Scott Gottlieb

It is Game On! at Commissioner Scott Gottlieb's U.S. Food and Drug Administration.

Recognizing the FDA lacks a direct role in drug pricing, his overarching strategy is to facilitate increasing market competition so as to drive down prices-- thereby increasing accessibility and innovation (see details of his Drug Competition Action Plan here). His parallel focus to achieve these goals is to curb abuses of the Orphan Drug Act (ODA). 

President Reagan signed the Orphan Drug Act in 1983 in an attempt to incentivize discovery. Smaller population ...

The cancer drug business is quite a profitable one. A “high risk, high reward” proposition has been the narrative for those in research and development (R&D). Successes, marketing, patent protection and discovery cost money. Failures cost money. Not pursuing a different path with a failure or even a success costs money. As does lost revenue while performing R&D. 

Can an accurate dollar value even be placed on what it takes from idea conception through utilization to develop a new drug? Due to the opaque nature of the industry’s disclosures, a new study published in JAMA Internal Medicine sought to quantify a standard amount by focusing on new cancer drugs and analyzing the...

Who among us hasn’t chuckled at a television prescription drug ad when it ventures into a litany of wide-ranging potential side effects like anal leakage to erections lasting more than four hours? Whether it be for depression, your heart or arthritic conditions, the major and minor adverse consequences of these advertised drugs often get promoted in ways that pose equivalent risk—this routinely does not reflect reality. 

With direct-to-consumer (DTC) ease of communication access today, product overstatements of health benefits with simultaneous minimization of possible harms has become the norm for such companies marketing to the public. The ability to do so wasn’t always the case. With such an evolution, for better or worse, has come cultural conflicts. And, now the...