[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11364-11382]
[From the U.S. Government Publishing Office, www.gpo.gov]




             PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

  The PRESIDING OFFICER (Ms. Klobuchar). Under the previous order, the 
Senate will resume consideration of S. 1082, which the clerk will 
report.
  The legislative clerk read as follows:

       A bill (S. 1082) to amend the Federal Food, Drug, and 
     Cosmetic Act to reauthorize and amend the prescription drug 
     user fee provisions, and for other purposes.

  Pending:

       Landrieu amendment No. 1004, to require the Food and Drug 
     Administration to premit the sale of baby turtles as pets so 
     long as the seller uses proven methods to effectively treat 
     salmonella.
       Dorgan amendment No. 990, to provide for the importation of 
     prescription drugs.
       Cochran amendment No. 1010 ( to amendment No. 990), to 
     protect the health and safety of the public.
       Stabenow amendment No. 1011, to insert provisions related 
     to citizens petitions.
       Brown (for Brownback/Brown) amendment No. 985, to establish 
     a priority drug review process to encourage treatments of 
     tropical diseases.
       Vitter amendment No. 983, to require counterfeit-resistant 
     technologies for prescription drugs.
       Inhofe amendment No. 988, to protect children and their 
     parents from being coerced into administering a controlled 
     substance in order to attend school.
       Gregg/Coleman amendment No. 993, to provide for the 
     regulation of Internet pharmacies.
  Mr. GRASSLEY. Madam President, we have three critical votes ahead of 
us this afternoon. These votes mean that today is the day we show the 
American people whether we can really pass drug importation or whether 
we are just giving it lip service and nothing else. The Dorgan 
amendment is the moment American consumers have been waiting for and 
today is the day.
  As I said last week, the Dorgan amendment is the result of a 
collaborative effort by myself with Senator Dorgan and with Senator 
Snowe and Senator Kennedy to finally make drug importation legal in 
this country.
  This is the golden opportunity this year to get it done.
  Now we have heard here on the floor the concerns that some have with 
drug importation and drug safety. Let me tell you that this is 
something I take seriously. Everyone who knows me knows that I care 
deeply about the safety of drugs, and I would not be standing here 
today urging support for the Dorgan amendment if I didn't think it had 
the right stuff on drug safety. And it does.
  The fact is that the unsafe situation is what we have today.
  Today, consumers are ordering drugs over the Internet from who knows 
where, and the FDA does not have the resources to do much of anything 
about it.
  The fact is that legislation to legalize importation would not only 
help to lower the cost of prescription drugs for all Americans but also 
should shut down rogue Internet pharmacies selling unsafe drugs.
  The Dorgan amendment would improve drug safety, not threaten it. And 
it would open up trade to lower cost drugs.
  We see news accounts on a regular basis describing Americans who log 
on to the Internet to purchase drugs from Canada and elsewhere.
  In 2004, my staff were briefed about an investigation by the 
Permanent Subcommittee on Investigations for the Senate Government 
Affairs Committee.
  The Permanent Subcommittee on Investigations conducted an 
investigation into current drug importation. They found that about 
40,000 parcels containing prescription drugs come through the JFK mail 
facility every single day of the year--40,000 packages each day.
  Now, the JFK airport houses the largest International Mail Branch in 
the United States, but even then it is the tip of the iceberg.
  Each day of the year 30,000 packages of drugs enter the United States 
through Miami, and 20,000 enter through Chicago. That's 50,000 more 
packages each day.
  What is worse, about 28 percent of the drugs coming in are controlled 
substances.
  These are addictive drugs that require close physician supervision.
  While most people are ordering their prescriptions from Canada, they 
are also ordering prescriptions from Brazil, India, Pakistan, the 
Netherlands, Spain, Portugal, Mexico and Romania.
  Although the Federal Food, Drug, and Cosmetic Act prohibits the 
importation of unapproved, misbranded, or adulterated drugs into the 
United States, the fact is that thousands of counterfeit and 
unregulated drugs are seeping through our borders. This is what is 
happening today.
  John Taylor, Associate Commissioner of Regulatory Affairs for the 
Food and Drug Administration, FDA, in his testimony before the House 
Committee on Energy and Commerce in June 2003 stated that, ``the 
growing volume of unapproved imported drugs, which often are generated 
from sales via the Internet, presents a formidable enforcement 
challenge.''
  Despite the hard work of both the FDA and BCBP to control our 
borders, the importation of illegal drugs has become an unenforceable 
problem. That is because today, the FDA does not have the authority or 
the resources to do much about it. The Dorgan amendment would change 
that.
  The basic approach to assuring the drugs are safe in the Dorgan 
amendment which I coauthored with him--is to give FDA the ability to 
verify the drug pedigree back to the manufacturer, require FDA to 
inspect frequently, and require fees to give FDA the resources to do 
this.

[[Page 11365]]

  For imports by individuals from Canada, the bill requires the 
exporters in Canada to register with FDA and to post a bond that they 
will lose if they send unsafe drugs. Frequent inspections by FDA ensure 
compliance.
  For commercial imports, American wholesalers and pharmacists must 
register with FDA and are subject to criminal penalties if they import 
unsafe drugs. Again, frequent inspections by FDA ensure compliance.
  The bill requires manufacturers to inform FDA whether foreign drugs 
meet FDA standards, and if they don't, the manufacturers have to give 
FDA the information necessary to evaluate the safety of the drug. If a 
foreign drug is manufactured in a plant the FDA has not inspected, FDA 
can inspect it.
  The bottom line is the legislation gives the FDA the authority and 
resources it needs to implement safely the drug importation program set 
up under this bill.
  The fact is that the unsafe situation is what we have today: 40,000 
drug packages coming in every day in New York, 30,000 drug packages 
coming in every day in Miami, and 20,000 drug packages coming in every 
day in Chicago. That is 90,000 packages with drugs coming in from other 
countries every single day.
  We are already saying yes to drug importation every day that we allow 
this unregulated and unsafe situation to exist. We say yes to it 90,000 
times a day.
  What we need to do and what the Dorgan amendment would accomplish is 
giving the FDA the resources to clean up this mess.
  The Dorgan amendment gives the FDA the resources and authority to 
crack down on the unsafe and unregulated importation of drugs. That is 
what we need. That is one of the key reasons I have been working with 
Senator Dorgan and Senator Snowe and Senator Kennedy on this 
legislation. One of our key aims is to improve drug safety.
  I have been doing a lot of work in the area of drug safety, as my 
colleagues know, and I felt that I should talk about why the Dorgan 
amendment is important for improving drug safety.
  A vote against the Dorgan amendment is a vote in favor of the unsafe 
situation we have today.
  I must also say that a vote for the Cochran amendment is a vote to 
kill the Dorgan amendment. So a vote in favor of the Cochran amendment 
is a vote in favor of doing nothing. It is a vote for keeping the 
unsafe situation we have today.
  Congress must act now on legislation that will not only shut down 
rogue Internet pharmacies selling unsafe drugs to consumers but will 
also lower the cost of prescription drugs.
  Legalizing the importation of prescription drugs through a highly 
regulated system overseen by FDA will stem the tide of unregulated 
pharmaceuticals coming into the United States and create a safe and 
effective system for obtaining low-cost prescription drugs.
  The bill before us is the vehicle this year to get it done. The bill 
we are debating is a must-pass FDA bill. The Senate should send a 
strong message that we are committed to finally getting it done this 
year.
  And that is what we are working together to do today.
  Making it legal for Americans to import their prescription drugs is a 
top priority at the grassroots. It needs to be a top priority here in 
Washington.
  I have long advocated allowing American consumers access to safe 
drugs from other countries. I have always considered it a free-trade 
issue.
  Imports create competition and keep domestic industry more responsive 
to consumers.
  In the United States, we import everything consumers want. So that 
should be the case on prescription drugs.
  We need to do it legally and safely. We need to give the FDA the 
authority and resources to do it. That is what the Dorgan amendment 
would do.
  Consumers in the United States pay far more for prescription drugs 
than those in other counties.
  If Americans could legally and safely access prescription drugs 
outside the United States, then drug companies will be forced to 
reevaluate their pricing strategies. They would no longer be able to 
gouge American consumers by making them pay more than their fair share 
of the high cost of research and development.
  Now, it is true that pharmaceutical companies do not like the idea of 
opening up America to the global marketplace.
  They want to keep the United States closed to other markets in order 
to charge higher prices here. However, with the Dorgan amendment, 
prescription drug companies will be forced to compete and establish 
fair prices here in America.
  Now some don't want this to happen. And I want to reiterate that 
there is an attempt to kill drug importation as has been done many 
times before in this Chamber. I am referring to an amendment by my good 
friend from Mississippi, Senator Cochran. His amendment would require a 
certification about health and safety. That amendment is designed to 
kill drug importation once again. It is a clever amendment but it is a 
poison pill.
  Our effort develops an effective and safe system that gives Americans 
access to lower prices. This amendment requires that all imported drugs 
be approved by the FDA. The amendment sets a stringent set of safety 
requirements that must be met before Americans can import drugs from 
that country. And there are stiff penalties for violating the safety 
requirements.
  Don't be fooled by the Cochran amendment. Voting for the Cochran 
amendment is a vote to kill drug importation.
  With the Dorgan amendment, we are working to get the job done.
  We need to make sure Americans have even greater, more affordable 
access to wonder drugs by further opening the doors to competition in 
the global pharmaceutical industry.
  Americans are waiting. We must make sure they have access to 
affordable prescription drugs.
  I urge my colleagues to vote against the Cochran amendment and in 
favor of the Dorgan amendment.
  Mrs. CLINTON. Madam President, for many years, the FDA has been 
considered the gold standard among the world's drug safety bodies. And 
no one here doubts the desire of the agency's many career employees to 
continue to carry out its mission of keeping our drug supply safe for 
all Americans. In the legislation we are considering today, S. 1082, 
the Food and Drug Administration Revitalization Act, we provide these 
dedicated employees with the resources necessary to continue their work 
to ensure the safety and efficacy of drugs and biologic products for 
Americans.
  Despite the dedication of the FDA's employees, we know there have 
been breakdowns at the agency. We know that, at times, it has taken too 
long to act when a drug may pose a threat. It took many months from the 
point when scientists became aware of the elevated risk of adverse 
cardiovascular events associated with Vioxx and the point when it was 
withdrawn from the market, during which time the FDA had multiple 
opportunities to engage in stronger actions to protect consumers.
  In recent years, we have seen the scientific process unduly 
influenced by political or economic factors. When Senator Patty Murray 
and I worked to secure a decision for over-the-counter availability of 
Plan B, we saw the ways in which science-based decisionmaking was 
compromised. The Government Accountability Office has confirmed that 
the FDA's 2004 decision not to approve over-the-counter sales of Plan B 
was politically motivated. Concerns about undue influence from factors 
other than science extend beyond this one example. According to a Union 
of Concerned Scientists survey, 61 percent of FDA scientists could cite 
examples of when ``Health and Human Services or FDA political 
appointees have inappropriately injected themselves into FDA 
determinations of actions.'' Twenty percent of those responding had 
been ``asked explicitly by FDA decision makers to provide incomplete, 
inaccurate, or misleading information.''

[[Page 11366]]

  Because of these examples, I believe that the American public lost a 
great deal of confidence in the ability of the agency to ensure the 
safety of their medications. With this legislation, we can begin the 
process of rebuilding consumers' confidence in the FDA. Through this 
bill, we are taking concrete steps to improve drug safety. S. 1082 
establishes steps to establish a routine active surveillance system for 
medications and sets up a process through which the FDA can better 
manage risks for a range of drugs, from requiring postmarket studies to 
improving communication about the risks and benefits associated with 
medications.
  In addition to establishing a framework to increase drug safety, we 
are also working to implement an atmosphere where science guides the 
agency's decisions. We need to put into place the systems to ensure 
that employees can engage in the open, evidence-based discourse needed 
as part of the drug approval and review process--discourse not unduly 
influenced by political concerns. This legislation goes a long way to 
doing some of that by increasing the transparency around drug approval 
decisions, addressing conflicts of interests on advisory committees, 
and creating a climate that protects the rights of employees to publish 
in peer-reviewed scientific journals.
  I know that many of my colleagues have raised concerns about safety 
in the context of reimportation of drugs, and I am pleased to note that 
on this legislation, we have found a way to allow for safe drug 
reimportation. S. 1082 contains the provisions of Senator Dorgan and 
Snowe's Pharmaceutical Access and Drug Safety Act, legislation I am 
proud to cosponsor. This amendment would establish the framework 
through which we could phase in drug reimportation from other nations 
where regulatory authority is similar to that in our country, allowing 
millions of Americans to safely obtain medically necessary drugs at 
lower cost.
  Americans pay higher prices for the exact same prescription drugs 
being taken by their counterparts in Canada and Europe. The 
Congressional Budget Office has found that prices for brand-name 
prescription drugs are 35 percent to 55 percent higher in the United 
States. This price disparity affects millions of Americans. Our 
seniors, many of whom are on fixed incomes, end up spending larger 
portions of their income on drugs, especially when falling into the 
``doughnut hole'' or wrestling with other gaps in a Medicare Part D 
benefit. And this isn't only a problem for seniors--we have 46 million 
uninsured individuals in our country, many of whom are unable to afford 
prescription drugs. Without these drugs, manageable chronic conditions, 
like asthma or high blood pressure, spiral out of control into serious 
health problems.
  The lack of affordable drugs does not just hurt those who are 
uninsured or underinsured, but it also places greater pressure upon our 
health care system. The cost of treating someone in the emergency room 
is much higher than the cost of a prescription. But the way our system 
is set up, we don't help people engage in cost-effective disease 
management by making those drugs affordable, and I believe that we need 
to examine the ways in which importation can lower costs not only for 
consumers but for our overall system.
  The Dorgan-Snowe amendment contains many provisions that will ensure 
safety while giving Americans access to cheaper drugs. This bipartisan 
provision will allow seniors to safely access drugs from Canada 
starting 90 days after enactment. It will provide the needed authority 
and funding to the FDA to regulate foreign pharmacies and wholesalers, 
so that we can be sure that any drugs that enter the United States are 
safe for our citizens. And it will increase the consumer protections 
involved with internet pharmacies, so that people who don't live near 
the border can access imported drugs without being defrauded.
  We need to make drug reimportation safe, we need to make drug 
reimportation unambiguously legal, and we need to do so as quickly as 
possible. The Dorgan-Snowe amendment would allow us to do all of those 
things, and I would urge all of my colleagues to support this amendment 
to the bill.
  In addition to the provisions of this legislation dealing with drug 
safety and reimportation, I am proud to note that the Food and Drug 
Administration Revitalization Act has an entire title devoted to 
pediatric issues. I worked with Senators Dodd, Kennedy, and Enzi to 
craft these provisions, which will be of great benefit to children. The 
pediatric device provisions will help us improve the number and types 
of medical devices designed for pediatric populations, and the 
reauthorization of the Best Pharmaceuticals for Children Act improves 
the applicability of the pediatric exclusivity incentive and increases 
the speed through which these studies can be requested by the FDA. When 
this bill was passed in 2002, I was able to work with Senator Dodd and 
the HELP Committee to increase provisions to assist pediatric cancer 
research, and I am pleased to be a cosponsor of this legislation this 
time around.
  S. 1082 also contains most of the provisions of the Pediatric 
Research Improvement Act, a bill that I introduced earlier this year to 
reauthorize the pediatric rule. Because of this authority, the Food and 
Drug Administration is able to ensure that drugs that are marketed for 
children are safe and effective in children.
  For the past decade, I have been working to ensure that drugs that 
are marketed to children are safe and effective in children. As of the 
early 1990s, only about 20 percent of drugs contained specific 
pediatric dosing information, but since 1998, we have had over 1,000 
drugs fall under the scope of the pediatric rule, resulting in hundreds 
of studies that have helped us gain valuable data about drugs commonly 
used by kids.
  The reauthorization of the pediatric rule contained in this larger 
bill will allow us to make additional strides in improving pediatric 
drug development. We will be able to remove unnecessary bureaucratic 
barriers and improve the ability of the Food and Drug Administration to 
require testing on already-marketed drugs when sponsors refuse to carry 
out such testing under the incentive provided by the Best 
Pharmaceuticals for Children Act.
  It will improve our ability to collect and analyze data about 
pediatric clinical trials so that we can better evaluate the impact of 
such trials upon children's health overall, and it will improve the 
FDA's ability to coordinate the incentives provided under Best 
Pharmaceuticals for Children Act with the pediatric rule so that these 
two pediatric programs of the agency can work together more seamlessly.
  However, I must note that I am disappointed that this bill does not 
consider what I believe to be a critical part of the Pediatric Research 
Improvement Act--the provision which would have made permanent the 
authority of the FDA to obtain important data through the pediatric 
rule.
  Instead, the legislation before the Senate today contains a sunset of 
this authority, meaning that if this provision isn't reauthorized 5 
years from now, the FDA will no longer be able to ensure that drugs 
used in children are safe and effective in children.
  We would never dream of placing a sunset on the FDA's authority to 
certify the safety and efficacy of drugs used in adults, and I fail to 
understand why we impose a different standard on drugs for children, 
and I will seek to address this issue as the bill moves forward.
  We must also improve the FDA's authority in the realm of follow-on 
biologics. While there is nothing in the version of the legislation 
that is on the floor today that addresses this issue, Senators Kennedy 
and Enzi have made a commitment that we will mark up legislation on 
this issue on June 13 in the HELP Committee and that we will 
incorporate this legislation into the conference negotiations on this 
drug safety bill.
  Earlier this year, in conjunction with a number of bipartisan 
cosponsors, I introduced the Access to Life-Saving Medicine Act, 
legislation to provide FDA with the authority to approve safe and 
effective generic versions of

[[Page 11367]]

biotech drugs. By bringing safe and effective follow-on biologics to 
the market, we can provide significant savings to patients, employers, 
and the government.
  More than $10 billion worth of biopharmaceuticals will come off 
patent in the next 5 years, and without this legislation, the 
manufacturers of these biotech drugs can continue to charge monopoly 
prices indefinitely. In 2005, the costs of biologics grew 17.5 percent 
compared to traditional drugs, which increased 10 percent. And in 2006, 
the Medicare Part B Program spent more than $5 billion on biologic 
drugs. It is clear that biotech drugs hold great promise, but this 
promise is wasted if we don't take action to ensure that all Americans 
have access to safe, effective, and affordable generic versions of 
these drugs.
  According to a report released by Engel and Novitt to the 
Pharmaceutical Care Management Association, PCMA, passage of this 
legislation could conservatively save an estimated $14 billion over the 
next 10 years.
  I look forward to working with Senator Kennedy and my colleagues on 
the HELP Committee to ensure that we enact legislation that provides 
the FDA with the authority and flexibility to approve 
biopharmaceuticals subject to a workable, abbreviated approval pathway 
that is efficient, effective, and scientifically grounded and that 
includes measures to ensure timely resolution of patent disputes, as 
well as adequate incentives for continued innovation.
  Another issue that has come up during debate on the Food and Drug 
Administration Revitalization Act is food safety. Recent illnesses 
involving E. coli in spinach and lettuce, the discovery of Salmonella 
in peanut butter, and the importation of unsafe pet food ingredients 
from China illustrate the continued vulnerability of the American food 
supply and expose weakness in the FDA's food safety program.
  In the latest case, a chemical used in plastic manufacturing was 
placed in feed material from China, causing the deaths of an unknown 
number of pets. This chemical was also consumed by 2.7 million chickens 
and 345 pigs that were slaughtered for human consumption. Our food 
system must be prepared to effectively prevent the chemicals found in 
these animals from endangering the health of consumers.
  That is why I supported the inclusion of certain provisions in this 
bill to begin to address many of the agency's problems with food 
safety, as a prelude to overall committee action on this issue.
  I have long been concerned about the siloing of authority at the FDA 
and Department of Agriculture, and I filed an amendment to this bill 
which would establish a joint task force between the FDA, U.S. 
Department of Agriculture, USDA, and the Centers for Disease Control 
and Prevention (CDC) to improve our response to foodborne illnesses.
  According to the CDC, unsafe foods cause an estimated 76 million 
illnesses, 325,000 hospitalizations, and 5,000 deaths each year. 
Despite these statistics, safety tests for domestically produced food 
have dropped nearly 75 percent when compared to the number conducted in 
2003. Meanwhile, the number of food imports has grown from under 4 
million food import line items in 1993 to nearly 20 million in 2007. We 
have a situation where inspections are declining, yet the number of 
outbreaks and contaminations in our food supply is on the rise. The 
fragmentation in our food safety system must be addressed in order to 
protect consumers.
  With several of my colleagues, I have repeatedly written to the 
Secretary of Agriculture, the Commissioner of the FDA and the Director 
of the CDC urging them to create an interagency task force to better 
enable us to prevent such illnesses. To date, no action has been taken 
to grant my request. If the delay is due to concerns that these 
agencies do not have the authority to pursue such authority, I stand 
prepared, along with many others in the Senate, to provide these 
agencies with such authority. I look forward to working with my 
colleagues in the HELP Committee to address concerns about food safety 
and help restore our Nation's confidence in the ability of both these 
agencies to protect American consumers.
  I would like to close by noting that while the Food and Drug 
Administration Revitalization Act takes several steps that will improve 
the agency's ability to ensure the safety and effectiveness of drugs 
and biologics, it is time that we begin to look at drugs in a new way.
  It is not enough that we have drugs that are effective--in order to 
reduce overall health care costs, we need to understand how these drugs 
are effective in comparison to each other, in order to assist providers 
and patients make the best health care decisions.
  While the Vioxx controversy highlighted the need for additional 
safety protections, many of which are contained in the Food and Drug 
Administration Revitalization Act, it also demonstrates the role 
comparative effectiveness can play in ensuring the use of the most 
appropriate treatment for a specific condition. I pushed for inclusion 
of comparative effectiveness studies in the Medicare Modernization Act. 
One of the first studies to be carried out under this provision was a 
systematic review of osteoarthritis drugs, including Cox-2 drugs. If 
this information had been compiled earlier, it could have helped many 
evaluate whether to use these drugs, as opposed to other pain 
relievers, many of which are available at a lower cost without a 
doctor's prescription.
  Comparative effectiveness assists physicians and patients in 
selecting the best treatment and helps to reduce inappropriate uses of 
treatments that pose unnecessary safety risks to patients--and more and 
more people are recognizing its potential in improving health care. 
Earlier today, the Blue Cross and Blue Shield Association announced 
their support to create a new, independent entity to explore the 
effectiveness of new and existing medical procedures, drugs, devices, 
and biologics. I am grateful for their leadership, and I will be 
introducing legislation shortly to expand comparative effectiveness 
research and its use at the Federal level.
  I have been involved in the debate over the Food and Drug 
Administration Revitalization Act for several months now and believe 
that the product we have produced represents a step forward for safety. 
I will be supporting this legislation and look forward to working with 
my colleagues to ensure that we can continue to strengthen this agency, 
lower prescription drug costs, and maintain a strong commitment to 
consumer protection and scientific innovation.


                           Amendment No. 1010

  The PRESIDING OFFICER. Under the previous order, there will be 2 
minutes for debate equally divided on amendment No. 1010 offered by the 
Senator from Mississippi.
  The Senator from Mississippi.
  Mr. COCHRAN. Madam President, Americans deserve continued access to 
safe and effective drugs which are approved by the Food and Drug 
Administration. A number of recent reports demonstrate that serious 
problems exist with products from other countries. The New York Times 
ran a front-page story yesterday about how counterfeit drugs 
contaminated with an industrial solvent have poisoned hundreds, if not 
thousands, of people around the world. The toxic syrup has been 
involved in at least eight mass poisonings around the world in the past 
two decades, and researchers estimate thousands have died as a result. 
Most recently an epidemic of contaminated cough syrup was traced back 
to counterfeit medication from China. The FDA last week issued a 
warning to U.S. consumers to be especially vigilant because of the risk 
of the poison reaching the United States. The New York Times article is 
entitled ``From China to Panama, a Trail of Poisoned Medicine.''
  Counterfeit products, those that have been tampered with, or those of 
unknown origin, should not be brought into this country.
  The amendment proposed by the Senator from North Dakota will put in 
jeopardy the process we now have to

[[Page 11368]]

ensure the safety of prescription medications and protect the health of 
the American people.
  I have offered a second degree amendment, with bipartisan support, 
that requires the Secretary of Health and Human Services to certify 
that the importation of drug products will not pose additional risks to 
Americans and will indeed lower costs to consumers.
  We have had this issue before the Senate on several previous 
occasions. In all of these cases, the Senate has adopted this 
certification amendment overwhelmingly. Safeguards continue to be 
necessary and are even more important now considering the terrorist 
threats we face.
  I urge the Senate to again support this amendment.
  I ask unanimous consent that a copy of the New York Times article to 
which I referred be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                 [From the New York Times, May 6, 2007]

           From China to Panama, a Trail of Poisoned Medicine

                  (By Walt Bogdanich and Jake Hooker)

       The kidneys fail first. Then the central nervous system 
     begins to misfire. Paralysis spreads, making breathing 
     difficult, then often impossible without assistance. In the 
     end, most victims die. Many of them are children, poisoned at 
     the hands of their unsuspecting parents. The syrupy poison, 
     diethylene glycol, is an indispensable part of the modern 
     world, an industrial solvent and prime ingredient in some 
     antifreeze. It is also a killer. And the deaths, if not 
     intentional, are often no accident.
       Over the years, the poison has been loaded into all 
     varieties of medicine--cough syrup, fever medication, 
     injectable drugs--a result of counterfeiters who profit by 
     substituting the sweet-tasting solvent for a safe, more 
     expensive syrup, usually glycerin, commonly used in drugs, 
     food, toothpaste and other products. Toxic syrup has figured 
     in at least eight mass poisonings around the world in the 
     past two decades. Researchers estimate that thousands have 
     died. In many cases, the precise origin of the poison has 
     never been determined. But records and interviews show that 
     in three of the last four cases it was made in China, a major 
     source of counterfeit drugs.
       Panama is the most recent victim. Last year, government 
     officials there unwittingly mixed diethylene glycol into 
     260,000 bottles of cold medicine--with devastating results. 
     Families have reported 365 deaths from the poison, 100 of 
     which have been confirmed so far. With the onset of the rainy 
     season, investigators are racing to exhume as many potential 
     victims as possible before bodies decompose even more. 
     Panama's death toll leads directly to Chinese companies that 
     made and exported the poison as 99.5 percent pure glycerin.
       Forty-six barrels of the toxic syrup arrived via a poison 
     pipeline stretching halfway around the world. Through 
     shipping records and interviews with government officials, 
     The New York Times traced this pipeline from the Panamanian 
     port of Colon, back through trading companies in Barcelona, 
     Spain, and Beijing, to its beginning near the Yangtze Delta 
     in a place local people call ``chemical country.'' The 
     counterfeit glycerin passed through three trading companies 
     on three continents, yet not one of them tested the syrup to 
     confirm what was on the label. Along the way, a certificate 
     falsely attesting to the purity of the shipment was 
     repeatedly altered, eliminating the name of the manufacturer 
     and previous owner. As a result, traders bought the syrup 
     without knowing where it came from, or who made it. With this 
     information, the traders might have discovered--as The Times 
     did--that the manufacturer was not certified to make 
     pharmaceutical ingredients.
       An examination of the two poisoning cases last year--in 
     Panama and earlier in China--shows how China's safety 
     regulations have lagged behind its growing role as low-cost 
     supplier to the world. It also demonstrates how a poorly 
     policed chain of traders in country after country allows 
     counterfeit medicine to contaminate the global market.
       Last week, the United States Food and Drug Administration 
     warned drug makers and suppliers in the United States ``to be 
     especially vigilant'' in watching for diethylene glycol. The 
     warning did not specifically mention China, and it said there 
     was ``no reason to believe'' that glycerin in this country 
     was tainted. Even so, the agency asked that all glycerin 
     shipments be tested for diethylene glycol, and said it was 
     ``exploring how supplies of glycerin become contaminated.''
       China is already being accused by United States authorities 
     of exporting wheat gluten containing an industrial chemical, 
     melamine, that ended up in pet food and livestock feed. The 
     F.D.A recently banned imports of Chinese-made wheat gluten 
     after it was linked to pet deaths in the United States. 
     Beyond Panama and China, toxic syrup has caused mass 
     poisonings in Haiti, Bangladesh, Argentina, Nigeria and twice 
     in India.
       In Bangladesh, investigators found poison in seven brands 
     of fever medication in 1992, but only after countless 
     children died. A Massachusetts laboratory detected the 
     contamination after Dr. Michael L. Bennish, a pediatrician 
     who works in developing countries, smuggled samples of the 
     tainted syrup out of the country in a suitcase. Dr. Bennish, 
     who investigated the Bangladesh epidemic and helped write a 
     1995 article about it for BMJ, formerly known as the British 
     Medical Journal, said that given the amount of medication 
     distributed, deaths ``must be in the thousands or tens of 
     thousands.''
       ``It's vastly underreported,'' Dr. Bennish said of 
     diethylene glycol poisoning. Doctors might not suspect toxic 
     medicine, particularly in poor countries with limited 
     resources and a generally unhealthy population, he said, 
     adding, ``Most people who die don't come to a medical 
     facility.'' The makers of counterfeit glycerin, which 
     superficially looks and acts like the real thing but 
     generally costs considerably less, are rarely identified, 
     much less prosecuted, given the difficulty of tracing 
     shipments across borders. ``This is really a global problem, 
     and it needs to be handled in a global way,'' said Dr. Henk 
     Bekedam, the World Health Organization's top representative 
     in Beijing.
       Seventy years ago, medicine laced with diethylene glycol 
     killed more than 100 people in the United States, leading to 
     the passage of the toughest drug regulations of that era and 
     the creation of the modern Food and Drug Administration. The 
     F.D.A. has tried to help in poisoning cases around the world, 
     but there is only so much it can do. When at least 88 
     children died in Haiti a decade ago, F.D.A. investigators 
     traced the poison to the Manchurian city of Dalian, but their 
     attempts to visit the suspected manufacturer were repeatedly 
     blocked by Chinese officials, according to internal State 
     Department records. Permission was granted more than a year 
     later, but by then the plant had moved and its records had 
     been destroyed.
       ``Chinese officials we contacted on this matter were all 
     reluctant to become involved,'' the American Embassy in 
     Beijing wrote in a confidential cable. ``We cannot be 
     optimistic about our chances for success in tracking down the 
     other possible glycerin shipments.''
       In fact, The Times found records showing that the same 
     Chinese company implicated in the Haiti poisoning also 
     shipped about 50 tons of counterfeit glycerin to the United 
     States in 1995. Some of it was later resold to another 
     American customer, Avatar Corporation, before the deception 
     was discovered. ``Thank God we caught it when we did,'' said 
     Phil Ternes, chief operating officer of Avatar, a Chicago-
     area supplier of bulk pharmaceutical and nonmedicinal 
     products. The F.D.A. said it was unaware of the shipment.
       In China, the government is vowing to clean up its 
     pharmaceutical industry, in part because of criticism over 
     counterfeit drugs flooding the world markets. In December, 
     two top drug regulators were arrested on charges of taking 
     bribes to approve drugs. In addition, 440 counterfeiting 
     operations were closed down last year, the World Health 
     Organization said.
       But when Chinese officials investigated the role of Chinese 
     companies in the Panama deaths, they found that no laws had 
     been broken, according to an official of the nation's drug 
     enforcement agency. China's drug regulation is ``a black 
     hole,'' said one trader who has done business through CNSC 
     Fortune Way, the Beijing-based broker that investigators say 
     was a crucial conduit for the Panama poison.
       In this environment, Wang Guiping, a tailor with a ninth-
     grade education and access to a chemistry book, found it easy 
     to enter the pharmaceutical supply business as a middleman. 
     He quickly discovered what others had before him: that 
     counterfeiting was a simple way to increase profits. And then 
     people in China began to die.


                          Cheating the System

       Mr. Wang spent years as a tailor in the manufacturing towns 
     of the Yangtze Delta, in eastern China. But he did not want 
     to remain a common craftsman, villagers say. He set his 
     sights on trading chemicals, a business rooted in the many 
     small chemical plants that have sprouted in the region. ``He 
     didn't know what he was doing,'' Mr. Wang's older brother, 
     Wang Guoping, said in an interview. ``He didn't understand 
     chemicals.'' But he did understand how to cheat the system. 
     Wang Guiping, 41, realized he could earn extra money by 
     substituting cheaper, industrial-grade syrup--not approved 
     for human consumption--for pharmaceutical grade syrup. To 
     trick pharmaceutical buyers, he forged his licenses and 
     laboratory analysis reports, records show.
       Mr. Wang later told investigators that he figured no harm 
     would come from the substitution, because he initially tested 
     a small quantity. He did it with the expertise of a former 
     tailor. He swallowed some of it. When nothing happened, he 
     shipped it.
       One company that used the syrup beginning in early 2005 was 
     Qiqihar No.2 Pharmaceutical, about 1,000 miles away in 
     Heilongjiang Province in the northeast. A buyer for the 
     factory had seen a posting for Mr. Wang's syrup on an 
     industry Web site.

[[Page 11369]]

       After a while, Mr. Wang set out to find an even cheaper 
     substitute syrup so he could increase his profit even more, 
     according to a Chinese investigator. In a chemical book he 
     found what he was looking for: another odorless syrup--
     diethylene glycol. At the time, it sold for 6,000 to 7,000 
     yuan a ton, or about $725 to $845, while pharmaceutical-grade 
     syrup cost 15,000 yuan, or about $1,815, according to the 
     investigator.
       Mr. Wang did not taste-test this second batch of syrup 
     before shipping it to Qiqihar Pharmaceutical, the government 
     investigator said, adding, ``He knew it was dangerous, but he 
     didn't know that it could kill.''
       The manufacturer used the toxic syrup in five drug 
     products: ampules of Amillarisin A for gall bladder problems; 
     a special enema fluid for children; an injection for blood 
     vessel diseases; an intravenous pain reliever; and an 
     arthritis treatment.
       In April 2006, one of southern China's finest hospitals, in 
     Guangzhou, Guangdong Province, began administering 
     Amillarisin A. Within a month or so, at least 18 people had 
     died after taking the medicine, though some had already been 
     quite sick.
       Zhou Jianhong, 33, said his father took his first dose of 
     Amillarisin A on April 19. A week later he was in critical 
     condition. ``If you are going to die, you want to die at 
     home,'' Mr. Zhou said. ``So we checked him out of the 
     hospital.'' He died the next day. ``Everybody wants to invest 
     in the pharmaceutical industry and it is growing, but the 
     regulators can't keep up,'' Mr. Zhou said. ``We need a system 
     to assure our safety.'' The final death count is unclear, 
     since some people who took the medicine may have died in less 
     populated areas.
       In a small town in Sichuan Province, a man named Zhou 
     Lianghui said the authorities would not acknowledge that his 
     wife had died from taking tainted Amillarisin A. But Mr. 
     Zhou, 38, said he matched the identification number on the 
     batch of medicine his wife received with a warning circular 
     distributed by drug officials. ``You probably cannot 
     understand a small town if you are in Beijing,'' Zhou 
     Lianghui said in a telephone interview. ``The sky is high, 
     and the emperor is far away. There are a lot of problems here 
     that the law cannot speak to.''
       The failure of the government to stop poison from 
     contaminating the drug supply caused one of the bigger 
     domestic scandals of the year. Last May, China's premier, Wen 
     Jiabao, ordered an investigation of the deaths, declaring, 
     ``The pharmaceutical market is in disorder.''
       At about the same time, 9,000 miles away in Panama, the 
     long rainy season had begun. Anticipating colds and coughs, 
     the government health program began manufacturing cough and 
     antihistamine syrup. The cough medicine was sugarless so that 
     even diabetics could use it. The medicine was mixed with a 
     pale yellow, almost translucent syrup that had arrived in 46 
     barrels from Barcelona on the container ship Tobias Maersk. 
     Shipping records showed the contents to be 99.5 percent pure 
     glycerin. It would be months and many deaths later before 
     that certification was discovered to be pure fiction.


                          a mysterious illness

       Early last September, doctors at Panama City's big public 
     hospital began to notice patients exhibiting unusual 
     symptoms. They initially appeared to have Guillain-Barre 
     syndrome, a relatively rare neurological disorder that first 
     shows up as a weakness or tingling sensation in the legs. 
     That weakness often intensifies, spreading upward to the arms 
     and chest, sometimes causing total paralysis and an inability 
     to breathe.
       The new patients had paralysis, but it did not spread 
     upward. They also quickly lost their ability to urinate, a 
     condition not associated with Guillain-Barre. Even more 
     unusual was the number of cases. In a full year, doctors 
     might see eight cases of Guillain-Barre, yet they saw that 
     many in just two weeks. Doctors sought help from an 
     infectious disease specialist, Nestor Sosa, an intense, 
     driven doctor who competes in triathlons and high-level 
     chess.
       Dr. Sosa's medical specialty had a long, rich history in 
     Panama, once known as one of the world's unhealthiest places. 
     In one year in the late 1800s, a lethal mix of yellow fever 
     and malaria killed nearly 1 in every 10 residents of Panama 
     City. Only after the United States managed to overcome those 
     mosquito-borne diseases was it able to build the Panama Canal 
     without the devastation that undermined an earlier attempt by 
     the French. The suspected Guillain-Barre cases worried Dr. 
     Sosa. ``It was something really extraordinary, something that 
     was obviously reaching epidemic dimensions in our hospital,'' 
     he said.
       With the death rate from the mystery illness near 50 
     percent, Dr. Sosa alerted the hospital management, which 
     asked him to set up and run a task force to handle the 
     situation. The assignment, a daunting around-the-clock dash 
     to catch a killer, was one he eagerly embraced. Several years 
     earlier, Dr. Sosa had watched as other doctors identified the 
     cause of another epidemic, later identified as hantavirus, a 
     pathogen spread by infected rodents. ``I took care of 
     patients but I somehow felt I did not do enough,'' he said. 
     The next time, he vowed, would be different. Dr. Sosa set up 
     a 24-hour ``war room'' in the hospital, where doctors could 
     compare notes and theories as they scoured medical records 
     for clues. As a precaution, the patients with the mystery 
     illness were segregated and placed in a large empty room 
     awaiting renovation. Health care workers wore masks, 
     heightening fears in the hospital and the community.
       ``That spread a lot of panic,'' said Dr. Jorge Motta, a 
     cardiologist who runs the Gorgas Memorial Institute, a widely 
     respected medical research center in Panama. ``That is always 
     a terrifying thought, that you will be the epicenter of a new 
     infectious disease, and especially a new infectious disease 
     that kills with a high rate of death, like this.'' Meanwhile, 
     patients kept coming, and hospital personnel could barely 
     keep up. ``I ended up giving C.P.R.,'' Dr. Sosa said. ``I 
     haven't given C.P.R. since I was a resident, but there were 
     so many crises going on.'' Frightened hospital patients had 
     to watch others around them die for reasons no one 
     understood, fearing that they might be next. As reports of 
     strange Guillain-Barre symptoms started coming in from other 
     parts of the country, doctors realized they were not just 
     dealing with a localized outbreak.
       Pascuala Perez de Gonzalez, 67, sought treatment for a cold 
     at a clinic in Cocle Province, about a three-hour drive from 
     Panama City. In late September she was treated and sent home. 
     Within days, she could no longer eat; she stopped urinating 
     and went into convulsions. A decision was made to take her to 
     the public hospital in Panama City, but on the way she 
     stopped breathing and had to be resuscitated. She arrived at 
     the hospital in a deep coma and later died.
       Medical records contained clues but also plenty of false 
     leads. Early victims tended to be males older than 60 and 
     diabetic with high blood pressure. About half had been given 
     Lisinopril, a blood pressure medicine distributed by the 
     public health system. But many who did not receive Lisinopril 
     still got sick. On the chance that those patients might have 
     forgotten that they had taken the drug, doctors pulled 
     Lisinopril from pharmacy shelves--only to return it after 
     tests found nothing wrong. Investigators would later discover 
     that Lisinopril did play an important, if indirect role in 
     the epidemic, but not in the way they had imagined.


                              a major clue

       One patient of particular interest to Dr. Sosa came into 
     the hospital with a heart attack, but no Guillain-Barre-type 
     symptoms. While undergoing treatment, the patient received 
     several drugs, including Lisinopril. After a while, he began 
     to exhibit the same neurological distress that was the 
     hallmark of the mystery illness. ``This patient is a major 
     clue,'' Dr. Sosa recalled saying. ``This is not something 
     environmental, this is not a folk medicine that's been taken 
     by the patients at home. This patient developed the disease 
     in the hospital, in front of us.'' Soon after, another 
     patient told Dr. Sosa that he, too, developed symptoms after 
     taking Lisinopril, but because the medicine made him cough, 
     he also took cough syrup--the same syrup, it turned out, that 
     had been given to the heart patient. ``I said this has got to 
     be it,'' Dr. Sosa recalled. ``We need to investigate this 
     cough syrup.'' The cough medicine had not initially aroused 
     much suspicion because many victims did not remember taking 
     it. ``Twenty-five percent of those people affected denied 
     that they had taken cough syrup, because it's a nonevent in 
     their lives,'' Dr. Motta said.
       Investigators from the United States Centers for Disease 
     Control and Prevention, who were in Panama helping out, 
     quickly put the bottles on a government jet and flew them to 
     the United States for testing. The next day, Oct. 11, as 
     Panamanian health officials were attending a news conference, 
     a Blackberry in the room went off. The tests, the C.D.C. was 
     reporting, had turned up diethylene glycol in the cough 
     syrup. The mystery had been solved. The barrels labeled 
     glycerin turned out to contain poison.
       Dr. Sosa's exhilaration at learning the cause did not last 
     long. ``It's our medication that is killing these people,'' 
     he said he thought. ``It's not a virus, it's not something 
     that they got outside, but it was something we actually 
     manufactured.''
       A nationwide campaign was quickly begun to stop people from 
     using the cough syrup. Neighborhoods were searched, but 
     thousands of bottles either had been discarded or could not 
     be found. As the search wound down, two major tasks remained: 
     count the dead and assign blame. Neither has been easy. A 
     precise accounting is all but impossible because, medical 
     authorities say, victims were buried before the cause was 
     known, and poor patients might not have seen doctors. Another 
     problem is that finding traces of diethylene glycol in 
     decomposing bodies is difficult at best, medical experts say. 
     Nonetheless, an Argentine pathologist who has studied 
     diethylene glycol poisonings helped develop a test for the 
     poison in exhumed bodies. Seven of the first nine bodies 
     tested showed traces of the poison, Panamanian authorities 
     said.
       With the rainy season returning, though, the exhumations 
     are about to end. Dr. Jose Vicente Pachar, director of 
     Panama's Institute of Legal Medicine and Forensic Sciences, 
     said that as a scientist he would like a final count of the 
     dead. But he added,

[[Page 11370]]

     ``I should accept the reality that in the case of Panama we 
     are not going to know the exact number.''
       Local prosecutors have made some arrests and are 
     investigating others connected to the case, including 
     officials of the import company and the government agency 
     that mixed and distributed the cold medicine. ``Our 
     responsibilities are to establish or discover the truth,'' 
     said Dimas Guevara, the homicide investigator guiding the 
     inquiry. But prosecutors have yet to charge anyone with 
     actually making the counterfeit glycerin. And if the Panama 
     investigation unfolds as other inquiries have, it is highly 
     unlikely that they ever will.


                           a suspect factory

       Panamanians wanting to see where their toxic nightmare 
     began could look up the Web site of the company in Hengxiang, 
     China, that investigators in four countries have identified 
     as having made the syrup--the Taixing Glycerine Factory. 
     There, under the words ``About Us,'' they would see a picture 
     of a modern white building nearly a dozen stories tall, 
     adorned by three arches at the entrance. The factory, the Web 
     site boasts, ``can strictly obey the contract and keep its 
     word.'' But like the factory's syrup, all is not as it seems.
       There are no tall buildings in Hengxiang, a country town 
     with one main road. The factory is not certified to sell any 
     medical ingredients, Chinese officials say. And it looks 
     nothing like the picture on the Internet. In reality, its 
     chemicals are mixed in a plain, one-story brick building. The 
     factory is in a walled compound, surrounded by small shops 
     and farms. In the spring, nearby fields of rape paint the 
     countryside yellow. Near the front gate, a sign over the road 
     warns, ``Beware of counterfeits.'' But it was posted by a 
     nearby noodle machine factory that appears to be worried 
     about competition. The Taixing Glycerine Factory bought its 
     diethylene glycol from the same manufacturer as Mr. Wang, the 
     former tailor, the government investigator said. From this 
     spot in China's chemical country, the 46 barrels of toxic 
     syrup began their journey, passing from company to company, 
     port to port and country to country, apparently without 
     anyone testing their contents.
       Traders should be thoroughly familiar with their suppliers, 
     United States health officials say. ``One simply does not 
     assume that what is labeled is indeed what it is,'' said Dr. 
     Murray Lumpkin, deputy commissioner for international and 
     special programs for the Food and Drug Administration. In the 
     Panama Case, names of suppliers were removed from shipping 
     documents as they passed from one entity to the next, 
     according to records and investigators. That is a practice 
     some traders use to prevent customers from bypassing them on 
     future purchases, but it also hides the provenance of the 
     product. The first distributor was the Beijing trading 
     company, CNSC Fortune Way, a unit of a state-owned business 
     that began by supplying goods and services to Chinese 
     personnel and business officials overseas.
       As China's market reach expanded, Fortune Way focused its 
     business on pharmaceutical ingredients, and in 2003, it 
     brokered the sale of the suspect syrup made by the Taixing 
     Glycerine Factory. The manufacturer's certificate of analysis 
     showed the batch to be 99.5 percent pure. Whether the Taixing 
     Glycerine Factory actually performed the test has not been 
     publicly disclosed. Original certificates of analysis should 
     be passed on to each new buyer, said Kevin J. McGlue, a board 
     member of the International Pharmaceutical Excipients 
     Council. In this case, that was not done.
       Fortune Way translated the certificate into English, 
     putting its name--not the Taixing Glycerine Factory's--at the 
     top of the document, before shipping the barrels to a second 
     trading company, this one in Barcelona. Li Can, managing 
     director at Fortune Way, said he did not remember the 
     transaction and could not comment, adding, ``There is a high 
     volume of trade.'' Upon receiving the barrels in September 
     2003, the Spanish company, Rasfer International, did not test 
     the contents, either. It copied the chemical analysis 
     provided by Fortune Way, then put its logo on it. Ascension 
     Criado, Rasfer's manager, said in an e-mail response to 
     written questions that when Fortune Way shipped the syrup, it 
     did not say who made it. Several weeks later, Rasfer shipped 
     the drums to a Panamanian broker, the Medicom Business Group. 
     ``Medicom never asked us for the name of the manufacturer,'' 
     Ms. Criado said.
       A lawyer for Medicam, Valentin Jaen, said his client was a 
     victim, too. ``They were tricked by somebody,'' Mr. Jaen 
     said. ``They operated in good faith.'' In Panama, the barrels 
     sat unused for more than two years, and officials said 
     Medicam improperly changed the expiration date on the syrup. 
     During that time, the company never tested the product. And 
     the Panamanian government, which bought the 46 barrels and 
     used them to make cold medicine, also failed to detect the 
     poison, officials said. The toxic pipeline ultimately emptied 
     into the bloodstream of people like Ernesto Osorio, a former 
     high school teacher in Panama City. He spent two months in 
     the hospital after ingesting poison cough syrup last 
     September.
       Just before Christmas, after a kidney dialysis treatment, 
     Mr. Osorio stood outside the city's big public hospital in a 
     tear-splattered shirt, describing what his life had become. 
     ``I'm not an eighth of what I used to be,'' Mr. Osorio said, 
     his partly paralyzed face hanging like a slab of meat. ``I 
     have trouble walking. Look at my face, look at my tears.'' 
     The tears, he said apologetically, were not from emotion, but 
     from nerve damage. And yet, Mr. Osorio knows he is one of the 
     lucky victims. ``They didn't know how to keep the killer out 
     of the medicine,'' he said simply.
       While the suffering in Panama was great, the potential 
     profit--at least for the Spanish trading company, Rasfer--was 
     surprisingly small. For the 46 barrels of glycerin, Rasfer 
     paid Fortune Way $9,900, then sold them to Medicom for 
     $11,322, according to records.
       Chinese authorities have not disclosed how much Fortune Way 
     and the Taixing Glycerine Factory made on their end, or how 
     much they knew about what was in the barrels.
       ``The fault has to be traced back to areas of production,'' 
     said Dr. Motta, the cardiologist in Panama who helped uncover 
     the source of the epidemic. ``This was my plea--please, this 
     thing is happening to us, make sure whoever did this down the 
     line is not doing it to Peru or Sierra Leone or some other 
     place.''


                      A Counterfeiter's Confession

       The power to prosecute the counterfeiters is now in the 
     hands of the Chinese. Last spring, the government moved 
     quickly against Mr. Wang, the former tailor who poisoned 
     Chinese residents. The authorities caught up with him at a 
     roadblock in Taizhou, a city just north of Taixing, in 
     chemical country. He was weak and sick, and he had not eaten 
     in two days. Inside his white sedan was a bankbook and cash. 
     He had fled without his wife and teenage son.
       Chinese patients were dead, a political scandal was brewing 
     and the authorities wanted answers. Mr. Wang was taken to a 
     hospital. Then, in long sessions with investigators, he gave 
     them what they wanted, explaining his scheme, how he tested 
     industrial syrup by drinking it, how he decided to use 
     diethylene glycol and how he conned pharmaceutical companies 
     into buying his syrup, according to a government official who 
     was present for his interrogation. ``He made a fortune, but 
     none of it went to his family,'' said Wang Xiaodong, a former 
     village official who knows Mr. Wang and his siblings. ``He 
     liked to gamble.''
       Mr. Wang remains in custody as the authorities decide 
     whether he should be put to death. The Qiqihar drug plant 
     that made the poisonous medicine has been closed, and five 
     employees are now being prosecuted for causing ``a serious 
     accident.'' In contrast to the Wang Guiping investigation, 
     Chinese authorities have been tentative in acknowledging 
     China's link to the Panama tragedy, which involved a state-
     owned trading company. No one in China has been charged with 
     committing the fraud that ended up killing so many in Panama.
       Sun Jing, the pharmaceutical program officer for the World 
     Health Organization in Beijing, said the health agency sent a 
     fax ``to remind the Chinese government that China should not 
     be selling poisonous products overseas.'' Ms. Sun said the 
     agency did not receive an official reply.
       Last fall, at the request of the United States--Panama has 
     no diplomatic relations with China--the State Food and Drug 
     Administration of China investigated the Taixing Glycerine 
     Factory and Fortune Way. The agency tested one batch of 
     glycerin from the factory, and found no glycerin, only 
     diethylene glycol and two other substances, a drug official 
     said. Since then, the Chinese drug administration has 
     concluded that it has no jurisdiction in the case because the 
     factory is not certified to make medicine. The agency reached 
     a similar conclusion about Fortune Way, saying that as an 
     exporter it was not engaged in the pharmaceutical business. 
     ``We did not find any evidence that either of these companies 
     had broken the law,'' said Yan Jiangying, a spokeswoman for 
     the drug administration. ``So a criminal investigation was 
     never opened.''
       A drug official said the investigation was subsequently 
     handed off to an agency that tests and certifies commercial 
     products--the General Administration of Quality Supervision, 
     Inspection and Quarantine. But the agency acted surprised to 
     learn that it was now in charge. ``What investigation?'' 
     asked Wang Jian, director of its Taixing branch. ``I'm not 
     aware of any investigation involving a glycerin factory.'' 
     Besides, Huang Tong, an investigator in that office, said, 
     ``We rarely get involved in products that are sold for 
     export. `` Wan Qigang, the legal representative for the 
     Taixing Glycerine Factory, said in an interview late last 
     year that the authorities had not questioned him about the 
     Panama poisoning, and that his company made only industrial-
     grade glycerin. ``I can tell you for certain that we have no 
     connection with Panama or Spain,'' Mr. Wan said. But in 
     recent months, the Glycerine Factory has advertised 99.5 
     percent pure glycerin on the Internet.
       Mr. Wan recently declined to answer any more questions. 
     ``If you come here as a guest, I will welcome you,'' Mr. Wan 
     said.

[[Page 11371]]

     ``But if you come again wanting to talk about this matter, I 
     will make a telephone call.'' A local government official 
     said Mr. Wan was told not to grant interviews. A five-minute 
     walk away, another manufacturer, the Taixing White Oil 
     Factory, also advertises medical glycerin on the Internet, 
     yet it, too, has no authorization to make it. The company's 
     Web site says its products have been exported to America, 
     Australia and Italy.''
       Ding Xiang, who represents the White Oil Factory, denied 
     that his company made pharmaceutical-grade glycerin, but he 
     said chemical trading companies in Beijing often called, 
     asking for it. ``They want us to mark the barrels glycerin,'' 
     Mr. Ding said in late December. ``I tell them we cannot do 
     that.'' Mr. Ding said he stopped answering calls from 
     Beijing. ``If this stuff is taken overseas and improperly 
     used. . . .'' He did not complete the thought. In chemical 
     country, product names are not always what they seem. ``The 
     only two factories in Taixing that make glycerin don't even 
     make glycerin,'' said Jiang Peng, who oversees inspections 
     and investigations in the Taixing branch of the State Food 
     and Drug Administration. ``It is a different product.''


                             All in a Name

       One lingering mystery involves the name of the product made 
     by the Taixing Glycerine Factory. The factory had called its 
     syrup ``TD'' glycerin. The letters TD were in virtually all 
     the shipping documents. What did TD mean?
       Spanish medical authorities concluded that it stood for a 
     manufacturing process. Chinese inspectors thought it was the 
     manufacturer's secret formula. But Yuan Kailin, a former 
     salesman for the factory, said he knew what the TD meant 
     because a friend and former manager of the factory, Ding 
     Yuming, had once told him. TD stood for the Chinese word 
     ``tidai'' (pronounced tee-die), said Mr. Yuan, who left his 
     job in 1998 and still lives about a mile from the factory. In 
     Chinese, tidai means substitute. A clue that might have 
     revealed the poison, the counterfeit product, was hiding in 
     plain sight. It was in the product name.

  Mr. KENNEDY. Madam President, if I could have the attention of the 
Senate, I was going to ask consent about a managers' amendment. Is it 
the intention of the Senator from North Dakota to object?
  Mr. DORGAN. Am I to be recognized for 1 minute at this point?
  Mr. COCHRAN. Madam President, point of order: What is the order?
  The PRESIDING OFFICER. The order is 2 minutes of debate equally 
divided.
  Mr. COCHRAN. One minute is consumed so that is all that remains; is 
that correct?
  The PRESIDING OFFICER. The Senator is correct.
  Mr. DORGAN. The Senator's point is I am entitled to 1 minute.
  The PRESIDING OFFICER. The Senator is entitled to 1 minute.
  Mr. KENNEDY. I yield a minute to the Senator from North Dakota.
  Mr. DORGAN. Madam President, I rise in opposition to the Cochran 
amendment. The Cochran amendment has been law since 2003. The Secretary 
cannot certify as a result of it. So it is an amendment that will void 
anything that is in the bipartisan legislation we have offered to try 
to make imported drugs, FDA-approved drugs, at a lower price available 
to American consumers. All Senator Cochran described would be dealt 
with by the safety amendments in our amendment. If his amendment 
prevails, none of the safety issues--pedigree, certification, 
anticounterfeiting--in our amendment will survive. That is the problem. 
If we stand with the American people who want lower drug prices--a safe 
drug supply, FDA approved--and believe they should not be paying the 
highest prices in the world, vote against the Cochran amendment and for 
the underlying Dorgan-Snowe amendment.
  The PRESIDING OFFICER. Under the previous order, the question is on 
agreeing to amendment No. 1010.
  Mr. KENNEDY. I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There appears to be a sufficient second.
  The clerk will call the roll.
  The legislative clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Delaware (Mr. Biden), 
the Senator from Connecticut (Mr. Dodd), the Senator from South Dakota 
(Mr. Johnson), the Senator from Illinois (Mr. Obama), the Senator from 
Rhode Island (Mr. Reed), and the Senator from Montana (Mr. Tester) are 
necessarily absent.
  Mr. LOTT. The following Senators are necessarily absent: the Senator 
from Colorado (Mr. Allard), the Senator from Kansas (Mr. Brownback), 
the Senator from Nevada (Mr. Ensign), the Senator from Oklahoma (Mr. 
Inhofe), and the Senator from Arizona (Mr. McCain).
  Further, if present and voting, the Senator from Oklahoma (Mr. 
Inhofe) would have voted ``yea.''
  The result was announced--yeas 49, nays 40, as follows:

                      [Rollcall Vote No. 151 Leg.]

                                YEAS--49

     Alexander
     Baucus
     Bayh
     Bennett
     Bond
     Bunning
     Burr
     Cantwell
     Carper
     Chambliss
     Coburn
     Cochran
     Coleman
     Corker
     Cornyn
     Crapo
     Dole
     Domenici
     Enzi
     Graham
     Gregg
     Hagel
     Hatch
     Hutchison
     Isakson
     Kennedy
     Kerry
     Kyl
     Landrieu
     Lautenberg
     Lieberman
     Lincoln
     Lugar
     Martinez
     McConnell
     Menendez
     Mikulski
     Murkowski
     Murray
     Nelson (NE)
     Roberts
     Rockefeller
     Salazar
     Specter
     Stevens
     Sununu
     Thomas
     Voinovich
     Warner

                                NAYS--40

     Akaka
     Bingaman
     Boxer
     Brown
     Byrd
     Cardin
     Casey
     Clinton
     Collins
     Conrad
     Craig
     DeMint
     Dorgan
     Durbin
     Feingold
     Feinstein
     Grassley
     Harkin
     Inouye
     Klobuchar
     Kohl
     Leahy
     Levin
     Lott
     McCaskill
     Nelson (FL)
     Pryor
     Reid
     Sanders
     Schumer
     Sessions
     Shelby
     Smith
     Snowe
     Stabenow
     Thune
     Vitter
     Webb
     Whitehouse
     Wyden

                             NOT VOTING--11

     Allard
     Biden
     Brownback
     Dodd
     Ensign
     Inhofe
     Johnson
     McCain
     Obama
     Reed
     Tester
  The amendment (No. 1010) was agreed to.
  Mr. COCHRAN. Madam President, I move to reconsider the vote, and I 
move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Madam President, I request that the next vote be a 10-
minute vote.
  The PRESIDING OFFICER. That request has been granted.


                           Amendment No. 990

  The PRESIDING OFFICER. Under the previous order, there will be 2 
minutes for debate, equally divided, on amendment No. 990, offered by 
the Senator from North Dakota, as amended.
  Who yields time?
  Since no one yields time, time will be equally charged to both sides.
  Mr. KENNEDY. Madam President, we yield back the remaining time, all 
time.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. I think we are ready to voice vote.
  The PRESIDING OFFICER. The question is on agreeing to amendment No. 
990, as amended.
  The amendment (No. 990), as amended, was agreed to.
  Mr. REID. Madam President, I move to reconsider the vote.
  Mr. NELSON of Florida. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  Mr. KENNEDY. Madam President, I ask unanimous consent that the 
managers' amendments be agreed to en bloc.
  The PRESIDING OFFICER. Is there objection?
  Mr. DORGAN. Madam President, reserving the right to object, we 
received the managers' amendment about 30 minutes ago and I am still 
reviewing some of the amendments. I object at this point.
  The PRESIDING OFFICER. Objection is heard.
  Under the previous order, there will be 2 minutes for debate equally 
divided prior to the vote on the motion to invoke cloture on the 
substitute amendment to S. 1082.
  Who yields time?
  Mr. BYRD. May we have order. May we have order.
  The PRESIDING OFFICER. The Senate will be in order.

[[Page 11372]]


  Mr. KENNEDY. Madam President, again, I thank all of the membership 
for their cooperation. We have been on this legislation for 1 week. We 
believe we have a managers' amendment which reflects the best judgment 
of Senator Enzi and myself and we will offer that at the appropriate 
time. I mentioned earlier during the debate and discussion, the essence 
of the managers' amendment. I think we probably have possibly two more 
votes that might require rollcall votes and then we would go to final 
passage. I think we have broad support for this legislation which is so 
essential if we are going to bring the FDA into the 21st century, and 
if we are going to assure safety for the prescription drugs our 
families take, insist on a safe food supply, and ensure that the FDA 
has the best in terms of science.
  I again thank my friend and colleague from Wyoming. I hope we can get 
a strong vote in favor of this bill.
  Mr. BYRD. Madam President, may we have order.
  The PRESIDING OFFICER. Could we please have order.
  Mr. BYRD. Would the Senator mind saying that again, please.
  Mr. KENNEDY. Madam President, 30 seconds. I was reminding the 
membership, as the Senator from West Virginia knows, this bill is going 
to ensure the safety of our pharmaceutical products. It is going to 
ensure the safety of our food products. It is going to insist that the 
FDA promote the latest in terms of science. We need to push the FDA 
into the 21st century, and this legislation will do it.
  The PRESIDING OFFICER. Who yields time?
  The Senator from North Dakota is recognized.
  Mr. DORGAN. Madam President, I am all for pulling or pushing the FDA 
into whatever century we determine at this point. I only pointed out 
that I wish to review some of the managers' package that deals with 
ginseng, baby turtles, tanning beds, and more, and I want a bit of 
time--and perhaps others would if they don't know these amendments 
exist--to take a look at the amendments.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Madam President, on our side of the aisle I do appreciate 
the tremendous amount of effort Senator Kennedy and his staff and many 
others on the other side of the aisle who have worked with those of us 
on this side of the aisle to get particularly the major concerns that 
were brought up during the markup in committee taken care of. There are 
tremendous amounts of things in here both sides have worked on and in 
some cases come up with a third way of doing it. I think we are on the 
right track here. The product will make a huge difference in the bill, 
and I hope we can move forward.


                             Cloture Motion

  The PRESIDING OFFICER. Under the previous order and pursuant to rule 
XXII, the Chair lays before the Senate the pending cloture motion, 
which the clerk will state.
  The assistant legislative clerk read as follows:

                             Cloture Motion

       We, the undersigned Senators, in accordance with the 
     provisions of rule XXII of the Standing Rules of the Senate, 
     hereby move to bring to a close debate on the committee 
     substitute amendment, as modified, to S. 1082, the FDA 
     Revitalization bill.
         Ted Kennedy, Dick Durbin, Byron L. Dorgan, B.A. Mikulski, 
           Patty Murray, Claire McCaskill, Amy Klobuchar, Sherrod 
           Brown, Jack Reed, Herb Kohl, Charles Schumer, 
           Christopher Dodd, Barbara Boxer, Bill Nelson, Jeff 
           Bingaman, Debbie Stabenow.

  The PRESIDING OFFICER. By unanimous consent, the mandatory quorum 
call has been waived.
  The question is, Is it the sense of the Senate that debate on the 
committee substitute amendment to S. 1082, as modified, shall be 
brought to a close?
  The yeas and nays are mandatory under the rule.
  The clerk will call the roll.
  The legislative clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Delaware (Mr. Biden), 
the Senator from Connecticut (Mr. Dodd), the Senator from South Dakota 
(Mr. Johnson), the Senator from Illinois (Mr. Obama), and the Senator 
from Montana (Mr. Tester) are necessarily absent.
  Mr. LOTT. The following Senators are necessarily absent: the Senator 
from Colorado (Mr. Allard), the Senator from Kansas (Mr. Brownback), 
the Senator from Nevada (Mr. Ensign), the Senator from Oklahoma (Mr. 
Inhofe), and the Senator from Arizona (Mr. McCain).
  Further, if present and voting, the Senator from Oklahoma (Mr. 
Inhofe) would have voted ``nay.''
  The yeas and nays resulted--yeas 82, nays 8, as follows:

                      [Rollcall Vote No. 152 Leg.]

                                YEAS--82

     Akaka
     Alexander
     Baucus
     Bayh
     Bennett
     Bingaman
     Bond
     Boxer
     Brown
     Bunning
     Burr
     Byrd
     Cantwell
     Cardin
     Carper
     Chambliss
     Clinton
     Coburn
     Cochran
     Coleman
     Collins
     Conrad
     Corker
     Cornyn
     Craig
     Crapo
     Dole
     Domenici
     Durbin
     Enzi
     Feingold
     Feinstein
     Graham
     Gregg
     Hagel
     Harkin
     Hatch
     Hutchison
     Inouye
     Isakson
     Kennedy
     Kerry
     Klobuchar
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Lott
     Lugar
     Martinez
     McCaskill
     McConnell
     Menendez
     Mikulski
     Murkowski
     Murray
     Nelson (FL)
     Nelson (NE)
     Pryor
     Reed
     Reid
     Roberts
     Rockefeller
     Salazar
     Schumer
     Sessions
     Shelby
     Smith
     Specter
     Stabenow
     Stevens
     Sununu
     Thomas
     Thune
     Voinovich
     Warner
     Whitehouse
     Wyden

                                NAYS--8

     Casey
     DeMint
     Dorgan
     Grassley
     Sanders
     Snowe
     Vitter
     Webb

                             NOT VOTING--10

     Allard
     Biden
     Brownback
     Dodd
     Ensign
     Inhofe
     Johnson
     McCain
     Obama
     Tester
  The PRESIDING OFFICER. On this question, the yeas are 82, the nays 
are 8. Three-fifths of the Senators duly chosen and sworn having voted 
in the affirmative, the motion is agreed to.
  Mr. KENNEDY. Madam President, as far as I know, on this side, I think 
we have one amendment. We are inquiring of the Senator to see whether 
it will be offered. I think Senator Enzi can speak for the other side. 
We still have to work through the managers' amendment. I want to make 
it very clear that we are glad to get into the details of all that. I 
tried to summarize the managers' amendment. It involves a great many 
ideas from our side of the aisle. So, hopefully, we will be able to 
move that process.
  I know Members want to know how we are going to proceed now through 
the afternoon. We have good attendance, and we would like to at least 
give the membership an idea about how we are going to proceed. We have 
been on this legislation now for a week, and we have made very good 
progress. I think the vote on cloture demonstrates the strong support 
for this underlying legislation.
  We would like to move this legislation in a timely way and not delay 
it needlessly. So we will inquire of our colleagues further--if they 
have amendments, hopefully, they will let us know. Hopefully, we will 
have the opportunity to deal with the managers' amendment in a timely 
way. It would be unfortunate if we did not, since we have given 
assurance to Members on both sides of the aisle and worked long and 
hard with them to try to get this through. Obviously, any Senator is 
entitled to review the managers' amendment. We are getting very close 
to the point where we are prepared to move along with this legislation. 
This would seriously compromise a lot of colleagues who voted with the 
assurance that we were going to move ahead. We are more than delighted 
to get into the description of these various amendments and explain why 
we have recommended them. I hope we will not have delay for delay's 
sake, but that we will find a way to move forward.
  The PRESIDING OFFICER. The Senator from Tennessee is recognized.
  Mr. ALEXANDER. Madam President, I ask the managers through the 
Chair--I have about a 10-minute speech on another subject I would like 
to make at an appropriate time. I don't want to

[[Page 11373]]

interfere with the progress of the bill. I ask the Chair whether now 
would be an appropriate time or whether they would like me to wait.
  Mr. KENNEDY. Madam President, I think it would be appropriate for the 
Senator to speak now. I thank him for his courtesy.
  Mr. ALEXANDER. Madam President, I ask unanimous consent to speak for 
up to 10 minutes as in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                     English: Our National Language

  Mr. ALEXANDER. Madam President, at the end of March, the U.S. Equal 
Employment Opportunity Commission sued the Salvation Army for allegedly 
discriminating against two of the Salvation Army's employees in a 
Boston-area thrift store by requiring them to speak English on the job. 
This lawsuit means that every business in America, from the shoe shop 
to Wal-Mart, will need to hire lawyers to prove it has a legitimate 
business purpose if that business wants to require employees to speak 
our national language while at work.
  I asked the chair of the EEOC in what language she holds staff 
meetings. She said, in English.
  We conduct Senate debates in English.
  Since 1906, no immigrant has been able to become an American citizen 
without first learning English. At Hillsboro High School in Nashville, 
where my daughter graduated, students speak 28 native languages, but 
classes are conducted in English.
  Federal law requires that all children in public schools be tested in 
English, and that if they do not know English, they must learn it as 
soon as possible.
  Over the last 40 years, I have voted for or supported, I believe, 
almost every civil rights or anti-discrimination law that has been 
offered. But in America, requiring English in the workplace is not 
discrimination; it is common sense. More important, it is our common 
language. Our common language helps unite the diversity in this Nation 
of immigrants.
  That is why, during the debate on immigration a year ago, the Senate 
adopted my proposals: First, to provide $500 grants to help prospective 
citizens learn basic English; second, to allow someone who becomes 
fluent in English to become a citizen after 4 years instead of 5.
  The Senate also declared English to be America's national language 
and provided that anyone illegally here must first learn English before 
gaining legal status.
  A few Senators said we were wasting our time debating national unity 
and language. But other nations are discovering just how important and 
difficult it is to unite one's country. Look at how today Turkey is 
struggling with whether to become more secular or more Muslim, 
struggling with what to do about its Kurdish minority. Germans are 
struggling to absorb Turkish workers. Italians are establishing 
agencies to help new Muslim residents ``feel Italian.'' Three alienated 
British citizens, children of Pakistani immigrants, blew up a London 
subway 2 years ago. The children of disaffected Muslim immigrants in 
France burned cars during that country's elections this weekend, a 
small echo of much larger riots 2 years ago.
  We Americans are rightly proud of our diversity. But Iraq and 
Jerusalem and the Balkans are also diverse. America's greatest 
accomplishment is not our magnificent diversity. Our greatest 
accomplishment is that we have united that diversity into one country.
  Our original national motto inscribed in the wall right above the 
Presiding Officer's chair is ``One from Many,'' not ``Many from One.''
  Most nations unite around ancestry or race, making it hard for 
newcomers. Imagine ``becoming Japanese'' or ``becoming German.'' In 
other words, the United States Constitution says race or ancestry can 
have nothing to do with someone becoming an American. Instead, American 
unity is based upon ideas, principles found in our founding documents--
such as liberty, equal opportunity, and the rule of law. New citizens 
must, therefore, pass an exam, which was recently improved, about the 
Declaration of Independence, our Constitution, and United States 
history.
  The first Europeans in America were French and Spanish, but our 
cultural beginnings and primary institutions and laws were Protestant 
and English. So English became the way Americans of many backgrounds 
communicated with one another.
  In the 20th century, according to the late president of the American 
Federation of Teachers, Albert Shanker, American common--or public--
schools were created primarily to help immigrant children learn 
arithmetic and to read and write in English with the hope that they 
would go home and teach their parents. Then, in 1906, all new citizens 
were required to know English.
  That has turned out to be a fortunate choice. English has also become 
a unifying language internationally. For example, every Chinese student 
is expected to study English. When Carlos Ghosn, who speaks several 
languages, became chief executive officer of Nissan, he began 
conducting business meetings in Nissan's Tokyo headquarters in English.
  The most fortunate children in our country are those who grow up 
learning more than one language, but American parents know that one of 
those must be English. Mastering English is how an American succeeds in 
school, in the workplace, on the computer, and in international 
affairs.
  A century ago, many American companies and private associations led 
an effort to Americanize new immigrants. They taught their employees 
English and the National Anthem. Today, the EEOC is suing the Salvation 
Army for doing the very same thing, insisting that its employees learn 
and speak this country's common language.
  According to an article that appeared today in USA Today:

       The number of charges filed with the Federal Equal 
     Employment Opportunity Commission (EEOC) alleging 
     discrimination based on such English-only policies is . . . 
     six times as large as 10 years ago, [growing] from 32 charges 
     in 1996 to about 200 in 2006.

  This is not only an astonishing waste of the EEOC's time and 
taxpayers' money--the EEOC has a backlog of 56,000 cases--but it is 
also contrary to everything we know about the importance of achieving 
unity in our country.
  Speaking English is not a punitive requirement; it is a requirement 
to help us communicate with one another. A 9-1-1 telephone call isn't 
of much help to a Chinese-speaking person if the employee answering the 
phone speaks only Spanish.
  In this case, the Salvation Army posted its requirements that 
employees in thrift stores speak English. The two employees in question 
had worked for the Salvation Army for 5 years. They were then given an 
extra year to learn English. When they didn't, they were let go.
  I intend to introduce legislation to put an end to these lawsuits by 
making it clear that requiring employees to speak English is not 
illegal discrimination as long as the policy is clearly posted.
  More than that, I can think of nothing that would be more in our 
national interest than helping anyone in our country learn our common 
language. That is why later this month, when the immigration 
legislation comes to the floor, I will introduce again my amendment 
that the Senate adopted last year giving every adult immigrant a $500 
voucher to receive English instruction and allowing those immigrants 
who want to become citizens to do that in 4 years instead of 5 if they 
become proficient--rather than just achieve a basic level--in English.
  Senator Kennedy and I have discussed the fact that there are too many 
adults eager to learn English standing in line in Boston and Nashville 
for adult learning programs. They need help learning English, and I 
hope we can rectify that soon.
  For 10 years I have suggested, most recently to Bill Gates at a 
hearing, that I would like to see established a private foundation that 
would loan $500 to any person living in this country who wants to spend 
it at an accredited

[[Page 11374]]

institution learning English, with the hope that someday that student 
would pay it back. The payoff to American unity would be worth the cost 
by itself. But I believe such a bank would eventually grow to a huge 
size funded by grateful new Americans.
  Without our common language we would be a giant Tower of Babel. It 
would be difficult for Americans to talk with one another, to debate 
political issues, and to vote. It would be harder to function as a 
democracy and to unite as one country. Without English, we would risk 
becoming just another United Nations instead of the United States of 
America.
  Madam President, I ask unanimous consent to have printed in the 
Record the article from the USA Today to which I made reference.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                     [From USA Today, May 7, 2007]

                 English-only Workplaces Spark Lawsuits

                         (By Stephanie Armour)

       Some companies are adopting policies that require employees 
     to speak only English on the job, spurring a backlash of 
     lawsuits alleging that such rules can discriminate against 
     immigrants.
       The English-only policies are coming as the number of 
     immigrants in the USA soars: Nearly 11 million residents are 
     not fluent in English, according to U.S. Census data, up from 
     6.6 million in 1990. Nearly 34 million residents are foreign-
     born, according to 2003 U.S. Census data. That's up from 24.6 
     million in 1996.
       ``This is becoming a much bigger issue,'' says Amy 
     McAndrew, an employment lawyer at Philadelphia-based Pepper 
     Hamilton. ``Employers want to have policies because of safety 
     and customer service, but they have to be careful not to be 
     discriminatory.''
       Employers may legally adopt an English-only speaking rule 
     if they can show it is a business necessity, such as the need 
     for communication with co-workers and customers or safety-
     sensitive situations where use of a common language could 
     prevent an emergency, she says.
       But Ronna Timpa, owner of Workplace ESL Solutions in 
     Henderson, Nev., says employers go too far in adopting strict 
     policies that prevent co-workers from talking in their native 
     language even during lunch.
       ``Imagine how you would feel if you couldn't speak your own 
     language in the bathroom,'' she says.
       The issue typically comes up in lower-wage and service-
     sector jobs.
       The number of charges filed with the federal Equal 
     Employment Opportunity Commission (EEOC) alleging 
     discrimination based on such English-only policies is small 
     but six times as large as 10 years ago, from 32 charges in 
     1996 to about 200 in 2006.
       ``If the rules enter work breaks, they will be difficult to 
     defend or justify,'' says Dianna Johnston, assistant legal 
     counsel with the EEOC, adding that some employers also have 
     policies requiring employees to be fluent in English.
       Employers have faced lawsuits for enforcing English-only 
     policies. In April, Flushing Manor Geriatric Center agreed to 
     pay $900,000 to settle an EEOC lawsuit based in part on the 
     company's English-only policy. The New York-based geriatric 
     center barred Haitian employees from speaking in Creole while 
     allowing other foreign languages to be spoken, according to 
     the EEOC.
       That prohibition also included that no Creole be spoken 
     during breaks, and largely affected employees who worked in 
     nursing, food service and housekeeping, the EEOC says.
       ``There was no justifiable reason when there's not a 
     specific business necessity,'' says Stella Yamada, an EEOC 
     lawyer.
       Marc Wenger, a New York-based lawyer representing the 
     geriatric center, says the EEOC characterization is 
     inaccurate and it believes its language policies are 
     consistent with EEOC guidelines. He says there was no 
     restriction on using other languages during breaks, adding 
     the consent decree was not an admission of wrongdoing.
       Some employers have extended the policy to customers, too. 
     Geno's Steaks, a Philadelphia landmark, generated a storm of 
     media and blogger attention in 2006 when its owner posted a 
     sign requesting that customers order only in English.
       At New York-based Hakia, which provides an Internet-based 
     search engine, employees who are hired must speak English, 
     and English is the language used for all business 
     communications, says President Melek Pulatkonak. Many 
     employees are immigrants who speak Turkish, German, Russian, 
     Indian, Romanian or Spanish. Employees are free to speak 
     their native language in private conversations.
       ``We have a very international team,'' Pulatkonak says. 
     ``Sometimes we have slips, and we just e-mail them back in 
     English.''

  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. HARKIN. Madam President, I wish to discuss the amendment Senator 
Roberts and I have worked on, along with Senator Kennedy and Senator 
Enzi, regarding direct-to-consumer advertising of prescription drugs. I 
am concerned about the proliferation of this kind of advertising, its 
effect on public health and health care spending, how much money we are 
spending on health care. Senator Roberts and I want to make sure they 
are done in a responsible way so that consumers have good information 
and it deals with safety and efficacy. I believe, along with Senator 
Kennedy and Senator Enzi, we have crafted an amendment that addresses 
any first amendment concerns, and I believe we have also crafted an 
amendment that will help the FDA get better safety and efficacy 
information to consumers who see these ads.
  I wish to take this time to discuss my concerns with direct-to-
consumer advertising of prescription drugs. Keep in mind, we are 
talking about ads you see on television, you hear on the radio, you see 
in newspapers and magazines for drugs that you cannot buy unless you 
get a prescription. It raises all kinds of questions. Why would you 
advertise drugs that you can't buy? I can see advertising Advil or 
Tylenol or a host of other over-the-counter-type drugs that you can go 
into a drugstore and buy, such as cold pills and antihistamines. But 
for prescription drugs, it raises an interesting question: Why would 
these drug companies be spending so much money advertising directly to 
you if you can't even buy it unless you get a prescription?
  Let's look at the history of what has happened. Information that is 
conveyed in these ads is supposed to balance risks and benefits of a 
specific drug and provide information to the public. But what we have 
seen happening over the last several years is less and less information 
and more and more promotion--ads that minimize the risks associated 
with the drugs and maximize the benefits. They are not balanced. As a 
result, in exchange for an increased market share for a drug company, 
the consumer is left with an incomplete and even a dangerous 
understanding of a drug's risks and benefits.
  More often than not, these ads do not provide consumers with accurate 
comparisons between new drugs or even older drugs that are still 
effective.
  For example, in a 2002 FDA survey of physicians, 65 percent of 
physicians thought patients were confused by the relative risks and 
benefits of drugs they saw advertised; 75 percent of the doctors 
believed the ads led patients to overestimate the efficacy of 
advertised drugs. All of this can only lead to one conclusion, that 
there is not a fair balance of risks and benefits in these ads.
  Worse still, 86 percent of physicians had a patient who asked about a 
specific drug. They didn't ask about something for their back pain or 
for allergies, they asked about a specific drug. Eighty-six percent of 
physicians said the patients asked about specific drugs. As it turns 
out, the patient usually got that drug.
  Seventy-seven percent of primary care physicians prescribed a drug a 
patient asked for; 74 percent of specialists did.
  Let's look at some of these drugs and what happened. We all know what 
happened when Vioxx, a pain reliever now associated with heart attacks, 
was pulled from the market after being heavily marketed to consumers. 
Consumers never had a clear picture of the risks and benefits 
associated with the drug. Millions of consumers were put at risk.
  One wonders how many doctors said to a patient who came in: You know, 
if Advil works for you now, you probably don't need Vioxx.
  Look what happened with Vioxx: 2 million Americans took it. It was 
marketed in 80 countries. Madam President, $100 million per year was 
spent on direct-to-consumer advertising of the prescription drug Vioxx 
over about 5 years. So about a half billion dollars was spent to tell 
you Vioxx was good for you.
  What happened? Because of all this heavy advertising, there was $2.3 
billion in sales in 2003. We all know what

[[Page 11375]]

happened. It was pulled from the market in 2004. Why? Because thousands 
of people died of heart attacks because they took Vioxx. Yet this 
product was subject to heavy direct-to-consumer advertising.
  We all remember the Vioxx ads, how good it was for you. Then we find 
out it was causing heart attacks. Again, this is a clear indication of 
the irresponsibility of these drug companies in direct-to-consumer 
advertising. It has just gotten out of hand. It has totally gotten out 
of hand.
  I will show on the next chart what I mean by getting out of hand. 
Here is the spending on direct-to-consumer advertising. Keep in mind, 
prior to 1996, we didn't have direct-to-consumer advertising very much 
on TV and radio. Pharmaceutical companies basically marketed to 
doctors. You went into the doctor's office. You saw things in the 
doctor's office. But the doctors were the ones who got the 
advertisements.
  In 1997, the FDA promulgated some rules which opened up the system. 
Then, all of a sudden, the drug companies started marketing to 
consumers. In the first year, they spent $791 million. Look what has 
happened every year. More and more and more. In 2003, $3.2 billion was 
spent on advertising. I made the chart before I got the latest figures, 
but today I got the 2005 figures. It is now $4.2 billion. Madam 
President, $4.2 billion was spent in 2005 advertising drugs you can't 
buy unless you get a prescription. Keep in mind, these are drugs for 
which you have to have a prescription. So it has gotten out of hand.
  To make matters even worse, most of this money that is spent, $4.2 
billion in 2005, was for the promotion of only 50 brand-name drugs. As 
a GAO study found out, these drugs are most often for chronic 
conditions, not for cancer--not for life-threatening diseases--but for 
chronic conditions. GAO found the ads tend to be for antihistamines, 
sleep aids, acid reflux, and--as we all know too well from watching 
evening television--things like impotence. We all know this is true. We 
know it. Look at the ads on TV every night.
  It is no coincidence these advertisements are for drugs that you must 
take repeatedly. It is so you will get hooked on a brand and then you 
have to keep taking it and taking it and taking it.
  Mr. DORGAN. Madam President, will the Senator yield for a question?
  Mr. HARKIN. I will yield.
  Mr. DORGAN. The Senator held up one or two charts dealing with Vioxx, 
a pain medicine. He is aware, I know--and I believe it was Dr. Graham 
from the FDA who testified--that somewhere around 50,000 to 75,000 
Americans died of heart attacks as a result of that drug. I know 
Senator Harkin is talking about the advertising of these drugs. That 
was a drug that was advertised as a new generation of pain killers--
distinctly different and distinctly better. Not only was that not the 
case, but it turns out that it posed a very substantial risk to tens of 
thousands of people, in the FDA's own testimony, who died.
  If I might make one additional point. The Senator is raising a 
question I have raised on the floor in the last week or so about this 
issue. You turn on the television in the morning while you are brushing 
your teeth--if you have a little television in your bathroom--and you 
are minding your own business, when a commercial comes on and says: You 
know what you ought to be doing? You ought to go to your doctor and ask 
him if the purple pill would be right for you. You don't know what the 
purple pill is, but there is a lot of advertising saying you are 
somehow unworthy if you don't go to the doctor to see if the purple 
pill isn't right for you because life would be a lot better if you were 
taking the purple pill.
  That is the way this advertising goes. You can only get these drugs 
by a doctor's prescription. Yet the television set is giving us all 
this advertising from a pharmaceutical industry saying: You know what 
you need to do, you need to ask your doctor if you shouldn't be taking 
more prescription drugs. Maybe a green pill, maybe a purple pill, but 
life will be better if you would do this.
  The reason I wanted you to yield, is that doctors are saying that 
what they are finding in their offices these days is patients are 
coming in and the patients are saying: Here is the medicine I want 
because I saw it on television. Obviously, the doctors aren't happy 
about that because they are the ones who should be diagnosing and 
prescribing.
  I wanted to make the point that I think your presentation is right. I 
think there are only two countries in the world, us and New Zealand, 
that allow virtually unrestricted, complete public advertising on 
prescription drugs that can only be prescribed by doctors.
  Mr. HARKIN. The GAO did this study which found that 86 percent of 
physicians responded that patients came in to ask about a specific 
drug--the purple pill, the green pill. You might say: Why are the 
doctors doing it? One doctor said to me: You are right. They shouldn't 
be advertising this. Patients coming in would be just as well served by 
taking an aspirin or something like that, very cheap and readily 
available, and I tell them that. The doctor is telling me this. I tell 
them that, and they say, no, no, they saw this ad. They want this. I 
tell them no, but they say: Well, Doctor, if it is all the same with 
you, I would just as soon have that pill. So he says: Well, if you want 
it, I will prescribe it.
  So there is an undue amount of pressure being put on doctors right 
now to prescribe these drugs because patients are demanding it.
  Mr. DORGAN. It is the case with this advertising that if you take 
this purple drug, you know, you will be riding in a convertible, 
perhaps through a beautiful meadow, where the Sun is shining and the 
birds are singing and life is wonderful. Why? Because you took the 
purple drug. And by the way, go ask the doctor if you shouldn't have 
some of this.
  The Senator is raising a very important question, especially about 
the dramatic growth in direct-to-consumer advertising about a product 
that can only be achieved through a prescription by a doctor.
  Mr. HARKIN. Well, I thank the Senator for his great leadership in all 
these areas on drugs, on reimportation, which I was proud to support 
him on. We have to get a handle on this.
  We all have first amendment concerns. People have the right to 
advertise, but I question whether they can advertise in a way, like 
with Vioxx, where they tell you all the benefits, but they do not tell 
you the risks, or they put them in such little fine print that it takes 
a 50-power magnifying glass to read them.
  On television, how many of you have seen the ads where they come on 
with this wonderful advertisement of a drug, and then in the end it 
says: Not to be taken by, and it goes so fast you can't understand what 
they are saying. It is akin to listening to an auctioneer. You can't 
understand what they are saying. So you see all the benefits of it, but 
you don't get any of the downsides.
  One might ask: Why are companies doing it? Well, simple. They make 
money. The Kaiser Family Foundation found an additional $4.20 in 
savings for every dollar spent on advertising. There you go. If you 
could spend a dollar and make $4.20, who wouldn't?
  So we have to ask some questions. What happens when we create an 
artificial demand? What is the effect on our budget? Some people might 
say: Well, that is OK, but people are spending their own money or the 
insurance company is. That is not so. Think of all the money we are 
spending on Medicare and Medicaid for these drugs that people are being 
beaten over the head with every day on these ads on television. Think 
about the baby boomers retiring.
  I said that by 2005 the spending had gone to $4.2 billion. Think of 
what it is going to be this year. I will bet it will be over $5 billion 
this year, spent on advertising alone, for drugs you can't buy unless 
you get a prescription. So it is clear to me it has very little to do 
with patient care and very much to do with making money. I don't mind 
drug companies making money. That is fine. They do good things. They 
invest money in research--not as much as I wish they would--and they 
come up with good drugs. We all take them when we get sick or when we 
have a

[[Page 11376]]

disease. The problem is it has gotten out of hand.
  It was OK when they did a little bit of advertising, but now it has 
gotten out of hand. It has gotten to the point now where an individual 
from a drug company--I will not mention who--said to me: Well, yes, you 
want to turn the clock back to 1996, when we didn't advertise much on 
TV. He said: That would be nice, but you could never get it done 
because not everyone would agree. Because, you see, the big drug 
companies, the big ones that have some major portion of these 50 drugs 
that are basically the ones being advertised, they have got the power. 
The little drug companies out there, which may have good drugs for you, 
lifesaving drugs and things such as that, they have to get in the game 
too. They have to compete. So it keeps ratcheting itself up every year. 
Every year it ratchets itself up with more and more advertising.
  Before I yield the floor, I wish to review a little bit the history, 
so we are clear on how we got to this point. In 1962, Congress gave the 
FDA the authority to regulate prescription drug advertising which, at 
that point, in 1962, consisted of ads in medical journals. Regulations 
followed from the FDA, after 1962, which required that all drug ads 
include ``a brief summary statement that discloses all the drug's known 
risks.'' That was done, and all the medical journals, whenever the drug 
company would put an ad in a medical journal about the benefits of the 
drug, they had to include, and they did include--they were very 
responsible for a long time--all the known risks. After all, they were 
advertising to doctors, people who were knowledgeable in the field.
  Until 1997, there was no real guidance beyond that as to what was 
required. Today, based on guidance that was finalized in 1999, an ad 
sponsor is only required to disclose ``the most important risks'' in a 
``major statement'' in the audio portion of a TV or radio ad. The FDA 
does not require that all risks be read in the ad.
  Think about that. You can tout all the wonderful benefits, but you 
don't have to tell what all the risks are. The FDA requires that an ad 
sponsor provide other places to find the list of all the risks. So you 
could have an ad on TV tell you Vioxx is great--there may be a problem 
with irregular heartbeat, maybe--but if you want to know all the known 
risks, you can call this toll-free number or you can go to a health 
care provider and ask your doctor or print ads.
  As I said earlier, it can be very easy for a statement about risks 
and benefits to get lost in the creative content of the ads. It is no 
wonder consumers demand newer drugs from their doctors. They don't have 
a clear idea of the true safety or the efficacy profile. Over time, it 
has become clear that sometimes the creative content of the drug ads 
has the effect of minimizing the safety profile of a drug while 
artificially spurring the demand.
  I have one other chart I wish to show. This ad right here. Here is an 
ad for Cialis. If you have ever watched television in the evening in 
the last several months, you have seen this ad. You could have seen it 
in the last few weeks. It seems like I can't turn on the TV that I 
don't see this ad, so I put it on a chart in case someone might have 
missed it. It is talking about Cialis. It has this wonderful scene at 
the end, with a woman in a bathtub, a man in a bathtub, and a beautiful 
valley scene--maybe Napa Valley, I don't know where it is--and they 
say: If a relaxing moment turns into the right moment, will you be 
ready?
  While this is on the screen and you are looking at this beautiful 
scene and thinking how wonderful it is, they come on and give you a 
couple of known risks. Are you going to listen to that? Or are you 
paying attention to how wonderful Cialis is for you?
  This is another example of the amount of money being put into 
advertising. This is not a drug preventing a disease someone might 
have. It is not for a life-threatening disease or anything like that. 
Not at all. Yet that is where the money is going. That is what the 
problem is with a lot of these ads.
  What our amendment does is it tries to fix some of these problems and 
to help the FDA and the companies to provide better information so that 
consumers can make real choices, not a choice based on a movie 
endorsement or a slick advertisement. So our amendment does four 
things:
  First, the 2-year moratorium on direct-to-consumer advertisements 
found in the underlying bill is dropped. While I believe this provision 
is constitutional, I understand and respect the concerns others have on 
this point.
  Secondly, in the underlying bill, every ad may be prereviewed by the 
FDA. In this amendment, as part of that process, the FDA may require 
specific safety information in the content of an advertisement as part 
of a risk evaluation and mitigation strategy. In addition, the company 
must include any changes the FDA requests about a serious risk in the 
content of the ad or they are subject to civil penalties.
  Third, civil monetary penalties can be assessed against a company for 
an ad that is false and misleading in the way it presents its safety 
and efficacy information.
  Fourth, the major statement relating to side effects, 
contraindications, and effectiveness that is included in every TV and 
radio ad must now be stated--and get this--in a clear, conspicuous, and 
neutral manner. A clear, conspicuous, and neutral manner.
  Hopefully, this will clarify the major statement about risk and 
benefits, which is paramount, and that the creative wonderful scenery 
will not distract from it. I think it is a good compromise. It is a 
step in the right direction. Hopefully, we will get the bill through, 
this will be a part of it, and we will see if the drug companies want 
to be responsible.
  We don't need to spend $5 billion a year advertising for drugs for 
which you have to get a prescription. I would rather they put that 
money into research, research on drugs that really are lifesaving and 
helpful to more people.
  I hope this amendment will be accepted. As I said, it is a 
compromise, obviously. It is not everything I wanted to do, but I 
think, again, it is a step in the right direction, and it will give us 
a yardstick. If, a couple of years from now, we see that the spending 
has gone from $4.2 billion to $5 billion to $5.5 billion to $6 billion, 
then we will really have to come back here and tighten down on it even 
more.
  This is a shot across the bow to the drug companies--rein it in, be 
responsible, or tougher things are coming in the future. So it is 
really up to the drug companies to now start to be responsible. It is 
up to FDA to use their authority to make sure the contraindications, 
the safety measures, the drug interactions--all the things that may 
happen to people--are presented in a clear, conspicuous, and balanced 
and fair manner. That is the essence of the amendment. I hope it will 
be adopted.
  I yield the floor.
  The PRESIDING OFFICER (Ms. Stabenow). The Senator from South Dakota.
  Mr. THUNE. Madam President, one of the biggest drivers of health care 
costs today is the cost of prescription drugs. This debate over 
reauthorization of the FDA has given us an opportunity to really home 
in on some of the reasons for those high costs of prescription drugs. 
We say we spend somewhere around $2.2 trillion on health care today or 
about 16 or 17 percent of our gross domestic product. Of that amount, 
about 15 to 20 percent of what we spend on health care is for 
prescription drugs. It is an enormous industry in this country.
  Frankly, some remarkable things have happened. We have wonderful 
therapies that have prolonged life, have improved the quality of life, 
and for that we can be grateful to those companies which are investing 
in the research and development that is necessary to bring these types 
of new therapies and drugs onto the market.
  At the same time, we have to be very concerned about the cost of 
these things. Everybody has to be concerned about that. The taxpayers, 
who underwrite the cost of Medicare and Medicaid, which is a big part 
of the cost of health care in this country, have a stake in this 
debate, as does every consumer who, for prescription drugs--

[[Page 11377]]

whenever they are diagnosed with something and a doctor prescribes a 
certain medication, a certain drug, and they have to go get it, 
obviously that cost is borne by them as consumers and by their health 
care provider, their insurer. Everybody has a stake in the cost of 
prescription drugs and doing everything we can to lower their costs, to 
make them more affordable to average people in this country.
  We have an amendment, the Stabenow-Thune-Brown-Lott amendment having 
to do with citizen petitions, which was just debated. It has been 
debated. It is under consideration as part of the managers' amendment. 
I thank the managers, Senators Kennedy and Enzi, for giving us an 
opportunity to perhaps have it included in the managers' amendment. I 
think this is an important amendment, one that addresses the issue we 
are talking about today, the high cost of prescription drugs.
  The amendment will reduce the filing of frivolous ``citizen 
petitions'' that delay entry of generic drugs to the market and 
unnecessarily increase drug costs for both taxpayers and consumers. My 
colleague from Michigan, the distinguished Presiding Officer, has 
discussed this earlier.
  A citizen petition is intended to be just that--it is a petition that 
is filed by an individual or a group in order to raise potential 
concerns. If you look at what has happened with that, that process has 
been abused. You can see that even from what the FDA Chief Counsel has 
said about this process:

       These petitions appear designed not to raise timely 
     concerns with respect to the legality or scientific soundness 
     of approving a drug application, but rather to delay 
     approval.

  What has happened in this process is it has become hijacked and is 
being used for purposes for which it was not intended.
  Under current FDA regulations, the simple act of filing a petition, 
no matter how meritorious or frivolous that petition may be, 
automatically delays the approval of a generic drug. Under current 
regulations, there is no risk or cost associated with filing a citizen 
petition. Yet the benefit to a brand-name company in maintaining their 
market share for even a few months is enormous.
  I want to show another chart which I think further defines why there 
is so much advantage for a company to use this process in a frivolous 
way, to delay the introduction of generic drugs into the marketplace. 
Take Flonase, for example. The delay caused by using the citizen 
petition was 645 days. During that period, the additional sales that 
were generated were over $1 billion--$1.6 billion. If you look at 
DuoNeb, another drug, 420 days' delay yielded $262.5 million additional 
revenue generated during that delay period.
  The amendment will allow the FDA to verify that citizen petitions are 
legitimate by requiring applicants to verify that they have not 
received compensation from another organization to file such a 
petition. It will also prohibit delays of generic drug approvals unless 
the FDA determines within the first 25 days that a petition is filed 
that the petition raises a genuine public health concern. This 
amendment helps to remove the incentive for drug companies to file 
unnecessary or illegitimate citizen petitions.
  Even the FDA has said the citizen petition process is inefficient and 
is often abused by pharmaceutical companies. This is troubling to me 
because the rising cost of prescription drugs is one of the largest 
drivers, as I said earlier, of health care costs in our country today. 
These costs contribute directly to the rising cost of health insurance 
premiums for families and small businesses and the cost to all 
taxpayers for what we pay for Medicare and Medicaid.
  As a Member of the House of Representatives in 2002, I sponsored 
legislation that would help speed access to lower cost generics. Back 
then, one of the major issues of concern to Congress and consumers was 
the automatic 30-month stay brand-name companies could request whenever 
a challenge was raised to the patent. FDA regulations at the time 
essentially allowed a pharmaceutical company to ask the FDA for an 
unlimited number of 30-month stays as generics sought entry into the 
market, effectively delaying their approval. Now we are looking at yet 
another loophole the industry has found to delay access to lower cost 
generic drugs.
  Access to generic drugs is one crucial part of the solution to 
controlling prescription drug costs. As I said earlier, in overall 
health care costs, what continues to increase over time is the cost of 
prescription drugs. As I said earlier, there are also some wonderful 
therapies, some medications that were brought onto the market that are 
doing remarkable things for health care in this country. But there is 
also a long period where drug companies that develop these types of 
medications and therapies have the exclusive right to market those. 
During that period, they have an opportunity to recover the cost of the 
research and development that goes into that particular drug. But there 
is a point at which that period comes to an end. When that period comes 
to an end and it is opened to competition, then other generic drug 
manufacturers can enter the marketplace. What you generally see happen 
is drug costs go down dramatically when competition takes hold.
  I am a big believer in the market. The market works when there is 
competition. What we will need, if we want to do something about the 
high cost of prescription drugs and the impact they are having in 
driving health care costs in this country, is to create more 
competition in the marketplace.
  What this particular loophole does, the citizen petition loophole, is 
it allows drug companies to take advantage and in a frivolous way use 
something that was intended for legitimate purposes; that is, to allow 
citizens to challenge this process, to extend the period in which they 
can continue to exclusively market a drug to the tune literally of 
billions and billions of dollars of additional cost. That is wrong.
  The amendment we have introduced--the Senator from Michigan, Senator 
Stabenow, Senator Brown, Senator Lott, myself--would simply bring some 
clarity to this and make sure, when the FDA has an opportunity to 
determine, to take a look at these citizen petitions, that petition 
does, in fact, raise a genuine public health concern. I believe this 
amendment will help remove the incentive drug companies have to file 
unnecessary or illegitimate citizen petitions in order to continue to 
reap some of these profits and take advantage of a loophole that exists 
today that needs to be closed.
  I hope the managers of the bill, those who have been working with us 
throughout the course of this process, will find their way to accept 
this amendment into the managers' package, allow it to be adopted as 
part of the FDA reauthorization and to do something that in a very 
significant and meaningful way will address what is a serious problem 
in America today; that is, the high cost of health care which is 
driving more and more people into the ranks of the uninsured, becoming 
a higher cost and burden on small businesses, and, as I said earlier, a 
big component of that cost of health care is the cost of prescription 
drugs.
  I think this amendment, along with others we have debated here today 
as well--and I happen to support allowing for the reimportation of 
drugs from Canada and Europe and places such as that, which will help 
bring drug costs down in this country--these things will all add 
competition to the marketplace. Competition drives down costs, it 
drives down costs for consumers, it drives down costs for taxpayers. 
That is a good thing. This particular amendment closes a loophole that 
needs to be closed that will bring about lower costs for consumers in 
this country.
  I thank the sponsors and the managers of the legislation for their 
cooperation and willingness to work with us, and I hope in the end we 
can have this amendment adopted and do something that is serious and 
meaningful in terms of eliminating unnecessary delays in allowing for 
generic drug approvals, getting them into the marketplace, and driving 
down the cost of prescription drugs.
  I yield the floor.

[[Page 11378]]

  The PRESIDING OFFICER. The Senator from North Dakota is recognized.
  Mr. DORGAN. Madam President, I have been trying to review the 
managers' package, as I indicated before. I read a number of the 
provisions. The one on domestic pet turtles--I looked that over. I 
guess I don't have an issue with that. Ginseng is all right. Tanning 
beds--we have a number of amendments, some small, some large, some 
important, some perhaps not. I have looked through them.
  I do think there a couple that ought to be added. I noticed in the 
managers' amendment that there is a note that there is additional 
language coming on several of them. I don't know what that would be.
  I suggested two additions to the managers' package that I hope will 
be considered. One is country-of-origin labeling with respect to 
prescription drugs:

       Any prescription drug dispensed in the United States shall 
     affix on each dispenser or container of the prescription drug 
     a label that includes the country in which the drug was 
     manufactured.

  The reason for that is there has been an assertion here that somehow 
the importation of prescription drugs would be unsafe because it comes 
from another country. In fact, a substantial portion of our 
prescription drugs comes from other countries. It would probably be 
useful for consumers to know that. I do not suggest they know that 
because it is apparently unsafe, as some seem to suggest with 
reimportation, but nonetheless I think that would be a useful thing.
  The second is the Secretary shall certify prior to the approval for 
marketing any new prescription drug that the approval of such drug 
poses ``no additional risk to the public health and safety,'' which is 
the identical provision in the Cochran amendment dealing with 
reimportation of prescription drugs. I would provide the same 
requirement for the new prescription drugs that are approved for use in 
this country.
  These are at least, to the extent there is validity in the Cochran 
amendment, as judged at least by a small majority of the Members of the 
Senate today--to the extent there is validity in that, it seems to me 
there might be some use for some consistency, and the consistency would 
be we would want to be able to have the same approval process with 
respect to no substantial risk from new drugs as they are suggesting 
would be the case when a U.S. consumer is trying to purchase a 
prescription drug, FDA approved prescription drug from another country.
  The second, the country-of-origin labeling just makes sense to me 
inasmuch as every time we debate this subject, we have people implying 
that there is something inherently unsafe about importing a 
prescription drug from another country. As I have indicated time and 
time again, they do this routinely in Europe and have done it for 20 
years. If you are in Italy and you want to buy a prescription drug in 
Spain or if you are in Germany and you want to buy a prescription drug 
in France, there is no problem. There is something called parallel 
trading, and you can easily, as a consumer, access the best price on 
that approved drug.
  It is just, if they can do it in Europe, we are told by our 
colleagues we do not have the capability or the wherewithal or the 
knowledge or whatever to be able to do it in our country.
  That, of course, I think, seriously shortchanges the ability of the 
American people to develop a system that the Europeans have used for 20 
years, a system that would help consumers. It would allow the global 
economy to work for consumers. Maybe the little guy ought to have a 
shot at accessing the benefits of the global economy.
  So I think both of those amendments have merit. I would ask that 
those who are working on the managers' amendment consider adding these 
two amendments to the managers' package. I hope between now and perhaps 
tomorrow, over either supper or breakfast, they might have some sort of 
an epiphany and believe that consistency is a virtue in the Senate, and 
as a matter of consistency include both of these amendments in the 
managers' amendment.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from New Hampshire.


                           Amendment No. 993

  Mr. GREGG. Madam President, I appreciate the Senator from Ohio who 
was going to move to morning business by giving me a little respite and 
let me speak.
  I rise relative to the amendment I have offered on this bill, which 
is the effort to try to protect people who purchase pharmaceuticals 
from Internet pharmacies. This is a major concern today. In fact, just 
last week I entered into the Record that the FDA reported they had 
identified 24 different Internet pharmaceutical sites that appeared to 
be selling adulterated drugs to people. At least in three instances 
they were selling adulterated drugs which came in packages that had a 
lot number on them, they had an expiration number on them, and they 
looked exactly like the drugs the individual would have bought had they 
bought them through a pharmacy in the United States.
  But it turned out those drugs, when they were opened by the FDA and 
tested by the producer of these pharmaceutical products, were 
adulterated, and in some instances the adulterated drugs could have 
caused severe harm to the person had they taken those drugs. In other 
instances, the drugs were simply sugar. They had no chemical compound 
in them.
  We have had a lot of instances of this occurring. The FDA has 
literally hundreds of instances of people purchasing drugs over the 
Internet sites which come in from international locations, which the 
FDA has no jurisdiction over. When the person received those drugs, 
they took them and they were harmed. In several instances, death has 
actually occurred as a result.
  So what I think is important is that we create a system where, when 
somebody uses the Internet--because everybody uses the Internet today, 
or just about everyone uses the Internet--to purchase the 
pharmaceutical product, that they be able to be fairly confident, in 
fact very confident, in fact assured that product is FDA approved.
  This is doable. This is not an impossible exercise. This capacity to 
make Internet pharmaceutical sites subject to FDA oversight and give 
consumers the information they need in order to ensure that the 
pharmaceutical site is FDA approved is a very doable event. That is 
what my amendment creates.
  Essentially what it will say is that the FDA will receive the 
resources necessary to be able to inspect and review and manage and 
overview Internet pharmaceutical sites after they have put an Internet 
pharmaceutical site through the system of testing and make sure that 
site first has responsibility in the United States, so that they are 
not in Russia or Albania or Pakistan or someplace and can't be reached 
if they do harm by selling an adulterated drug to an American citizen, 
that that site has a bonded individual in the United States who is 
responsible for actions taken by that site in selling products in the 
United States.
  Second, that the products that are sold through that site are FDA 
approved and have a review process which assures that they have been 
FDA approved. At that point the FDA will put a tamperproof recognition 
symbol on that site so that a person who goes on the Internet and looks 
up a pharmaceutical site will immediately see this tamperproof 
identification that it has been FDA approved, sort of like in the old 
days when you used to have the Good Housekeeping seal of approval on a 
product. That is what this will do so that an American citizen buying 
through an Internet site will know that the product coming through that 
site is FDA approved, that it is what they say it is, what the 
pharmaceutical site says it is. This is a step which needs to be taken, 
obviously, in order to assure that American consumers are safe.
  As we see, American consumers are more and more going to the Internet 
for purposes of buying their products. Now, regrettably, some fairly 
large pharmaceutical--not pharmaceutical companies but some fairly 
large drug retail companies which run Internet sites in most instances 
have reservations about this language because they

[[Page 11379]]

are concerned about the fee system which is set up to pay for it. I can 
understand that. I am willing to look at ways of addressing that so 
that we can alleviate, to some degree, their concern.
  But the simple fact is, you have to come up with a system which 
assures that resources are available for the FDA to be able to go out 
and monitor these sites. It should be a consumer-producer retail sales-
fee system so that the people who are taking advantage of this site and 
the people who are benefiting from the site, both economically and 
through purchasing the product, are essentially bearing the cost of 
making sure the FDA has the resources necessary to monitor the site.
  That is a reasonable approach. It is something we do on most issues 
of this type. So there is a fee system in this proposal which would 
basically pay for the resources necessary and give the FDA the support 
it needs financially so that it can expand its review process to cover 
these pharmaceutical products which are being sold over the Internet. 
This is a step we have to take. This is not something where we can sort 
of bury our heads in the sand and say, well, we are just going to let 
this happen. We are going to let these sites continue to function, and 
we are going to ignore their existence because more and more Americans 
are moving to this process of purchasing drugs.
  You cannot have, in the United States, two different streams of 
supply of pharmaceuticals for American citizens: one which is 
absolutely safe and when American citizens are purchasing that product 
they are sure that it is not going to harm them; and, two, where they 
are basically rolling the dice, playing Russian roulette with what they 
purchase when they use an Internet site but thinking they are actually 
purchasing something that is claimed to be the medication they need.
  You cannot do that and claim we have a safe and efficient system, a 
safe system which has efficacy in the quality of the drugs and have 
those drugs be safe when they are delivered to the consumer. We cannot 
have two different systems and still make that claim. We are basically 
undermining one of our great strengths as a culture, which is that we 
have a very strong system for protecting the food that Americans eat 
and the drugs America uses.
  So it is critical that we face up to this very significant problem we 
have, which is that the Internet pharmacy situation is basically a 
``wild west'' of supply. Nobody knows what they are getting. Well, they 
think they know what they are getting, but nobody actually knows what 
they are getting. They can be harmed as a result. So I believe this 
proposal is a reasoned proposal. It is one I hope we will take a hard 
look at as a Congress because I believe it is our responsibility. This 
is an area where the Federal Government has chosen to legislate and has 
done quite well over the years, FDA proposals dealing with the safety 
of drugs and food in our country and in our supply chain. We have a lot 
of history. We can take considerable pride in it. But the market has 
changed. We need to change the process by which we review the quality 
of the drugs as they come through this new market structure, which is 
called the Internet. This is not a partisan or political issue. This is 
just a question of how we substantially improve FDA's capacity on 
oversight of the delivery of drugs to the American citizen.
  So it should, I hope, be accepted at some point. I understand it is 
going to be opposed, regrettably, by the other side of the aisle. This 
makes no sense to me. I think it has something to do with the fee 
system that is in place and the fact that the large drug delivery 
companies in this country are opposed to this type of system. But as I 
stated, this is negotiable. There should be some way to deal with that.
  But, in any event, at some point I hope we face up to the reality of 
needing this type of an amendment and giving the FDA this type of 
authority. At this point I am not going to ask for a vote on the 
amendment. I may before we move to final passage. But I am also 
considering other approaches to getting this type of language 
considered.
  I will review the situation as we go down the road. But I did want to 
speak tonight to outline again the need for this type of protection. As 
I said, just last week the FDA sent out a warning, actual warning to 
American consumers, that said: Do not use these 24 Internet sites 
because we cannot tell you that the drugs you purchase over these sites 
are going to be safe, that they are going to be what they say they are. 
In fact, we can tell you in these three incidents that they were not.
  That means people were put at risk by purchasing drugs from these 
sites. So we need to give the FDA this authority, and hopefully we 
will. If not now, at least before this bill completes the whole process 
and comes back from the conference committee.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Ohio is recognized.
  Mr. BROWN. Madam President, I have a few comments on this afternoon's 
proceedings. I was disappointed, as I know many in the Chamber were, in 
the passage of the Cochran amendment and what that means to the price 
of prescription drugs.
  An awful lot of us believed--those of us running for election last 
fall, those of us who were just observers of the American political 
scene--understand that the drug industry has had way too much influence 
in the Senate and the House and particularly the White House in the 
last many years.
  Many of us talked about reimportation of prescription drugs, 
particularly from Canada. Many of us--I know the Presiding Officer has 
done this. I have, from my Northeastern Ohio Congressional District 
before I was elected to the Senate last fall, taken busloads of senior 
citizens to Canada to buy less expensive but identical--same drugs, 
same dosage, same packaging, same manufacturing,--drugs in Canadian 
drugstores.
  We all thought that it made no sense for Americans to leave our 
country to buy drugs, often made in the United States, but certainly 
drugs that are safe as those at a drugstore in Elyria, Ashtabula or 
Toledo or Dayton.
  Many of us were disappointed at the passage of the Cochran amendment, 
which is what the drug companies wanted, and what again stands in the 
way of direct reimportation so that American seniors and other 
Americans could get less expensive drugs. There is simply no reason the 
Canadian drugs--that our drugs should cost two, three, four times what 
people pay for the same drug, same manufacturer, same dosage, the same 
packaging in Canada.
  I am intrigued by Senator Dorgan's idea of country-of-origin labeling 
on prescription drugs. We know, for example, that a doctor prescribes 
Lipitor, and the patient buys Lipitor; that these actual drugs were 
manufactured--that medicine was manufactured in Ireland. We do not seem 
to think there is anything wrong with that. So it makes sense to me to 
put on country-of-origin labeling because then Americans would see that 
these drugs, whether they are made in Ireland, whether they are made in 
Canada, whether they are made in Germany, whether they are made in the 
UK, whether they are made in the United States, that because of the FDA 
we know those drugs are safe in our country. We know they are safe if 
they are coming from Britain or Ireland or Canada.
  I am intrigued by Senator Dorgan's idea. I also, for a moment, wanted 
to speak on the amendment that the Presiding Officer has led the charge 
on with Senator Thune and with Senator Lott and myself, on the citizen 
petition issue. That, I understand, is in the managers' amendment. I am 
hopeful that will become part of this bill as it moves through the 
process.
  We know of abuse of the citizen petition process. We know that while, 
of course, we want to protect peoples' rights in this country to 
petition their Government always, we also note the drug companies have 
gamed that system, turned that system to their advantage and used that 
petition process to block the generics getting on the market.

[[Page 11380]]

  We know the drug companies will do darn near anything to get their 
way, to keep their prices higher. It is the most profitable industry in 
the country--return on investment, return on sales, return on equity--
for almost a generation, almost every year except for when the oil 
industry does slightly better than the pharmaceutical industry. We know 
they will try almost anything.
  But Senator Stabenow's work on this issue and this amendment will 
draw a balance so that citizen petition rights are protected, that 
consumers are protected, which will mean generics are earlier to 
market, safe generics, identical generics that will mean lower prices 
for our consumers.
  I am hopeful we can get this bill in better shape than it has been. I 
appreciate particularly the efforts of Senator Dorgan on reimportation.


                        BIOEQUIVALENCE STANDARDS

  Mr. HATCH. I rise to speak about the amendment I offered to S. 1082 
on antibiotics access and innovation. My amendment is supported by the 
Infectious Diseases Society of America, IDSA, the Alliance for Aging 
Research, the National Organization of Rare Disorders, and the Immune 
Deficiency Foundation. It is intended to take initial steps to address 
the important issue of drug resistant microorganisms and the need for 
new antibiotics. Senate Health, Education, Labor, and Pensions 
Committee Chairman Ted Kennedy and its Ranking Member Mike Enzi have 
worked with me on the provision as well as Senators Burr, Brown, and 
Cochran. I appreciate all their efforts to address this important issue 
and am pleased that we have reached an agreement on language to include 
in S. 1082.
  Mr. KENNEDY. I want to thank the Senator from Utah for introducing 
this important amendment. I am concerned with the alarming increase in 
the number of drug-resistant infections. Physicians from Massachusetts 
have written me in support of this amendment saying that patients are 
routinely lost to infections caused by resistant bacteria for which we 
have few to no options. I appreciate the efforts of infectious disease 
experts from the Infectious Diseases Society of America to raise these 
concerns and propose solutions.
  Mr. HATCH. Senator Kennedy has always been a leader in public health 
issues and I appreciate the efforts of him and his staff to address 
this important matter. However, I am concerned one provision of my 
amendment that was not included which deals with bioequivalence 
standards for locally-acting non-absorbed drugs. In the amendment I 
filed for Committee, I had asked for the Food and Drug Administration 
to establish a new bioequivalence standard for these drugs through a 
guidance allowing for transparency and a public process. The underlying 
bill deals with drug safety and although I am a supporter of the 
generic drug industry, I want to ensure that their bioequivalence 
standards are based on science--we need to ensure that FDA is applying 
high scientific standards and allowing for public input when these 
standards are developed by the Office of Generic Drugs.
  Mr. BROWN. I appreciate his leadership on this matter and want to 
work with him to ensure that we exercise appropriate oversight over FDA 
and hold the agency, and in this case, the Office of Generic Drugs, 
accountable for its decisions. I also appreciate working with him and 
other members of the HELP Committee on the issue of antimicrobial 
resistance. So my question is, isn't this a public health crisis that 
requires immediate action?
  Mr. HATCH. Yes, it is. I appreciate the remarks of the Senator from 
Ohio. I yield to the Senator from Mississippi.
  Mr. COCHRAN. I want to thank the Senator from Utah for his leadership 
on this issue. I have been working on this issue of FDA standard 
setting and process for bioequivalence standards for almost a year now. 
We have not yet had resolution to concerns regarding bioequivalence 
standards and I had hoped to include language in this bill requiring 
FDA to engage in a process to inform the public of a change in 
standard, explain their scientific rationale, and allow for public 
input before a new standard is implemented. I understand we have agreed 
to continue to work with FDA on this issue and defer including the 
provision in this bill. I am hopeful that we can address these concerns 
through our continued work with the FDA. However, I think we all 
understand that if FDA does not sufficiently answer our questions, 
Congress will revisit this issue.
  Mr. HATCH. I thank the Senator from Mississippi for his leadership on 
this matter. I agree that we need to pursue this further if we don't 
get good answers from the FDA. The agency's lack of a response is a big 
concern to me.
  I might also add that your health advisor, Leigh Ann Ross, who is a 
pharmacist, has been very helpful in explaining the issues of 
pharmaceutical science at issue here. I also want to acknowledge the 
work of my colleague from Massachusetts who has shown great leadership 
here and his dedicated staffer, David Dorsey, who has worked tirelessly 
on this entire bill and this issue in particular. I also appreciate the 
hard work of Senator Enzi's staff person, David Schmickel, who has made 
great efforts to reach an agreement on this issue. We would not have 
been able to reach this point without Senator Kennedy's and Senator 
Enzi's leadership on the entire bill.
  In addition, I would like to acknowledge Senator Brown's health 
staffer, Ellie Dehoney, who has made valuable contributions to this 
discussion.
  Mr. ENZI. Would the Senator yield for a moment? I want to commend 
Senator Hatch for raising this issue of antimicrobial resistance and 
the need for innovation. The problem that the Senator is addressing 
here is a real threat to public health. The Director of the CDC reports 
that more than 63,000 patients in the United States die every year from 
hospital-acquired, antibiotic resistant infections. Although I strongly 
support this amendment as it is an excellent first step, a 
comprehensive response is needed. I hope we can continue to address the 
broader issue within the Committee this Congress. I also agree that we 
need to continue to work with FDA on this issue of accountability and 
look forward to working with the Chairman and other members of the 
Senate on this issue.
  Mr. HATCH. I thank the Senator. I appreciate my colleagues' 
willingness to work with me on this important issue. Although the 
language on the bioequivalence issue is not in the agreed-to version of 
the amendment, by accepting the revised amendment, I want to make it 
perfectly clear that we want to have clear answers from the FDA on its 
current process in establishing a bioequivalence standard for locally-
acting non-absorbed drugs. It is certainly not my intent or the intent 
of my colleagues to suggest that we have concluded the oversight of FDA 
on this issue. Instead, we have agreed to engage with FDA through the 
oversight function of the HELP Committee to ensure that the scientific 
standards and procedures used in establishing bioequivalence for this 
life-threatening antibiotic are appropriate.
  Mr. SPECTER. Would the Senator yield for a question? My office has 
also been in contact with FDA on this issue of bioequivalence for a 
life-saving antibiotic because leading infectious disease experts in my 
state have expressed concern that FDA did not take appropriate steps to 
establish this new standard for demonstrating bioequivalence. I would 
like to work with my colleagues on this important issue as well.
  Mr. HATCH. I thank the Senator from Pennsylvania and I know that he 
has been in communication with FDA regarding this issue. His 
contributions to this dialog have been considerable. I look forward to 
working with him, Senator Cochran and my HELP Committee colleagues in 
getting some answers from the FDA on this situation.


                          Authorized Generics

  Mr. ROCKEFELLER. Madam President, I rise today with my colleagues to 
speak about so-called authorized generics. An authorized generic drug 
is a brand-name prescription drug produced by the same brand 
manufacturer on the same manufacturing lines, yet repackaged as a 
generic in order to confuse consumers and shut true generics out of the 
market. Because it

[[Page 11381]]

is not a true generic drug and does not require an additional FDA 
approval, an authorized generic can be marketed during the federally 
mandated 6-month exclusivity period for generics. This discourages true 
generic companies from entering the market and offering lower priced 
prescription drugs. I have introduced legislation--the Fair 
Prescription Drug Competition Act--in order to ban authorized generics 
during this protected 180-day period, and I had hoped that this 
legislation could be accepted as part of this bill.
  Mr. KENNEDY. I appreciate the leadership of the Senator from West 
Virginia on this important issue. He has been a staunch advocate of 
consumer access to lower cost generic prescriptions, successfully 
working to include authorized generics in the Medicaid best price 
calculation. I support his efforts and believe that the bill before us 
includes significant provisions to lower prescription drug costs. While 
I know that our legislation does not directly address the Senator's 
concerns, I want to continue to work with him on this important issue 
and believe that we can reach consensus on authorized generics as part 
of the patent settlement debate.
  Mr. ENZI. As the Senator from West Virginia knows, we included 
language in the underlying bill on authorized generics in part due to 
his urging. Our bill would require the Food and Drug Administration to 
keep track of authorized generics marketed since January 1, 1999, and 
to make such data publicly available in electronic form. The language 
in our bill will help the Federal Trade Commission complete its study 
in a timely fashion, and it will also help to shed some light on this 
elusive marketing practice. Let me be clear: I do not agree with the 
other policy statements being made regarding authorized generics 
because I don't believe we have enough information yet to make those 
assessments. However, I do agree that we need more information to shed 
light onto this subject. That is why I supported the language in the 
underlying bill to allow us to have that data and to provide a strong 
platform for future discussions.
  Mr. ROCKEFELLER. I appreciate the chairman and ranking member's 
interest in looking into this deceptive marketing practice. And, while 
I had hoped that we could reach agreement on my legislation as part of 
this bill, I appreciate the chairman's commitment to working with me to 
solve this problem as part of the patent settlements discussion. I am 
also grateful for Senators Kennedy, Enzi, and Hatch's support of the 
authorized generics language Senator Brown and I worked to include in 
the underlying bill. This language will undoubtedly help the FTC finish 
its work, but I want to be clear that I do not believe Congress needs 
to wait on the FTC study to be completed to act on the problem of 
authorized generics. At the very least, Congress should impose a 
moratorium on authorized generic drugs until such time as the FTC study 
is complete.
  Mr. HATCH. My friend from West Virginia has had a longstanding 
interest in looking into this issue, and I certainly don't fault his 
tenacity in this area. When Congressman Henry Waxman and I wrote the 
Drug Price Competition and Patent Term Restoration Act in 1984, our 
intent was to improve generic competition, while preserving the ability 
of brand-name manufacturers to discover and market new and innovative 
products. I think this legislation has worked fairly well at achieving 
its intended goals. I know there have been a few problems along the 
way, but I think we addressed many of them in the Medicare 
Modernization Act of 2003. In that law, Congress closed several 
loopholes that were delaying generic competition and hindering consumer 
access to lower cost generic drugs. The law also clarified the 180-day 
period of market exclusivity for generic manufacturers. Now, I know 
Senator Rockefeller is very concerned about authorized generics, and I 
think we should have updated data on the number of authorized generic 
drugs are on the market. The language already included in S. 1082 will 
help the Federal Trade Commission complete its authorized generics 
study, which I know Senator Rockefeller requested along with Senators 
Grassley and Leahy. I support the completion of that study; however, 
Congress shouldn't contemplate additional legislation before having 
necessary data on authorized generics. I will work with my good friend 
and colleague from West Virginia to ensure that the FTC has the data 
needed to complete its study. So, I want to let my friend from West 
Virginia know that I want to continue to have a dialogue about this 
issue.
  Mr. ROCKEFELLER. I thank my colleagues for these commitments. I look 
forward to working together with Chairman Kennedy, Senator Enzi, 
Senator Hatch, and the cosponsors of this amendment Senators Schumer, 
Leahy, Kohl, and Stabenow to develop strong consensus language that can 
be enacted as part of the patent settlements legislation.


                           AMENDMENT NO. 1042

  Mr. ENSIGN. Madam President, prescription drugs and medical 
technology save lives. Advances in medicine have given patients who are 
fighting deadly diseases or managing chronic conditions hope for a 
healthier future.
  Prescription drugs are working to meet the emerging diabetes 
epidemic, save the lives of cancer patients, and forestall the terrible 
burden of Alzheimer's. These advances in medicine are helping patients 
today.
  Although these lifesaving drugs have the enormous potential to 
improve lives, at times they also have the potential to harm. We all 
know that no prescription medication is absolutely safe. There is 
always some degree of safety and health risks.
  Drug companies selling products in the United States must comply with 
regulations and procedures mandated by the Food and Drug 
Administration. FDA approval, however, does not always guarantee drug 
safety.
  The bill we are debating today intends to improve drug safety and 
will significantly change the drug approval process at the FDA. I 
believe it is important to improve the drug approval process and, at 
the same time, ensure patients access to new and innovative therapies. 
In order to achieve this goal, a carefully balanced approach is 
necessary.
  As we debate how to improve the drug approval process, it is 
important for Congress to take actions to ensure that legal efforts to 
enforce drug safety are directed toward the appropriate parties.
  I am particularly concerned that this bill does nothing to protect 
physicians and pharmacists from being named in product liability 
lawsuits. We cannot allow for additional waste in our legal system by 
naming doctors and pharmacists to these lawsuits--especially when these 
professionals have nothing to do with the design or manufacture of the 
product in question. It is for that reason that I rise to speak on 
amendment No. 1042.
  Product liability lawsuits usually involve claims that a product is 
unreasonably dangerous, either in its design, manufacture, or its lack 
of a proper warning or instructions regarding use.
  Historically, trial lawyers name the product manufacturer as well as 
each party that handled the product in the stream of commerce as a 
defendant. This includes the shipper of the product, as well as the 
store owner who sells the product. In most cases, the store owner is 
never liable for a design defect, manufacturing defect, or failure to 
warn. Why? Because these cases have nothing to do with the negligence 
of the store owner.
  Doctors and pharmacists are similar to store owners. They have 
nothing to do with the design or manufacture of a product. Yet time and 
time again, doctors and other health care providers are named as 
parties to product liability lawsuits involving prescription drugs and 
medical devices. Why? Because class action lawyers are constantly 
looking for the best courtrooms to file their lawsuits. These lawyers 
routinely shop for venues that are known for siding with the patient 
who has been harmed. By bringing their cases in front of plaintiff-
friendly judges and juries, these lawyers immeasurably enhance their 
probability of securing a jackpot jury award.
  Judgments are virtually never entered against doctors and pharmacists

[[Page 11382]]

in product liability lawsuits. Yet these health care professionals are 
often forced to spend thousands of dollars in legal costs and take 
valuable time off from work, time away from the patients who need them, 
to provide lawyers with rounds and rounds of depositions and to provide 
juries with testimony. This is completely ridiculous. We need doctors 
in our emergency rooms and family practice centers--not in the 
courtrooms when they have nothing to do with the product in question.
  I want to tell you about a woman named Hilda Bankston. Hilda owned a 
pharmacy in Jefferson County, MS, and has been named as a defendant in 
so many lawsuits that she has lost count. In each instance, Hilda was 
sued for doing nothing more than filling legal prescriptions. In other 
words, she wasn't doing anything wrong. Nevertheless, Hilda has been 
dragged into court to testify in hundreds of national lawsuits brought 
in Jefferson County against the pharmacy and out-of-State manufacturers 
of drugs. Why is this? Because the party who initiated the lawsuit was 
shopping for a friendly court in order to file their national lawsuit 
in that county.
  Does this bill we are considering today provide any protection to 
Hilda Bankston? No, it does not. Does the bill provide any protection 
to doctors and pharmacists with respect to product liability lawsuits? 
No. It doesn't do that either. The bill allows these health care 
providers to continue to be named in product liability cases. This is 
outrageous.
  My amendment is simple. It prohibits a health care provider, 
including a doctor or a pharmacist, from being named in a product 
liability lawsuit or in a class action lawsuit merely because the 
health care provider prescribed or sold a drug or device that was 
approved by the Food and Drug Administration.
  My amendment does not deprive patients of the right to sue a 
physician or a pharmacist who behaves in a negligent manner. It does 
not provide blanket immunity to a physician or pharmacist who behaves 
in a negligent manner. That would be a separate cause of action, which 
lies outside the scope of my amendment. What my amendment does say is 
that health care providers should not be dragged into a product lawsuit 
that they have no business being in. Doctors and pharmacists are 
routinely named in product liability lawsuits and are virtually always 
removed from these cases without having damages assessed against them. 
They are not responsible for the design or manufacture of drugs and 
devices and should not be dragged into these types of lawsuits.
  Patients pay for product liability lawsuits in the form of higher 
health benefits and premiums.
  I urge my colleagues to join me in taking action to curb this abuse 
of our legal system. Let's protect our health care providers from 
incurring frivolous unnecessary costs. Our health care providers should 
be focused on providing the best care possible to their patients, not 
on product liability lawsuits when they have nothing to do with the 
product in question.
  I ask unanimous consent to have printed in the Record letters of 
support for my amendment from the American Medical Association and the 
American Osteopathic Association.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                 American Medical Association,

                                         Chicago, IL, May 3, 2007.
     Hon. John Ensign,
     U.S. Senate, Russell Senate Office Building, Washington, DC.
       Dear Senator Ensign: The physician and student members of 
     the American Medical Association (AMA) commend you for 
     introducing an amendment to S. 1082, the ``Prescription Drug 
     User Fee Amendments of 2007,'' that would clarify physician 
     and other health care provider liability.
       Specifically, the amendment would prevent physicians and 
     other healthcare providers who prescribe or dispense a drug, 
     biologic product, or medical device approved, licensed, or 
     cleared by the Food and Drug Administration from being named 
     in class action product liability lawsuits for forum-shopping 
     purposes. The amendment would address situations in which a 
     local physician or other health care provider is named as a 
     defendant as a way to file a lawsuit in a legal jurisdiction 
     more likely to award large damage awards, even though such 
     jurisdiction has little or no connection to the local 
     defendants. In such cases, the local physician or other 
     health care provider is often dropped from the suit or not 
     found liable for damages. Instead, liability attaches to the 
     manufacturer, whose conduct is the real subject of the 
     litigation. Nonetheless, physicians and other health care 
     providers are exposed to the significant legal costs, 
     distress, and time away from their patients.
       The AMA is pleased to offer its support for this amendment 
     and looks forward to continuing to work with you to bring 
     about common sense liability reforms, such as this amendment.
           Sincerely,
                                                 Michael D. Maves,
     MD, MBA.
                                  ____



                             American Osteopathic Association,

                                      Washington, DC, May 3, 2007.
     Hon. John Ensign,
     U.S. Senate, Russell Senate Office Building,
     Washington, DC.
       Dear Senator Ensign: As President of the American 
     Osteopathic Association (AOA), I am pleased to inform you of 
     our support for your amendment to the ``Prescription Drug 
     User Fee Amendments of 2007'' (S. 1082), which would provide 
     clarification on physician liability.
       Your amendment seeks to clarify that a physician who 
     prescribes a drug, biological product, or medical device, 
     which has cleared successfully the Food and Drug 
     Administration's approval process, cannot be named as a party 
     in a class action lawsuit. The AOA shares our concerns that 
     physicians and other health care providers frequently are 
     names as defendants in such cases as a means of securing a 
     venue which is more likely to produce larger monetary awards. 
     In most cases, physicians are dismissed from he lawsuit or 
     found not liable for damages. Regardless of the ultimate 
     outcome, physicians face significant legal costs and time 
     away from their patients as a result of this practice.
       We believe your amendment takes the appropriate steps to 
     ensure that future class action lawsuits are targeted at 
     those whose conduct is in question. Additionally, we believe 
     your amendment rightfully prevents attorneys from using 
     physicians as a means to pursue legal action in venues they 
     deem more favorable. For these reasons, we re pleased to 
     offer our support.
           Sincerely,
                                               John A. Strosnider,
     DO, President.

                          ____________________