https://amgreatness.com/2019/12/18/the-deep-state-will-challenge-the-new-fda-head/
If we are to realize the kind of aggressive, innovation-promoting deregulation called for by President Trump, Stephen Hahn will need to disrupt the agency’s built-in bias for overregulation.
Now that the Trump Administration’s new FDA commissioner, Dr. Stephen Hahn, has been confirmed, he’ll find he has one of the most difficult and important jobs in government. The FDA’s purview is wide, regulating pharmaceutical and other medical, food, and vaping products that account for more than 25 cents of every consumer dollar, over a trillion dollars annually.
Government regulation offers some reassurance to the public, to be sure, but when it is wrong-headed or merely fails to be cost-effective, it actually costs lives—directly by withholding life-saving and life-enhancing products, and also indirectly by diverting societal resources to gratuitous regulatory compliance.
Dr. Hahn is inheriting an organization that is huge, critical, and dysfunctional. The stakes are high. For example, FDA has pushed the average cost (including out-of-pocket expenses and opportunity costs) to bring a new drug to market to over $2.5 billion. That ensures that many new drugs will have a hefty price tag, and that others will never be developed at all.
Putting FDA on the right track will require toughness and discipline at an agency where more than 99.9 percent of the employees are civil servants who cannot be fired even for incompetence or insubordination. (Did we hear someone mutter, “deep state?”)