Dr. Scott Gottlieb, nominated by Trump as FDA commissioner on March 10, beat out the more libertarian competitors Jim O’Neill and Balaji Srinivasan, both Silicon Valley insiders without a medical background.
An advocate of deregulation
Previous statements from Gottlieb suggest that he favors simplification of the approval pathway for generic drugs, in order to inject competition into the pharmaceutical market and ultimately reduce drug prices, which have risen rapidly.
Gottlieb favors lowering the quality of evidence and statistical rigor required to prove the effectiveness of a program for a successful new drug application, which would speed up the approval of novel drugs and encourage drug innovation.
In line with the flexibility shown by the FDA’s cancer division in recent years, initial drug approvals could hinge on relatively weak evidence, and doctors would be granted more decision-making power over which drugs they prescribe.
Criticism of Gottlieb’s plans
Opponents argue that the FDA review pathway is already the fastest in the developed world, and that solving the long-term decline in genuine innovation in the pharmaceutical industry is more complex than simply removing regulatory hurdles.
Some critics say that doctors do not have the time or ability to provide regulatory oversight over the safest and most effective novel treatments for patients. They also point out that while the FDA has access to unpublished patient-level clinical trial data and the statistical expertise to correctly interpret it, physicians do not.
Reforms rather than regulatory rollbacks
The selection of Gottlieb is far more in line with existing FDA practices and policy directions than his competitors would have been, and his nomination will raise far less opposition from either side of the political aisle.