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In This Month’s E-News: April 2019

Ned Sharpless, director of the National Cancer Institute (NCI), will become acting commissioner of the Food and Drug Administration (FDA) next month following the expected departure of Scott Gottlieb, who announced his resignation March 5. The commissioner’s post requires Senate confirmation. HHS Secretary Alex Azar announced Sharpless’ appointment during a March 12 hearing before the House Energy and Commerce Health Subcommittee on the agency’s fiscal year 2020 budget, terming Gottlieb’s two-year tenure “incredibly successful.” Azar added that, at “some point in early April, NCI’s deputy director, Dr. Douglas Lowy, will serve as acting director of the institute.” Lowy previously was the acting NCI director from 2015-2017.

In response to a question from Rep. Michael Burgess, R-Texas, subcommittee chair, about the progress made in generic drug approvals under Gottlieb, Azar said such initiatives would continue. “We’re going to be carrying forward Commissioner Gottlieb’s vision without him. His agenda is my agenda; my agenda is his agenda,” Azar said. (3/14/19)

A recent audit by the HHS Office of Inspector General (OIG) concluded “NIH did not consider the risk presented by foreign [principal investigators] when permitting access to United States genomic data [and] has not assessed the risks to national security when permitting data access to foreign” PIs, a finding Sen. Chuck Grassley, R-Iowa, called “alarming.” OIG issued a one-page version of the audit on Feb. 13 (“OIG Outlines Multiple Probes Into NIH, PIs Who May Have Failed to Disclose All Support,” RRC 16, no. 3). According to a statement by Grassley on March 7, OIG posted a longer version of the report on March 6.