[Congressional Record Volume 159, Number 160 (Tuesday, November 12, 2013)]
[Senate]
[Pages S7939-S7944]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PILLARD NOMINATION
Mr. GRASSLEY. Madam President, I come to the floor to speak in
opposition to the motion to invoke cloture on the nomination for the DC
Circuit nominee Cornelia Pillard. Although her record makes clear that
her views are well outside the mainstream on a host of issues, I am not
going to focus any attention on those concerns today. I am going to
focus instead on the standard the Democrats established in 2006. Based
on that standard, the court's caseload makes it clear that the workload
simply doesn't justify additional judges, particularly when those
additional judges cost approximately $1 million per year per judge.
I have walked through these statistics several times now, and I am
not going to go in depth again. The bottom line is the data
overwhelmingly supports the conclusion that the DC Circuit is
underworked. Everyone knows this is true. That circuit does not need
any more judges. Take, for instance, the appeals filed and appeals
terminated. In both categories the DC Circuit ranks last, and in both
categories the DC Circuit is less than half the national average. To
provide some perspective on this point, compare the DC Circuit to the
Eleventh. After another judge took senior status about a week ago, both
the DC Circuit and the Eleventh Circuit have eight active judges. If we
don't confirm any more judges to either court, the numbers remain the
same as last year. The Eleventh Circuit will have 875 appeals per
active judge compared to the 149 appeals filed per active judge in DC,
which also has 8 active judges. Again, that is 875 cases for the
Eleventh compared to 149 for DC.
Some might argue that we shouldn't look only at active judges because
those averages will change if and when we confirm more judges to the
Eleventh Circuit. Suppose we fill each judgeship on the Eleventh
Circuit and each judgeship on the DC Circuit, as the Democrats want to
do. If we fill them all, there would be 583 appeals filed per judge for
the Eleventh Circuit and only 108 for the DC Circuit. The Eleventh
Circuit, then, would have over five times the caseload. This is why
everyone who has looked at this objectively understands that the
caseload for the DC Circuit is stunningly low. That is why current
judges on the court have written to me and said things such as this--
and I will quote from one of the letters: ``If any more judges were
added now, there wouldn't be enough work to go around.''
Some of my friends on the other side recognize that the DC Circuit's
caseload is low, and they claim then that the caseload numbers don't
take into account the ``complexity'' of the court's docket. They argue
that the DC Circuit hears more administrative appeals than other
circuits do, and they claim these administrative appeals are more
complex. This argument is nonsense, and I will tell my colleagues why
it is nonsense.
I have heard my colleagues argue repeatedly that the DC Circuit's
docket is complex because 43 percent of the docket is made up of
administrative appeals. But, of course, that is a high percentage of a
very small number. When we look at the actual number of those so-called
complex cases per judge, the Second Circuit has almost twice as many as
the DC Circuit. In 2012 there were 512 administrative appeals filed in
DC. In the Second Circuit, there were 1,493 compared to that 512.
We can look at this differently as well. In DC there were only 64
administrative appeals per active judge. The Second Circuit has nearly
twice as many per judge with 115. Again, that is 64 administrative
appeals per active judge in the DC Circuit as opposed to the Second
Circuit, which has almost twice as many with 115.
So this entire argument about complexity is what I already called
it--nonsense--and the other side knows it, and if they don't know it,
they ought to know it.
Let me raise another question regarding caseload. If these cases were
really that hard, if these cases were really so complex, then why in
the world would the DC Circuit take the entire summer off? I am not
talking about just a couple of weeks in August; they don't hear any
cases for the entire summer. The DC Circuit has so few cases on their
docket that they don't hear any cases from the middle of May until the
second week of September. This past term, the last case they heard
before taking the summer off was May 16. The court didn't hear another
case until September 9--4 months later.
The bottom line is everyone knows this court doesn't have enough
cases as it is, let alone if we were to add more judges. That is why,
when we ask the current judges for their candid assessment, they write:
``If any more judges were confirmed now, there wouldn't be enough work
to go around.''
While I am discussing the caseload issue, I will remind my colleagues
of a little bit of history that is very pertinent to this debate. In
2006 the Democrats on the Judiciary Committee blocked Peter Keisler's
nomination to the DC Circuit. They blocked Mr. Keisler's nomination
based upon--my colleagues can guess it--the court's caseload. Since
that time, by the standard set by the other side, the court's caseload
has declined sharply.
We did not set this standard. The Democrats set that standard. I
recognize that the other side wants to rewrite history. They try to
compare John Roberts' second nomination to the circuit, which passed
fairly easily, with the current nomination. What they conveniently
forget in a misleading way is that they blocked Keisler's nomination
after Roberts' nomination.
I recognize the other side hopes we on this side will forget they
established these rules and these precedents. I recognize the other
side finds those rules very inconvenient today. But these are not
reasons to ignore rules and precedents they established. There is
simply no legitimate reason the other side should not embrace those
very same rules, those very same standards they established in the year
2006.
So under that standard established by the Democrats in 2006, then,
very simply, these nominations are not needed. According to the current
judges themselves, these judges are not needed. According to the chief
judge of the DC Circuit, who happens to be a Clinton appointee, the
senior judges are contributing the equivalent of an additional 3.25
judges. So, as a result, the court already has the equivalent of 11.25
judges, and that is beyond even the authorized number.
It seems pretty clear the other side has run out of legitimate
arguments in support of these nominations. Perhaps that is why, then,
they are resorting to such cheap tactics.
Over the last couple days, I have heard my colleagues on the other
side
[[Page S7940]]
come to the floor and actually argue that Republicans are opposing the
nominee because of her gender. That argument is offensive. But, you
know, it tends to be very predictable. We have seen this before. When
the other side runs out of legitimate arguments, their last line of
defense is to accuse Republicans of opposing nominees based upon gender
or race. It is an old and it is a well-worn card, and they play it
every time.
The fact is--and this is why it is offensive to me--I voted for 75
women nominated to the bench by President Obama, as well as a host of
other nominees of diverse backgrounds. Those are the facts. But the
other side is not concerned with facts. They are more interested in
coarse rhetoric as well as demagoguery, and it is very unfortunate.
Those types of personal attacks on Members of the Senate are beneath
this institution.
Given there is no legitimate reason to fill these seats, why is the
other side pushing these nominations so aggressively? And this is
really the bottom line. But you can also ask, why waste $3 million a
year of taxpayers' money for reasons that are not legitimate,
particularly in violation of the constitutional checks and balances?
As to these other reasons, we do not have to guess. We know the
reason. We have all heard the President pledge repeatedly: If Congress
will not act, I will. What he means, of course, is that he will rule by
executive fiat. He will not go to Congress. He will not negotiate. He
will go around this constitutionally elected body whose constitutional
powers are to make law. That is not his power. He does not need
legislators, then, to enact legislation. He will just issue executive
orders or issue new agency rules. Why bother with us pesky Senators and
Members of the House when you can make laws with a stroke of the pen?
In effect, the President is saying: If the Senate will not confirm who
I want when I want them, then I will recess-appoint them when the
Senate is even in session. If Congress will not pass cap-and-trade fee
increases, then I will go around them. And I will do the same thing
through administrative action at the Environmental Protection Agency.
If Congress will not pass gun control legislation, then I will issue
executive orders.
That is what the President means when he says: If Congress will not
act, I will. But remember, we have a system of checks and balances.
Under our system, when the President issues orders by executive fiat,
it is the courts that provide a check on his power. It is the courts
that decide whether the President is acting unconstitutionally.
So the only way the President's plan works is if he stacks the deck
in his favor. The only way the President can successfully bypass
Congress is if he stacks the court with ideological allies who will
rubberstamp those executive orders.
There is no big secret here. The other side has not been shy about
this strategy. Here is how the Washington Post described this strategy:
Giving liberals a greater say on the D.C. Circuit is
important for Obama as he looks for ways to circumvent the
Republican-led House and a polarized Senate on a number of
policy fronts through executive order and other
administrative procedures.
Here is how another high-profile administration ally put it:
There are few things more vital on the president's second-
term agenda. With legislative priorities gridlocked in
Congress, the president's best hope for advancing his agenda
is through executive action, and that runs through the D.C.
Circuit.
So the President is willing to waste $3 million of taxpayers' money a
year--and every year--in order to bypass Congress and make sure his
executive orders do not lose in court. Every Member of this body should
find that very troubling.
Finally, I want to mention a couple points on the so-called Gang of
14 agreement, which argument comes up quite frequently here on the
floor, even though it is going back to the 109th Congress.
First, by the very terms of that agreement, it applied only to those
14 Senators for that specific Congress, the 109th.
Second, even though that agreement, by its own terms, expired at the
end of the 109th Congress, just last week one of the Members who was
actually in the Senate back in 2005 determined that these nominations,
in his judgment, constituted ``extraordinary circumstances,'' which
those two words implied that a filibuster would be justified.
And third, in 2006, after the so-called Gang of 14 agreement, Senate
Democrats created a standard that we call the Keisler standard. They
blocked Peter Keisler based on caseload, after the so-called Gang of 14
agreement. Peter Keisler waited in committee for over 900 days for a
vote, a vote that never came.
These are the rules established by the other side. And now, when they
are on the receiving end of those same rules, they want those rules
changed. We do not intend to play by two sets of rules around here.
And that brings me to the constant threat from the majority about
changing the rules on the filibuster. I have been in the minority for a
number of years. I have also had the privilege of serving in the
majority for a number of years. Many of those on the other side who are
clamoring for rules changes--and almost falling over themselves to do
it--have never served a single day in the minority. All I can say is
this: Be careful what you wish for.
I have come to the conclusion that if the rules are changed, at least
we Republicans will get to use those new rules when we are back in the
majority. Republicans had the chance 7 or 8 years ago to change the
rules, and we decided, out of respect for the integrity of this
institution, not to change them. I am glad we did not. And I would
imagine we would not be the first to change them in the future.
Remember, it was the Democrats who first used the filibuster to
defeat circuit judges. It was the Democrats who first used the caseload
argument to defeat circuit judges such as Peter Keisler. So if the
Democrats are bent on changing the rules, then I say go ahead. There
are a lot more Scalias and Thomases out there whom we would love to put
on the bench. The nominees we would nominate and confirm with 51 votes
will interpret the Constitution as it was written. They are not the
type who would invent constitutional law right out of thin air.
I urge my colleagues to oppose cloture on the Pillard nomination.
I yield the floor.
I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. HARKIN. Madam President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. HARKIN. Madam President, I have high hopes that the Senate will
soon vote to enact the Drug Quality and Security Act, the so-called
compounding and trace and track bill. This legislation helps ensure the
safety of compounded drug products. It also secures the pharmaceutical
supply chain.
I am pleased to report that it is the product of excellent bipartisan
collaboration on the HELP Committee, where I worked very closely with
our ranking member, my good friend Senator Lamar Alexander. It also
reflects productive conversations with our colleagues in the House,
including Chairman Upton and ranking member Waxman of the House Energy
and Commerce Committee.
The House passed this bill on September 28. Now it is our turn to do
our part. Title I of the bill addresses drug compounding. This is
basically what happened here just over a year ago, when we were shocked
to learn one of the worst public health crises that we have experienced
in recent years was a meningitis outbreak that claimed the lives of 64
Americans and sickened 651 people in 20 States.
You can see the hardest hit were the home State of Senator Alexander,
153; Indiana, 93; Michigan, 264; Virginia 54, New Jersey, 51; Florida
25. Twenty States. A lot of people got really sick. I will be talking
in a moment about those that still linger today.
What this outbreak did is it brought attention to the legal and
regulatory gaps that allowed owners and managers at the New England
Compounding Center to disregard basic procedures to ensure that the
products they were manufacturing were sterile and safe.
This gross negligence had heart-breaking consequences for families
nationwide, patients that were sick--patients such as Karina Baxter,
whose
[[Page S7941]]
three adult children--Anita, Andrew, and Brian--lost their mother, and
whose community lost a dedicated math teacher and tutor when she died
of this meningitis outbreak at age 56.
Dawn Elliot, from Indiana, who used to scuba dive in her free time is
now in unrelenting pain and has had to give up her job and deplete her
savings.
Evelyn Bates, from Michigan, who was diagnosed last November,
continues to struggle with tremendous pain every day, and her daughter
had to quit her job to take care of her.
Dennis Blatt lives on the West Virginia-Ohio border with his wife and
three young children. They have had to watch their father go from being
an involved parent with a steady income to a man whose daily life
feels, in his own words, like a ``slow, tortuous death.''
These meningitis outbreaks linger on. It also has a personal
sensitivity to me. My older brother some years ago went deaf at a very
young age because of meningitis. So it has lingering effects for a
lifetime. That is what happened a little over a year ago. Although we
know that it was not just an isolated incident, we know it was the
biggest.
This chart is somewhat hard to read. It shows--going clear back to
2001--that we have had 4, 11, 64, 18. In other words, every year we
have had some results we have noted from compounding that made people
sick or cause deaths. So this has been ongoing for a long time.
It is just that what happened a little over a year ago in Tennessee
and in these other States was that the dam broke. It is beyond all
comprehension how many people got sick and died. So again, in response
to these facts, beginning last year Senator Alexander and I convened
the members of the HELP Committee, with assistance from Senator Franken
and Senator Roberts, in an effort to identify the gaps in current
policy, to solicit stakeholder views, to craft bipartisan legislation
to better ensure the quality of compounded drug products.
We formally solicited three rounds of public comment. We held two
public hearings before marking up the bill last May. Then over the
summer we worked with our colleagues in the House to craft a package
with strong bipartisan and bicameral support.
Now, the compounding provisions in this bill are an unqualified step
forward from current law and practice. Basically, what this bill does
in the compounding in title I--I will get to title II in a second--it
distinguishes compounders engaged in traditional pharmacy practice from
those making large volumes of compounded drugs without individual
prescriptions.
So those who wish to remain in traditional compounding, that we might
know where they are making small amounts for a certain type of illness
or for a certain hospital--that sort of thing--they stay under the
State boards of pharmacy as they are in current law.
An entity that neither stays within those limits of traditional
pharmacy compounding nor registers as an outsourcing facility, if they
do not do one of those two, then they are illegally selling unapproved
drugs.
So that is what it does. It distinguishes. It defines the Food and
Drug Administration's role in the oversight of these outsourcing
facilities. They will be subject to FDA oversight in much the same way
as traditional drug manufacturers are today.
FDA will know who these outsourcers are and what they are making,
receive adverse event reports about compounded drugs, and have
authority and resources to conduct risk-based inspections. In other
words, the lines of responsibility are more clearly defined.
I give much credit to my friend from Tennessee for continuing to work
on who is raising the flag, who has the flag, and who is responsible,
because we found out there was a confusing mess for everybody about who
was responsible and who was not. Thanks to Senator Alexander, we have
cleared that up in this bill.
The bill offers providers and patients better information about
compounded drugs, and it directs FDA to make a list of FDA-regulated
outsourcer facilities that will be available on their Web site. It
requires detailed labeling of compounded drugs and prohibits false and
misleading advertising. Finally, it clarifies current Federal law
regarding pharmacy compounding. It strikes the unconstitutional
provisions that were in current law which led to a lot of this mess. We
had different courts in different parts of the country interpreting it
differently. So anyway, we resolve that patchwork and apply a uniform
standard nationwide.
Now, that is title I. Title II of the bill is the track and trace
provisions. Basically, this committee, again working in a bipartisan
fashion a little over a year ago--as you may remember--brought an FDA
user bill to the floor, passed and signed by the President. That
cleared up the upstream part of where drugs come from; in other words,
from the initial--from the plant derivation to the distilling of a
product to everything--all the way up to the manufacturing. So now we
have a much better regulation, a clearer picture of drugs that come
from China and Indonesia and the U.S.--no matter where they come from,
up to the manufacturing standpoint.
What we did not have at that time was a real understanding of or an
agreement on how to control it from the manufacturer down to the
consumer. So our committee got involved. Again, Senator Alexander was
helping to lead the way with Senator Bennet and Senator Burr--almost 2
years working on this issue. So now we have this system. I think this
chart shows it. As I said, everything up to the manufacturer we took
care of in the FDA user bill.
Now this bill takes care of everything from the manufacturer down to
the dispenser; that is, down to the consumer. So no matter where the
drug goes, whether it goes directly from a manufacturer to a wholesaler
to a dispenser, or whether it goes from here to a secondary wholesaler,
another secondary wholesaler, and another secondary wholesaler, we
found that in this country there is a patchwork, all kinds of different
ways for a drug to get from a manufacturer down to a consumer.
So Senator Burr, Senator Bennet, Senator Alexander, and our staffs
worked together to get this picture put together and to have a track
and trace so that we can track the drug. No matter how it goes, we can
track it and we can trace it. That will come into being over 10 years
with electronic interoperable product tracing.
You might say that 10 years is a long time. I would point out that
the House had 27 years. They agreed with us and made it 10 years. But
that is for electronic interoperability. Beginning in January 2015,
they will have to start paper tracing. So there will be paperwork, but
it will take 10 years to get it all at a unit-level and all electronic
and interoperable. You can understand, it takes a long time; different
manufacturers and different suppliers have different systems. So these
will be worked in over that period of time.
But we will have tracing after January, 2015. It establishes
nationwide drug serial numbers and requires a pathway to unit-level
tracing, as I said. It strengthens licensure requirements for wholesale
distributors and third-party logistic providers. Again, there was a lot
of hodgepodge of different kinds of licensures for wholesalers. We
strengthened that. Then, as I said, we have a nationwide serial number
established for that. That will come 4 years after the date of
enactment. That will serialize drugs in a consistent way across the
country.
Again, this is a bill that many might say is long overdue. Better
late than never. I am sorry it took a terrible calamity such as the
outbreak of meningitis to get us to really focus on this and move it.
But it did. I think this is a good example of where the Congress can
work in a bipartisan, bicameral fashion. I met Chairman Upton on the
House side earlier this year to talk about a pathway of getting this
done. In fact, what we are working on here is the House bill. The House
passed it by unanimous consent. If you have been reading much about the
House, you know they do not do a lot by unanimous consent. That just
shows you how much work went into the bill and how it was done in a
true bipartisan, bicameral fashion. So the House passed it by unanimous
consent. Now we have it. I daresay, but for a Senator, one person, we
probably would have passed it by unanimous consent here.
I have not found anyone who is opposed to this bill and who does not
recognize that this is well supported. We
[[Page S7942]]
have a plethora of people and industry and consumer support: American
Pharmacists Association, American Public Health Association,
Biotechnology Industry Organization, plus a lot of the big
pharmaceutical manufacturers and some of the small pharmaceutical
manufacturers. Everyone recognizes that we need a better system to
clearly outline who the traditional compounders are and who the
outsourcers are, to give the FDA clear-cut authority over one segment,
give the States the clear-cut authority over the other segment. As I
said, if you do not fall into one of those two, you are outside the
law. So it really does clear it up. This will ensure the quality and
safety of the drugs on which patients rely.
We have a cloture vote later today. I am hopeful we will have a good
strong vote on cloture on this bill. As I said, I honestly can say
standing here I have not heard one Senator from either side of the
aisle tell me or inform my staff that they were opposed to the bill as
such.
I hope we have a strong vote. I am going to yield the floor and again
pay my compliments and my highest respect to Senator Alexander for his
leadership. His State was hit very hard. I know he is very sensitive to
that. I know from my talks with him that it pained him a great deal to
see so much suffering and death in his own State. Senator Alexander got
on top of this and pulled us all together and basically said: We have
to get it done.
So I thank Senator Alexander very much.
The PRESIDING OFFICER (Mr. Manchin). The Senator from Tennessee.
Mr. ALEXANDER. On behalf of the people of Tennessee, whom I
represent, and the American people, as well, I wish to thank the
Senator from Iowa for his leadership on these two bills, but
particularly on the compounding pharmacy bill.
Our differences of opinion in the Senate are well advertised on
ObamaCare, on debt, on Syria, and on a whole variety of matters. In
fact, one would say the reason we exist is to debate the big issues
that haven't been resolved somewhere else.
There is another aspect of the Senate that is rarely well advertised,
and that is when we get a result. Sometimes the results take a long
time, involve a lot of people, and are very difficult to reach, and
that is the case with this bill. Had not Senator Harkin been patient,
as well as aggressive at the same time, in working with Republicans and
Democrats and with Members of the House, we would not have reached this
point today.
It is important to call the attention of the American people to this
result, these two pieces of legislation. One makes it clear who is in
charge, as Senator Harkin said, who is on the flagpole when it comes to
making sure the sterile drugs that are injected into your back--because
a person has back pain--are safe so that they don't end up with a
horrible death from fungal meningitis. Who is responsible for
preventing that?
The second bill is how are we going to make sure the 4 billion
prescriptions we have every year in this country are safe, that they
are not stolen, and that they do what they are supposed to do. How are
we to make sure we can track them all the way from the manufacturer to
the pharmacy who dispenses them?
We have been working on these bills for 2 years. Lest anyone think
that because it was a voice vote in the House and because we are close
to unanimous consent in the Senate that it was easy to do, it is not
that easy to do. In fact, it is worth going through how this happened
before I say just a word to add to what the Senator said about the
importance of bills.
The FDA became involved in the fungal meningitis issue in September
of 2012, 1 year ago, after reports from Tennessee that fungal
meningitis was tied to a sterile compounded drug. This hits home to
many Americans because a great many Americans have been injected in
their necks, their backs, or their feet with a drug that is supposed to
be sterile. If it is not, it could have terrible consequences.
Immediately, Senator Harkin called a hearing. November 15, 1 year
ago, we had our first hearing. Within 6 months we released draft
legislation to address the compounding pharmacy issue. We then had a
hearing on that legislation. Then we passed the legislation after a lot
of comment, all in the open. Everyone had a chance to weigh in. We
passed it unanimously.
This committee on which we serve, Health, Education, Labor and
Pensions, probably reflects the widest span of ideological differences
we have in the Senate. The Republicans can be very conservative and the
Democrats can be very progressive or very liberal, so one would think
it would be hard to get a unanimous agreement, but we did.
The House went to work and came up with their own version of the
bill, taking our work into account. We then worked with them through
the summer to reach an agreement on how to reconcile the two. The House
passed it by a voice vote and sent it to us. Today we have a piece of
legislation that has been hot-lined. That means that both sides have
sent it around to every single office. All but one Senator have agreed
we can pass it by unanimous consent. The Senator has that right, as I
have that right, the Senator from West Virginia, and the Senator from
Iowa has that right, and sometimes we exercise that right. Later this
afternoon we will be having a cloture vote, a vote to move to this
bill. That cloture vote is going to succeed. There will be a sufficient
number of Republican votes and a sufficient number of Democratic votes
to say we are ready to deal with this.
Why are we ready to deal with this? Because Commissioner Hamburg of
the Food and Drug Administration told us at our hearing what would
happen if we don't. She said:
We have a collective opportunity and responsibility to help
prevent further tragedies. If we fail to act, this type of
incident will happen again. It is a matter of when, not if,
I'm afraid. If we fail to act now, it will only be a matter
of time until we're all back in this room asking why more
people have died and what could have been done to prevent it.
No one is saying this legislation is going to guarantee that there
will never ever be a tragedy again, but it will help prevent future
tragedies. It will take up the responsibility she challenged us to do.
We have spent 1 year on it, so many people have been involved, and it
is time we move to do it. My hope is that after the cloture vote
tonight, very soon thereafter, after everyone has had a chance to speak
and say what they have to say, that we can pass this by unanimous
consent, send it to the President, and say to the American people that
our differences are well advertised, but our results can be equally
important. We can pass a piece of legislation which, when taken with
the track-and-trace legislation which accompanies it, affects the
health and safety of every single American, period. I know the people
of Tennessee would welcome a prompt solution to this, and this is what
I hope we have.
Senator Harkin, as he often does, spoke in very personal terms about
this legislation. I want to tell one story from Tennessee so we know
what we are talking about.
Diana Reed, 56, of Tennessee, had tried massage and acupuncture, but
neither eased her neck pain. One of the potential causes for her pain
was an injury sustained while helping her husband, who has Lou Gehrig's
disease, in and out of the wheelchair. Diana Reed was healthy, either
ran or swam every day, in addition to becoming Wayne's arms, legs, and
voice, according to her brother, Bob.
She decided to try a series of epidural steroid injections for her
neck problems before her health insurance ran out after losing her job
at a nonprofit group. This decision ended her life on October 3 of last
year. She began receiving injections August 21, with a total of three
scheduled, one every 2 weeks. She felt pain and nausea for a full day
after the first two injections. After the third she began having
headaches.
September 23, she finally agreed to go to a doctor and was quickly
diagnosed with meningitis. While she remained stable for a few days and
was mostly concerned about her husband's well-being--remember, he has
Lou Gehrig's disease--and getting home to him as soon as possible, she
took a turn for the worse. Her speech began to slur, she had trouble
seeing, and eventually she had a stroke. One day later she was in a
coma.
[[Page S7943]]
One thousand people packed Otter Creek Church for her funeral, among
them the alumni of a childcare learning center for inner-city
preschoolers that she and her husband had founded. The autopsy found
fungal meningitis at the injection site and in Mrs. Reed's brain.
Mr. Reed has a rare form of ALS that worsens more slowly, and his
mind has not been affected. Diana Reed would help him get in and out of
bed, the shower, and his wheelchair. She became more instrumental in
his accounting business as his speech worsened. After her death,
members of their church brought meals, did laundry, and the church
accepted donations to hire help to assist Mr. Reed with his personal
care.
This is only one story of the tragedy that the Commissioner of the
FDA says will happen again if we don't act. We believe this bill will
help to prevent such a tragedy. Steroid injections last year were meant
to ease the pain of hundreds of Americans, and for many Tennesseans,
instead, it became their worst nightmare. These vials of compounded
medicine were contaminated. Sixty-four Americans, including sixteen
from my State, died from the outbreak. It is a horrible way to die.
When the HELP Committee held its first hearings on this tragic
outbreak in November of last year, we looked at how could this possibly
happen. It became clear that these contaminated vials were produced in
a facility that was nothing like a traditional pharmacy, a corner
drugstore, if you will. It operated more like a manufacturer, but it
was unclear which regulator was in charge. Was the State in charge or
was the FDA in charge? I made it clear at the beginning of the hearing
that my priority was to find a way to clarify who is accountable for
large-scale drug compounding facilities, who is on the flagpole for
overseeing the safety of drugs made in these facilities.
I used the example of Hyman Rickover and the nuclear Navy in the
1950s. Admiral Rickover was doing something new. He was doing something
dangerous, potentially dangerous. He was putting reactors on submarines
and ships, and no one knew quite how that was going to work.
What did he do about it? Admiral Rickover hired the captain. He
interviewed the captain and said: First, you are responsible for your
ship; and, second, you are responsible for the reactor. If there is
ever a problem with the reactor, your career is over.
The U.S. Navy has never had a death on a nuclear ship as a result of
a reactor problem because everyone knew, after Admiral Rickover made
those decisions, who was on the flagpole.
There should be no confusion, after this bill is passed and signed by
the President, who is on the flagpole for a particular facility that
makes sterile drugs. We should be able to walk into any one of our
60,000 drugstores, pharmacies, our doctors' offices, or pain clinics,
and not have to worry about whether the medicines we get there are
safe. The bill we are voting on represents that year of work we talked
about to find a solution.
Today we have drug manufacturers on the one hand and traditional
pharmacies, the corner drugstore, on the other. This legislation
creates a new, voluntary third category which we call an outsourcing
facility. If a drugstore chooses to be in this category, they follow
one nationwide quality standard, and the FDA is responsible for all the
drugs made in that facility. FDA is on the flagpole.
What is the advantage of this? First, it eliminates the confusion, it
eliminates the finger pointing. If, Heaven forbid, this should happen
again, it will be clear whose fault it was, who didn't do their job of
regulating.
Second, it provides an option available to doctors and hospitals who,
if they wish, can choose to buy all their sterile drugs from a facility
regulated by the FDA.
Outsourcing facilities are subject to regular FDA inspections. The
New England compounding center that caused these problems was not
inspected by the State or the FDA from 2006 to 2011. Outsourcing
facilities must report the products made at the facility to the FDA.
The New England center that caused the problems was making copies of
commercially available drugs, which is illegal. Outsourcing facilities
must report to FDA when things go wrong with a product. Currently,
large-scale compounders don't have any required reporting to FDA if
they know about a problem with a product.
Finally, outsourcing facilities, this new category, must clearly
label their products so patients know it is compounded rather than FDA
approved. Traditional pharmacy compounders will continue to be
primarily regulated by the States, but for outsourcing facilities, the
FDA is in charge.
During our discussions we heard a lot about drug shortages. The
Senator from Iowa and I worked especially to deal with that. We tried
to address it where appropriate in this legislation. We know that
compounded products aren't the answer to drug shortages. We don't want
compounded products to be the backup solution to drug shortages; we
want a better answer than that. We recognized the problem and tried to
address it.
Because of heroic reactions of State officials with the Tennessee
Department of Health, more people didn't become sick from the outbreak
last fall. I don't intend to sit through another hearing where FDA can
point the finger at someone else instead of taking responsibility or
claim it doesn't have enough authority, and if we pass this
legislation, FDA won't be able to.
This legislation also establishes clear rules for outsourcing
facilities and puts FDA on the flagpole for drugs made in those
facilities.
I hope my colleagues will vote this afternoon to move to the bill,
and then shortly after that we will be able to move to approve it, as
the House did.
Just one other comment, Mr. President. The chairman, the Senator from
Iowa, and Senator Burr, Senator Bennett, and others have been working
for at least 2 years on this form of legislation we call track and
trace. It has been through vetting. I think everybody has had a chance
to read it and to make a suggestion about it. There have been many
changes and adjustments to make sure it works.
Here is the problem. In the United States today, we have about 4
billion prescriptions written every year. We don't have a uniform
system to track and trace these drugs once they leave the manufacturer,
which makes it easier for counterfeits and substandard products to
enter the market and puts patients at risk. The laws governing the
tracking of drugs haven't been updated since 1988. In the last 2 years
alone there have been three cases of counterfeit Avastin--a cancer drug
being distributed in the United States to physicians and patients--
where the counterfeit did not contain any of the active ingredient.
We have seen an increase in drug theft. We have no way of knowing if
and when these drugs are resold in the U.S. supply chain. In 2009
insulin stolen from a truck much earlier was sold by pharmacies, and
the insulin was ineffective due to improper storage. Stealing drugs has
turned into a big business, and without assurance that drugs are stored
under certain conditions and handled correctly throughout the supply
chain, the drugs may not work.
This legislation would set up a system over time--10 years--where
products that are stolen could be flagged as such, preventing
distribution to patients. It represents a consensus on establishing a
national system for all prescription drugs to have a specific serial
number on the bottles. That means wholesalers, repackagers, and
pharmacies will be able to check the serial number on the bottle with
the manufacturer to see whether that number was assigned by the
manufacturer. The serial number will not only help prove it is not
counterfeit, but the information can also be used to determine whether
anything else has been reported about that bottle, including whether
the product was stolen.
This won't happen overnight. Creating a system that traces 4 billion
prescriptions, made by over 80 manufacturers on over 3,600
manufacturing lines, that are dispensed to patients through a variety
of ways will take some time. But the path laid out for us over a number
of years will ensure that the U.S. drug supply chain is secure and that
consumers receive drugs that work.
I want to thank the Senator from Iowa, as I have already, for his
leadership on these two extraordinary pieces of legislation; Senator
Burr and Senator Bennet on the track-and-trace legislation; and Senator
Roberts and
[[Page S7944]]
Senator Franken worked hard on compounding legislation.
Let me end where I began. The FDA Commissioner challenged us. She
said that if we don't act, this tragedy will happen again. We have an
opportunity to act tonight. I hope we do. The families who were
devastated by this tragedy because of contaminated sterile injections
that caused fungal meningitis in many of our States, especially in
Tennessee, expect us to act. If we do, it will not be as well
advertised as the differences of opinion we can have in the Senate, but
it will demonstrate how, when we work together over a period of a
couple of years, we can take a very big piece of complex legislation--
in fact, two--that affects the health and safety of every American and
come to a consensus that takes a large step forward.
I thank the Chair, and I yield the floor.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Mr. President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. CORNYN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
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