Speeches & Floor Statements

Floor Remarks: Cloture on Dr. Robert Califf to lead FDA

Posted on February 22, 2016

I join the Senator from Washington state in urging our colleagues to vote to end debate on the nomination of Dr. Califf and then to vote for him.

We are very fortunate to have a man of this distinction accept this position. I congratulate the President for his nomination. I note, as the Senator from Washington said, that his nomination has been widely applauded across this country and received strong bipartisan support in our committee after an intense investigation.

I ask unanimous consent to have printed in the record, following my remarks, a list of 124 organizations that have submitted letters in support of Dr. Califf's nomination to our committee. The list does not include press releases or other statements of support that were not submitted to the committee.

Dr. Califf will be in charge of the Food and Drug Administration. That agency is responsible for the safety and effectiveness of our nation's medicines, devices, and other medical products in protecting our country's food supply.

It is not too much to say that this job affects virtually every single American. It is a huge job. The FDA affects nearly every single American and regulates about one-quarter of all consumer spending in the United States—about $4 trillion annually. It is responsible for product areas as diverse as prescription drugs for humans as well as for animals, for medical devices, for biologics, for cosmetics, over-the-counter medications, food and tobacco.

To accomplish this, the FDA employs 15,700 full-time employees worldwide, with an annual total budget of $4.505 billion from funds appropriated by the Congress and user fees paid by the industries it regulates. Managing an enterprise of this size is no small undertaking. It requires strong leadership and a steady hand.

Last year, on September 17, the President nominated Dr. Califf. My staff and I reviewed the nomination carefully. I found him to be well qualified to take charge of the FDA. He is one of the nation's leading cardiologists. He was a professor at one of the nation's top medical schools for over 30 years. He is an expert on clinical research. He has been recognized by the Institute for Scientific Information as one of the top 10 most cited authors, with more than 1,200 peer-reviewed publications. He has managed large organizations, including the Duke Clinical Research Institute as a founding director. In his current position, he is FDA's Deputy Commissioner for Medical Products and Tobacco, in which capacity he oversees the regulation of products including human drugs, biological products, medical devices, and tobacco.

He has conducted scores of important clinical trials and has advised and worked on research with some of the nation's leading pharmaceuticals and biopharmaceutical companies.

In addition, Dr. Califf, like every full-time nominee, has been through an in-depth process to review his background. Before the President even announced his nomination, there was an extensive vetting by the White House and the FBI. He submitted paperwork to the Office of Government Ethics, which carefully reviewed that information looking for conflicts of interest.

The form he submitted is public and includes every source of income over $200, every asset worth more than $1,000, and every potential conflict that the Office of Government Ethics determined would require a recusal.

Before our committee held a hearing, Dr. Califf answered 37 pages of questions from the bipartisan leadership of the committee, including confidential questions on financial information, and he responded to written follow-up questions.

His responses included over 3,000 pages of articles and lectures my staff and Senator Murray's staff reviewed and any Member of the Senate could review.

On November 17, the HELP Committee held a hearing on his nomination. He provided testimony and took questions. Afterward, he answered 100 pages of written questions. Throughout this process, we have carefully reviewed everything submitted and not found anything that would call into doubt Dr. Califf's ability to lead the FDA fairly, ably, and impartially.

I am pleased to support his nomination. I am pleased the full Senate now will have an opportunity to vote on that nomination in a prompt way.

Dr. Califf's nomination comes at an important time for the FDA. For the past year, the FDA has been operating without a confirmed Commissioner. There are important issues there. It needs a confirmed Commissioner to provide the leadership that will carry the agency into the future.

One issue that has been on many of our minds is how to make sure American patients have access to affordable drugs. Of course, the FDA's job is not to set drug prices. I am pleased Dr. Califf agreed at his confirmation hearing that he understands the FDA's role is to make sure that drugs are safe and effective, not to regulate their price, but the FDA can help 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, and reviewing new applications as expeditiously as possible, will allow lower-cost drugs to be available to patients. I am confident the FDA can improve its performance. Just last month, our committee held a hearing on this issue and the FDA was optimistic about making progress.

We also needed a confirmed Commissioner who can guide the agency to make sure it keeps pace with medical innovation. There has never been a more exciting time in medical research than today. We know more about biology and medicine than ever before, and knowledge is being applied in innovative ways.

We are talking about actually curing, not just treating cancers. We are using 3-D printing to help doctors replace knees. In one case the FDA has approved a drug to treat epilepsy that is made by 3-D printing. The President has announced a Precision Medicine Initiative designed to promote personalized treatments to take into account an individual's genes, environment, and lifestyle. These are exciting developments.

First, the FDA needs to make sure that regulation is appropriate. Too much regulation could reduce investment. Not enough regulation could lead patients to getting therapies that are not safe and effective.

At the same time, the FDA will need to make sure its policies and its procedures, many of which were adopted decades ago, are capable of addressing the technologies of today and tomorrow. Second, as we continue to make medical advances, the FDA will need to keep up with the science and rely on expertise outside the FDA when appropriate. Doing that will require a leader who can manage a large and complex organization—not just on big policies that make headlines but on day-to-day matters such as hiring and training scientists on the core mission and integrating information technology.

Medical products take more time and money to discover, develop, and reach American patients than ever before. We hear stories about drugs and devices that are available to patients outside the United States 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 United States. According to one recent study, the costs have tripled in the last 10 years.

Senator Murray and I are working with our colleagues on our committee on bipartisan legislation to help get safe, cutting-edge drugs, medical devices, and treatments into Americans' medicine cabinets and doctors' offices more quickly.

We held a markup on February 9, in which we approved seven important bills with bipartisan support that will help both manufacturers and the FDA to get innovative treatments to patients more quickly. They are all bipartisan bills.

Senators Bennet, Warren, Burr, and Hatch offered the Advancing Targeted Therapies for Rare Diseases Act of 2015, S. 2030. If you are the parent of a child suffering from a rare disease like Cystic Fibrosis, this bill increases the chances that researchers will find a treatment or cure for your child's disease. It does that by allowing researchers to reuse good data they have collected, because it is hard to find enough patients for a clinical trial studying a rare disease with multiple genetic mutations.

Senators Burr and Franken offered the FDA Device Accountability Act of 2015, S. 1622. If you are one of the millions in our country who will need a medical device such as a pacemaker or knee implant, this bill will help drive the faster development of better devices—cutting unnecessary red tape from the review process for these devices.

Senators Baldwin and Collins offered the Next Generation Researchers Act, S. 2014. If you are a smart young scientist who wants to find a cure for cancer, this bill will help the National Institutes of Health create opportunities for you to get funding for your research, so that you don't head to another country or into another field. It will also help you pay back more of your student loans.

Senators Kirk, Bennet, Hatch, Murkowski, Isakson, and Collins offered the Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act, S. 800. If you are one of the millions of Americans with disabilities, illnesses and chronic conditions that require medical rehabilitation—maybe you suffered a stroke and need to relearn how to walk—this bill will help ensure that the government is supporting research that will help you have the best chance at rehabilitation.

Senators Isakson and Murphy offered the Advancing Research for Neurological Diseases Act of 2015, S. 849. If you are the child of a parent with Parkinson's, this bill will help speed a treatment or cure for your parents' disease by helping researchers have access to more data on neurological diseases.

Senator Murray offered the Preventing Superbugs and Protecting Patients Act, S. 2503. If you suffer from something as common as indigestion, or perhaps something scarier like cancer, that requires putting a scope down your throat to diagnose or better understand your ailment, and this bill will help ensure that the scope the doctor uses is clean and doesn't give you an infection.

I offered with Senator Murray the Improving Health Information Technology Act, S. 2511. If you are anyone who has ever changed doctors or needs to see a specialist and you want to be sure the new doctor you are seeing knows your medical history so he or she can help you best, this bill takes several steps to get health records flowing between doctors, hospitals, and patients to help realize the promise of health information technology by turning these systems from something that doctors and hospitals dread into something that actually helps patients.

We will be taking up more of these proposals in March and in April.

The next FDA Commissioner will have a lot of work to do, both to implement the legislation we are passing and to take the existing authority and make sure we help patients as best we can. He will be dealing with one-quarter of the consumer spending in the United States and affecting virtually every American. He is the right person for this job.

I strongly encourage my colleagues to vote for Dr. Califf, first today, to end debate on the nomination, and tomorrow, once that has ended, to confirm him in this important position.

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