President Donald Trump has made the decision to hire Scott Gottlieb as the head of the FDA. Gottlieb’s strong history of faster approvals, more regulatory transparency and being able to keep a balance of power between doctors and the FDA made him a strong candidate for the position. Since he is an insider to the industry, this makes him a safer choice to go with than some of the other candidates.
Gottlieb has hit the ground running by publicly speaking out about multiple regulatory topics that need to be addressed within the FDA.
As a believer in the strong potential that FDA actions have to cut down the costs of drugs, the fast, flexible approach used in the cancer division of the Administration could spread into the other areas. This means more applications will be approved, while more doctors need to act as gatekeepers.
Gottlieb also has the potential to overhaul many aspects that come with the generic drug regulation policies. This holds up the prices of generic drugs on the market long after patents on the medications have expired.
The nomination of the commissioner elect (still needs to be confirmed through Senate), has a long history of releasing response letters, complete with all the information consumers need to know. Gottlieb stated, “we should have done this a long time ago, the public deserves to see the agency’s explanations for its decisions.”
While moving away from the current practices of the FDA, the ones put forth are less extreme than some of the other candidates that were running for the position. Chosen as a first choice by those in biopharma. Gottlieb’s restraint, along with his understanding of the FDA and drug industry as a whole makes him the first choice.
Concern With Gottlieb’s Industry Connections
Most of the concerns have come from those outside of the industry. They’re more concerned about Gottlieb’s close ties within the industry and his position on the need for reform within the Administration. He was called out for having dangerous approaches to regulations and the entagled web of pharma backings that so many are saying are cause for potential issues.
Daniel Carpenter, a Harvard professor and FDA historian admitted that Gottlieb will be “the most interest-conflicted commissioner in American history, by far.” Robert Califf, M.D., the previous FDA head was also subject to the same type of criticism due to his ties with the industry. The cardiologist is still defending the flexibility shown within the agency under the regulatory framework that currently exists.
Samantha Skinner is a freelance writer and internet marketer providing quality content and keeping up with the latest in world news. With interests in medical, family, travel and technology, she is passionate about what she writes about. You can follow her on Facebook.