Article

Scott Gottlieb May be Selected to Head FDA

Expedited drug approvals may become a reality if Scott Gottlieb confirmed as head of FDA.

Scott Gottlieb, MD, is President Donald Trump’s pick to head the Food and Drug Administration (FDA), according to several published media reports and a statement from the Senate health committee chairman.

Gottlieb has held several positions at the FDA, serving as the agency’s Deputy Commissioner under President George W. Bush, as well as serving as a senior advisor to the FDA commissioner, and as the agency’s Director of Medical Policy Development.

Prior to joining the FDA, Dr Gottlieb was board director or advisor to several drug companies, including Tolero, GlaxoSmithKline, and Glytec Pharmeceuticals. He was also a partner at New Enterprise Associates and director at TR Winston & Company, both of which have strong ties to health care.

Based on his previous experience, Dr Gottlieb's ties to the pharmaceutical industry promise to be a hot topic of discussion at hearings on his appointment.

A statement from Senate health committee chairman Lamar Alexander (R-Tenn.) noted that "Dr. Gottlieb has impressive qualifications helping American patients as both a physician and in his previous roles at the FDA." Alexander added in the statement that he planned to schedule a hearing to "discuss his plans to implement 21st Century Cures and work with Congress to bring safe and effective drugs and medical devices to patients more quickly and to protect the nation’s food supply.”

The views of Dr Gottlieb, who has written in various newspapers and other media about the need to expedite drug approvals, fall in line with President Trump’s criticism of the current FDA regulatory process, which he recently described in a statement to Congress as "slow and burdensome," and in need of an overhaul to limit restraints.

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