Califf Nomination Gets Fishy With Murkowski Hold
This article was originally published in The Rose Sheet
Executive Summary
Senator Murkowski promises a hold on Robert Califf’s nomination for FDA commissioner over the agency’s approval of genetically engineered salmon.
Sen. Lisa Murkowski intends to place a hold on Robert Califf’s nomination as FDA commissioner following the agency’s approval of genetically engineered salmon.
The Alaska Republican said in a Nov. 23 statement that she would block the nomination “due to the lack of cooperation and communication from the FDA surrounding their announcement.”
Robert Califf
It is the second promised hold on Califf’s nomination, although the first for an issue that Califf would have direct control over as commissioner. The first was by Sen. Ben Sasse, R-Neb., who announced he would block all HHS nominations until he received an accounting of the collapse of the Affordable Care Act’s CO-OP program, which is outside FDA’s purview (Also see "Califf Nomination CO-OPed By Sen. Sasse In Fight Over Obamacare" - Pink Sheet, 19 Oct, 2015.).
A Murkowski spokesperson said that at a minimum, FDA would have to mandate labeling of genetically engineered salmon to have the hold lifted.
The Food, Drug and Cosmetic Act permits FDA to require additional labeling of genetically engineered food only if there is a “material difference,” like a different nutritional profile, between it and a non-genetically engineered counterpart, according to an agency statement.
FDA did not find those differences with AquAdvantage Salmon, a genetically engineered farm-raised salmon that reaches full size quicker than conventional salmon, which was approved by the agency Nov. 19. FDA's draft guidance allows for voluntary labeling of genetically engineered salmon (Also see "FDA Labeling Guidance Stresses Genetically Engineered Is Not 'GMO' And ‘Free’ Is Rare" - Pink Sheet, 20 Nov, 2015.).
As commissioner, Califf would be in a position to affect whether the labeling requirement could be changed, although it would seem unlikely given that FDA scientists have determined there is no difference between the GE salmon and non-GE counterparts.
FDA traditionally has prided itself as being a science-based agency that prefers to keep politics out of its decision-making.
Its scientific independence was questioned in 2011 when then-HHS Commissioner Kathleen Sebelius overruled FDA’s decision to allow the emergency contraceptive Plan B One-Step to be marketed over-the-counter without restrictions (Also see "Legal Experts Debate FDA Independence After Plan B Fallout" - Pink Sheet, 6 Nov, 2013.).
‘Boom, Lay It On The Table’
It appears FDA could have avoided some of Murkowski’s ire if the approval of AquAdvantage Salmon had not taken her by surprise.
Murkowski was infuriated by the decision, and her umbrage apparently was compounded by the fact that even though FDA knew of the issue’s importance to the Alaska congressional delegation, she was not given a heads-up that the news was coming.
“At 7:55 last night my assistant got an email from the FDA saying that [the] commissioner would like to talk to me about some imminent news,” Murkowski said during a Nov. 19 Senate floor speech
.
“By the time the morning came around, the imminent news was already made public.”
Murkowski is well-known for her opposition to GE salmon. She is up for re-election in 2016 and may be using the approval in part to generate attention and support among voters and contributors.
Murkowski’s Senate colleague from Alaska, Dan Sullivan, also a Republican, issued a statement condemning the approval, and a spokesperson said he supported the hold.
Murkowski has placed amendments in several FDA appropriations bills that would require FDA to label GE salmon, but they have not been enacted.
She also proposed an amendment to the 2012 FDA Safety and Innovation Act that would have required an environmental and economic impact analysis of genetically-engineered fish before FDA could approve GE salmon. The amendment failed (Also see "PDUFA Reaches Approval Altitude; Can House Maintain Senate Speed?" - Pink Sheet, 28 May, 2012.).
Murkowski did not bring up GE seafood during Califf’s confirmation hearing. She instead focused on naming of Alaska Pollock as well as forthcoming FDA advice on seafood consumption for pregnant women and nursing mothers.
“There was no heads-up that this was coming our way, just kind of, boom, lay it on the table,” she said in the floor statement on the salmon approval.
The Senate Health, Education, Labor and Pensions Committee is expected to vote on Califf’s nomination in December. Any hold would not affect the committee vote, only Senate floor consideration.
But with Murkowski holding a seat on the HELP Committee, GE salmon may be an issue that must be resolved to move Califf's name forward.
Califf also has been under close scrutiny by some Democrats due to his background in academia and previous relationships with study sponsors (Also see "Califf’s Confirmation Fall-Out: Should Sponsors Worry About Research Contracts?" - Pink Sheet, 23 Nov, 2015.).
HELP Committee member Bernie Sanders, I-Vt., also opposes the nomination, skeptical that Califf will stand up for consumers against industry (Also see "FDA Can Help On Drug Prices – Except When It Can't, Califf Says" - Pink Sheet, 17 Nov, 2015.).