LSIPR 50 2018: Scott Gottlieb

Name: Scott Gottlieb

Organisation: Food and Drug Administration

Position: Commissioner

Scott Gottlieb is a physician, medical policy expert, and public health advocate. Although new to the Food and Drug Administration (FDA)—Gottlieb was appointed the 23rd Commissioner of Food and Drugs in May 2017—he has already advanced initiatives on addressing drug pricing.

Under Gottlieb’s guidance, the FDA introduced a new policy in June aimed at expediting the review of generic drug applications where competition is limited, allowing US consumers quicker and cheaper access to medicines.

According to the FDA’s analysis, the most significant consumer savings occur when there are three or more generic versions of a drug on the market. Gottlieb’s policy fast-tracks applications for drugs where there are fewer than three competing generic manufacturers, pushing them to the front of the line for approval. Previously, the FDA only prioritised applications for the first company to apply for a generic version of a brand-named product.

Another key policy Gottlieb introduced in December last year increased the FDA’s oversight of homeopathy drugs, an area which was largely unregulated by the agency, in order to target products which pose the greatest safety risks. He also caused a stir in the tobacco industry when he delayed application deadlines on new tobacco products, announcing that the FDA would be taking steps to regulate nicotine levels in combustible cigarettes to decrease their addictiveness.

In his past roles, Gottlieb was instrumental in initiating the early development of the FDA’s generic drug user fee programme, which assisted American consumers in getting timely access to low cost, high quality generic drugs; and the physician labelling rule, which made the content and format of prescribing information for drug products easier to access and understand.

He also assisted with the development of the FDA’s policies related to the President’s Emergency Plan For AIDS Relief.