An interesting side note to Robert Califf’s decision to leave Duke University and become FDA deputy commissioner for medical products and tobacco may be how he unwinds the industry ties that he cultivated while in academia.

Not surprisingly, several pharma companies have worked with the renowned cardiologist and clinical trialist over the years. And most, if not all, of them likely would have to be severed to take the government job, since employees and their immediate families, save some exceptions, cannot have a financial interest in a regulated organization, according to FDA ethics rules (see tableat end of story).

FDA said Jan. 26 that Califf would start in his new position in late February. It is unlikely the new position would allow Califf time for consulting, even if it was permitted. Former FDA officials expect he will be overseeing a number of agency priority issues once he joins the agency (see[A#00150202008]).

His disclosure lists are not heavily detailed, but it is possible the loss of consulting fees and related compensation could prove a significant dent in Califf’s overall income. The annual revenue he reported on Duke University tracking forms could have been more than $100,000 or $200,000 in many years from 2007 through the majority of 2014, although the potential maximum payments he could have received has decreased in recent years (see charts below).

FDA job notices listed the salary for the deputy commissioner position as between $119,554 and $250,000, depending on the federal mechanism used to make the hire Also see "FDA Ready To Hire New Deputy Commissioner For Medical Products And Tobacco" - Pink Sheet, 16 August, 2013..

Industry ties also could become an issue if, as a number of people expect, Califf becomes the frontrunner to be the next FDA commissioner Also see "FDA Lands Duke’s Califf As Top Deputy, Potential Next Commissioner" - Pink Sheet, 26 January, 2015..

The number of companies paying Robert Califf fees for consulting and other services, including continuing medical education, has decreased in recent years. From 2012 through most of 2014, most companies paid $5,000 or less, according to data on his commercial relationships released by Duke University.

*2014 data includes January through September only.

Source: Data contained in Duke Clinical Research Institute commercial relationship tracking forms. The organization changed its disclosure requirements in 2012, lowering the initial benchmark to $5,000.

Two Company Equity Stakes

Califf listed two companies in which he or a family member owned a stake greater than $5,000 or 1%: Nivalis Therapeutics Inc. and Portola Pharmaceuticals Inc., according to a January-September 2014 Duke Clinical Research Institute commercial relationship tracking form. He listed the same stakes in 2012 and 2013.

Portola released a statement shortly after FDA announced his hire saying that Califf had retired from its board of directors. He was first elected to the board in 2012.

“I want to thank Rob for his invaluable contribution in helping to advance Portola's groundbreaking clinical trials program across our pipeline,” Portola CEO Bill Lis said in the statement.

From 2007 through 2011, Califf said on the forms that he owned equity greater than $10,000 in Nitrox LLC, a pharma company spun out of Duke in 2004.

Also from January through September 2014, Califf said he received between $5,000 and $25,000 for consulting and other services, including continuing medical education, outside his university salary from Amgen Inc., Merck & Co. Inc. and Novartis AG as well as less than $5,000 from a number of other companies.

In 2013, he received between $5,000 and $25,000 in consulting and other payments from Medscape Inc./heart.org and Roche, in addition to less than $5,000 from a number of other companies. From 2012 to 2014, no companies paid him more than $25,000 in fees during each year, according to the forms.

Open Payments Database Shows More Industry Ties

The Open Payments database maintained by CMS listed 25 transactions for Califf, all of them occurring from August through December 2013. They totaled more than $29,000 in consulting, travel, food and other payments.

F. Hoffmann-La Roche AG paid Califf the most – and all of it on a single day. On Aug. 31, 2013, Califf amassed nearly $9,000 in travel, food and consulting payments. Janssen R&D LLC paid Califf nearly $8,000 in consulting fees in August as well. And St. Jude Medical Inc. paid him $2,500 for non-consulting services, such as to speak at an event not considered a continuing education program.

The CMS database did not list any company ownership investments under Califf’s name.

Nearly 63% of Califf’s total payments listed in the database – more than $18,000 – were classified as consulting fees. Another $7,600 was for travel and lodging.

The CMS database is not considered complete, however. Stakeholders have criticized it because some reported payments were not made public because of delays or other problems Also see "Sunshine Website Goes Live With Some Context Sought By Industry" - Pink Sheet, 1 October, 2014..

Consulting, Food, Other: Robert Califf’s Sunshine Payments
Payments By Company
F. Hoffmann-La Roche AG	$8,940.72
Janssen Research and Development LLC	$7,875
Merck Sharp and Dohme Corp.	$6,046.98
St. Jude Medical Inc.	$2,500
E.R. Squibb and Sons LLC	$2,124
AstraZeneca Pharmaceuticals LP	$1,182
Kowa Research Institute Inc.	$625
Payments By Category
Consulting Fees	$18,384
Travel and Lodging	$7,606.93
Compensation for services other than consulting, including serving as a faculty member or as a speaker at a venue other than a continuing education program	$2,500
Food and Beverage	$802.77
Total Payments	$29,293.70
Note: Entries only include payments from a portion of 2013. Source: CMS Open Payments database

Califf Has Several Industry Ties To Sever Before Joining FDA

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