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MDDI Reports 5(32):4-5. August 6, 1979.At the Senate Health Subcommittee's August 1st hearing on women in health and science, the question arose as to why drug companies would oppose the use of the cervical cap in the United States - a cuplike device which fits over the cervix and is widely used in Europe. The statement of the Federal Drug Administration as of July 11th in regard to this question was the following: "The sterile integrity of some units of various lots of these products may be compromised due to the presence of defective seals."
FDC Reports. 1979 Sep 10; 41(37):4-5.Congressman Weiss (Democrat-New York) in an August 15th letter to Federal Trade Commission (FTC) Chairman Pertschuk made the point that a full and detailed accounting of the Commission's "non-public investigation" of the OTC vaginal contraceptive ad investigation would offer important information. In July Weiss introduced a "Contraceptive Labeling and Advertising" bill and hearings on this legislation have been called for by several representatives. Weiss was disturbed over the FTC's rejection of the Students for Examination of Contraceptive Effectiveness (SEXCE) petition for a Trade Regulation Rule to require effectiveness summaries in OTC vaginal contraceptive ads. Weiss maintained that a more complete explanation of the FTC's action is needed.
International Drug Regulatory Monitor. 1979 Jun; (73):1-14.The Pan American Health Organization (PAHO) has recently formulated a new model National Drug Control Plan for regulatory use by the developing countries of Latin America and the Caribbean. PAHO's plan includes drugs, cosmetics, and therapeutic devices. The central features of the plan are the following: 1) member states should include cosmetics and therapeutic devices in the scope of their national drug programs; 2) the plan draws heavily on the structure and organization of Canada's Food and Drug Act and regulatory authority; and 3) PAHO recommends priorities to member governments for legislation, regulations and regulatory activities covering drugs, therapeutic devices and cosmetics, in that order. A summary of PAHO's recommendations for regulating drugs, cosmetics and therapeutic devices is presented, including a list of basic requirements for the registration application for a drug. Focus is on the national drug control program, quality control of drugs, registration of drugs, cosmetic and therapeutic devices, requirements for cosmetics, requirements for therapeutic devices, powers of inspectors, authority to establish a list of essential drugs, export of articles not meeting national requirements, conditions of release, registration of marketed drugs, registration on cosmetics, registration of therapeutic devices, and licensing of manufacturers.
International Digest of Health Legislation 29(3):671-675. 1978In the United States there is a new requirement for labelling drugs that is directed to the patient. Regarding oral contraceptives (OCs) (Subsection (a) of Part 310 (New Drugs) of Subchapter D (Drugs for Human Use) of Chapter I (Food and Drug Administration, Department of Health, Education and Welfare) of Title 21 (Food and Drugs) of the United States Code of Federal Regulations, January 19, 1978), the Commissioner of Food and Drugs concludes that the safe and effective use of OCs requires that patients be fully informed of the benefits and risks involved in the use of these drugs. A brief summary of information in lay language concerning effectiveness, contraindications, warnings, precautions, and adverse reactions shall be furnished to each patient receiving OCs. Included in this brief summary provided to the patient by the dispenser is 1) a statement that OCs are effective, but that any failure to take them in accordance with the recommended dosage increases the chance of pregnancy; 2) a statement of the specific items of history to be told the physician that would lead the physician not to prescribe OCs; 3) a statement that OCs should be taken only under medical supervision; 4) a listing of the serious side effects of OCs; 5) a statement in the form of a boxed warning that cigarette smoking increases the risk of serious side effects on the heart and blood vessels from OC use, and advising women who use OCs not to smoke; and 6) a statement of the most common side effects, such as nausea and vomiting, weight change, change in menses, and breast tenderness.
San Francisco, San Francisco Press, 1974. 292 p.Despite its high effectiveness, lack of side effects, ease of use, and low cost, condom utilization has declined in the U.S. from 30% of contracepting couples in 1955 to 15% in 1970. The present status of the condom, actions needed to facilitate its increased availability and acceptance, and research required to improve understanding of factors affecting its use are reviewed in the proceedings of a conference on the condom sponsored by the Battelle Population Study Center in 1973. It is concluded that condom use in the U.S. is not meeting its potential. Factors affecting its underutilization include negative attitudes among the medical and family planning professions; state laws restricting sales outlets, display, and advertising; inapplicable testing standards; the National Association of Broadcasters' ban on contraceptive advertising; media's reluctance to carry condom ads; manufacturer's hesitancy to widen the range of products and use aggressive marketing techniques; and physical properties of the condom itself. Further, the condom has an image problem, tending to be associated with venereal disease and prostitution and regarded as a hassle to use and an impediment to sexual sensation. Innovative, broad-based marketing and sales through a variety of outlets have been key to effective widespread condom usage in England, Japan, and Sweden. Such campaigns could be directed toward couples who cannot or will not use other methods and teenagers whose unplanned, sporadic sexual activity lends itself to condom use. Other means of increasing U.S. condom utilization include repealing state and local laws restricting condom sales to pharmacies and limiting open display; removing the ban on contraceptive advertising and changing the attitude of the media; using educational programs to correct erroneous images; and developing support for condom distribution in family planning programs. Also possible is modifying the extreme stringency of condom standards. Thinner condoms could increase usage without significantly affecting failure rates. More research is needed on condom use-effectiveness in potential user populations and in preventing venereal disease transmission; the effects of condom shape, thickness, and lubrication on consumer acceptance; reactions to condom advertising; and the point at which an acceptable level of utilization has been achieved.