Alexander Concerned That Right Person Leads The FDA

  • Tuesday, November 17, 2015
The Senate Health Committee Chairman Senator Lamar Alexander 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 Tuesday's hearing to consider the nomination of Dr. Robert Califf to head the Food and Drug Administration,

At the hearing,  Sen. Alexander 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. 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.”

Sen. Alexander asked Dr. 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,” Sen. Alexander said.

Second, Sen. 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,” Sen. 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, Sen. Alexander said Dr. 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,” Sen. Alexander said.

Sen. Alexander noted Dr. 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,” Sen. 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.”
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