[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.
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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
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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.