Ned Sharpless slammed with critical letter from a key Democratic Senator unhappy with e-cig policies
Acting FDA Commissioner Ned Sharpless has run into trouble with a key figure in the Senate — a signal that he’d face some headwinds to win approval to the permanent job should he be nominated.
Democratic Senator and minority whip Dick Durbin admonished Sharpless on his approach to curbing youth use of e-cigarettes, following what he called “one of the most disappointing and alarming meetings in my time in public service.”
Specifically, Durbin lamented that Sharpless seemed to have no intention in addressing the issue even after Sharpless’ predecessor Scott Gottlieb declared it a “public health epidemic” and, recently, admitted he “struck the wrong balance” on regulating e-cigarettes.
“Do not repeat the mistakes of Commissioner Gottlieb by underestimating the danger these products present to our nation’s children. As Acting FDA Commissioner, you must not be a spectator to this ‘epidemic,’ Durbin wrote in a strongly worded letter.
The FDA had stated that it would respond directly to Durbin’s office.
While the biopharma industry has largely welcomed Sharpless with open arms — likely more so after the former National Cancer Institute director vowed to continue on a course that Gottlieb has set in terms of speeding approvals whenever appropriate but holding the gold standards — this episode highlights the political fights that Sharpless might face as head of the agency.
Notably, on this very issue, a couple of Republican senators have previously pushed back on stricter tobacco regulations in the Gottlieb era.
President Donald Trump and Health and Human Services Secretary Alex Azar have yet to make up their mind whether to nominate Sharpless as permanent FDA commissioner.