[Congressional Record Volume 158, Number 73 (Monday, May 21, 2012)]
[Senate]
[Pages S3307-S3316]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                          FDA Reauthorization

  Mr. COONS. Mr. President, I rise today in strong support of the 
bipartisan legislation to which the Senate will move to reauthorize the 
Food and Drug Administration user fees and critical programs to ensure 
Americans have access to safe and effective medications.
  Most of us do not think about the FDA on a regular basis. In fact, we 
rarely think about where our medicines come from, the scientists who 
invented them, the investments required to develop them, and the 
innovative, cutting-edge new treatments that are essential to keeping 
Americans healthy and safe or the regulators who make sure these 
pharmaceuticals, devices, and treatments work as they are supposed to. 
But when the moment comes that we face a health crisis and our doctors 
prescribe us essential medication, we want those pharmaceuticals 
available right away, and we want them to work as promised.
  One example of the many constituents who have contacted me about 
PDUFA is Virginia from Newark, DE, who recently sent a letter to my 
office. She volunteers with the National Brain Tumor Society and is 
concerned that without reauthorization of this legislation, safe and 
effective brain tumor therapies will be slower to be developed and made 
available to patients who need them. She wrote:

       It has been too long since any new therapies have become 
     available for brain tumor patients that significantly extend 
     survival. Anyone can be diagnosed with a brain tumor, and 
     they are the second leading cause of cancer death in children 
     under twenty.

  I say to the Presiding Officer, I am sure, like me, in your office, 
as a Senator from Connecticut, you regularly are visited by folks from 
around the country or around your State who are deeply concerned about 
continuing medical progress, discovery and development of the 
lifesaving treatments Americans have developed over the last two 
decades. It is my hope that the Senate will continue to clear the way. 
That is why we need this legislation.
  This reauthorization helps take care of innovation and safety so 
consumers and patients do not have to worry. It permanently authorizes 
programs that have helped make medicines safer for millions of 
children. It upgrades the FDA's tools to police the global supply chain 
and helps reduce the risk of drug shortages of the kind we saw 
recently, which Senator Klobuchar just spoke to earlier this afternoon, 
when supplies of critical cancer medications ran low.
  This is a matter of great urgency. The current FDA authorization will 
expire in a few short months. If we allow that to happen, we put at 
risk patient access to new medications as well as America's ongoing 
global leadership in biomedical innovation.
  Worst of all, failing to reauthorize would cost us thousands of jobs, 
and more pink slips is not what we need as our economic recovery gains 
strength. If new drug and medical device user fee agreements are not 
authorized before the current ones expire, the FDA must lay off nearly 
2,000 employees. Because that does not happen overnight, layoff notices 
would start going out as early as July. The good news is we are moving 
forward with a timely reauthorization to save those jobs, save 
America's leading role in innovation, and ensure that the FDA continues 
to make progress.
  This is an all-too-rare display of bipartisanship across both 
Chambers. This legislation was unanimously approved by the House 
committee and found strong bipartisan support in the HELP Committee 
here in the Senate, ably led by Chairman Harkin and Ranking Member 
Enzi.
  There is a reason Members of the House and Senate of both parties are 
in such strong support of this reauthorization.

[[Page S3314]]

  The American economy has always been driven by innovation, and some 
of our most extraordinary innovations have come in the biomedical 
sector. In the years ahead, it is my faith, my hope, that we will see 
more and more narrowly targeted drugs created specifically for certain 
kinds of patients or very specific diseases. In the lifecycle of 
innovation, this is different than the last few decades when 
blockbuster medications were used and then developed on a very wide 
scale across the country or world. But it is an equally impressive feat 
of innovation that lies in the years ahead, and one that is only 
possible because of amazing advances in technology, the mapping of the 
human genome, the disassociation across many labs and small startup 
businesses, of the machinery, the mechanics, and the capabilities to 
innovate in the discovery and development of pharmaceuticals.
  We have to continue to support and encourage this kind of innovation 
in order to stay competitive in the global economy. At the moment, the 
FDA continues to keep pace with many of our global competitors in terms 
of their review time for new drug applications, but we are at real risk 
of falling behind.
  One recent example to which I paid close attention, the blood-
thinning drug Brilinta, was manufactured by a company--was developed 
and discovered by a company--in my home State of Delaware, AstraZeneca. 
It was finally approved by the FDA in July 2011. But prior to that 
approval, 33 other countries, including the EU and Canada, had already 
approved the drug months or years before. This delay in review and 
approval in some certain cases can be bad for patients who rely on 
these medications and bad for the competitiveness of the United States. 
So I am glad this reauthorization clears away some of the conflict in 
the underbrush and will reauthorize and strengthen and streamline the 
review timeline for new pharmaceuticals.
  Not only will this provide the kind of predictability and certainty 
any business needs to succeed, but it helps make sure the FDA's 
essential regulatory process keeps pace with scientific innovation. In 
my home State of Delaware, there are more than 20,000 jobs that 
directly rely on biomedical research and innovation. But around the 
country there are more than 4 million indirectly and more than 675,000 
jobs that directly benefit from this area.
  Frankly, it is also one of our strongest export areas of growth for 
the long term. So we need this reauthorization now. In my view, moving 
forward with this legislation also means finding the fine balance 
between speed and safety, between getting treatments to patients 
without delay, and being certain these new drugs will be effective and 
safe.
  In a recent editorial, the Washington Post noted:

       This time around, the balance appears to be tilting 
     slightly toward faster approval. That's good.

  I agree. Safety is paramount, but with today's technology and the 
FDA's century of experience, I think we can move more quickly to put 
innovative treatments in the hands of patients who desperately need 
them. The Prescription Drug User Fee Act originally passed by Congress 
in 1992 and reauthorized every 5 years since is what allows the FDA to 
collect user fees from pharmaceutical manufacturers and provide a 
stable, consistent funding stream that has steadily decreased drug 
review times by nearly 60 percent since it was first enacted. It has 
provided access on a faster and more predictable timeframe to over 
1,500 new medicines since it was first enacted and deserves to be 
reauthorized to help expedite approval for breakthrough medications to 
treat rare and widely experienced diseases.
  In closing, the FDA is the oldest comprehensive consumer protection 
agency in the Federal Government. Its relevance has not decreased with 
age; in fact, quite the opposite. As our researchers and scientists 
have made major breakthroughs in care and technologies for treatment, 
the FDA has continued to serve as the conduit between innovators, 
physicians, and patients.
  We face tremendous hurdles in treating devastating diseases of all 
kinds. In addition to ancient puzzles such as cancer that continue to 
allude us, there are new challenges cropping up every day. One example 
would be the need for new drugs to treat increasing cases of bacterial 
infections, greatly resistant to conventional antibiotics, so-called 
superbugs. That is why I have joined with the Presiding Officer and 
Senator Corker as a cosponsor of the GAIN Act, to spur development of 
these specific types of drugs. This is one of many examples of the 
kinds of innovations that will solve the medical mysteries of the 21st 
century, ease the suffering of millions of Americans, secure high-wage 
and high-skilled jobs in the biomedical research field, and ensure our 
competitiveness globally.
  So let's continue working in the bipartisan spirit that has carried 
this reauthorization thus far and proceed to pass it without delay.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from California.
  Mrs. FEINSTEIN. Mr. President, at 5:30 we will be voting on the 
nomination of Paul Watford for the Ninth Circuit Court of Appeals. I 
would like to say a few words about him at this time. But before I do, 
I think Members might want to consider the fact that the Ninth Circuit 
is by far the busiest U.S. circuit in the Nation. It has over 1,400 
appeals pending per three-judge panel. That is the most of any circuit. 
It is over two times the average of other circuits combined.
  The Judicial Conference of the United States has declared each Ninth 
Circuit vacancy a ``judicial emergency.'' So today we are, in fact, 
filling one of the seats which is a judicial emergency. The candidate 
is Paul Watford, a Ninth Circuit nominee with stellar credentials and 
support across the political spectrum. I am delighted that cloture was 
vitiated so the vote will be directly on his nomination, and it is 
anticipated that he will be confirmed without controversy.
  Mr. Watford earned his bachelor's degree from the University of 
California Berkeley in 1989 and his law degree from UCLA in 1994 where 
he was editor of the UCLA Law Review and graduated Order of the Coif. 
After finishing law school, Mr. Watford clerked for Ninth Circuit Judge 
Alex Kozinski, an appointee of President Reagan's. He then clerked for 
Justice Ruth Bader Ginsburg on the U.S. Supreme Court.
  Following his two clerkships, he spent a year in private practice at 
the prestigious firm of Munger, Tolles, and Olson and then moved into 
public service as an assistant U.S. attorney in Los Angeles in 1997. 
There he prosecuted a broad array of crimes, including bank robberies, 
firearms offenses, immigration violations, alien smuggling, and various 
types of fraud.
  He later served in the major fraud section of the criminal division, 
focusing on white collar crime. Among his many cases, he prosecuted the 
first case of an online auction fraud on eBay in California. During his 
tenure as a Federal prosecutor, Mr. Watford appeared in court 
frequently, typically several times per week. He tried seven cases to 
verdict, and he worked on numerous Ninth Circuit appeals, arguing four 
of them.
  In one such case, a cocaine dealer had already convinced the State 
court that a drug seizure had violated his fourth amendment rights. Mr. 
Watford prevailed on appeal in forcing the dealer to forfeit over 
$100,000 in drug trafficking proceeds.
  In 2000, Watford rejoined Munger, Tolles, and Olson where he is 
currently a partner. This is one of the premiere appellate law firms in 
California. Paul Watford specializes in appellate litigation at the 
firm. Like most major law firms, Munger's docket is dominated by 
business litigation. Thus the focus of Mr. Watford's work has been 
appellate litigation for business clients. For example, he represented 
Verizon Communications in a consumer class action case. He represented 
the technology company, Rambus, in two complex patent infringement 
cases. He also represented Shell Oil in an antitrust case.
  Mr. Watford and his colleagues at Munger won a 9-to-0 reversal on 
behalf of Shell Oil in the Supreme Court. He has also represented 
numerous other American businesses, such as Coca-Cola and Berkshire 
Hathaway, as well as business executives and municipal government 
agencies.
  In total he has argued 21 cases in the appellate courts, and he has 
appeared as counsel in over 20 cases in the U.S. Supreme Court. So he 
is well equipped.

[[Page S3315]]

  His extensive experience as a prosecutor and private practitioner, 
including his specialty in appellate work, will serve the Ninth Circuit 
extremely well. Mr. Watford is also regarded by attorneys on both sides 
of the aisle, including conservative Republicans who praise him for his 
keen intellect and fair-minded approach to the law. He has been 
endorsed by two former presidents of the Los Angeles chapter of the 
Federalist Society.
  One, Jeremy Rosen, says Watford is, ``open-minded and fair,'' and a 
``brilliant person and a gifted appellate lawyer.'' The other, Henry 
Weissman, says that although he ``do[es] not agree with President Obama 
on issues, [he] completely agree[s] with his nomination of Paul 
Watford.'' So that is a good thing.
  Daniel Collins, who clerked for Justice Scalia and served as an 
Associate Deputy Attorney General in the Bush Justice Department, says 
Watford ``embodies the definition of judicial temperament--very level-
headed and even keeled.''
  Thirty-two Supreme Court clerks from the term when Watford clerked 
for Justice Ginsburg have written in support of the nomination. These 
include clerks from every Justice on the Court at that time, including 
all of Justice Scalia's clerks from that year, as well as several from 
Justices Rehnquist, Thomas, and Kennedy. I find that quite amazing.
  A group of over 40 former clerks for Judge Kozinski have also written 
in support of Watford's nomination. This group includes numerous 
individuals with unquestionable conservative credentials. Many clerked 
for Justices Rehnquist, Scalia, Alito, and Kennedy. Several, such as 
Steve Engel, Charles Duggan, and Ted Ullyot also served in the Bush 
administration, including in the White House Counsel's Office and the 
leadership of the Justice Department.
  Watford also has strong support in the business community. The 
general counsels of leading American corporations, including Google, 
Mattel, Verizon, and CIRCOR, have also written in support of Mr. 
Watford. They say Watford ``is exactly the kind of individual that any 
plaintiff or defendant--person, business, or government--would welcome 
deciding their case.''
  In short, Paul Watford is truly both an excellent and distinguished 
choice for the Ninth Circuit. He is extremely bright. He is experienced 
at the trial and appellate level and in both civil and criminal cases. 
He is uniquely respected for his intellect and judgment, and he has 
broad support across the political spectrum and in the business 
community.
  Maybe this is the reason cloture was vitiated. He is not 
filibusterable. I hope people see the fine and keen intellect this man 
is, and he should have a very large vote. If confirmed, he would be one 
of just two African-American active judges on the Ninth Circuit. The 
Ninth Circuit, by far the busiest circuit in the Nation, urgently needs 
him to begin his service.
  As I said the Ninth Circuit is a judicial emergency. This will fill 
one vacancy. So I urge my colleagues to vote at 5:30, in 15 minutes, 
for Mr. Watford's nomination.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. GRASSLEY. Mr. President, today we are going to turn to a 
nomination that the Senator from California has just referred to, Paul 
Watford, to be circuit judge for the Ninth Circuit. I am disappointed 
that the majority leader has brought this nomination to the floor.
  The reason I say that is there are at least 10 nominations on the 
Executive Calendar that might fall into the category of consensus 
nominees. Six nominees on the calendar had significant opposition in 
committee and clearly are not consensus nominees. Mr. Watford falls 
into this category of not being a consensus nominee.
  I will oppose Mr. Watford's nomination and ask my colleagues to 
oppose the nomination as well. My opposition to this nomination is 
based upon substantive concerns that I have regarding Mr. Watford's 
views on both immigration and the death penalty.
  Mr. Watford partnered with the American Civil Liberties Union and the 
National Immigration Law Center in two cases to oppose Arizona's 2010 
immigration bill. In the first case, Friendly House, a class action 
lawsuit, Mr. Watford served as cocounsel for most of the plaintiffs, 
including the class action representative Friendly House.
  The Friendly House complaint attacks the Arizona law on a variety of 
grounds. He argued the law violates the Supremacy clause; that it 
violates the Equal Protection clause by promoting racial profiling; 
that it violates the first amendment by chilling the speech of non-
English speakers; that it violates the fourth amendment; and that it 
violates due process by inviting racial profiling and employing vague 
definitions of ``public offense'' and other statutory terms.
  In the second case, United States v. Arizona, Mr. Watford served as 
cocounsel on an amicus brief filed by the Friendly House plaintiffs. 
This brief covers most of the arguments raised in the Friendly House 
complaint. But in addition, it asserts that Arizona ``fails to account 
for the complexities and realities of Federal immigration law'' because 
individuals lacking immigration registration documents are put at risk 
of ``constant and repeated criminal prosecution.''
  I do not believe an attorney should be held accountable for the legal 
positions he advocates on behalf of a client. Of course, there are some 
exceptions to that general rule; for instance, if the legal positions 
are far outside the mainstream of legal theory, are frivolous or 
indicate an unacceptable level of professional competence. However, in 
this case, Mr. Watford has not simply argued on behalf of a client, he 
adopted those legal theories as his very own. On July 14, 2010, Mr. 
Watford gave a speech analyzing the constitutionality of the Arizona 
law. His speech concentrated on ``why S. 1070 is unconstitutional,'' 
and he recapped many of the arguments he made in the Friendly House 
case.
  Moreover, despite the fact that he discussed his views on immigration 
publicly, he nonetheless declined to answer many of my questions during 
his hearing before the Judiciary Committee. For instance, I asked about 
an argument in his brief that the Arizona statute prohibiting illegal 
aliens from soliciting work somehow violated the first amendment. The 
nominee responded that it would be inappropriate for him to comment on 
questions related to whether illegal immigrants were entitled to 
constitutional protections other than those contained in the fifth, 
sixth and fourteenth amendments. Again, remember, he had already given 
a speech on this topic, so I was disappointed that he would not share 
his views on these important topics.
  With regard to the death penalty, Mr. Watford assisted in submitting 
an amicus brief to the Supreme Court in Baze v. Rees on behalf of a 
number of groups that opposed Kentucky's three-drug lethal injection 
protocol.
  In its plurality opinion, the Court rejected the arguments raised in 
the brief. Ultimately, Kentucky's three-drug protocol was upheld on a 
7-to-2 vote in the Supreme Court.
  At the hearing we had for Mr. Watford, in following up questions, Mr. 
Watford gave the standard response that he would follow Supreme Court 
precedent regarding the death penalty. Yet it is very curious to me 
that he would go out of his way to provide his services to a case that 
would undermine the death penalty.
  Furthermore, his concession that he would give consideration to 
foreign or international law in interpreting the meaning of the Cruel 
and Unusual Punishment clause makes me wonder how he would approach 
this issue.
  I have other concerns based on positions this nominee has taken in 
his legal advocacy, as well as some of his presentations.
  I am generally willing to give the President's nominees the benefit 
of the doubt when the nominee on the surface meets the requirements I 
have previously outlined. But I don't think this nominee meets these 
requirements.
  Finally, Republicans continue to be accused of obstruction and delay 
when it comes to judicial nominations. This comes even as we have now 
confirmed 145 of this President's district and circuit court nominees. 
That, of course, is during a period when we also confirmed two Justices 
to the Supreme Court. The last President who had two Supreme Court 
nominees had only 120

[[Page S3316]]

confirmations. So this argument of obstruction, of delay, and of 
unfairness doesn't hold up.
  I remind my colleagues on the other side of the aisle of the 
obstructionism, delay, and filibusters, which they perfected. The 
history of President Bush's nominees to the ninth circuit provides some 
very important examples.
  President Bush nominated nine individuals to the ninth circuit. Three 
of those nominations were filibustered. Two of those filibusters were 
successful. The nominations of Carolyn Kuhl and William Gerry Myers 
languished for years before being returned to the President. A fourth 
nominee, Randy Smith, waited over 14 months before finally being 
confirmed after his nomination was blocked and returned to the 
President. After being renominated, he was finally confirmed by a 
unanimous vote.
  President Obama, on the other hand, has nominated six individuals to 
the ninth circuit. Only one of those nominees was subject to a cloture 
vote. After that vote failed, the nominee withdrew. If confirmed, Mr. 
Watford will be the fourth nominee of President Obama nominated to 
serve on the ninth circuit. Those four confirmations took an average of 
about 8 months from the date of nomination.
  For all of President Obama's circuit nominees, the average time for 
nomination to confirmation is about 242 days. For President Bush's 
circuit nominees, the average wait for confirmation was 350 days. Given 
this history that I have spelled out, one might wonder then why 
President Bush and his nominees were treated differently and so much 
more unfairly than President Obama's nominees.
  Mr. Watford received his B.A. from University of California, Berkeley 
in 1989 and his J.D. from the University of California, Los Angeles 
(UCLA) School of Law in 1994. Upon graduation, he clerked for Judge 
Alex Kozinski on the Ninth Circuit and then for Justice Ginsburg on the 
Supreme Court. In 1996, he began working as an associate in the 
Litigation Department at the Los Angeles law firm of Munger, Tolles & 
Olsen. From 1997 2000, Mr. Watford was an Assistant United States 
Attorney in the U.S. Attorney's Office for the Central District of 
California, in Los Angeles, handling a variety of criminal 
prosecutions, such as immigration, narcotics, firearms trafficking, 
bank robbery, computer fraud, mail and wire fraud, and securities 
fraud.
  In 2000, Mr. Watford returned to private practice as an associate in 
the appellate practice group at Sidley & Austin's Los Angeles office. 
In 2001, he rejoined Munger, Tolles & Olsen as an associate, becoming a 
partner there in 2003. His practice focuses primarily on appellate 
litigation, specifically business and commercial disputes. Mr. Watford 
has also taught a course on Judicial Opinion Writing at the University 
of Southern California's Gould School of Law for three semesters (2007, 
2008, and 2009).
  The ABA Standing Committee on the Federal Judiciary unanimously rated 
him as Well Qualified for this position.
  I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. REID. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                  Unanimous Consent Agreement--S. 3187

  Mr. REID. Mr. President, I ask unanimous consent that the cloture 
vote on the motion to proceed to Calendar No. 400, S. 3187, the Food 
and Drug Administration Safety and Innovation Act, be vitiated; that at 
2:15 tomorrow, Tuesday, May 22, the motion to proceed be agreed to; 
that the Harkin-Enzi substitute amendment, which is at the desk, be 
agreed to, and the bill, as amended by the Harkin-Enzi substitute, be 
considered original text for the purposes of further amendment, and 
that the majority leader be recognized at that time.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  Mr. REID. Mr. President, based on this, we will have a vote that 
should start in 5 minutes, which will be the only vote of the day.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the role.
  Mr. REID. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. REID. Mr. President, I yield back all time and ask unanimous 
consent that the vote start now.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. REID. Mr. President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The question is, will the Senate advise and consent to the nomination 
of Paul J. Watford, of California, to be United States Circuit Judge 
for the Ninth Circuit.
  The clerk will call the roll.
  The bill clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Missouri (Mrs. 
McCaskill) is necessarily absent.
  Mr. KYL. The following Senators are necessarily absent: the Senator 
from South Carolina (Mr. DeMint), the Senator from Nevada (Mr. Heller), 
the Senator from Illinois (Mr. Kirk), and the Senator from Louisiana 
(Mr. Vitter).
  Further, if present and voting, the Senator from South Carolina (Mr. 
DeMint) would have voted ``nay.''
  The PRESIDING OFFICER (Mrs. Hagan). Are there any other Senators in 
the Chamber desiring to vote?
  The result was announced--yeas 61, nays 34, as follows:

                      [Rollcall Vote No. 104 Ex.]

                                YEAS--61

     Akaka
     Alexander
     Baucus
     Begich
     Bennet
     Bingaman
     Blumenthal
     Boxer
     Brown (MA)
     Brown (OH)
     Cantwell
     Cardin
     Carper
     Casey
     Collins
     Conrad
     Coons
     Durbin
     Feinstein
     Franken
     Gillibrand
     Graham
     Hagan
     Harkin
     Inouye
     Johnson (SD)
     Kerry
     Klobuchar
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lugar
     Manchin
     McCain
     Menendez
     Merkley
     Mikulski
     Murkowski
     Murray
     Nelson (NE)
     Nelson (FL)
     Pryor
     Reed
     Reid
     Rockefeller
     Sanders
     Schumer
     Shaheen
     Snowe
     Stabenow
     Tester
     Udall (CO)
     Udall (NM)
     Warner
     Webb
     Whitehouse
     Wyden

                                NAYS--34

     Ayotte
     Barrasso
     Blunt
     Boozman
     Burr
     Chambliss
     Coats
     Coburn
     Cochran
     Corker
     Cornyn
     Crapo
     Enzi
     Grassley
     Hatch
     Hoeven
     Hutchison
     Inhofe
     Isakson
     Johanns
     Johnson (WI)
     Lee
     McConnell
     Moran
     Paul
     Portman
     Risch
     Roberts
     Rubio
     Sessions
     Shelby
     Thune
     Toomey
     Wicker

                             NOT VOTING--5

     DeMint
     Heller
     Kirk
     McCaskill
     Vitter
  The nomination was confirmed.
  The PRESIDING OFFICER. Under the previous order, the motions to 
reconsider are considered made and laid upon the table, and the 
President will be immediately notified of the Senate's action.

                          ____________________