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Columbia, Maryland, Westinghouse Health Systems (AID/pha-C-1063). 1977 Dec; 68.In July 1974, Westinghouse Health Systems began the process of establishing a contraceptive retail sales program (CRS) to market condoms and oral contraceptives in Jamaica. The program, designed to utilize existing retail distribution systems, had as its major focus the development of indigenous resources to augment the existing clinic activities of the Jamaica National Family Planning Board, and centered on 5 major areas: 1) advertising and promotion; 2) product pricing and packaging; 3) distribution; 4) consumer and retailer education; and 5) program evaluation and monitoring. Initial research was aimed at educating the public, distributors, and retailers in the availability, usage, and potential side effects of oral contraceptives. A major advertising campaign involving radio, television and the press was directed at promoting the 2 contraceptive brands - Perle oral contraceptives and Panther condoms. In September, 3 years after implementation, management of the program was turned over to the Jamaican National Family Planning Board. Annual program sales had reached 184,000 cycles of pills, and 880,000 condoms through 267 Perle outlets and 1108 Panther outlets, nearly doubling and tripling pill and condom sales. Introduction of the new brands has had no effect on sales of competitive brands, nor has there been a negative impact on distribution of condoms and oral contraceptives through the public clinic sector. In addition, the cost per acceptor has been less when compared to costs per acceptor in the public sector clinics. By 1979, the projected costs per acceptor will be $262 in the CRS program versus $32.73 in the public sector program.
Worldwide regulatory requirements and their effects on the clinical study and transport of investigational new drugs.
DRUG INTELLIGENCE AND CLINICAL PHARMACY. 1977 Aug; 11(8):470-6.This article reviews regulatory requirements for the import, export, transport, and clinical study of investigational new drugs in those countries that make up the major pharmaceutical markets of the world. Regulations governing both human and veterinary drugs are discussed. The author states that the regulatory requirements on the extent and acceptability of clinical trial data are as diverse as the countries in which trials are conducted. He divides major pharmaceutical market countries into 3 groups. The 1st is made up of countries that accept foreign clinical studies for regulatory review; the 2nd of countries where local clinical trials are usually necessary for compliance with local regulatory requirements; and the 3rd (which includes India, Japan, and France) of countries where foreign data are not accepted and severe restrictions are placed on the importation of formulated clinical supplies for use in local clinical trials. The types of data that are required for investigational new drug approval are summarized for selected countries. Regulations on the transport of clinical drug supplies are discussed with a focus on whether countries require pretransport notification or documentation, the time factors involved in receiving approvals, whether authorized personnel or institutions are required to conduct clinical trials, and customs considerations. Particular attention is given to transport requirements in the U.S., the world's leader in controlling and regulating the transport and investigation of clinical drug supplies.
[Unpublished] 1977. 148 p. (Authorization Ltr. POP/FPSD: 8/30/77; Assgn. No.: 1100-072)An investigation of complaints of condom breakage, discoloration, odor, or moldy appearance was undertaken at the request of AID to verify reports from AID recipient programs that unacceptable condoms had been supplied to them. The history of reports of deteriorated or defective condoms, Federal specifications for condoms, possible causes of problems with condoms, and observations regarding packaging and boxing, expiry date, breakage, occluded powder, discoloration, color, storage and distribution, specifications, and field sampling are discussed, and the sampling procedure and test results are presented. The condoms tested appear to have met the various GSA specifications under the GSA Quality Assurance Program, but the suitability of their packaging for long-term storage in humid tropical environments was questioned. General recommendations and recommendations specific to Jamaica, Thailand, and Bangladesh were offered to avoid such difficulties in the future, particularly through ensuring appropriate packaging and storage. A series of appendices included the reports of laboratory tests on condom samples from Jamaica, Thailand, and Bangladesh; interim Federal specifications for condoms, pertinent excerpts from the 1976 Annual Book of Standards, and the packaging film specifications of the company which supplied most of the condoms under scrutiny.
Washington, D.C., American Public Health Association, 1977. 75 p. (APHA Assign. No. 1100-079)In order to evaluate and assess basic progress and problems in the implementation of the AID contract with Syntex Laboratories for a Commercial Retail Sales(CRS) project in Tunisia, various specific tasks and the overtly specific schedules are divided into 6 broad categories: 1) the dissemination of better medical information on oral contraceptives and condoms; 2) publicizing of the products directly to consumers by advertising through mass media, point of purchase, and other advertising promotional methods; 3) improvement of the current commercial system of distributing oral contraceptives and condoms through pharmacies; 4) extension of availability of both products nationwide by initiating distribution through general retail outlets; 5) establishment of a retail sale price affordable by the poor and with sufficient profit incentive for all merchants along the distribution chain; and 6) attainment of an economically self-sustaining system. It is believed that too much emphasis is put on developing a comprehensive, activity-specific plan with a rigid, artificial schedule, and that it is more productive to focus on practical expectations for the program within the general areas of program action. This review of progress to date is therefore centered on actual achievements and obstacles within the 6 program areas than on the detailed requirements and deadlines in both the contract and the marketing plan. Recommendations are made in the following areas: 1) general and basic; 2) administrative; 3) programmatic--information and advertising; 4) programmatic--distribution; and 5) programmatic--pricing. The following appendices are included: 1) evaluation of Tunisian Program, July 1975; 2) GOT documents announcing decisions to restrict importation of oral contraceptives to 3 brands, July 1977; 3) letter exchange between GOT and USAID approving contract AID/pha-C-1143; 4) letters of John Thomas and Robert Smith, 1977; 5) initial package designs for project commodities; 6) report from Institute Superior de Gestion on brand name choices; 7) proposed Advisory Board; 8) examples of information/ education materials produced by ONPEP; 9) list of persons contacted during Nov. 5-14 visit to Tunisia; 10) program statistics, 1971-76; and 11) scope of work for evaluation of CRS project in Tunisia.
Adopted. 1977 Oct 2; 3.The statements made in these summary minutes of the OTC Panel on Contraceptives and Other Vaginal Products are provisional in nature and may be modified or revised in subsequent meetings of the Panel or in their final report to the Commissioner of the Food and Drug Administration. At the 35th meeting of the Panel discussion focused on the merits of having information on the relative use-efectiveness of the currently available contraceptive methods including vaginal products in patient labeling. The panel concluded that there was insufficient scientifically valid data to provide any useful information to the consumer. In discussion of the term deodorizing the Panel agreed that deodorizing is a result of cleansing but left for future deliberation the final classification of the term "deodorizing."
Legal Medicine Annual, 1977. p. 299-313.The legal status of physicians prescribing oral contraceptives is reviewed, with particular emphasis on Pennsylvania state statutes. The discussion is prompted by the overwhelming epidemiological evidence associating oral contraceptive usage with breast cancer. The reason for joining the prescribing physician as a defendant in a OC case is that it is his or her duty to warn of the potential adverse effects of the medication. To this end, some insurance companies recommend patients sign an informed consent form. Because the Food and Drug Administration (FDA) exercises controls on the use of drugs, if the plaintiff could demonstrate that the physician used the drug in a way that was proscribed by the FDA, and the court accepted the proposistion that the physician knew or should have known of the proscription, in the eyes of the jury the burden of proof might well shift from the need for the plaintiff to prove the culpability of the physician to the necessity for the physician to prove his lack of culpability. The other theory of damages for responsibility argues for culpability of the drug company. Other legal considerations include an action in trespass alleging negligence against the drug company for its breach of express and implied warranties, and for its alleged failure to make timely, adequate warnings to the medical profession of dangers which the manufacturer knows or has reason to know are inherent in the use of its drug. Such suits are really product liability suits. One commentator argues that OCs should be taken from the legal realm, instead advocating that, barring isolated incidents where the doctor excercises poor judgement, the OC user should assume risk of harm similar to risks of smoking.
Medical devices: good manufacturing practice regulations for manufacture, packing, storage and installation.
Federal Register. 1977 Mar 1; 42(40):11998-12008.Because of the diversity of manufacturing processes in the production of medical devices, the FDA (Food and Drug Administration) proposed good manufacturing regulations for the manufacture, packing, storage and installation of medical devices under the Federal Food, Drug and Cosmetics Act. In response to this proposal, the FDA received a sizable number of comments and suggestions from small and large manufacturers of medical devices, resulting in a revised draft regulation. The comments from the manufacturing industry, and the FDA Commissioner's response to them are herein discussed, as are the changes in the general provisions, definition of terms, organization and personnel, buildings and equipments, control of components, container and in-processes materials, packaging and labeling control, holding distribution, product evaluation, records and reports. The Agency will subsequently analyze the inflationary impact of the regulations based on available data, and the Federal Register will publish such analysis for public examination before final regulations are promulgated.
(Press release. Contact: Shaffer, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20852) November 4, 1977. 2 p.An FDA (Food and Drug Administration) ruling required that a special brochure describing uses and risks associated with IUDs be given to women before physicians could insert IUDs. A similar ruling involving birth control pills and steroidal preparations was enforced in 1970 and 1977. FDA Commissioner Donald Kennedy stated that it was the FDA's objective to provide information regarding the advantages and disadvantages of contraceptive methods to facilitate the decision-making process of couples. The brochures described the IUD; its effectiveness; things a woman should know and discuss with her doctor before IUD insertions; how to check to see if the IUD is still in place, what to do if it is not; possible side effects and adverse effects to be reported to doctors; and, what to do in case of pregnancy with the IUD still in place. The regulation also provided for uniform professional labeling for IUDs. Required information directed to physicians included instructions for IUD insertions, indications for IUD removal, possible complications, and when IUD should be replaced or not used at all. The ruling took effect November 7, 1977.
Press Release. Contact: Ed Nids, United States Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland, 20852. January 24, 1977. 7 p.Increased consumer demand for more oral contraceptive information prompted the FDA (Food and Drug Administration) as of April 3, 1978 to require, in pamphlet form, additional patient information on effectiveness rates and side effects of oral contraceptives along with a change in information physicians receive. A strong warning advising women not to smoke if taking the pill is emphasized along with the following pertinent facts: 1) Theoretical effectiveness for the combination pill is about 99% and about 97% for the progestogen only pill; 2) Contraindications include smoking; blood clotting; cancer of the breast or reproductive organs; stroke; heart attack and pregnancy. It is strongly advised that women with irregular of light menses not take the pill; 3) Serious side effects include blood clots, liver tumors, hemorrhages, birth defects, high blood pressure and gall bladder disease; while breakthrough bleeding, nausea, vomiting, weight gain, and breast tenderness are considered less serious; 4) Heart attack risks by nonsmoking women taking oral contraceptives are double, however, the risk is 10 times greater for those combining the pill with smoking; 5) Although current studies do not confirm a cause-effect relationship between estrogen, an ingredient in the pill, and cancer in humans, the relationship has been found in some animal studies; 6) venereal disease is not prevented or cured by oral contraceptives; 7) the onset of pregnancy should be delayed several months after stopping the pill. Donald Kennedy, FDA Commissioner, commented on the new requirements reiterating the dangerous effect of combining the pill with smoking.
Planned Parenthood-World Population Washington Memo W-3. 1977 Mar 1; 4-5.The British Joint Working Group on Oral Contraceptives, established to determine whether the present system of limiting oral contraception prescription to doctors inhibits women from obtaining effective contraceptive protection, has recommended that properly trained nonphysicians be allowed to prescribe the pill without direct physician supervision. A cadre of nurses, midwives, home health visitors, and pharmacists will be specially trained to advise patients on the risks and benefits of oral contraception. The Group's report notes that single women, especially teenagers, and some married women are unable or unwilling to approach their family doctor for contraceptive help. In the U.S., a Food and Drug Administration proposal to require an additional patient brochure as well as a package insert for the pill represents yet another new approach to protecting the health of oral contraception users. While in agreement with the concept of intensive patient education regarding the side effects and contraindications of the pill, Planned Parenthood has recommended several revisions in the brochure's content so as to achieve a greater balance of information on both benefits and risks and to reflect the most current scientific findings.
(FDA to require distribution of brochure explaining the benefits and risks of the hormone estrogen) (Press release)
Washington, D.C., USDHEW, October 17, 1977. 3 pEffective October 18, 1977, women receiving prescriptions for drugs containing the female sex hormone estrogen must be given a special lay-language brochure explaining the benefits and risks of the drug. About 5,000,000 women in the U.S. use estrogen-containing prescription drugs every year to treat menopausal or postmenopausal problems. The brands prescribed include Premarin, Hormonin, Estratab, Evex, Menest, Femogen, and Ogen. Donald Kennedy, Commissioner of Food and Drugs, has stated that FDA has become increasingly concerned that estrogens are used too frequently and for too long a period. The brochure, to be printed and supplied by manufacturers of the drugs, indicates that estrogens are associated with cancer of the uterus when used for extended periods. Additionally, the brochure advises women to take estrogen drugs for the shortest time possible and in the lowest effective dose for treatment of menopausal systems and to reevaluate, with their doctors, the need for estrogen every 6 months. It states that these drugs should not be used to treat simple nervousness and depression during menopause because they have not been shown to be effective for these purposes and that they have not been shown to be effective for keeping the skin soft or for helping women feel younger after menopause.
In: Seaman, B. and Seaman, G. Women and the crisis in sex hormones. New York, Rawson, 1977. p. 251-261Despite the simple technical nature of the condom, it remains the preferred method in such low birthrate, sexually sophisticated countries as Japan, Sweden, and England. Yet in the U.S. restrictions still exist which prevent open television and newspaper advertisment, which emphasizes the venereal disease preventative nature of condoms. American condoms remain much thicker, by 1/2 to 1/3, than most foreign brands, such as the Japanese. Condoms are considered by some users to interfere with sensation. Their effectiveness approaches that of the diaphragm and the pill. Significant barriers also exist in obtainability for young people. Some problems of packaging and size still persist. Directions for the proper use of condoms are provided, as well as a review of American brands. Vaseline should not be used for lubrication, as it can deteriorate the material. They can be used in conjunction with spermicidal foams.
Family Planning Perspectives. May-June 1977; 9(3):138-140.There have been no IUD-related spontaneous abortion deaths since the occurrence of mass media publicity about the Dalkon Shield and the risks associated with leaving an IUD in place following conception. Scientific publications, drug company labeling changes, drug package inserts, and other professional warnings do not seem to have been as effective as mass media publicity in causing a change in a dangerous clinical practice. It seems that publicity directed against a preventable health problem will affect both clinical practice and public health. Such publicity could be useful in getting doctors to prescribe lower estrogen dosage pills and in getting women to obtain abortions as early in the pregnancy as possible.