Clinton campaign questioned FDA commissioner’s Big Pharma ties: WikiLeaks

Hillary Clinton at a Human Rights Campaign event. (photo by Gage Skidmore courtesy of Flickr.com)

New evidence has come to light from a series of emails released by the whistle-blowing website WikiLeaks that Hillary Clinton’s legal team worried about FDA commissioner Califf’s ties to the biopharma industry and wanted someone “willing to stand up to Pharma.”

In the emails dated Sept. 26 last year, Ann O’Leary--a lawyer and a senior policy advisor in Hillary Clinton’s 2016 Presidential Campaign--raised concerns about cardiologist Dr Robert Califf, who was President Barack Obama’s pick for the U.S. regulator’s top job--a role he was later cleared to take.  

But in the email O’Leary says: “Califf the Obama nominee does have real ties to the drug industry--[health policy veteran] Chris Jennings is calling a few people for me to learn more so we don't tip our hand directly.”

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O’Leary added that she thought the team was “clean” as the “Clinton Admin FDA Commissioner [who] was David Kessler, an academic who had run a teaching hospital---and best known for taking on big tobacco.

“We could certainly signal that we want someone willing to stand up to Pharma (in the same way Kessler stood up to Tobacco).”

O’Leary did however urge caution over rebuffing this nomination. “BUT--I want to do a little more digging and due diligence before we hit this guy. Having been through a nomination fight with my husband (in which he lost), this is personal and messy and horrible on the person nominated and their families--so I don't take attacking this guy lightly.”

In the same email chain, Jake Sullivan, the foreign policy advisor to Hillary Clinton's 2016 election campaign, appeared to back away from attacking Califf. “This is ultimately a political call, not a policy call,” he wrote in reply. “I don’t really like the idea of bashing this White House’s nominees, knowing their vetting process and standards.”

He did however add: “But if you guys want to do it, I cannot identify a policy reason not to--you all know the facts.” A few in the email didn’t seem to know anything about Califf, and/or wanted more info.

Dr Califf joined the FDA in 2015 as deputy commissioner for medical products and tobacco and was nominated for the commissioner role by Obama after the long-standing Dr Margaret Hamburg announced her departure from the role last year.

Califf was the subject of a New York Times piece, also cited (and helping prompt) the Clinton campaign emails, in which the paper said his ties to drugmakers “worried some,” and noted his running of research at the Duke University, which it says had around 60% of its funding injected by biopharma backers, as well as earning some of his money via his salary and consulting fees from the likes of Eli Lilly ($LLY), Merck ($MRK) and Novartis ($NVS).  

There has in recent weeks been some controversy coming out of the FDA directly linked to the FDA’s CDER director Dr Janet Woodcock and Califf, and again called into question the links between FDA and the industry, although this has been part of fairly long-running concerns over the years.

Woodcock, in partly redacted documents released last month by the FDA, appeared to lobby internally for the approval of Sarepta’s ($SRPT) controversial DMD drug eteplirsen, and against the advice of many of the regulator’s scientists who argued that the data for the med wasn’t strong enough for the green light.

Woodcock said the FDA must be: “Prepared to be flexible with respect to a devastating illness with no treatment options.” Califf agreed, saying he would “defer” to Woodcock in this case, thus allowing an approval.

In another newspaper clipping, this time from USA Today, an email was forwarded to Mandy Grunwald, who helps run Clinton's comms, noting her tweet last year that "clobbered biotechs". Clinton's team's response?  "Great! [...] FYI - We have started the war with Pharma!!"

Clinton has already come out against Big Pharma and criticized its pricing tactics, but it remains to be seen--if she does enter the White House--whether FDA regulation/personnel will also be put into the crosshairs. 

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