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A headshot photo of Robert Califf. He is wearing a dark grey suit with a purple tie and white button up shirt. He is a white man with brown hair. He is smiling directly at the camera. The background has an American flag.

Robert M. Califf, MD

Candidate For FDA Commissioner

Robert Califf is a cardiologist and academic researcher who has previously served as the Food and Drug Administration (FDA) commissioner during the Obama Administration. Califf has spent much of his career at his alma mater Duke University in a number of leadership roles. Although significant changes to labeling for Mifepristone (also known as Mifeprex®) were made during his tenure as commissioner, as of 11/12/21, Equity Forward did not find sufficient evidence to categorize Califf as a supporter of reproductive rights and LGBTQIA+ equity.

Califf Was Reported As A Candidate For Commissioner Of The Food And Drug Administration (FDA) In October 2021 And Named As President Biden's Nominee In November 2021

It Was Announced On October 14, 2021 That The White House Was Considering Califf To Lead The FDA Once Again. “The White House is closing in on former Food and Drug Administration commissioner Robert M. Califf as its choice to serve again as agency chief, according to five people who spoke on the condition of anonymity to detail the discussions. The agency, which has been overseen by acting commissioner Janet Woodcock, has been without a permanent leader for more than eight months during a health crisis that has subjected its decisions to unprecedented scrutiny. Under federal law, President Biden faces a mid-November deadline to either nominate Woodcock or pick an alternate leader for the agency, which plays a central role in regulating vaccines, therapies and other medical products. A White House official said no final decision has been made, and Biden did not respond to questions after delivering prepared remarks Thursday on his administration’s coronavirus response. Califf, a professor of cardiology at Duke University School of Medicine, declined a request for comment.” [The Washington Post, 10/14/21].

President Biden Announced Califf As His FDA Commissioner Nominee On November 12, 2021. [The White House, 11/12/21]

As Commissioner Of The FDA Under Obama, Califf Made Moves To Increase Access To Mifepristone But Kept Measures In Place Which Severely Limited How The Drug Could Be Dispensed

As Commissioner Of The FDA Under Obama, Califf Made Moves To Increase Access To Mifepristone But Kept Measures In Place Which Severely Limited How The Drug Could Be Dispensed

Under Califf’s Leadership, The FDA Approved Updated Labeling Of Mifepristone, A Move That Affirmed The Safety Of Medication Abortion. “On March 29, 2016, the U.S. Food and Drug Administration (FDA) approved updated labeling for mifepristone (also known as the abortion pill or by its brand name, Mifeprex®), which is prescribed along with another medication, misoprostol, for medication abortion in the United States. The FDA’s move to change the label is important in many ways. Although off-label use of drugs is generally accepted in the United States, many clinicians see FDA labels as guides to appropriate and legally defensible clinical practice. First and foremost, the label update reaffirms that medication abortion is very safe and highly effective. It also has the potential to increase access to medication abortion in this country.” [Guttmacher, 6/30/16]

The Updated Labeling Allowed For More Patients To Be Eligible For Abortion Care Via Mifepristone. “One of the most significant changes to the mifepristone label is an increase in eligibility from 49 days’ to 70 days’ gestation. This change is supported by substantial evidence demonstrating that the mifepristone/misoprostol regimen is safe and effective through the 10th week of gestation. This change has significant implications for access to medication abortion: Under the original protocol, just 37% of all U.S. abortions were eligible for mifepristone, but as a result of the updated protocol, the proportion of all abortions now eligible has doubled to 75%.” [Guttmacher, 6/30/16]

Increased Eligibility Meant Patients Could Access Abortion Care Earlier In Pregnancy. “In addition to increasing eligibility for medication abortion, the mifepristone label update will likely strengthen an existing trend towards earlier abortions. According to data from the Centers for Disease Control and Prevention, the timing of abortions has shifted to earlier in the first trimester over the past decade, likely due in part to the availability of medication abortion. Additionally, although the overall number of abortions in the U.S. has been declining since the 1990s, the share of abortions performed using medication has increased, from 6% of all abortions in 2001 (one year after mifepristone was approved) to 23% of abortions in 2011 (the most recent year for which data are available).” [Guttmacher, 6/30/16]

In Short, The FDA’s Decision Increased Abortion Access And Affirmed The Importance Of Evidence-Based Policy. “In addition, North Dakota, Ohio and Texas require that mifepristone be provided in accordance with the FDA-approved label. In these states, the updated label will likely improve current access to medication abortion; however, these state laws do not allow for additional improvements in practice if further advances are made to the medication abortion regimen. For example, research has found mifepristone to be effective in facilitating some second-trimester abortion procedures, but these practices will not be permitted in these states. Similarly, if research uncovers further improvements to the early medication abortion regimen, these state laws will prevent implementation of those improvements to medical practice. The FDA’s decision to update the mifepristone label will help ensure that individuals seeking abortion have easy, safe access to a medication option. In turn, the label change is a validation of clinical research showing that this protocol is safe, effective and medically sound.” [Guttmacher, 6/30/16]

In Addition To Changing Label Requirements, The FDA Approved A Research Study To Examine Telemedicine Abortion, Which Lifted Risk Evaluation And Mitigation Strategy (REMS) Barriers For Those Participating In The Study. “Also in 2016, the FDA approved a research study on telemedicine abortion, a research exception to the REMS restriction called TelAbortion, run by Gynuity Health Projects. Under the study, clinicians are able to provide medication abortion care by videoconference and mail the pills to patients.” [Ms., 9/27/21]

However, For The General Public, Access To Mifepristone Was Limited By REMS And Only Permitted To Be Dispensed Under A Health Care Provider’s Supervision... “Under this restriction, the FDA prohibited retail pharmacies from stocking and distributing mifepristone, instead requiring mifepristone to be dispensed in a doctor’s office, clinic or hospital registered with the drug manufacturer. The FDA allowed use of mifepristone only in the first seven weeks (or 49 days) of pregnancy and required patients to take the medication in the doctor’s presence. This meant patients had to make three visits to their healthcare providers to obtain the medication.” [Ms., 9/27/21]

…And Although Changes Were Made To Mifepristone REMS In 2016, The In-Person Requirement Remained. “Another example of a modification to the Mifeprex REMS in 2016 was changing the provider reporting requirement to mandate reporting only of deaths (whereas the reporting of ongoing pregnancies, hospitalizations, transfusions, or other serious adverse events had previously also been required) [[25]].The modified Mifeprex REMS still requires, however, that Mifeprex be dispensed in person to patients only in clinics, medical offices, or hospitals by or under the supervision of a prescriber certified to participate in the Mifeprex REMS [[26]]. The modified REMS also continues to require that patients complete the Patient Agreement [26]].” [Contraception, 4/24/21]

A Hawaiian Doctor, Alongside The ACLU, Sued The FDA Over REMS, Citing The Restrictions Made Abortion Care Inaccessible To His Patients On The Hawaiian Islands. “"The current [Trump] administration is trying to portray itself as the most anti-choice, anti-abortion administration in history. So, yes, I think there is pressure on people at the FDA to continue to restrict access to the abortion pill," she told IHP. It's not the first time FDA has been accused of letting politics dictate its decisions on mifepristone. The American Civil Liberties Union's 2017 suit against FDA says former FDA chief Robert Califf, who led the agency under the Obama administration, overruled the FDA's drug review team when it recommended removal of one of the REMS requirements. ACLU noted it was an "unusual interference" consistent with past FDA decisions made due to political pressure.” [Inside Health Policy, 10/20/20, accessed via LexisNexis].

Califf Described That In His Opinion, Politics Should Be Kept Out Of Science

Califf Described That In His Opinion, Politics Should Be Kept Out Of Science

At The Time Of His Departure From The Role of FDA Commissioner At The End Of The Obama Administration, Califf Argued That Political Appointees Should Not Make Decisions About Individual Medical Products. “Political appointees should not be making decisions about individual medical products,” Califf says. “Political appointees, in my view and in the history of the FDA, should not be interfering, because once that happens for the wrong reason, how do you ever stop politics from dominating this arena?” [Forbes, 1/23/17]

Califf Has Advocated For Improved Healthcare Quality

Califf Has Advocated For Improved Healthcare Quality

Califf Has Pushed For Expanding COVID-19 Vaccine Availability Globally. “Califf, who has advised Google and its spinoff, Verily Life Sciences, since leaving the Obama administration, has also focused on combating chronic disease. He was among the experts who pressed the Biden administration to take more action on the global vaccine response this summer, warning the long-lasting effects of coronavirus is likely to plague the U.S. health system for years to come.” [The Washington Post, 10/14/21].

During His Time At Duke University, Califf Has Worked To Improve Methodologies Of Clinical Research. “While at Duke, Dr. Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke's Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center.” [FDA, 2/21/20].

Califf Has Supported Breaking Down Outcomes Research And Data To Be More Accessible To All. “Califf has spent more than 35 years in leadership roles at his alma mater, Duke University School of Medicine, plus more in training and fellowship programs. His career at Duke has been entwined with data science and outcomes research, and he has been a longtime advocate for breaking down research and data silos.” [Fierce Healthcare, 12/23/19].

In An Interview, Califf Discussed The Challenges Translating Health Data To Actionable Steps For Individuals. “The question is, how do we take that data and turn it into actionable information so it's appealing to people so their behavior changes to lead to healthier lives? That is a huge problem. We carry cell phones around for instant gratification, but improvement of health is the opposite — to not smoke that cigarette, to take your exercise, to eat a healthy diet, take your pills. Those are the opposites of instant gratification. We will see amazing advances in what people need to do, but the challenge is how to translate that into action.” [San Francisco Business Times, 5/18/17].

Califf’s Medical Research Is Highly Regarded

Califf’s Medical Research Is Highly Regarded

Califf Is A Nationally And Internationally Recognized Expert In Health Outcomes Research And Has Hundreds Of Peer-Reviewed Publications. “A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.” [FDA, 2/21/20].

Califf Has Served On Several National Organizations, Committees, And Boards. “Dr. Califf became a Member of the National Academy of Medicine (formerly known as the Institute of Medicine (IOM)) in 2016, one of the highest honors in the fields of health and medicine. Dr. Califf has served on numerous IOM committees, and he has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging.” [FDA, 2/21/20].

In A Number Of Tweets, Califf Has Advocated For Increased Clinical Research On And For Pregnant People

In A Number Of Tweets, Califf Has Advocated For Increased Clinical Research On And For Pregnant People

A January 2020 Tweet By Califf Called For Federal Funding To Investigate Maternal-Fetal Interactions.

 

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[Robert Califf Twitter, 1/23/20].

 

Califf Amplified A Tweet Which Called For Increased Enrollment Of Women And Pregnant People In Clinical Trials.

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[Robert Califf Twitter, 5/23/18]

Califf Has Faced Criticism For His Ties To The Pharmaceutical Industry

Califf Has Faced Criticism For His Ties To The Pharmaceutical Industry

During His First Confirmation For Commissioner For The FDA in 2016, A 2014 Financial Disclosure Revealed Large Drug Making Companies Had Contributed To Califf’s Salary And Funding For Research Studies. “Democratic presidential candidate Sen. Bernie Sanders (Vt.) has staunchly opposed Califf’s confirmation, insisting that his professional history — a 2014 financial disclosure showed his salary at Duke was underwritten partly by funding from large drugmakers such as Eli Lilly and Merck, and drug companies helped fund research studies he oversaw — would prevent him from aggressively regulating the industry and looking out for ordinary patients.” [The Washington Post, 2/24/16].

Senator Bernie Sanders and Senator Joe Manchin Have Criticized Califf’s Receiving Of Consulting Fees From Pharmaceutical Companies. “Califf, a cardiologist, served as FDA commissioner for less than a year at the end of Barack Obama’s presidency, after being confirmed in an 89-4 vote in February 2016. His confirmation process faced resistance from lawmakers like Sens. Joe Manchin III (D-W.Va.) and Bernie Sanders (I-Vt.), who criticized the longtime Duke University researcher’s ties to pharmaceutical companies that helped fund his work and paid him significant consulting fees.” [The Washington Post, 10/14/21].

Concerns Have Been Raised About Califf’s Previous Work With Verily, A Research Organization Formerly Apart of Google. “Watchdogs said they were reviewing Califf’s regulatory decisions from his first term at FDA, and some predicted his industry ties would complicate his nomination and possible agency leadership.“It would obviously improve Verily’s prospects on the markets if everyone knows they have a friend in charge of the agency approving their products,” said Jeff Hauser, who leads the Revolving Door Project, part of the Center for Economic and Policy Research, a progressive think tank. “There are plenty of other, highly qualified doctors and leaders who don’t bring his corporate ties to this most crucial agency.” [The Washington Post, 10/14/21].

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