  Mr. KENNEDY. Will the Senator yield for a question?
  Mr. SIMON. I am pleased to yield to my colleague.
  Mr. KENNEDY. My good friend serves with me on our Human Resources 
Committee. We had been considering an FDA reform legislation, had we 
not, over the period of recent weeks? And the House of Representatives 
Commerce Committee also had been in the process of marking up over 
there even as we meet here this afternoon. As a matter of fact, I 
understood they are going to try to work out in a bipartisan way a 
number of the areas in that FDA bill. And the Senator understands I 
believe that this whole question of the Medguide has been included in 
the alleged FDA reform. So it was a matter that was going to come on up 
here on the floor of the Senate under the FDA reform both in the House 
and in the Senate.
  I am just wondering whether the Senator was as surprised as I was to 
find out that this provision was taken out of the FDA reform. It had 
been a matter of some considerable discussion and difference in the 
Human Resources Committee. We had good debate on it for some of the 
reasons that have been outlined here this afternoon. Then to find out 
that it is tacked onto an agriculture appropriations bill, I do not 
know whether the Senator was as surprised as I was to find that out. 
The Senator might remember that we used to have the understanding that 
there was not going to be legislation on appropriations. That was ruled 
out, and now we permit it evidently under the various precedents on 
legislation on appropriations.
  I am just wondering whether the Senator was as surprised as I was to 
see this measure on this bill. I would think the Senator, representing 
the great State of Illinois which is industrial in the north and 
agricultural in the south, is eager to see this legislation go forward.

[[Page S8600]]

  I do think that it is important to note that this would be a matter 
that was going to be considered in a timely fashion we had hoped with 
the FDA reform. Now it is on an agriculture appropriations bill that is 
some distance from both committees of jurisdiction and subject matter. 
And I am just wondering if the Senator is somewhat surprised to see 
this emerge in this form.
  Mr. SIMON. The Senator from Massachusetts knows that we were all 
surprised--most of us were surprised--that it emerged here. We had been 
working, as he indicated, in a bipartisan way in our committee to try 
to deal with some of these problems, and they are very complex. But to 
say I was surprised is factual. I have to say I am also puzzled. Why 
does this happen to hit on an agriculture appropriations bill? To my 
knowledge no one on that agriculture appropriations bill has been 
called in any of these negotiations. Does the senior Senator from 
Massachusetts have any idea how it happened to come on this agriculture 
bill?
  Mr. KENNEDY. No; I do not. And I think this is an issue that deserves 
a full debate and discussion. I would be hopeful that we could work out 
some measure that would defer at least full debate so we would be able 
to permit the agriculture appropriations bill to move ahead without 
interfering with the current status. That was certainly our hope 
earlier in the day because I think that is really the best way to make 
sure that we are going to get the agriculture appropriations. None of 
us are interested in seeing this delayed at all, because of the 
importance of it. But I must say having this legislation which is of 
such enormous importance I think is a matter of importance, and we want 
to make sure that the Senate is fully apprised of it.
  So it is my hope that we can still work something out. We have been 
in contact with a number of Senators who are interested in it, and we 
will have a chance to see if we cannot resolve this so that we can get 
back to considering some of the agriculture amendments.
  Mr. SIMON. Mr. President, I simply want to again commend my colleague 
from Massachusetts for his leadership in this whole area, not just on 
this amendment but he has made a huge contribution in protecting the 
American public as we look at the FDA.
  Mr. President, if no one else seeks the floor, I question the 
presence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative 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 (Mr. Thomas). Without objection, it is so 
ordered.
  Mr. GREGG. Mr. President, I ask to proceed as if in morning business 
for a period of approximately 10 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GREGG. I appreciate the courtesy of the managers of the bill in 
allowing me to proceed in morning business.


                          RETIREMENT SECURITY

  Mr. GREGG. Mr. President, I rise to talk a little bit about an issue 
that is absolutely critical, obviously, to the future of America. It is 
on the minds of many. And that is the issue of retirement of Americans 
and how we are going to pay for it.
  This has become increasingly an issue that is receiving some 
visibility in a substantive way verses in a political and demagogic way 
as a number of proposals have been discussed over the last few months 
regarding the issue of how we are going to pay for retirement for our 
senior citizens who are presently receiving funds from the Social 
Security fund or from private pensions and also for those who are 
headed toward some sort of retirement benefit.
  The reason that the visibility of the issue has increased is probably 
because the largest generation in America, in American history, I 
guess--the postwar baby boom generation--is starting to see the whites 
of the eyes of retirement coming over the hill and it is necessary for 
the postwar baby boom generation to focus on how its retirement years 
are going to be paid for. It is a very big issue, and it is one that 
needs to be addressed.
  This Republican Congress has actually passed a series of major 
proposals in the area of retirement security. Most of these major 
proposals were included in last year's Balanced Budget Act, and they 
were aimed at making pensions more available and at making personal 
savings more attractive and at improving the Medicare system.
  The President, regrettably, vetoed that proposal, which would have 
gone a long way toward assuring solvency specifically of the Medicare 
system. Perhaps as a result of that veto, the White House has become 
concerned about their culpability in not addressing the important issue 
of how we protect the retirement systems of this country, especially 
Medicare, which, we have heard from the trustees, is going to go 
bankrupt in the year 2001, potentially 2000.
  And so, as a result of that, the President has now put forward a 
proposal. Of course, he puts forward a proposal on something almost 
every day, recognizing that most of it is not going to become law or 
enacted. Although it is really political in nature, it is still at 
least of some value in that he has put forward a proposal called the 
Retirement Security and Savings Act. The congressional leadership on 
the Democratic side of the aisle has also decided to put forward some 
proposals in this area called pension security bills--well, they were 
pension security bills. In May of this year, they put them forward and 
they were part of their families first agenda.
  My concern is that many of these ideas which are being initiated on 
the other side of the aisle not only miss the mark, but they actually 
aggravate the problem because, for the most part, most of these ideas 
come out of the position of big government resolves problems and it is 
to the big-government approach that we should turn in order to address 
the problems. They are ideas born in the 1930's, which should have died 
with the passage of the Berlin Wall but, unfortunately, continue to 
engender themselves on the other side of the aisle.

  However, at the same time that those ideas have been put forward, 
during the past year myself and Senator Simpson have been holding a 
series of coordinated hearings on the Nation's retirement policy, both 
in the Finance Committee and in the Labor Committee, where we chair the 
various subcommittees that are charged with this responsibility, I 
being responsible for the Committee on Aging, and he is responsible for 
Social Security.
  So we have examined the current status of the Nation's public and 
private retirement system and the nature and magnitude of the challenge 
that system confronts as the baby boom generation moves towards 
retirement.
  We have learned some important facts that provide a message of 
perspective on the current retirement security debate. These facts tell 
us that the scope of the problem we confront is enormous and, if 
anything, the American public is underestimating the problem and is 
underanxious about the problem.
  Fact No. 1 is that the Social Security system presents a major 
problem in its present structure. Within 35 years, our country as a 
whole will have more senior citizens than Florida does today. Think 
about that. In 35 years, the average age of the American population 
generally will exceed today's average age of Florida's population. This 
wave of senior citizens will have a life expectancy 8 years longer than 
current seniors, which is good, obviously, but it also creates issues.
  Social Security is terribly unprepared to cope with this change in 
demographics. The program operates on a pay-as-you-go basis, which 
works all right today when about 4.5 workers support each retiree, but 
by the year 2030 the ratio will have fallen to 2 workers supporting 
each retiree, and the program will simply collapse. Absent reform, 
nearly $8 trillion of unfunded liability exists today--$8 trillion. 
That is more than the national debt. That is what the unfunded 
liability is. Tomorrow's workers and the economy will never be able to 
withstand the taxes necessary to sustain an unreformed program once the 
baby boom generation begins to draw its retirement.
  Fact No. 2: Our private pension regime presents a major problem. 
Keeping in mind Social Security's future, it should be considered a 
national crisis that just half of today's full-time workers participate 
in employer-sponsored pension plans or that 45 million

[[Page S8601]]

Americans have no access to a private pension plan or that over the 
past decade corporate contributions to pension plans have declined by 
50 percent.
  These sad facts are driven by the even sadder state of the pension 
access in smaller businesses and for lower income workers.
  We passed a law just a few weeks ago which will correct some of this 
problem, but it does not solve all the problem, and it has not been 
signed by the President so we do not know that it will be agreed to. 
Today only 15 percent of the firms with less than 25 workers offer 
pensions to their employees. Whereas almost 80 percent of today's work 
force earning over $50,000 have pension plans, only 44 percent of the 
workers earning between $10,000 and $25,000 have pensions, and only 9 
percent of those earning less than $10,000 have a pension. While many 
likely theories underlie our Federal pension system regime, the fact 
remains that the marketplace's reaction to it is failing our workers. 
Proposals that we did pass just in the last few weeks will help 
alleviate this to some degree, but it will not correct the fundamental 
problem.

  Fact No. 3, personal savings presents a major problem. The typical 
working American retires with less than $10,000 of personal savings. 
Baby boomers now earning $75,000 a year, those doing well under the 
current pension statistics and expected to receive a typical employer-
provided pension, would have to triple their current savings rate to 
maintain their current standard of living upon retirement. It is just 
logic that tells you this. The fact is, people today work for about 30 
years. But because life expectancy has been extended, they also retire 
for about 30 years. So you cannot save just a few dollars while you are 
working and expect to have enough to cover you during your retirement 
when your retirement years are actually almost equaling your working 
years.
  The majority of Americans are very unprepared in the area of 
pensions. Americans do not save anywhere near the rate required to 
sustain themselves. The reasons for this likely vary--the triumph of 
consumerism over thrift, the increase in family tax burdens, the 
welfare state's culture of dependency, the burdens of repaying student 
or other loans which now exist at levels unheard of for prior 
generations--but the effects are all too real. We simply are not saving 
enough as a culture.
  These three basic facts concerning the three legs of the retirement 
stool--Social Security, private pensions, and savings--when viewed in 
combination, present a startling and disheartening picture. They also 
lead to some important lessons for judging the adequacy of any 
retirement security proposals the Congress may address over the next 
year.
  Lesson No. 1: We can no longer ignore the Social Security problems. 
We have a lot of faith in the common sense of the American people, at 
least we do in New Hampshire, and believe that the true root of their 
retirement anxiety is the fear that Social Security will not be there 
for them. They are right to be scared. Continuing to ignore Social 
Security reform because the program is now running a surplus is 
inexcusable. Retirement policy is long-term policy. We must allow the 
public adequate time to adjust their pension and savings activities to 
any Social Security changes we may enact. Every additional year of 
delay makes any change not only more Draconian but also less fair and 
less likely to succeed.
  Further, any reforms to Social Security should complement and 
reinforce the changes that must also be made to address today's savings 
and pension inadequacies. Those who champion ``retirement security'' 
but steadfastly ignore the Social Security problems not only mislead 
the American public but also now present a real danger to the 
retirement security of today's workers.
  Lesson No. 2: We must act to buttress the private pension and 
personal savings activity of Americans. While the need for Social 
Security reform has gained some national attention and numerous reform 
proposals have been made, Social Security is just one portion of our 
national retirement policy. We must also reform the other components 
with similar zeal and creativity. Just as the debate on Medicare was 
taken to a new level last year, with a general consensus developing 
that more individual choices should be offered, and just as the debate 
on Social Security is moving toward a new level with the discussion 
gravitating toward personalized savings options, the debate on 
employer-provided pension reform must move to another level as well.

  Our current pension structure does nothing for roughly half of our 
working population and neglects mainly the poorer workers at that. We 
do not need further tinkering, but we need new ways of thinking. We 
must also move with similar urgency and innovation to address the 
significant inadequacies in personal savings. While new tax incentives 
for savings seem to be the standard for the solution, increasing 
education on the need to save and changing the cultural attitude toward 
thrift may be even more effective and at a lower price in some regards.
  Lesson No. 3: We do not have time for political silliness. Our most 
basic lesson is that we must consider and deal with the totality of the 
problem. Any retirement reform proposal must be looked at through a 
comprehensive, long-term lens. The fundamental test for each private 
pension or personal savings proposal must be: Will it really expand 
pension coverage or savings? And a key test for Social Security reforms 
must be: Will they complement, not undermine, our pension and savings 
goals?
  Based on the facts I have just discussed, we do not have time to pass 
feel-good proposals that will end up making a bad situation even worse. 
We believe that many of the Democratic proposals would fail this test. 
While in theory they may work to give workers more pension security, in 
practice we know increased mandates, administrative expenses, and 
regulation causes businesses--and particularly small businesses--to opt 
out of pension activities. We have seen that in the defined benefit 
area especially.
  Some Republican proposals should be reexamined as well. If tax 
incentives like IRA's only cause shifting of savings and not new 
savings, a tax cut that offers working folks new money to save may be a 
better approach.
  It is important to keep in mind that the problems we confront result 
from an excess of good news. Americans are living ever longer, the 
Nation is prosperous, and we have come to expect a relatively 
comfortable retirement lifestyle. Our senior population is, as a whole, 
a generation that is in better financial shape than the other 
generations within the country.
  These expectations, however, are running head-on into unavoidable 
demographic facts. Thus, we believe the Nation's retirement structure, 
a public program designed in the 1930's and which has become a Rube 
Goldberg hodge-podge of tax and regulatory provisions built up over 
time, must be overhauled and restructured in light of the population 
pressures the Nation confronts. Continuing a process of incremental 
changes will continue failure. Outdated structures offer little hope 
for achieving what must be achieved.
  During the next few weeks, it is my intention to offer specific 
options which will lead to a comprehensive response to the problems 
which we have in the Social Security accounts, the pension accounts, 
and the savings area. I do not expect these proposals to be the end of 
the discussion but rather to be an effort to energize and promote the 
discussion. What is critical, however, is that we dedicate ourselves to 
the fact that we have to take action and we have to take it within the 
context of the next Congress. During this election year, when many 
politicians are putting their heads in the sand on this issue, we 
cannot afford that type of action.
  As we go into this election cycle, there should be a significant 
national debate and discussion of just what we are going to do in the 
area of retirement security.
  Mr. President, I yield the remainder of my time and I suggest the 
absence of a quorum.
  The PRESIDING OFFICER (Mr. Kempthorne). The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mrs. FEINSTEIN. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

[[Page S8602]]

  Mrs. FEINSTEIN. Mr. President, I ask unanimous consent to speak as in 
morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mrs. FEINSTEIN. I thank the Chair.
  (The remarks of Mrs. Feinstein and Mrs. Hutchison pertaining to the 
introduction of S. 1985 are located in today's Record under 
``Statements on Introduced Bills and Joint Resolutions.'')
  Mr. BRADLEY addressed the Chair.
  The PRESIDING OFFICER (Mr. Thompson). The Senator from New Jersey is 
recognized.
  Mr. BRADLEY. Mr. President, I ask unanimous consent to proceed as in 
morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The remarks of Mr. Bradley and Mr. Wellstone pertaining to the 
submission of Senate Resolution 282 are located in today's Record under 
``Submission of Concurrent and Senate Resolutions.'')
  Mr. BRADLEY. 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. EXON. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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