How did you get your start in food and drug law?
It began with the fact that my father, and before him his father and grandfather, had a retail diary in Buffalo, New York. Every paper that I wrote through high school, college and law school related to the diary industry. In my third year at Harvard, I read in the Harvard Law Record that there was going to be a lecture by the General Counsel of the FDA. My dad had some issues pending in the New York state legislature relating to food law affecting the diary industry, so I talked to this gentleman, Bill Goodrich, extensively. Finally, after he got tired of answering my questions, he said “Let’s have dinner.” At the end of dinner he offered me a fellowship to study food law at NYU Law School.
I was planning on going back to be a lawyer in Buffalo after law school. My friends there still wonder when I’m coming back. I thought, “well, I’ll put it off a year.” So I went off and got my LLM and then on a lovely day I decided I’d go down and see if there were any jobs in Washington. To make a very long story short, I was offered a job at the Federal Trade Commission, FDA, and Covington and Burling, which at that time had the biggest food and drug law practice and still does today. I thought, “Well, I’ll do this for two years and then go back to Buffalo.” Actually, the interesting part of the story is, when I got the three offers, I asked Bill Goodrich, the Chief Counsel at FDA, “What should I do?” He told me, “Go become a partner at Covington and Burling and then you’ll get a good government job later on. That’s the way it works in Washington.” So I did exactly what he said. I went to Covington, became a partner, and the day he retired he called me at eight in the morning and said, “Do you want to take my place?” and without thinking for an eighth of a second I said “yes” and so off I went to become Chief Counsel of FDA.
How many food and drug lawyers would you say there were when you began your career?
Let me break that down. First, almost every large food or drug company would have an in-house counsel who would, along other responsibilities, deal with food and drug law. In terms of the private bar, there was only a handful that did nothing but food and drug law. Now as an aside, I’ve said forever that if you want to practice food and drug law, it has to be a full time occupation. This isn’t something that you can do part time because every year it gets more complex and difficult. Indeed, most young lawyers today have to specialize within food and drug law. They specialize in medical devices, cosmetics, or prescription drugs or even over the counter drugs. But in those days—let’s face it, I started out in 1960—that’s 51 years ago, I’m afraid I’m dating myself—it was much simpler. For example, drugs were the least significant of the issues. Food was the primary area of food and drug law and there were in Washington D.C. perhaps ten people that I would call food and drug lawyers. Not many more; maybe fifteen. And when I went to be Chief Counsel in 1971, there were fewer than fifteen lawyers on my staff. Now there are ninety.
How many food and drug lawyers would estimate work in D.C. firms today?
First, let me point out that all of what I would call the “top tier” food and drug lawyers are in D.C. with maybe two exceptions, with one or two in Chicago and one or two in New York. The private bar has always been concentrated in D.C. for reasons that none of us are totally clear about because you don’t spend a lot of time going to the agency and you could practice food and drug law from anywhere in the country. Today, if you’re talking about people who really work on food and drug law full-time, there are fewer than fifty. If you count people who are tangentially involved, however, the number’s much larger. I’ll give you a couple of examples, there are lawyers in our firm for example who spend one-hundred percent of their time on transactional work involving the food or drug industry. In order to do that you have to understand food and drug law, but I don’t count them as food and drug lawyers. Same with anti-trust, the same with patents, and all other kinds of fields that tangentially impact food and drug law. That’s why so many people who want to become patent lawyers take my course on food and drug law.
What would you say a typical workday looks like for someone that you would consider a true food and drug lawyer? What type of things do they do?
Well, food and drug law is primarily administrative law. Occasionally, a true food and drug lawyers will get involved in litigation, but it’s very rare. Litigation ties up your time and most food and drug lawyers are accustomed to dealing with clients over the phone—for the most part—maybe by email, but talking to many, many people in any given day. You’re almost always talking to people on the phone, answering questions. You’ll get a call, “can I make this claim on my label” and the conversation may be five minutes. So it’s a counseling type of practice. Occasionally someone will call up and say, “Look we have a new product. We want someone to give us strategic advice that will take half a day, but we want you to come out here to California or wherever because we don’t want to bring ten people to Washington for a meeting.” Sure, that also happens. But it is a counseling-heavy type of practice.
It’s interesting, if you got tied up in litigation, you wouldn’t have time for counseling. Whenever one of my clients gets involved in litigation, I am delighted to hand it off to one of my partners who thinks litigation is fun. I don’t understand why he does, but he does. It’s nowhere near as fun as food and drug law.
How common is to find attorneys whose practices focus solely on food law?
When I started in 1960, that was eighty to ninety percent of food and drug law. Today, it’s ten percent. Because of the overwhelming growth of drugs, medical devices, and biological products. But it’s still possible to focus just on food law. There are a couple of small firms, one in particular in Washington, that focuses primarily on food law, although it does some drug work. It’s Ollson, Frank, and Weeda. Rick Frank and Phil Ollson wanted a niche firm and started focusing on USDA regulation of meat and poultry. That’s a very narrow food law focus, but they became the known experts. It was a brilliant legal niche strategy for them. They became so well known for this that they have pretty much tied up the market. Then they expanded from that into other areas of food and ultimately, perhaps, they touch upon drugs and devices also. But Rick Frank, I think, still to this day specializes in USDA and virtually nothing else.
During your tenure as FDA Chief Counsel, you invented the “regulatory letter,” now called the “warning letter.” Can you explain why you did this and tell us whether there was any pushback on this practice?
In my eleven years in private practice before I went to FDA, I saw how seizures were handled. The FDA would issue a seizure and then the company would put in a claim, run out their inventory for a year, change their label or do whatever they had to do, and then default on the seizure. Now, that seemed to me a travesty of enforcement. The whole idea of a seizure is to stop something and it wasn’t stopping anything for six months or a year as long as the inventory was there. And I figured that if I sent a letter and said “you have fifteen days to reply or we’re going to take serious action, including criminal action,” then that would get people’s attention, and I would get enforcement within a month at most. Now that was the first reason. The second reason was pure economics. In order to conduct a seizure, FDA has to do a massive inspection, then the US Attorney and a court have to sign off on it, and then a US Marshall has to go out and actually sticker the product and “seize it” in the technical sense. That takes a lot of money! Say $5,000 to pick a figure. A letter costs $50. Therefore, I could send 100 letters for the cost of one seizure. So, it just seemed like common sense.
To answer your second question about pushback. Interestingly, there wasn’t any. No one knew how to pushback. After all, all they were receiving was a letter. How could they claim that this was illegal? So, no, there was no pushback on the procedure per se. There was a question—an interesting legal debate—when I started regulatory letters I took the position that they had been cleared by the Office of Chief Counsel and there were only one of two solutions: either the company would agree to change (whatever it was) or FDA would agree that it had been in error. But it would just wouldn’t hang around forever. It wasn’t a friendly letter; it was an enforcement technique.