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Administration, the Food and Drug Administration and state

agencies must have the authority to promptly act against designer

drug manufacturers who are threatening the health of thousands of

people. Yet, at the same time, the Congress must ensure that any changes in federal law do not restrict legitimate research

activities seeking to find therapeutically needed medicines.

with this in mind, I would ask this committee to consider

two questions: 1) does adequate authority exist under current law

to deal with the designer drug problem; and 2) will the Senate

passed controlled substance analog legislation unnecessarily

affect legitimate research on psychoactive drugs.

Just two years ago the Congress recognized the need to give

DEA the ability to respond quickly to the problem of designer

drug manufacture by enacting the "emergency scheduling" authority found in section 508 of the Comprehensive Crime Control Act of

1984 (21 U.S.C. $811(h)).

When considering this measure, the

Congress recognized the need to protect legitimate research and

amended the legislation to include appropriate safeguards.

has used its emergency authority 13 times over the past year and

a half to promptly schedule controlled substance analogs which

have appeared on the street.

DEA now has the power under the

Controlled Substances Act to take action against the unauthorized

manufacture and distribution of these substances.

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Under the emergency scheduling provisions, designer drugs

become controlled substances relatively soon after clandestine

manufacturers begin to produce them.

What was "legal" can

rapidly be made illegal. Thereafter, law enforcement agencies can use the applicable provisions of the law to halt unauthorized manufacture, distribution and possession of the newly scheduled

drug.

And, importantly, legitimate scientists in pharmaceutical

companies, academia and elsewhere do not have to be concerned

that, in conducting research, they are unwittingly violating the

law.

They, like everyone else, know when a drug is a controlled

substance and can, when necessary, meet the regulatory require

ments for investigating scheduled compounds.

The Senate has passed a bill which deals with the designer

drug problem in a manner that differs greatly from the emergency scheduling provision. The administration has made a good faith effort to draft legislation in such a way as to make the actions

of designer drug manufacturers illegal while trying to protect

the thousands of legitimate researchers studying psychoactive

agents.

However, in applying criminal penalties to some manu

facture, distribution and possession of controlled substance

analogs before these drugs are scheduled, the proposed amendment

is contrary to the philosophy and practice of the Controlled

Substances Act and may lead to unintended consequences.

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Under current law, manufacturers, distributors, researchers

and others must obtain a DEA registration before they can handle scheduled drugs. Failure to get the necessary authorization is a

violation of the law and DEA can take steps, including criminal

prosecution, to ensure compliance.

These enforcement actions are

premised on there being a "controlled substance," i.e., a drug

which DEA has placed in the schedules of the Act, either through

the normal, somewhat lengthy, administrative procedures or, much

more rapidly, under the new emergency scheduling authority.

The designer drug legislation takes a different approach.

It makes actions involving a controlled substance analog unlawful

prior to its being scheduled.

The Senate bill makes it a

prohibited act to knowingly or intentionally manufacture, possess

or distribute a controlled substance analog, which is intended

for human consumption, unless the person who manufactures,

possesses or distributes the substance complies with the provi

sions of an approved new drug application (NDA) or an exemption

for investigational use (IND) under the Federal Food, Drug, and

Cosmetic Act.

A controlled substance analog is defined as a

compound which has a chemical structure similar to a schedule I

or II controlled substance or which was specifically designed to

produce an effect substantially similar to such a substance.

This is a reasonable attempt to prevent designer drug

manufacturers from marketing their dangerous products.

But it is

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also possible that some legitimate researchers could inadver

tently violate the law by producing and investigating substances

which may meet the criteria of the proposed amendments.

As an

example, there are substantial questions as to the interpretation

of the term "intended for human consumption." Virtually every

time a pharmaceutical company researcher synthesizes a compound,

he or she is looking for something that will eventually be

intended for human consumption after FDA approval.

Would that

researcher violate the law because of his long-term intention?

There are literally tens of thousands of pre-IND drugs, many of which could, chemically or pharmacologically, be considered

controlled substance analogs. Likewise, researchers overseas might develop compounds which would qualify under the law as

controlled substance analogs.

Would it be illegal to conduct

preliminary, pre-IND studies of these compounds in the United

States?

I realize that, in drafting the designer drug legislation,

the Senate and the administration have made every effort to avoid

vagueness and not impede legitimate research.

DEA should be

congratulated for its willingness to consider all aspects of this

problem.

Yet, these amendments may result in researchers being

unsure of what is prohibited and what is allowed.

And this could

negatively affect drug development.

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The control status of a compound is an important factor in

determining whether to go forward in developing a drug.

I have

heard testimony from pharmaceutical company representatives that

the early scheduling of drugs clearly impedes research.

If a

drug firm has a choice between investing the substantial

resources needed to develop a schedule I controlled substance or

to bring to market a non-controlled compound, they will pick the

non-controlled drug. Companies will not assume the burdens of investigating a controlled drug when they can focus their

research on other potentially useful substances.

This is the

case even if the controlled compound might be attractive commer

cially.

One industry representative testified that her company

would only go forward with research on a schedule I controlled

drug if it were going to be used to treat a life-threatening

condition.

I believe that legislation such as the designer drug bill

would have a similar chilling effect on psychoactive drug research. (It should be noted that controlled substances account

for over 15% of the medical prescriptions written in the United

States today.)

If researchers are concerned that psychoactive

drug investigations may result in a violation of the Controlled

Substances Act, they understandably will be less willing to

experiment with those substances.

They will not risk even the

remote possibility of prosecution under federal criminal law when

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