Advertising & Content Sponsorship Solutions:|

Trump FDA Appointment Gottlieb Signals Pharma Regulatory Reform

Home/Innovation, Pharma CMC, Regulation/Trump FDA Appointment Gottlieb Signals Pharma Regulatory Reform

Trump FDA Appointment Gottlieb Signals Pharma Regulatory Reform

Trump FDA Appointment Gottlieb Signals Pharma Regulatory Reform

Trump FDA Appointment Gottlieb Signals Pharma Regulatory Reform

There is widespread relief throughout the pharmaceutical industry as the U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a vastly experienced health policy expert to head up the U.S. Food and Drug Administration.

If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.



He is a former FDA Deputy Commissioner who advocates a streamlining of requirements needed for approval of new medical products. Comfortable engaging with Capitol Hill, he has briefing experience on issues such as drug pricing where he has testified on numerous occasions.

Gottlieb wins out over the controversial candidate Jim O’Neill, who holds unconventional views on drug approvals which may have led to widespread approvals for placebo drugs which frightened the horses in the pharma industry.


In addition to his public health and health policy roles, Gottlieb has been involved in supporting and investing in various life sciences, medical technology and healthcare services.

Critics argue the physician Dr. Gottlieb would face some conflicts of interest. However the new White House administration would struggle to find a candidate with the requisite competencies necessary to execute effectively the important office of FDA Commissioner in an era of unchartered political waters and during a delicate stage of pharmaceutical reform and during the roll out of the newly signed 21st Century Cures Act.


Related Article

10 Things You Need To Know About The New 21st Century Cures Act


Changes At FDA Expected


Dr. Gottlieb will be supported by the recently passed 21st Century Cures Act which instructs the FDA to consider the use of “real world evidence” to support new drug applications. This can sometimes include anecdotal data, observational studies and patient reports.

Requirement such as the requirement that reasons for non approvals must be given in detail will be of interest to many stakeholders in the pharmaceutical sector and lead to greater transparency in the process overall.

New streamlining of the process for approvals of generic versions of complex or difficult to copy drugs will likely lead to a innovative forked approach.

Key patient advocates welcomed the news of the appointment of the physician which is a return to tradition.


To Source Trusted Peer Recommended Pharmaceutical Machinery Equipment And Excipients Explore Here

Join The Discussion

If you want to share your opinion or insights on pharma topics you can join the conversation on LinkedIn, Twitter and other social media channels below using the hashtag #PharmaCMC.

Share Quality Reports, Papers & Articles

To submit your own report, video, white paper or article that adds value for our community of pharmaceutical engineers, procurement managers and key decision makers please contact us via email.


About the Author:

The PharmaCMC Journal editorial team is made up of a panel of experienced pharmaceutical engineers, scientists, procurement managers and content specialists. We focus on valuable content that solves the everyday challenges facing pharma professionals interested in sourcing pharmaceutical machines and equipment from peer recommended suppliers who meet the modern "Quality by Design" QbD and "Risk Based Design" requirements and specifications.