Originally published May 1996
An Interview with Peter Barton Hutt
Partner, Covington & Burling, Washington, DC
Twenty years ago, the Medical Device Amendments of 1976 were enacted--14 years behind schedule. They were supposed to be written up and put into law during the early 1960s, but Congress got sidetracked. Only when FDA pushed--and pushed hard--in the early 1970s did the amendments become reality.
The prime mover back then was Peter Barton Hutt, who left private practice in 1971 to become chief counsel for FDA, a position he held until 1975. One of the primary charges given Hutt at that time was to draft this legislation. In this interview with MD&DI, Hutt, now a partner in the law firm of Covington & Burling (Washington, DC) and an instructor of food and drug law at Harvard Law School, describes the effort and intent behind the amendments and assesses how well their current implementation reflects the spirit in which they were created.
What was the legal basis of medical device regulation before the 1976 amendments were implemented?
One of the major purposes of the original Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 was to impose a national form of regulation on the medical device industry. Prior to that time there was a national statute, the Food and Drugs Act of 1906, but that only covered food and drugs and not medical devices. From 1938 until the early 1960s there was very little thought of adding additional regulatory requirements for medical devices. Devices were subject only to what we call policing. In other words, FDA determined whether a device was safe and effective, and, if it was not, would bring charges in the courts for adulteration or misbranding. But there was no requirement for premarket testing, review, approval, or anything of that kind. Then, under President Kennedy, a proposal was put forth to change the way medical devices entered the market. In 1962, there were extensive congressional hearings on proposals to revise the FD&C Act in a number of different ways, one of which was to impose the equivalent of new drug applications for medical devices.
What stopped Congress from acting on those proposals?
In the middle of the summer of 1962, information became available about the thalidomide tragedy. Congress set aside the issue of medical devices at that point and focused solely on what ultimately became the Drug Amendments of 1962. At that time, it was thought that Congress would return to medical devices the next year. As it turned out, it was 14 additional years before medical device legislation was considered by Congress.
In those intervening years several things happened. First, the courts ruled that many medical devices could also be classified as drugs, thus imposing more stringent requirements on the device industry. And, in the late 1960s, a very important committee was organized and chaired by Ted Cooper, then head of the National Heart Lung and Blood Institute. The report of this committee recommended that any new legislation authorizing regulation of medical devices should be specifically targeted to the device industry and should not be like the regulation of new drugs. The committee recommended creating different tiers of medical devices and tailoring the regulatory controls to the risk involved. For example, tongue depressors would just be under general controls of the types that exist today. Other devices, like artificial hearts, would go through premarket approval.
How did you get involved in creating the legislation that would make that happen?
When I became FDA chief counsel in late 1971, the legislation was in draft form, but it had not yet been introduced into Congress. Elliott Richardson, the secretary of Health, Education, and Welfare, and Charlie Edwards, the commissioner of food and drugs, charged me with getting it into final form, getting the other governmental agencies and departments to agree with it, and getting it introduced in Congress. I spent a great deal of time my first year getting others in the government to agree to the form of regulation that was to be included. That draft legislation, which was introduced in 1972, attempted faithfully to carry out the recommendations of the Cooper committee report. It used different terminology for all of the critical regulatory aspects so that the standard for proof of effectiveness was different than for drugs. The regulatory requirements were purposely set out to be different as well.
What happened to this legislation?
The Senate focused on it on a number of occasions, but the House did not. We in FDA then decided to force the issue on the House, and we set up the Bureau of Medical Devices even before the legislation was created. We also began to take an inventory of all medical devices, something the statute would require. And indeed we began to classify all medical devices into Classes I, II, and III. That finally got the attention of the House as well as the Senate, and they both began to show renewed interest in late 1974.
Then in late 1974 and early 1975, one of the most crucial events in the development of the legislation took place. I and three others--one of them was the House legislative counsel who worked on FDA legislation--hammered out a revision of the draft legislation that would satisfy FDA policy while also accommodating some of the concerns of industry, as well as those of members of Congress. That legislation was put in final form in early 1975, and it was basically that draft that ultimately captured the complete policy; it was enacted into law in 1976.
What were the concerns of industry that you were dealing with back then?
Interestingly, the concerns of today are not what industry was concerned about back then. One thing industry wanted and got written into law was a product development protocol. This is a statutory provision under which a company would make an agreement with FDA on a specific protocol and development process. The company would then perform all the testing pursuant to that protocol, and, if the results were as everyone hoped, the product would receive swift approval. FDA has never wanted to use this system, and surprisingly, industry has not been anxious to use it either. Since it was enacted into law, to my knowledge the product protocol has been used only once.
It seems rather ironic, given that companies often loudly complain that they do not know what FDA wants.
Yes, but just like FDA, industry has always been ambivalent about being too specific early on in a product development process, because there are always things that come along that are not anticipated.
What other issues did industry raise 20 years ago?
Industry wanted to make the distinction between a drug and a device clear, in order to avoid further court cases of the type that helped precipitate the Medical Device Amendments legislation. Industry was specifically concerned with the court ruling that gave FDA the discretion to reclassify some devices into the drug category. We were very careful to make this distinction clear and to use very specific wording. In the definition of effectiveness, the words were carefully chosen to emphasize that drugs and devices were different.
It would seem then that FDA, in applying the rules used to evaluate drugs, is now trying to diverge from both the letter and spirit of the law.
That is correct.
What is your opinion of the legality of doing that?
It all depends on the facts of any specific case. Unfortunately, in this field one can seldom make sweeping generalizations about what is lawful and what is not. One simply must look at the detailed facts. But I will make one generalization: From their enactment in 1976 until the early 1990s, the Medical Device Amendments' implementation was quite faithful both to the specific language and to the spirit and intent of the legislation. In the past five years, this has changed dramatically. What FDA is doing in many areas today is both outside the statute's specific language and contrary to Congress's original intent in enacting the statute. *