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FDA Commissioner, Personalized Medicine Proponent Scott Gottlieb Resigns

NEW YORK (GenomeWeb) – FDA Commissioner and personalized medicine champion Scott Gottlieb announced he will resign as the head of the agency in a month. 

In a letter to HHS Secretary Alex Azar, Gottlieb highlighted his efforts to modernize the development process for novel medical technologies, gene therapies, and targeted treatments as among his accomplishments.

Since his confirmation in May 2017, Gottlieb oversaw an agency that was particularly active in the personalized medicine space. Last year, the agency approved a record number of molecularly informed personalized treatments — 25 new drugs and expanded indications compared to 19 in the prior year.

Among the drugs approved last year was the pan-cancer drug Vitrakvi (larotrectinib). The agency also finalized guidelines that would help drugmakers develop similar tissue-agnostic treatments, issued draft guidelines on class labeling for companion diagnostics, and recognized the first genetic variant database that sponsors can draw on to demonstrate clinical validity of their tests.

During his stint at the agency, Gottlieb also took on one of the most contentious issues in the diagnostics industry: FDA regulation of lab-developed tests (LDTs). "The agency helped support major legislative efforts to secure a more modern framework for the efficient regulation of diagnostic tests," Gottlieb told Azar in his letter.

One of the centerpieces of the draft legislation, called the VALID Act, is a precertification program, which was adapted from a similar effort in the digital health space and sought to reduce the regulatory burden on test developers. Gottlieb had worked with industry players to generate support for the proposals in the draft bill with the hope of resolving the longstanding controversy around FDA regulation of LDTs, and bringing all diagnostics under a single regulatory pathway.

Azar praised Gottlieb's record in a statement, writing that "he has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation."