Alexander: We Must Ensure the Right Person is Leading FDA, an Agency that Affects Nearly Every Single American & Regulates Over $4 Trillion Annually

At nomination hearing, Alexander asks how Dr. Califf will address FDA’s backlog of generic drugs to help the market lower drug prices, ensure agency’s regulations encourage innovation without sacrificing safety, effectiveness

Posted on November 17, 2015

WASHINGTON, November 17 – At today’s hearing to consider the nomination of Dr. Robert Califf to head the Food and Drug Administration (FDA), the Senate health committee chairman said we must ensure the right person is leading the agency, which “affects nearly every single American and regulates about a quarter of all consumer spending in the United States—over $4 trillion annually.”

At the hearing, Sen. Lamar Alexander (R-Tenn.) said the first thing he would like to hear from the nominee is how he would “help ensure that affordable drugs are available to American patients. The FDA’s job, of course, is not to set drug prices,” Alexander said. “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.”

Alexander asked Califf how he would address the FDA’s backlog of generic drugs—which has increased from a median time of 30 months, according to the FDA website in 2011, to 48 months, according to a survey of generic drugmakers. “This is despite generic drugmakers agreeing in 2012 to give the agency approximately $1.6 billion in user fees over 5 years, nearly $1 billion of which the FDA has already collected,” Alexander said.

Second, Alexander noted that with today’s knowledge of biology and medicine—which is greater than ever before—and advancements like regenerative cell therapies, 3D printing, and the president’s Precision Medicine Initiative—“there has never been a more exciting time to lead the agency.”

“Your job, if confirmed, will be to make sure that FDA regulation is appropriate,” Alexander said. “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.”

At the hearing, Alexander said Califf had been through an “exhaustive process”—including vetting by the White House, the FBI, and responding to questions from the Senate health committee. “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,” Alexander said.

Alexander noted Califf has impressive qualifications as a leading cardiologist, a professor at one of the nation’s top medical schools for over 30 years and expertise in clinical research—with recognition from the Institute for Scientific Information as one of the top 10 most cited medical authors.

“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,” Alexander said.

“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 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.”

The chairman’s prepared remarks follow:

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. 

  

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