Scott Gottlieb Confirmed as FDA Commissioner

Biotech industry welcomes appointment

By a vote of 57 to 42, the Senate has confirmed Dr. Scott Gottlieb as the new head of the FDA. Gottlieb at one time served as a deputy commissioner at the agency.

A resident fellow with the conservative American Enterprise Institute, Gottlieb has a record of articles, speeches, and congressional testimony that explain his priorities, according to an article posted on the STAT website. He has expressed concern about the safety of the nation’s blood supply; called for easing restrictions on truthful, off-label promotion of medical products; and vowed to focus on combating the opioid epidemic and ensuring food safety.

Gottlieb has also argued for the publication of complete response letters––documents issued by the FDA when it has rejected a new medication for approval. Currently, the agency is not obligated to share these letters with the public.

Gottlieb will have to tackle other major tasks once he sits behind the commissioner’s desk, such as implementing the 21st Century Cures Act, a directive requiring the FDA to speed up and modernize its approval process for drugs and medical devices, among other priorities.

It remains to be seen how far he will go in implementing President Trump’s plans for the agency, the STAT article notes. For example, will he support the deep budget cuts that Trump has proposed, even though they could affect his ability to implement the 21st Century Cures Act? Further, will he move to “slash restraints” at the FDA to speed up what Trump has called a “slow and burdensome” process of drug approvals?

The biopharma industry, at least, appears to be happy with Gottlieb’s appointment, according to FierceBiotech.

The California Life Sciences Association, for example, said it “applauds” his confirmation, with its president and chief Sara Radcliffe adding: “Over the span of his distinguished career, Gottlieb has a proven track record as a strong advocate for both protecting public health and promoting biomedical innovation.”

Jim Greenwood, CEO of the Biotechnology Innovation Organization, commented: “We look forward to working with Gottlieb to ensure that the FDA has the necessary staff, resources, and flexibility required to keep pace with the marvelous advances taking place in the fields of biomedical, agricultural, and animal biotechnology.”

Some Democrats, however, have accused Gottlieb of being a little too cozy with the biopharma industry, given that he sits on the boards of several small biopharma companies and is an advisor to GlaxoSmithKline.

Earlier this year, Gottlieb said he would recuse himself from any decisions on matters in which he has a financial interest, and that includes a lengthy list of biopharma companies.

Sources: STAT; May 9, 2017; and FierceBiotech; May 10, 2017.