Updated 11/21/15 6:45 p.m.
President Obama's nominee to lead the Food and Drug Administration temporarily recused himself from overseeing several large pharmaceutical companies due to potential conflict of interests in order to comply with federal ethics rules.
Several of those recusals have since expired, however, and in his current position as a federal employee, several others will end in the next few months, allowing Dr. Robert Califf to oversee multi-million dollar decisions affecting his former clients, which include such big names as AstraZeneca and Novartis. If confirmed, Califf would be subject to further recusals under administration policy.
Califf is a widely respected cardiologist with years of experience in the design of clinical trials. His nomination has come under scrutiny as critics argue that the drug industry has undue influence over drug approval and monitoring at the FDA, and that the agency no longer adequately performs its primary mission of ensuring the safety and efficacy of new drugs and medical devices.
At issue is consulting Califf did for a company called Faculty Connection LLC when he was a professor and administrator at Duke University. On Sept. 21, a little less than two months before a Senate hearing on his nomination, Califf wrote the ethics officer of the Health and Human Services department to say that that he would temporarily recuse himself from matters involving several large pharmaceutical companies in order to avoid any “actual or apparent conflicts of interest” if he were confirmed.
Neither Califf’s letter to the ethics officer nor his personal financial disclosure statement, also submitted in September, indicate what services he provided the companies. The personal financial disclosure says that he received “more than $5,000” each from five of the companies, as well as Roche Pharmaceuticals and Genentech. His 2014 financial disclosure statement at Duke indicates he was paid between $15,000 and $75,000 annually by three companies from whose dealings he has recused himself: Amgen, Inc., Merck & Co., Inc., and Novartis AG.
Since then, several of the recusals have expired. The other recusals will expire either before his nomination receives a vote in the Senate or by the end of February next year. The four other companies involved are AstraZeneca PLC, Daichi Sankyo Inc., Medscape, LLC, and Sanofi SA.
Califf declined to be interviewed for this article. In a February interview with TIME he said that there is “a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive, and the FDA’s got to do both.”
In response to questions submitted after Califf's nomination hearing, the FDA said that the goals of Faculty Connection were to "contribute the knowledge of Duke's leading scholars to the development of new medicines and technologies" and to "maintain the intellectual independence of Duke scholars and to assure compliance with all rules and regulations regarding conflict of interest." The agency said the expiration of the recusals was the result of regulations issued by the U.S. Office of Government Ethics, which require a one-year recusal measured from the last date on which the incoming employee provided services to the entity.
Califf is unquestionably qualified to lead the FDA. Along with an illustrious career in cardiology, he is among the most widely cited authors in peer-reviewed articles and is a leader in the design of clinical trials. Long-time FDA and industry critic, Dr. Steven Nissen of the Cleveland Clinic, told the New York Times in September that Califf’s “integrity in scientific matters is impeccable, and his innovation in clinical trial design is legendary.”
Still, there are concerns. A recent report by the Project on Government Oversight found FDA reviewers and outside consultants had sharply criticized a clinical trial of the $1.5 billion per year blood thinner Xarelto co-chaired by Dr. Califf. The POGO report found some reviewers concluded that parts of the trial were managed poorly and that “lack of care in designing and conducting” the clinical trial “could have resulted in some Xarelto subjects suffering unnecessary strokes.” A second report out this week from POGO says Duke is now reviewing the Xarelto study in light of additional shortcomings uncovered by the whistleblower organization.
Xarelto was cleared for sale in 2011, and the FDA stands by its approval of the drug. "This class of drug has proven safe and effective in trials and in post-marketing assessments," the FDA said in an e-mail to TIME.
At Califf’s nomination hearing Tuesday, Massachusetts Sen. Elizabeth Warren, who has gone to bat for medical device companies in the past, asked Califf whether drug companies had exerted influence over drug trials at Duke while he was there. Califf responded that while there was regularly “input” from companies sponsoring drug trials, design, analysis and publication could only be changed with the consent of the academic researchers.
Warren also asked Califf whether he supported lowering regulatory standards at the FDA. He responded, “If you look at my record, you will find I have never been a proponent of lowering standards; if anything I’ve argued for raising standards.”
Vermont Sen. Bernie Sanders, also a member of the Health, Education, Labor and Pensions Committee which has jurisdiction over the nomination, said he would not support Califf for the position because of his close ties to industry.
Over the years, some drug companies have become adept at boosting their profits by gaming uncertainty in drug and medical device testing to their advantage, sometimes at increased risk to patients. Critics say that by intertwining themselves ever more deeply into the academic and regulatory worlds where drugs are developed, the companies unduly affect decision-making on the safety and efficacy of drugs and medical devices.
The Califf nomination comes at what Harvard Professor Daniel Carpenter, an expert on the history of the FDA, has called a “deregulatory moment” at the agency. The House has moved a bill that would change how drug testing is done, including speeding some drugs to the market. Critics worry it would “bring back some of the problems we thought we had left behind in the 20th century.” The Senate is taking a long, thorough look at FDA reforms through hearings and sub-committee investigations to come up with its own bipartisan bill, expected later this year or early next.
Califf is in many ways the personification of the tension between increased efficiency and potential conflict of interest brought by close collaboration between academia, industry and government in the research and development of medical products. Both the Democratic and Republican leaders of the committee, and many others on the panel, made clear at the hearing that they will support him.
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This story has been updated to reflect that if confirmed, Califf would be subject to further recusals under administration policy.