Laws and Norms Both Shape Policy

By Eric F. Greenberg, Attorney-at-law

When you go to someone’s house for dinner, you’re supposed to bring a gift. A bottle of wine, some flowers, a knick-knack for the shelf, some such thing, to show your appreciation for their hospitality. But what happens if you don’t? In a word, nothing much. You won’t get arrested, fined or ticketed. That’s because the house gift thing isn’t a legal requirement, it’s a social norm.

There’s been a lot of talk in recent years about norms because the current administration seems to have a knack for identifying norms about government action and failing to follow them. One of them relates to how frequently the President places people in high government positions on an acting basis. While there’s long been a procedure for allowing the President to appoint executive officers into various positions on a temporary or acting basis, which the law says can last up to 210 days, the current administration is using it a lot for a lot of different positions, including even cabinet posts. (Permanent is what you call an official who has been confirmed by the Senate, per the legal requirement for Senate “advice and consent” for some federal appointees.)

The President recently replaced the acting FDA commissioner by another acting commissioner, who in turn will himself be replaced soon by a permanent commissioner. The nominee for the permanent FDA spot is Dr. Stephen Hahn, is a radiation oncologist and widely published cancer specialist who is currently the chief medical executive at the University of Texas MD Anderson Cancer Center in Houston.

It’s likely that Dr. Hahn’s approach to the job would be generally anti-bureaucratic, to mirror that of the administration, trying to avoid adding burdens to the regulated industries, while still assuring that the agency protects the public health. Hahn’s predecessor, Dr. Scott Gottlieb, seemed to have found a way to thread that needle, keeping the agency active without literally promulgating new regulations, by, for example, announcing changes in priorities to help improve drug product approvals, and issuing revised industry guidance on numerous topics, while also tackling the safety of tobacco and vaping.

So what’s the problem with having acting officials? Well, anytime you appoint an acting official, you avoid the Senate’s scrutiny of that person, so there’s no thorough Senate check of their background, no Senate hearings, no legislative process to make sure they are qualified for the job.

Also, the conventional wisdom is that acting officials won’t take on long-term plans or impose important new initiatives, because they are just temporary place-holders. If you’re ideologically opposed to essentially all regulatory officials doing things, that sounds like a good approach, but for the most part, society is better when people with jobs do their jobs.

Eventually, having too many acting officials takes power away from the legislature and gives it to the President, but the real bottom line consequence would only come if the public isn’t pleased about this practice. After all, like the dinner guest who fails to bring a gift, a President who fails repeatedly to follow norms runs the risk of not being invited back.

This article is informational only and is not intended as, and should not be considered to be, legal advice.

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The Long Reach of FDA Accusations

The Long Reach of FDA Accusations

By Eric F. Greenberg, Attorney-at-law

The Long Reach of FDA Accusations

For those of you who think that regulators only pick on the small companies, have I got a story for you. And this story is also eye-opening if you have wondered who the government is most likely to go after when a problem arises, in a world of complicated chains of commerce involving multiple actors making and moving and bringing packaged products to market.

The short version of the story is that the Food and Drug Administration took action against Amazon for products sold on its website. Yes, that Amazon, the one with the big website where you can buy essentially everything for handy delivery. And this wasn’t the first time FDA has warned Amazon about products available on its popular website.

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