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03/01/2016

Senator Markey and the Unfortunate Politicization of the F.D.A.


Senator
Edward (Ed) John Markey (D.-Mass.) announced on January 24, 2016, that he was
exercising one of his prerogatives as a United States Senator and placing a
hold on the confirmation vote for Food and Drug Commissioner nominee Robert
Califf, MD. 
President Obama nominated Dr. Califf on September 15, 2015, to succeed Margaret Hamburg, MD, who left
the position last year
Interestingly, Dr. Califf won
unanimous approval by the Senate Committee on Health, Education, Labor, and
Pensions. However, Senator Markey questions Dr. Califf’s fitness to serve not
because he lacks credible individual qualifications, but because he is upset
with the way the agency deals with prescription opioid medicine approvals, and
specifically the manner in which the F.D.A. handled adding a label indication
for the narcotic pain killer OxyContin (Purdue Pharma LP) to treat children’s pain.


Moreover, Markey is not alone.
At least two other senators agree that Califf is not a good choice for F.D.A.
commissioner and also place “holds” on the nomination: Senator Bernie Sanders
(Ind.-Vt.) believes that Califf is too close to the pharmaceutical industry and
lacks commitment in controlling drug prices
; and Senator Lisa
Murkowski (R.-Alaska) objects because the F.D.A. approved a genetically
modified salmon which is a competitor in the marketplace to “natural” Alaska
salmon. 
Because of these member
“holds,” Dr. Califf’s nomination may never come to the Senate floor for a
confirmation vote. And with the Obama Administration in its last year, it may
not really matter that much anyway. Dr. Califf is presently serving as Deputy
Commissioner for Medical Products and Tobacco
; and the F.D.A.’s chief
scientist, Stephen Ostroff, MD, is serving as acting head of the agency.
 Both Drs. Ostroff and Califf
are relatively recent F.D.A. administrative additions and probably will
collaborate in effecting Obama policy directives.


Regardless, the question
remains: Should senators hold up F.D.A. appointments for what appear to be
personal political views? Views that are clearly are important, but grounded
more in policy disagreements with agency actions that may not be related to the
qualifications of the candidates nominated to manage the agency? Surely there
are more civil and direct ways of expressing opinions without attempting to
grind government to a halt?

 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI’s online graduate programs, please visit our website.


 



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