HHS names FDA acting chief as Gottlieb resignation sparks worries

Mar 11, 2019

How FDA Chief Gottlieb’s resignation could impact the pharma industry.

HHS has named Ned Sharpless, MD, as the acting FDA Commissioner after Scott Gottlieb, MD, resigned last week.

Sharpless, currently the director of the National Cancer Institute previously led the University of North Carolina's Lineberger Comprehensive Cancer Center.

Gottlieb's resignation sparked worry among pharma makers-especially generic and biosimilar manufacturers. FDA boasted a record number of novel drug approvals during Gottlieb’s tenure, and Gottlieb worked to ensure that branded drug manufacturers did not stifle competition from generic and biosimilar drugs. In fact, he launched programs to quicken approval of generic and biosimilar treatments.

Gottlieb also aggressively battled the opioid epidemic, as well as teenage smoking and vaping.

Related: FDA clears record number of drugs

“The generic and biosimilars industry will miss this true champion of patient access,” the Association of Accessible Medicines said in a statement provided to FormularyWatch. “Through his generic and biosimilar action plans, education efforts about the safety and efficacy of the U.S. drug supply, and ongoing and open dialogue with industry, Dr. Gottlieb set a high bar for those who are working to bring relief to American patients from the burden of high drug costs.”

AAM praised the record number of drug approvals during Gottlieb’s tenure, but said that “Dr. Gottlieb understood that approvals were not enough to spur competition, and his leadership extended to improving market conditions to ensure these generic and biosimilar medicines would not be blocked by ‘shenanigans’.”

Related: Generic asthma inhaler gets FDA nod

“Dr. Gottlieb used his bully pulpit to speak out early and forcefully about brand drug companies withholding samples needed by generic drug makers, about rebate traps and other anti-competitive abuses in the pharmaceutical supply chain which unfortunately widen the gap between patients and the affordable generic and biosimilar medicines they deserve,” AAM said.

Soon after Gottlieb announced his resignation (March 5), biotech stocks plummeted. Amgen, Gilead Sciences and Biogen initially realized he biggest drops, CNBCreported.

Gottlieb said he is resigning to spend more time with his family, and the resignation was not sought by the White House, The Washington Postreported.

FDA has not named a replacement for Gottlieb.

Read more: FDA approves first biosimilar to Rituxan

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