[Congressional Record Volume 161, Number 171 (Thursday, November 19, 2015)]
[Senate]
[Pages S8153-S8154]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
NOMINATION OF DR. ROBERT CALIFF
Mr. ALEXANDER. Mr. President, I ask unanimous consent to have printed
in the Record a copy of my remarks to the Senate Committee on Health,
Education, Labor, and Pensions.
There being no objection, the material was ordered to be printed in
the Record, as follows:
NOMINATION OF DR. ROBERT CALIFF
Today we are reviewing the nomination of Dr. Robert Califf
to serve as Commissioner of Food and Drugs. Dr. Califf,
congratulations on your nomination. Welcome to you and to
your family members who are here. I enjoyed having the
opportunity to visit with you in my office.
If confirmed to lead the Food and Drug Administration (FDA)
as its Commissioner, you will be in charge of steering the
agency responsible for assuring the safety and effectiveness
of our nation's medical products and protecting our country's
food supply. That is a huge job. The FDA affects nearly every
single American and regulates about a quarter of all consumer
spending in the United States--over $4 trillion annually. It
is responsible for product areas as diverse as prescription
drugs for humans and animals, medical devices, biologics,
cosmetics, over-the-counter medications, food, and tobacco.
That is a vital mission, and we all want to make sure that
the right person is leading it.
The president has nominated you to do that job, and like
every full-time nominee, you've been through an exhaustive
process to make sure that you do not have any conflicts of
interest or other problems in your background.
Before the president even announced your nomination, there
was an extensive vetting process by the White House and the
FBI. You also submitted paperwork to the Office of Government
Ethics, which carefully reviewed your financial information
and found that, with several recusals which you have
committed to do, there would not be any remaining conflicts
of interest that would prevent you from doing your job. The
form you submitted is public and includes every source of
income over $200 and every asset worth more than $1,000, and
every potential conflict that the Office of Government Ethics
determined would require a recusal.
You answered 37 pages of questions from our committee,
including some confidential questions on financial
information, and responded to written follow-up questions.
Your responses included over 3,000 pages of articles and
lectures my staff reviewed and that any member of the
committee could review.
[[Page S8154]]
You were nominated on September 17. My staff has spent two
months carefully reviewing everything you submitted and has
not found anything that would call into doubt your ability to
lead the FDA fairly and impartially.
You come here today with impressive qualifications. You are
one the nation's leading cardiologists and have been a
professor at one of the nation's top medical schools for over
30 years. You are an expert on clinical research and have
been recognized by the Institute for Scientific Information
as one of the top 10 most cited medical authors, with more
than 1,200 peer-reviewed publications. You have experience
managing large organizations, including in your current
position supervising all of the FDA's work on medical
products and tobacco, and in your past work as the founding
director of the Duke Clinical Research Institute.
Moreover, you have conducted scores of important clinical
trials, and you have advised and worked on research with some
of the nation's leading pharmaceutical and biopharmaceutical
companies. So you understand how research gets done in the
real world, where there are opportunities for the FDA to help
address challenges, and where the FDA needs to get out of the
way.
I'm eager to hear about your priorities, and how you intend
to manage an organization as large and diverse as the FDA. I
also think everyone on this committee will have some
questions for you. Here are a few of mine.
First, I would like to hear what you will do to help ensure
that affordable drugs are available to American patients. The
FDA's job, of course, is not to set drug prices. It is to
make sure that drugs are safe and effective. And I hope
you'll agree with me on that. But FDA can help the market
lower drug prices by approving generic drugs and other
products as quickly as it possibly can, so there is more
choice and competition in the market.
There are thousands of applications for generic drugs
sitting at the FDA, awaiting approval. Addressing this
backlog will allow lower-cost drugs to be available for
patients. Approval times have gotten worse instead of better.
In 2011, the FDA published the median approval time on its
website, and it was 30 months. Since then, the FDA has
stopped publishing the statistics online, but the Generic
Pharmaceutical Association surveyed its members and estimates
that the median approval time is now about 48 months. This is
despite generic drugmakers agreeing in 2012 to give the FDA
approximately $1.6 billion in user fees over 5 years, nearly
$1 billion of which the FDA has already collected. I'm eager
to hear what you think the FDA can do to improve.
Second, there has never been a more exciting time to lead
the agency. We know more about biology and medicine than ever
before, and that's not likely to stop anytime soon given
advancement of regenerative cell therapies, 3D printing, and
the president's Precision Medicine Initiative--which is aimed
at developing our knowledge so that medical treatments and
devices can be tailored to individual patients. For example,
Smith & Nephew, a device company I toured in Memphis a few
weeks ago, uses 3D printing to make tools that doctors use in
approximately 25% of knee replacements.
Your job, if confirmed, will be to make sure that FDA
regulation is appropriate. Too much regulation could reduce
investment in these areas in its track, and not enough
regulation could lead to patients getting therapies that are
not safe or effective.
Your job also will be to make sure the FDA keeps up with
science and relies on the expertise outside the FDA when
appropriate. Doing that will require you to manage a large
and complex organization--not just on the big policies that
make headlines, but on the less flashy stuff like hiring and
training scientists on the agency's core mission, and
integrating information technology in the right ways.
There is work to be done. Medical products take more time
and money to discover, develop, and reach American patients
than ever before, and we hear stories about drugs and devices
that are available to patients outside the U.S. before they
become available here, often because it is difficult for
manufacturers to navigate the FDA's often unclear approval
requirements. It often takes over a decade to develop a drug
that gains marketing approval in the U.S., and, according to
one recent study, the costs have nearly tripled in the last
ten years. In 2003, it cost an inflation-adjusted $1 million
in capital and out-of-pocket expenses; in 2014, it cost over
$2.5 billion.
In this Committee, we are working on legislation to help
get safe cutting-edge drugs, medical devices and treatments
into Americans' medicine cabinets and doctors' offices more
quickly, and we hope to move on that by the end of the year.
I want to hear what you think the FDA can do to build its
capacity and fix the impact of its regulations so that the
FDA is a partner in innovation, rather than a barrier.
Thank you, and I look forward to hearing your testimony on
these important issues.
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