Mr. HUGHES. Our next witness is Robert T. Angarola.
Mr. Angarola.

STATEMENT OF ROBERT T. ANGAROLA, ESQUIRE Mr. ANGAROLA. Thank you, Mr. Chairman. I will try to highlight my testimony.

Mr. HUGHES. We appreciate that.

Mr. ANGAROLA. As the testimony indicates, I have been involved in the controlled substances area both in the Government and in private practice for approximately 14 years. Recently I have had occasion to be involved in some proceedings which focused on the question of the negative impact of control under the Controlled Substances Act on research into psychoactive drugs. It is clear today from what we have seen and what we have heard that the designer drug problem is a serious one and one which the Federal enforcement agencies must have power to address. At the same time, we have heard concerns about the impact upon research of the legislation which is before the Congress and which has passed the Senate.

With this in mind I would ask the committee to consider two basic questions. The first one is “Do the Federal enforcement agencies presently have enough authority under Federal law to take action against designer drug manufacturers?And two, “Do we have enough information to determine the impact upon research of the legislation which is now under consideration? "

Two years ago the Congress enacted the emergency scheduling provisions of the Controlled Substances Act. This is a more traditional approach to addressing the problem of designer drugs in that DEA was given the authority to quickly schedule a substance if it appeared to be presenting a danger to the public. What was legal, that is, designer drug manufacture, was quickly made illegal. I think it is important to note that in response to the MPTP problems that were addressed in the films that we saw, MPTP was made a controlled substance as a result of emergency scheduling. This emergency scheduling allowed the enforcement agencies to take action to prevent illicit activities, and also importantly, alerted researchers, the legitimate researchers, that if they were going to conduct any studies on this compound that they would have to get the proper authorizations, and failure to do so would be a violation of the Controlled Substances Act.

The designer drug legislation which has passed the Senate, of course, takes a different approach. It makes actions performed prior to a drug being a controlled substance unlawful. Again there is the language which states that the drug was intended for human consumption it would be illegal to manufacture, possess, or distribute that drug unless you had an IND or an NDA. While this bill obviously reflects the good faith efforts by the administration and the Congress to incorporate in the legislation protections for legitimate manufacturers, I question whether the protections go far enough.

It appears to me, and again in speaking with some individuals in the pharmaceutical industry, that under the legislation as it now exists legitimate researchers could inadvertently violate the law by


producing and investigating substances which meet the criteria contained in the proposed amendments. For example, there is a question, as has been raised already today, and to what is the meaning of the term “intended for human consumption”? Every time a pharmaceutical researcher sits down at a workbench he or she is looking for a substance which would be ultimately intended for human consumption after FDA approval. Would that violate the law? Would that be a criminal act? Another example would be a drug developed in Western Europe, for example, which is similar to a schedule I or II controlled substance. A company could import that into the United States to see if indeed it could be commercially viable in the United States. Would that be a violation of the law if there was no IND filed for it? These are questions which have been touched on and I think have to be looked at even further.

Once again I recognize that the administration, and DEA in particular, have worked very diligently in drafting legislation which attempts to allay these concerns. However, the control status of a substance is an important factor in determining whether investigations will go forward which would ultimately result in a drug being made available for medical purposes. I have heard testimony from pharmaceutical company representatives that early scheduling of a drug clearly impedes research. If a firm has a choice between investigating a controlled substance or a noncontrolled substance, they will typically choose the noncontrolled compound because of the regulatory burdens that researchers must meet, which are not overwhelming but are more difficult to comply with than for noncontrolled substances.

But these manufacturers have other concerns. One representative testified to the fact that her company would not go forward in investigating a schedule I controlled substance unless the condition which was to be treated was life-threatening. The controlled substance analog legislation could have a similar chilling effect. You will see in my testimony that I state it "would” have a similar chilling effect on pschoactive drug research. I think that is too strong. It was a typo. It should be “could” have a similar impact.

The fact is that 15 percent of the therapeutically useful drugs in the United States now are controlled substances, so you don't want to affect this kind of research. Therefore, I would urge the Congress to take into consideration several factors in working with the administration to look at this issue.

First, I would ask that you determine precisely, as precisely as possible, what is the extent of the designer drug problem that we are talking about. We see terrible, horrible effects of the misuse of these products; but, in fact, how many people are we talking about? How many designer druggists are there out there? I would be concerned that a Federal law should not be aimed at a handful of people if indeed other means of enforcement are already available.

I think also you might wish to look initially at how the emergency scheduling provision could be improved. I know DEA and others in the Government are working to see if this authority will be transferred to the States so that therefore once emergency scheduling takes place at the Federal level the State authorities would have a similar power to take action against illicit manufacture.

A third point might be to reevaluate the use of the Federal Food, Drug, and Cosmetic Act to address the problems of designer drugs. It is a Federal crime to violate the new drug provision of that act, which is within section 505 of the act, which is cited in the legislation before you. Designer drug manufacture appears to be a violation of that section. Perhaps the administration should direct FDA, working with DEA, to be more active in enforcing this provision when a designer drug problem exists.

And finally, and this is something I know you are already doing, and the questions that you just posed demonstrate this. I would see if greater protections could be afforded to legitimate pre-IND research activities. I share the problem that you face, and that Dr. Hawks testified to, and I, frankly, haven't been able to come up with a formulation which would solve this problem, but I think it is one where perhaps a bit more attention could be given.

So in conclusion, I would just say that I recognize and the controlled substances manufacturers recognize, that actions have to be taken to stop designer drug manufacturers. But I also would caution against allowing fears of drug abuse to prevent the discovery of therapeutically needed psychoactive substances, particularly if alternate enforcement mechanisms already exist to handle the problem.

Thank you.

Mr. HUGHES. Thank you, Mr. Angarola.
[The statement of Mr. Angarola follows:]




Before the




May 1, 1986

- 1

Chairman Hughes and Members of the Committee:

My name is Robert T. Angarola.

I appreciate the opportunity

to testify before you today on the designer drug issue.

I am a

member of the Washington, D.c. law firm of Hyman, Phelps &

McNamara, P.C.

Prior to entering private law practice I was on

the staff of both the Nixon and Carter White House drug abuse

offices, serving from 1977 to 1981 as General Counsel of the

White House Office of Drug Abuse Policy.

In that position I had

specific responsibilities for developing policies and legislative

initiatives in the prescription drug diversion and abuse area.

I am currently serving on the American Medical Association's Informal Steering Committee on Prescription Drug Abuse and am

chairman of that Committee's Subcommittee on Legislation.


the past few years I have represented several large health care

companies which research, develop and market a variety of

prescription drugs, including controlled substances.

Among the

issues I have addressed during that period is whether the

scheduling of drugs under the Controlled Substances Act nega

tively affects research.

Illicit designer drug manufacture and abuse is a serious

problem, particularly since some of these substances have high

abuse potential and contain impurities which have led to death or

severe illnesses.

I am convinced that the Drug Enforcement

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