Before we begin, let me do some formal introductions: Drs. Hamburg and Sharfstein, these are the investors. Investors, these are the people who will ultimately determine how well the drug company portion of your portfolio does.
The new commissioner and principal deputy commissioner of the Food and Drug Administration introduced themselves yesterday and gave investors a first look at how they plan to run the agency. The perspective was printed in The New England Journal of Medicine, so technically they weren't really talking to investors, but we can use the article to get a better sense of how hard it might be for the companies that we invest in to get drugs approved.
The picture doesn't look all that rosy from my perspective.
Obviously the agency's leadership is supposed to look at the bigger picture, but drug approvals don't seem all that important to Hamburg and Sharfstein, "The ultimate measures of the FDA’s success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved."
Umm, hello? Those so called "intermediate measures" are what drive stock prices. Pfizer
While the leadership might not think that approvals are a good measure of how well the agency is doing, at least they're somewhat focused on how fast they get them completed, saying, "the FDA should always ask whether delays in approval or safety problems can be prevented." That has to be good news for Eli Lilly
We'll have to see how the new leadership responds in practice. The good news is that the agency has been moving at such a slow pace recently that, even if the leadership isn't entirely focused on getting decisions about marketing approvals out the door, the process might not slow down that much more.
More pontification on the FDA:
- The agency needs to hold a bake sale.
- Take the F out of FDA.
- Will the FDA approve these drugs?
