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.
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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.
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