Advocacy News

March 1, 2016



Advocacy at #AAOS2016 Annual Meeting

New Annual Meeting Symposium: Medicare PQRS Pathways for Payment

2015 EHR “Meaningful Use” – Hardship Exemption Deadline Extended

House and Senate Hearings on HHS Budget

Election 2016 Graphic of the Week

Senate Finance on Examining the Opioid Epidemic

What We’re Reading

Senate Confirms New FDA Commissioner

ONC Introduces Interoperability Proving Ground

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Senate Confirms New FDA Commissioner

On February 24, 2015, the Senate confirmed Robert Califf by a vote of 89-4 as the new Food and Drug Administration (FDA) commissioner. There had been some opposition from lawmakers who were protesting the agency’s role in the prescription painkiller epidemic, but Senate Majority Leader Mitch McConnell (R-KY) pushed the nominee forward with bipartisan support. The FDA, responsible for regulating industries that account for about 25 percent of consumer spending in the United States, had been without a Senate-confirmed leader since Margaret Hamburg left the post last March.

“Today the U.S. Senate voted in support of the confirmation of Dr. Robert Califf, M.D. to be Commissioner of U.S. Food and Drug Administration,” Dr. Stephen Ostroff stated on behalf of the FDA. “Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine. He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public, across the many areas we regulate – and I am confident that our public health and scientific contributions will further grow under his exceptional leadership.”

Sen. Patty Murray (D-WA) praised Califf's research accomplishments and track record of transparency in working with industry, arguing he would be a strong agency leader and partner to Congress.

“He has made clear he will continue to prioritize independence as commissioner at the FDA and continue to put science over politics,” she stated before the vote.

Califf joined the FDA as deputy commissioner for medical products and tobacco in January 2015 where he provided executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Healthand the Center for Tobacco Products. Prior to working at the FDA, Califf was vice chancellor of clinical and translational research at Duke University. Other prominent roles during his tenure at Duke include director of the Duke Translational Medicine Institute (DTMI), and professor of medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina.

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Califf enters the role at a critical time for the FDA, with drug and medical device user fee pacts under renegotiation, the White House’s cancer Moonshot and Precision Medicine Initiative gaining momentum, and legislation moving through Congress focused on FDA reforms (read more in an earlier Advocacy Now article). Still, there is less than a year left in the current administration leaving Califf with little time to make a meaningful impact. He could make a play to stay on into the next administration, but will likely focus on a few legacy items and stewarding FDA through its current initiatives.