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Point-of-sale promotion of breastmilk substitutes and commercially produced complementary foods in Cambodia, Nepal, Senegal and Tanzania.
Maternal and Child Nutrition. 2016 Apr 7; 12(S2):126-139.In order to assess the prevalence of point-of-sale promotions of infant and young child feeding products in Phnom Penh, Cambodia; Kathmandu Valley, Nepal; Dakar Department, Senegal; and Dar es Salaam, Tanzania, approximately 30 retail stores per site, 121 in total, were visited. Promotional activity for breastmilk substitutes (BMS) and commercially produced complementary foods in each site were recorded. Point-of-sale promotion of BMS occurred in approximately one-third of sampled stores in Phnom Penh and Dakar Department but in 3.2% and 6.7% of stores in Kathmandu Valley and Dar es Salaam, respectively. Promotion of commercially produced complementary foods was highly prevalent in Dakar Department with half of stores having at least one promotion, while promotions for these products occurred in 10% or less of stores in the other three sites. While promotion of BMS in stores is legal in Senegal, it is prohibited in Cambodia without prior permission of the Ministry of Health/Ministry of Information and prohibited in both Nepal and Tanzania. Strengthening legislation in Senegal and enforcing regulations in Cambodia could help to prevent such promotion that can negatively affect breastfeeding practices.
The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.
Food and Drug Law Journal. 2013; 68(2):115-35, i.The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss.
Revista de Saude Publica / Journal of Public Health. 2006 Jun; 40(3):513-520.The objective was to assess the advances in the Brazilian norm for commercialization of infant foods from 1988 to 2002, comparing the different texts with each other and with the International Code of Marketing of Breast-Milk Substitutes. This was a descriptive study based on data collected from documents, reports, ordinances and resolutions from the Brazilian Ministry of Health. The versions utilized in the comparison were from 1992 and 2002. Comparative analysis made it possible to identify important advances in the legislation. In 1992, liquid and powdered milk were included in the scope, along with teats and dummies (pacifiers), and also warning phrases in advertising and on product labeling. In 2002, regulations for products were published by the National Agency for Sanitary Surveillance, thereby strengthening supervisory actions and including regulations for baby foods, nutrient formulae for high-risk newborns, and nipple protectors. The phrases used in commercial advertising and on product labeling, including dummies, teats and bottles, became Ministry of Health warnings. The labeling was defined according to product types, on the basis of more restrictive rules. Significant modifications in the control over the marketing of products aimed at mothers during the lactation period. However, there are still some legislative questions that would make it possible to improve the Brazilian norm, in order to protect breastfeeding. There is also a need for the government to implement systematic monitoring routines to supervise this legislation. (author's)
Journal of the National Cancer Institute. 2004 Jul 7; 96(13):985.A politically challenged debate about labeling condoms with warnings about the link between human papillomavirus (HPV) and cervical cancer has erupted following a related Congressional hearing on the issue in March. Although the dispute centers on the protection of women from cervical cancer, the debate is just as much about ideology: premarital abstinence or monogamy in marriage versus condom use for those who choose to be sexually active. The hearings, called by Rep. Mark Souder (R-lnd.) at the urging of Tom Coburn, M.D., co-chair of the Presidential Advisory Committee on HIV/AIDS continue to raise questions about a public law Coburn authored in 2000 and that former President Bill Clinton signed days before leaving office. Souder confronted the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention with his belief that the agencies had not complied with the public law. (excerpt)
An Act (No. 72 of 1987) to prescribe the law in relation to the sale of condoms and related matters and to repeal the Police Offences (Contraceptives) Act 1941 and the Police Offences (Contraceptives) Repeal Act 1976. Date of assent: 27 November 1987. (The Sale of Condoms Act 1987).
INTERNATIONAL DIGEST OF HEALTH LEGISLATION. 1988; 39(2):387.This Act comprises the following Parts: I. Preliminary (Secs. 1-5); II. Sale of condoms (Secs. 6-8); III. Licenses (Secs. 9-22); IV. Advertising (Secs. 23-24); and V. Miscellaneous (Secs. 25-33). 1 of the provisions in Sec. 6 lays down that a person may not sell or supply a condom unless it complies with the standards prescribed by regulations. Details are given in Part IV of the procedures for the monitoring, by the Publications Classification Board, of advertisements relating to condoms. Details are given in Sec. 32 of the matters in respect to which the Governor may make regulations for the implementation of this Act. Such regulations may, inter alia, deal with the labelling, packaging, information provided in or on packages, and storage of condoms, as well as the procedures to be followed, and the action that may be taken, to prevent the sale or supply of condoms that do not comply with the prescribed standards. It is likewise laid down that, with respect to standards for condoms, the regulations may adopt either wholly or in part and with or without modification (either specifically or by reference) any of the standard rules, codes, or specifications of any prescribed authority (defined to mean (a) the Standards Association of Australia; (b) the British Standards Institution; (c) the International Organization for Standardization; and (d) such other body, organization, or Government department or agency as is specified in the regulation. (full text)
Report to Congress pursuant to the Federal Cigarette Labeling and Advertising Act for the years 1982-1983.
[Unpublished] 1985 Jun. 50 p.This report is the most recent in a series of reports on cigarette advertising that the Federal Trade Commission (FTC) has submitted annually to the US Congress since 1967 pursuant to the Federal Cigarette Labeling and Advertising Act. On September 26, 1984, Congress passed and on October 12, 1984, the President signed into law the Comprehensive Smoking Education Act. This Act amends the Federal Cigarette Labeling and Advertising Act. It provides for establishment of a Committee on Smoking and Health in the Department of Health and Human Services to coordinate federal and private efforts in educating the public on the adverse health effects of smoking. Additionally, Section 4 of the Act amends the Federal Cigarette Labeling and Advertising Act by requiring all manufacturers and importers to display on a quarterly rotating basis 4 specified health warnings on all cigarette packages and advertisements other than outdoor billboards. In 1983 the Commission sued successfully in the US District Court for the District of Columbia to enjoin Brown & Williamson Tobacco Company from advertising its Barclay cigarettes as a 1 mg "tar" cigarette or from using any "tar" number not specifically approved by the FTC. Brown & Williamson appealed, and the argument was heard on October 2, 1984, but no decision has been issued. Advertising expenditures for US cigarette manufacturers reached nearly $2 billion in 1982. By the end of 1983, the figure was almost $2.65 billion. Cigarette manufacturers led all other national advertisers in newspaper advertising and ranked second in magazine advertising. Associating smoking with high-style living, economic and social success, and healthy activities were the prevailing messages sent by the industry to consumers. In 1985, there was a marked increase in the market share of generic brands that were first introduced in late 1982. In 1983, R.J. Reynolds introduced the 25-cigarette pack. There have been numerous efforts to reformulate brands that failed achieve sales success when first introduced but were regarded positively in market surveys. Cigarettes sales are believed to have been affected by the increased cost of cigarettes due to an increased cost of cigarettes due to an increase in the excise tax and the continued reports on the health consequences associated with both active and passive smoking. Some of the major findings of the Surgeon General about the health consequences of smoking since initial consideration by the Congress of the rotational health warning legislation are summarized. The Surgeon General's reports on the health consequences of smoking have provided a significant stimulus to make the public aware of the adverse effects of tobacco usage. The most recent of these have dealt particularly with with the impact of cigarette smoking on cancer, chronic obstructive lung disease, and coronary heart disease. A table shows the totals of US cigarettes sold for the years 1963 and 1983.
Indian National Code for Protection and Promotion of Breast-feeding. [Resolution No. 18-11/81-NT dated 19 Dec 1983].
Indian Pediatrics. 1984 Mar; 21(3):259-64.The objective of the Indian National Code for Protection and Promotion of Breastfeeding is to contribute to the provision of safe and adequate nutrition for infants by the protection and promotion of breastfeeding and by ensuring the proper use of breast milk substitutes, when these are necessary, on the basis of adequate information and through appropriate marketing and distribution. The Code applies to the marketing and practices related thereto, of the following products: breast milk substitutes, including infant formula; other milk products, foods, and beverages, including bottle fed complementary foods, when marketed or otherwise represented to be suitable, with or without modification, for use as a partial or total replacement of breast milk; and feeding bottles and teats. It also applies to their quality and availability and to information about their use. Article 4 of the Code maintains that the government shall ensure that objective and consistent information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition. This responsibility shall cover the planning, provision, design, and dissemination of information and their control. Informational and educational materials, whether, audio, or visual, should include clear information on the following: the benefits and superiority of breastfeeding; maternal nutrition and preparation for the maintenance of breastfeeding; the negative effect on breastfeeding of introducing partial bottle feeding; the difficulty of reversing the decision not to breastfeed; and where needed, the proper use of infant formula. According to the Code, there shall be no advertising or other form of promotion to the general public of products within the scope of the Code. Manufacturers and distributors should not provide, directly or indirectly, to anybody, samples of products within the scope of this Code. Other provisions of the Code include: health authorities should take appropriate measures to encourage and protect breastfeeding and promote the principles of the Code; health workers should encourage and protect breastfeeding; in systems of sales incentives for marketing personnel, the volume of sales of products within the scope of this Code should not be included in the calculation of bonuses, nor should quotas be set specifically for sales of these products; labels should be designed to provide the necessary information about the appropriate use of the product so as not to discourage breastfeeding; the quality of products is an essential element for the protection of the health of infants and should be of a high recognized standard; and the government shall give effect to the principles and objective of the Code through legislation and other appropriate measures.
[Letter concerning] public health message regarding which contraceptives provide protection against sexually transmitted diseases (STDs) and which do not.
[Unpublished] . 2 p.In 1983, the US Food and Drug Administration (FDA) informed various consumer groups that it now required manufacturers to note on certain contraceptive labels that the product does not protect against sexually transmitted diseases (STDs), including HIV infection. FDA also asked for help in communicating this message to others. The contraceptives include oral contraceptives (OCs), Norplant, Depo-Provera, and IUDs. FDA is in the process of reviewing scientific studies regarding spermicides, Today Sponge, cervical caps, and diaphragms before taking any action on the relabeling of these contraceptives. The modified information must be conspicuously displayed and must be clear, understandable to the consumer, and not overshadowed by other information. FDA has taken this action in an attempt to eliminate the confusion created by the information of previous labels and contraceptive packages concerning STDs and HIV transmission. Various consumer representatives and health professionals had informers FDA that this information confused people who practice risky sexual behavior, especially teenagers and young adults. Since 1987, FDA has recommended that natural-membrane condoms be labeled as inferior to latex condoms in providing protection against STDs. Individual latex condom wrappers and the outer packages not state: "If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other STDs. "The natural-membrane condom packages read: "This product is intended to prevent pregnancy. It does not protect against AIDS and other STDs. In order to help reduce the risk of infection of many STDs, including AIDS, use a latex condom." FDA requires almost identical labeling on packages for OCs, Norplant, Depo-Provera, and IUDs, but does not require the statement about using a latex condom.
Lancet. 1992 Oct 17; 340(8825):962-3.[The Indian] parliament has passed the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Bill, which, when it comes into force, will severely restrict the advertising and promotion of these baby products. Essentially the bill incorporates the contents of the International Baby Food code adopted by the World Health Assembly in 1981, but expands its scope to include infant foods--i.e., foods being marketed "as a complement to mother's milk to meet the growing nutritional needs of the infant after the age of 4 months". Apart from disallowing the advertising of these products, the bill prohibits the distribution of free samples and the offer of other inducements for promoting them. Donations of infant-milk substitutes and bottles may be made only to orphanages. The law also lays down stringent conditions for the labeling of baby foods and categorically bans the use of pictures of an infant or a woman or both, or the use of words such as "humanized" or "maternalized" in the information printed on the containers. All information material on the product must promote breastfeeding and stress the "financial and social implications" of using infant formulas and baby bottles. Further, manufacturers are forbidden from offering inducements to or fixing salaries of employees on the basis of volume of sales. Offenses under this act may be punishable by imprisonment for up to 3 years or a fine of up to Rs 500. Not surprisingly, baby-food manufacturers opposed the bill tooth and nail and succeeded in stalling it for a considerable time. There is, after all, a huge and growing market at stake. According to a Voluntary Health Association of India estimate, the market for baby foods, worth nearly Rs 7200 million (approximately 180 million pounds)--almost entirely shared between Amul, the manufacturing unit of a highly successful and pathbreaking Indian milk cooperative venture, and Nestle--is growing at 6%/year. The bill has had a long and interrupted passage. A diluted version was 1st introduced in Parliament in 1986, when it was passed by the Upper House but lapsed with the dissolution of the Lower House. The current version of the bill was introduced in January; again it lapsed with the dissolution of the House and was reintroduced in May. Institutions such as the Indian Academy of Pediatrics, the Consumer Guidance Society of India, and the Voluntary Health Association of India have endorsed the bill and have played a leading role in having it enacted in parliament. The question now is whether the law can be implemented successfully. The problems are many. For one, the law makes food inspectors appointed under the food Adulteration Act responsible for taking cognizance of any offenses under it. The already overworked and often corrupt inspection staff is hardly likely to take the new task seriously. Secondly, the bill makes illegal the use of the health system or its employees for the promotion or advertising of these baby products, which implies the existence of an agency that will monitor or at least keep watch over the functioning of the health system. There is no such agency and the proliferating private sector in health care is largely unregulated. And thirdly, there is the other side of the coin--restricting the promotion of baby food must be accompanied by creation of conditions that enable the vast majority of poor women to breastfeed. Such a task in a country where most women are forced to work in the unorganized sector would be colossal. (full text)
Social Science and Medicine. 1992 May; 34(9):959-64.Insufficient information contributes to failure in markets. Government officials also use it to justify intervention in the health sector in the developing countries. Further, in these countries,health care workers have misused pharmaceuticals considerable as well as make improper diagnoses. Moreover both health practitioners and the general public do not always follow instructions on drug use. A shortage of information on appropriate use may indeed cause these problems. A staff member of the World Bank proposes a methodology to use to balance 2 competing risks. Either public health officials allow drugs to be available to consumers over the counter or they require a prescription from a licensed health professional. The risks include obvious diagnostic errors made my consumers untrained in medicine and patients not receiving needed, potentially life saving, drugs. Since there is a shortage of medical personnel in most developing countries, people face considerable obstacles (e.g., travel time and expense) when it comes time to go to a licensed medical facility. The proposed methodology to evaluate the tradeoff between the 2 risks involves looking at the problems as one of determining the value of a more accurate diagnosis through the intervention of a skilled professional as a specific and costly mechanism for acquiring an accurate diagnosis. The article applies the model to illustrative examples to identify the information to answer the regulatory issue question. Further the model also allows public health policy makers to determine the appropriate level of training needed for medical professionals and to evaluate projects which improve public access to information on the use of drugs.
JOURNAL OF CONSUMER POLICY. 1990 Jun; 13(2):201-14.Recent epidemiological studies show a correlation estrogen based oral contraceptives and breast cancer. In certain groups, the studies indicate a 2-4-fold increase in breast cancer. The epidemiological data are bolstered by a well-accepted connection between estrogens and breast cancer. The unique status of OCs and the special problem of breast cancer make this 1 of the 1st viable consumer "toxic tort" cases. Consumers in the US who use OCs and develop breast cancer should be able to recover damages based on a theory of failure to warn. (author's) (summary in GER)
Seattle, Washington, PATH, 1990 Apr. v, 80,  p.A private contractor for the US Agency for International Development did a study on the provision of assistance to the private sector in developing nations for the production of contraceptives. The study has 4 objectives; to provide USAID with various strategies for meeting the demands for contraceptives in developing countries in the 1990's; to recommend activities to facilitate local private production of contraceptives; to provide an update on certain examples in the production of contraceptives in Egypt, Bangladesh, India, and Mexico; and to outline how developing countries can gain technical assistance for private sector production from US private and government agencies. Results indicate that estimated capital investments required for local production are modest. There are large scale projects in Egypt, India, and Bangladesh to initiate large scale local production of contraceptives. Most of the capital investment and operating costs can be paid in local currency. However, in countries other than Bangladesh and Egypt, there are limited opportunities for USAID to assist in the establishment of new private sector production ventures, but there are possibilities for upgrading and expanding existing facilities. Technical services provided by government and private agencies can assist developing country firms with local production of contraceptives. It was recommended that assistance be provided to initiate, upgrade, and expand local contraceptive production in selected developing countries. The transition from imported donor supplied to local production should be facilitated as well as intermediate production. Long term investment by technology suppliers should be ensured. Public-private partnerships should be included and supported. USAID should provide assistance in quality oversight capabilities, establish a clearinghouse for requests, and coordinate with other agencies. Case studies on contraceptive production in India, Bangladesh, Egypt and Mexico are presented.
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.
FOOD DRUG COSMETIC LAW JOURNAL. 1986 Jul; 41(3):241-56.Courts in the US uniformly have held until recently that the duty of drug manufacturers to warn of risks associated with prescription drugs runs only to physicians and not to consumers. The rule is based on the premise that the consumer is protected when the manufacturer provides an adequate warning to the physician, for the physician acts as a "learned intermediary" between the drug manufacturer and patient. Now, several courts have held that drug manufacturers have a duty to warn consumers directly of the dangers associated with the use of oral contraceptives (OCs). In identifying this duty, these courts have pointed out that OCs differ from most other prescription drugs: unlike most prescriptive drugs, OCs are "elective" drugs that the patient herself largely decides whether or not to use, and the "learned intermediary" doctrine thus is not as applicable in these cases; and Food and Drug Administration (FDA) regulations require consumer warnings for OCs. The remainder of this article discusses further the prescription drug rule, mass immunization cases, FDA regulation, OC cases, the adequacy of the warnings, and prospects for further exceptions to prescription drug rule. Until recently the only exception to the prescription drug rule had been carved out by a trilogy of cases involving polio vaccines -- Davis v Wyeth Laboratories, Reyes v. Wyeth Laboratories, and Givens v. Lederle. Beginning in the late 1960s, FDA began to issue regulations that challenged the assumptions of that to protect consumers it was sufficient if manufacturer's warnings went only to prescribing physicians. In 1970, FDA issued a rule requiring that patient package inserts (PPIs) be dispensed to consumers of OCs. It subsequently revised the regulation in 1978 to require more detailed information about risks of OCs, including hazards discovered since the initial rule. In the earliest OC case, Lukaszewicz v. Ortho Pharmaceutical Corporation, the court based the manufacturer's duty to warn the consumer entirely on FDA's OC rule. Another case to hold that manufacturers must directly warn consumers of the dangers of OCs was Stephens v. G.D. Searle & Company. In MacDonald v. Ortho Pharmaceutical Corporation, the jury returned a special verdict for the plaintiff who had suffered a stroke after taking Ortho-Novum OCs for 3 years, finding that the defendant had not adequately warned the plaintiff although it had adequately warned her physician.
Federal Register. 1979 Jun 26; 44(124):37434-67.The final ruling on the required format for physician labeling of prescription drugs for human use is presented. The Food and Drug Administration (FDA) intends, through the act, to improve prescription drug labeling by establishing standards that will bring all labeling up to the level of the better labeling currently available. Comments on the proposed act were solicited during the summer of 1975. 97 responses were received from physicians, professional societies, drug manufacturers, trade associations, individual consumers, and consumer groups. General comments proposed 35 changes or objections to the act, e.g., that the act was an invalid invasion by the federal government in the field of medicine, and that it would increase the cost of prescription drugs because of the expenses incurred by manufacturers in rewriting the labeling. Comments on specific requirements and format of labeling were received concerning the following sections of the act: the required descriptive informtion necessary for the safe and effective use of the drug, information on clinical pharmacology, indications and usage, contraindications, warnings, precautious (especially informtion concerning use during pregnancy), adverse reactions, overdosage, dosage and administration, how supplied, animal pharmacology and/or animal toxicology, and clinical studies and references. Additional comments on full disclosure, package inserts, and advertisements are reviewed. The presentation concludes with the final amendments to the proposal concerning the content and format of prescription drug labeling.
New York State Journal of Medicine. 1983 Dec; 83(13):1259.1 year after the issuance of the original Surgeon General's report, Congress passed the Federal Cigarette Labeling Advertising Act, requiring all cigarette packages distributed in the US to carry a Surgeon General's warning that smoking may be hazardous to health. Congress pased the Public Health Cigarette Smoking Act in 1969. This banned cigarette advertising from radio and television. The Surgeon General published the most comprehensive volume on smoking ever issued in the US in 1979, the 15th anniversary of the 1st report. The data on cigarette smoking's adverse effects on health were overwhelming, and the press recognized this. No longer able to rely on journalists to cast doubt on the reliability of the data, the industry changed its strategy by attempting to portray smoking as a civil rights issue. The tobacco industry began to pour millions of dollars into campaigns to prevent the passage of municipal, state, and federal legislation that would ban cigarette advertising or restrict smoking in public places and at the work site. "Healthy People," the Surgeon General's 1st report on health promotion and disease prevention, emphasized the necessary future direction of medicine: prevention. Efforts to end the cigarette pandemic will need to focus on the following in the future: an end to the victimization of women; a greater focus on adolescents; more effective strategies for smoking cessation; more attention to clean indoor air rights; abandonment of recommendations to switch to low-tar, low-nicotine cigarettes; and revelation of chemical additives in cigarettes. The epidemiologists have now documented the devastating nature of the health problems attributable to cigarette smoking, but the minimal budgetary allocations to fight smoking testify to the lack of political will on the part of government.