FDA Under Pressure

Agency Faces Challenges After Resignation of Former Commissioner Gottlieb

Two months have passed since Scott Gottlieb resigned as commissioner of US Food and Drug Administration (FDA). While his successor Ned Sharpless plans to continue the work Gottlieb started, it's clear that the FDA faces challenges.

The appointment of Gottlieb as FDA commissioner in 2017 was initially met with limited acceptance and a fear that the former pharmaceutical manager could not muster the necessary support required to succeed in the role. However, he proved doubters wrong: Gottlieb was able to prevail against strong interest groups. He has fought the opioid crisis by removing certain medicines that are known for leading to addiction from the market. He has also accelerated the approval of generics to reduce high expenditure in pharmaceuticals. At the same time, he supported innovation in the industry by assisting new technologies in their regulatory approval process.

After nearly two years at the helm of the FDA, Gottlieb resigned and Norman (Ned) Sharpless, former director of the National Cancer Institute, was named as acting FDA commissioner shortly afterwards. In his first speech, Sharpless pledged to continue the work where Gottlieb left off.

The biggest challenge is to drive innovation in the pharmaceutical industry while simultaneously addressing safety and quality issues. The modernization of good manufacturing practices (GMPs) plays a major role here. Gottlieb championed modern manufacturing methods for pharmaceuticals to ensure product quality. It is hoped that Sharpless, being an experienced scientist and administrator, will place his focus on the same relevant topics. Gottlieb was known for building successful relationships with legislators and constituencies. During his period of office, he expanded FDA resources and authority in critical areas such as tobacco regulation. To continue the successful work of Gottlieb, Sharpless must be able to use his own expertise to drive innovation, engage with stakeholders and to make decisions that enhance the safety and quality of pharmaceutical products. 


FDA Faces challenges after Gottlieb (http://www.pharmtech.com/fda-faces-challenges-after-gottlieb?pageID=1)

Sharpless: "No Pause" Following Gottlieb's Departure (https://www.natlawreview.com/article/sharpless-no-pause-following-gottlieb-s-departure)