[Congressional Record Volume 153, Number 74 (Monday, May 7, 2007)]
[Senate]
[Pages S5634-S5651]
From the Congressional Record Online through the 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.
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
[[Page S5635]]
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 ``
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.
[[Page S5636]]
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 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.
[[Page S5637]]
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 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,
[[Page S5638]]
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.
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,
[[Page S5639]]
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, ``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
[[Page S5640]]
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. ``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?
[[Page S5641]]
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.
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),
[[Page S5642]]
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 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
[[Page S5643]]
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 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
[[Page S5644]]
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 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
[[Page S5645]]
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 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.
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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--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.
[[Page S5647]]
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.
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
[[Page S5648]]
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 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,
[[Page S5649]]
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.
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
[[Page S5650]]
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 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.
[[Page S5651]]
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
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.
____________________