« ForrigeFortsett »
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.
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
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
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
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.
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
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.
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.
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
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
Yet, these amendments may result in researchers being
unsure of what is prohibited and what is allowed.
And this could
negatively affect drug development.
The control status of a compound is an important factor in
determining whether to go forward in developing a drug.
heard testimony from pharmaceutical company representatives that
the early scheduling of drugs clearly impedes research.
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
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
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
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