2 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 Senatepassed 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, 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. DEA - 3 · 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 requirements 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 manufacture, 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 provisions 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 63-720 0 - 86 - 4 -5 also possible that some legitimate researchers could inadvertently 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. - 6 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 commercially. 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 |