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Pesticides have been used for many years. In earlier times they were a protection against fungi and insect pests. The great increase in the use of pesticides occurred with the development of new organic chemicals following World Wars I and II. In addition to chemicals for the control of fungi and insects, new developments were nematocides, herbicides, rodenticides, avicides, defoliants, wood preservatives, etc. The use of chemicals helped increase productivity, but caused great concern about their effect on human health and safety. On the other hand, chemicals did help tremendously from the standpoint of protecting against diseases that were carried by insects, especially mosquitoes. Adverse publicity has caused great concern about pesticides and this is especially so since our society has undergone great changes from an agricultural society to an industrial society and finally to a communications society. Unfortunately, publicity relating to the use of pesticides has seldom been balanced from the standpoint of the good and the bad. In fact, the communications media has and does usually stress the potential adverse effects of pesticides without reference to the good. This has caused concern on the part of advocates and the average person to the extent that it has placed heavy constraints on agriculture. There is a need for the dissemination of balanced information on the good as well as the bad of pesticides.

In the UK, postnatal evaluation of offspring, extending beyond weight and survival data, is currently only required under the guidelines for testing human medicines. Such testing is carried out as part of fertility studies and, under some circumstances, as part of perinatal studies. In the 10 years of experience since the guideline was introduced, the majority of test data submitted have focused on physical, sensory and motor development of the offspring. More complex behavioural tests of cognitive function are generally only carried out for drugs with therapeutic actions on the central nervous system. Some of the reasons behind the present reluctance to introduce behavioural teratology testing for classes of chemicals other than drugs are discussed.

Drug distribution in the U.S. allows certain products to be used only under the supervision of a physician or dentist. The distribution of other products is underrestricted, such that they may be used by consumers without any supervision. This article discusses the possibility of establishing a third class of drugs that would be available without a prescription but could be purchased only from a pharmacist. The current prescription-to-OTC switch process may provide an excellent opportunity to establish a third class of drugs. However, significant obstacles exist to such a move. For there to be sufficient public policy justification for a third class of drugs, it must be shown that the public will benefit through increased quality of health care and that the economic consequences will not be prohibitive.

To determine the impact of FDA advisory committee review on the approval time of new drug applications (NDAs) approved during the five-year period 1983 through 1987, we compared NDA phase lengths of reviewed new chemical entities (NCEs) with those that were not reviewed and examined the elapsed time from final committee recommendation for approval to NDA approval. Of the 95 drugs approved during the study period that met the Center for the Study of Drug Development's definition of an NCE, 40 (42%) were submitted for review--mean NDA phase length was 36.9 months versus 32.4 months for unreviewed drugs. Reviewed drugs in the neuropharmacologic division had a longer NDA phase, while those in the metabolic/endocrine and oncology/radiopharmaceutical divisions had shorter NDA phases, than unreviewed drugs in those divisions. For NCEs grouped by therapeutic rating, reviewed drugs in each category had longer NDA phases than unreviewed drugs; the difference was largest for 1-B rated drugs. The elapsed time from committee recommendation for approval to NDA approval as a percent of the total NDA phase was greatest for drugs submitted by the metabolic/endocrine division (83.0% of NDA phase) and for drugs rated 1-A (63.2%). Results indicate that advisory committee review is associated with a small overall delay in NDA approval when compared with the regulatory fate of drugs not submitted for review.

Carcinogenicity data are presented for compounds used as pesticides which have been evaluated in the IARC Monograph series. These pesticides have been both poorly and scantily tested for carcinogenicity. Additional tests have been carried out under the NCI Carcinogenesis Program, and detailed results of the bioassays are published in the NCI Carcinogenesis Technical Report Series. A prpcedure was developed whereby 'preliminary reports' could be made in the Federal Register. In the second part of the paper, regulatory approaches to pesticides are described. International activities are outlined; and examples are given of factors, such as public concern, scientific work and governmental response, which are highlights in the development of approaches to such regulations. The problem of risk assessment has been approached from many sides but remains largely unsolved. Besides risks and benefits, an essential component in evaluation is the analysis of technological alternatives. Two other factors are public documentation of the process of evaluation and registration of environmental carcinogens and their uses. Reduction of exposure to environmental carcinogens to a 'minimum feasible level' depends on social, economic and temporal factors and implies the acceptance of a finite level of risk.

This paper examines the extent to which a "toughened" drunk driving law in Massachusetts has deterred drunk driving and the law's impact on criminal justice system operations. Included are analyses of pre- to postlaw trends in: alcohol-related highway fatalities and arrests, drunk driving arraignments and convictions, and jail sentences served by drunk driving offenders. Many of the positive trends found since the implementation of the law (increased arrests, reduced fatalities, and increased conviction rates) actually began before the law took effect. Moreover, the law has exacerbated existing problems in the criminal justice system such as overcrowded jails.

Antimicrobial agents used as disinfectants and antiseptics are increasing in epidemiologic importance. The regulation of topical antiseptics has ranged from nonexistent, lax and confusing to inclusion in the Food and Drug Administration (FDA) over-the-counter (OTC) review of drug ingredients. This article simplifies the complex history, current status and future possibilities for the hospital use of topical antiseptic products.

Various aspects of regulatory decisions involving the concepts of "unacceptably hazardous" and "acceptably safe" as related to the growing emphasis on the legal terminology of de minimis are outlined. It is concluded that with rare exceptions a proper public policy for risk evaluations is far from implementation.

Genetic engineering provides the opportunity for the synthesis of human proteins and derivatives thereof which are of significant value for replacement therapy. However, in addition to genetic engineering an extensive process development has to be carried out in order to establish an economic production process and to guarantee consistently high product quality from batch to batch. This includes the characterization of the production host cell vector construct, the validation of the fermentation and the protein purification process as well as the lyophilization and the reconstitution of the final product. A number of in-process and final product controls have to be established and limits for the specification have to be elaborated to provide consistent product quality. Real time stability data have to be supplied because data from accelerated conditions do not allow extrapolation of the shelf life of proteins. Data obtained from process development and validation of the production process contributes to the preparation of the chemical pharmaceutical dossier and the expert report to be submitted to the regulatory authorities.

The European Community (EC) is scheduled to become a fully integrated market by 1992. Currently the present national variations in pharmaceutical marketing authorization constitutes an unresolved barrier. The need is for agreed and clearly specified requirements to afford EC wide marketing authorization within agreed time frames. Great care will be required to avoid such problems as a European drug-lag and mounting cost, to the detriment of patients, government, and the research-based pharmaceutical industry.

This article looks at the history and development of drug regulation in Australia, concentrating on the changes that have occurred in the last few years. It touches briefly on the system by which many drugs are subsidized and examines the way in which a de facto "restricted" list became less restricted. It deals with clinical trial approval procedures as these have changed markedly and turns to consider advertising and promotion of drugs. In concluding, it discusses the advantages and some of the shortcomings of the system.

Historically, new drug introductions have played a central role in medical progress and the availability of cost-effective therapies. Nevertheless, public policy toward pharmaceuticals has been characterized in recent times by increasingly stringent regulatory controls, shorter effective patent terms, and increased encouragement of generic product usage. This has had an adverse effect on the incentives and capabilities of firms to undertake new drug research and development activity. The industry has experienced sharply rising research and development costs, declining annual new drug introductions, and fewer independent sources of drug development. This paper considers the effects of government regulatory policies on the pharmaceutical innovation process from several related perspectives. It also examines the merits of current public policy proposals designed to stimulate drug innovation including patent restoration and various regulatory reform measures.

South Africa has a population of approximately 30 million people. The country has a mixture of advanced industrial and rural economies, but the medicine control system is consistent with similar systems established in the major industrial countries of Western Europe and North America. Because most of South Africa's population lives in conditions more closely akin to the developing world than to the Western nations, it is important to examine whether the country is optimally served by this drug regulation model and to define critically the strengths and limitations of the established system. The conclusions might be relevant for other countries at a comparable stage of development.