[Congressional Record (Bound Edition), Volume 159 (2013), Part 12]
[Senate]
[Pages 16827-16832]
[From the U.S. 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 
D.C. 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 D.C. 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 D.C. Circuit ranks last, and in both 
categories the D.C. Circuit is less than half the national average. To 
provide some perspective on this point, compare the D.C. Circuit to the 
Eleventh. After another judge took senior status about a week ago, both 
the D.C. 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 D.C. 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 D.C. 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 D.C. 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 D.C. 
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 D.C. 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 D.C. 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 D.C. 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 D.C. 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 D.C. 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 D.C. 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 D.C. 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 D.C. 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

[[Page 16828]]

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 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

[[Page 16829]]

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 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

[[Page 16830]]

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 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

[[Page 16831]]

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.
  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

[[Page 16832]]

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 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.

                          ____________________