New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.

FDA Enforcement Shows Little Change with New Administration

Do the agency’s 2017 enforcement statistics reflect a new anti-regulation philosophy? Not so far, but maybe wait till next year!

Eric Greenberg, Legal + Regulatory Columnist
Eric Greenberg, Legal + Regulatory Columnist

All right, I confess: Every year, I summarize FDA’s annual enforcement statistics in some detail, then wisecrack that there’s a limit to what anyone can learn from looking at them. Most years, I say that because the statistics usually look roughly the same as those from the year before.

This year, though, I thought would be different. The fiscal year figures for 2017 arrived one year into a new federal administration that has loudly and actively proclaimed its opposition to regulatory actions of all kinds. Fiscal year 2017 ran from Oct 1, 2016 through the end of September 2017, so most of it was Trump administration time.

Well, do these 2017 statistics reflect the new anti-regulation philosophy? In a word, no.

None are dramatically different from prior years. Here are some highlights, comparing this year’s figures to those for fiscal 2016 and fiscal 2015:

Domestic inspections: 14,098. Before that, 14,210 and 13,694

Warning letters: 15,318 (but note, 14,875 are about tobacco violations). Before that, 14,590 and 17,323

Seizures: 3. Before that, 4 and 1

Injunctions: 12. Before that, 21 and 17

Why don’t the statistics show dramatic drops in activity? I offer at least two theories. First, perhaps the new administration is still just getting going, and dramatic changes will start to show up in next fiscal year’s data.

Second, maybe these enforcement statistics never have been the full story of FDA’s level of activity and effectiveness at doing its job.

To figure out if that’s true, we need to define FDA’s job. It’s long been said that FDA has two main jobs: One is to protect the public health, primarily via enforcement actions. The other is to help companies by approving new, innovative products for marketing (mostly drugs and devices.)

If the administration’s ideology says that regulatory agency actions are bad and burdensome on companies, would we expect the new administration to reduce FDA actions in product review activity, too? It appears that that answer so far is no as well, likely because FDA’s not trying to reduce regulatory activity as much as it’s trying to reduce regulatory burdens on industry. FDA has taken several steps designed to speed up or simplify aspects of the new drug approval process, for example.

After all, not all regulatory actions are created equal. Conceptually, when FDA’s protecting the public, it’s playing its cop role, primarily adversarial vis a vis industry. When FDA is clearing new products, it’s primarily industry’s partner, consulting, discussing and working with industry applicants. No, they don’t always see eye-to-eye with applicants, but the crux of the relationship is commonly not adversarial.

Now, it’s also long been true that even in enforcement matters, FDA reflects a cooperative spirit, and wants most of all for companies to get into compliance rather than kick industry butts. That is one reason they don’t commonly bring serious enforcement actions against violators—another reason is their limited resources.

Finally, one more caution: If the administration wants to clear out regulatory burdens like underbrush, that often requires changes to laws or regulations, and there are already serious questions being raised about whether they can effectuate all the changes they intend quickly or even at all. But it appears that for now we’re going to have to wait till next year to see if the new philosophy is reflected in the agency’s enforcement statistics.

Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Read More
Test Your Supply Chain Smarts
Discover Our Content Hub
Access Healthcare Packaging's free educational content library!
Read More
Discover Our Content Hub