Several consumer groups are opposing President Obama’s choice of Robert Califf as the next FDA Commissioner, citing long-held financial ties to industry.

“The Senate should reject Califf and demand that the president nominate someone who has not been so closely connected to FDA-regulated industries,” said Michael Carome, director of Public Citizen’s Health Research Group.

On Sept. 15, the president announced his intention to nominate Califf, who has served as FDA's deputy commissioner for Medical Products and Tobacco since earlier this year. (See Also see "Duke's Califf Tapped For FDA Deputy Post; Some See Succession Planning" - Medtech Insight, 26 January, 2015..) Califf, who needs to be confirmed by the Senate before he takes the top post, is an internationally recognized researcher and cardiologist who spent most of his career at Duke, and has also served as an external advisor to FDA on regulatory issues, with a particular focus on clinical trial issues.

Industry and many research groups support the nomination, saying that Califf's expertise in clinical trials and regulatory issues, and knowledge of medical technologies make him uniquely qualified for the job. He is well versed on medical device issues and has put a particular focus on improving the review process for drug-device combinations since he joined the agency. (See Also see "FDA Nominee Califf Seeks Clinical Trial, Combo Product Reforms" - Medtech Insight, 15 September, 2015..)

But his long career as a researcher has led to significant financial ties to drug and device companies. That is a liability that will contribute to an over-eagerness to move new products onto the market quickly, argue Public Citizen, the National Center for Health Research and other groups.

“During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few,” Public Citizen's Carome commented. "Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed," he claimed.

Califf had to sever his financial ties to industry when he took his current leadership post at FDA. (See [A#00150202007].)

Focus On Health Concerns Urged

“With Dr. Califf, the industry ties concern me,” said Perry Menard, a Herndon, Va., consumer advocate who runs the websites Overy.org and Gynreform.com. “He wants to strengthen companies’ impact and get more products approved when what we really need is for him to step away from all these financial ties to industry, and pay more attention to patients’ needs,” she told "The Gray Sheet."

“I believe that FDA thinks their current role is to expedite medical product companies’ interests over our concerns – we need someone strong, who has a focus on science and medicine, and not money.” Menard cited her experience at a 2014 FDA advisory panel meeting addressing findings of elevated risks of spreading cancer with the use of laparoscopic power morcellators for hysterectomies. (See [A#01140721008].) She said physician advisors seem to be less interested in consumers’ opinions, and only interested in what fellow doctors were saying. “You can go into an advisory panel meeting and tell them that women are dying, but if doctors are sitting on the other side of the table saying 'that’s not an issue,' then FDA will come down on the side of the money, or only listen to what the doctors are saying,” Menard elaborated.

National Center for Health Research President Diana Zuckerman also mentioned Califf’s “close ties to the pharmaceutical industry” in a Wall Street Journal interview. “The ties raise important questions about this nomination,” she said.

But colleagues in the clinical and research community suggest such concerns are misguided.

"Dr. Califf is ... a physician with an understanding of what patients need with respect to access to the latest technology as well as to assurances of product safety," said Joseph Drozda, a cardiologist and director of outcomes research of Mercy Center for Innovative Care. "In recent years Dr. Califf has devoted his considerable talents to issues of significant public health importance. It is hard to imagine anyone more qualified to lead FDA," said Drozda, who has also worked closely with FDA, particularly on implementation of unique device identifiers.

“Besides a high level of integrity, [Califf] has a deep understanding of what needs to be done to strengthen postmarket safety monitoring of devices to avoid situations of the type we ran into with metal-on-metal hips and morcellators,” Drozda said.

Margaret Anderson, executive director of research advocacy group FasterCures, said Califf "understands that getting new medical products from discovery to patients requires all sectors – academia, industry, government, clinical care, nonprofits and patients – to work together throughout the research and development process.”

A Look At The Payments

“Dr. Califf is confident that he accurately and thoroughly disclosed all reportable payments through the Duke conflict of interest reporting system," an FDA spokeswoman said.

"The Gray Sheet" examined Califf's financial conflict of interest forms to Duke University for 2014, where he most recently served as director of Duke University’s Translational Medicine Institute and vice chancellor for Clinical and Translational Research." (See Exhibit 1.)

The data shows relationships with a range of companies, though more in the pharmaceutical arena rather than the device space.

Exhibit 1

2014 data accessed from Duke University Commercial Relationships Tracking Form for Robert M. Califf

Company

Research Grant Partially Supporting Salary

Consulting Services: <>

Consulting Services: $5K-$25K

Equity in Companies

Amylin

X

Amgen

X

Bayer Healthcare

X

BMEB Services LLC

X

BMS

X

Eli Lilly & Co.

X

Janssen R&D, LLC

X

Medscape LLC/ heart.org

X

Merck

X

X

N30 Pharma

X

Novartis

X

X

Portola

X

Regado NJ

X

Roche

X

"The Gray Sheet" also looked at some 2014 payments to Califf recorded by drug and device companies in the government's Open Payments database. (See Exhibit 2.)

Open Payments records device and pharmaceutical companies’ transfers of value to physicians, including consulting fees, travel and lodging expenses, investments, and research payments, and even food and beverage payments. Payments made by firms to doctors in 2014 were released in the Open Payments database on June 30, 2015. (See [A#01150706012].) Payments recorded in the database to Califf from industry in 2014 totaled about $30,000.

For company payments recorded for Califf in 2014 in the Open Payments database, the chart below reflects only consulting fees; Open Payments also shows what Califf received in food, beverage and travel and lodging expenses from medical product firms.

Exhibit 2

2014 data from Open Payments on consulting fees paid to Robert M. Califf

Company	Payment Type	Payment Date	Amount
Amgen Inc.	Consulting fee, third party	06/09/2014	$2,500
Amgen Inc.	Consulting fee, third party	07/29/2014	$1,500
Amgen Inc.	Consulting fee, third party	07/29/2014	$4,000
Amgen Inc.	Consulting fee, third party	10/17/2014	$1,250
Amgen Inc.	Consulting fee, third party	12/12/2014	$312
Daiichi Sankyo Inc.	Consulting fee, third party	10/14/2014	$3,000
F. Hoffmann-La Roche AG	Consulting fee, third party	03/28/2014	$720
Merck Sharp & Dohme Corp.	Consulting fee, third party	10/07/2014	$6,450
Merck Sharp & Dohme Corp.	Consulting fee, third party	12/10/2014	$3,937
Sanofi-Aventis U.S. LLC	Consulting fee, NO third party	11/17/2014	$1,190

Records Mismatch

Entries in Duke University’s conflict-of-interest disclosures for Califf in 2014 do not always match up to the Open Payments database for a variety of reasons.

For example, Duke reported that Bayer Healthcare, BMEB Services LLC, Medscape LLC/Heart.org and Regado NJ gave Califf less than $5,000 each in 2014, but the payments are not reflected in Open Payments. Also, Duke reported Novartis paid Califf between $5K-$25K, but that transfer is not listed in Open Payments.

The consulting services payment that Regado NJ gave to Califf was not reported because the company was a startup with no sales in 2014, and exempt from Open Payments reporting requirements, according to Tobira Therapeutics Inc., which merged with Regado Biosciences Inc. in January.(See [A#00150126014].)

In addition, Bayer Healthcare told "The Gray Sheet": “Bayer can confirm that in 2014 we contracted with Faculty Connection, LLC of Durham, N.C., for consulting services in the cardiovascular area. Faculty Connection is a consulting company that works with biomedical and clinical researchers to provide services to health care companies. As stated in the Consultation Agreement between Bayer and Faculty Connections, a presentation was to be made by Dr. Califf related to cardiovascular disease. Faculty Connection is neither a CMS covered teaching hospital nor on the list of accepted accredited organizations subject to reporting on the CMS Open Payments database.”

Also, equity in companies N30 Pharma (now Nivalis Therapeutics) and Portola – which Califf reported and shows up in the Duke reports – are missing, also perhaps due to the start-up exemption.

Further, Open Payments records a $1,190 consulting fee to Califf from Sanofi-Aventis on Nov. 17, 2014, that Duke University did not record.

Consumer Groups Oppose Califf To Head FDA, Citing Industry Ties

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