[Congressional Record (Bound Edition), Volume 161 (2015), Part 13]
[Senate]
[Page 18596]
[From the U.S. 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.
       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.

                          ____________________