Pharmaceuticals for Developing Countries Conference Proceedings (1979) / Chapter Skim
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PROBLEMS AND CONSTRAINTS
PROBLEMS AND CONSTRAINTS
Pages 175-280
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From page 176... ...
However, in 1976, only 40 companies accounted for 53 percent of all corporate funds spent on research and development. Pharmaceutical companies do not appear among the top 20 companies in annual dollar expenditures for research, a function of their relatively small size within American industry.
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From page 177... ...
There is also an extreme concentration of research and development within the pharmaceutical industry itself. Only 14 of the 26 pharmaceutical companies that spend more than one million dollars annually on research and development actually spend at the industry average rate of 50 percent of net income.
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From page 178... ...
Unique capacity carries with it a unique obligation. Even from the most limited commercial view, it is important that the pharmaceutical industry respond to the potential increase in demand for its products by the people in less-developed countries who now have inadequate access to existing pharmaceuticals, let alone access to optimum new pharmaceuticals for diseases peculiar to the southern hemisphere.
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From page 179... ...
It developed in a time when the infrastructure for health care was already in place; it continued its own development in parallel with the growth of that infrastructure. Its growth mirrored that of the pharmaceutical industry in other "developed" countries -- those countries undergirded by highly developed educational systems, crowned by outstanding universities -- countries concerned for the public health and possessed of mechanisms for providing and improving it.
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From page 180... ...
" Frustrated by the ever-increasing costs of total health care, government understandably turns its eyes constantly to medicines because their costs are so easily identifiable, even though their costs have remained remarkably constant and, in this country, are a declining percentage of total health care expenditures.
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From page 181... ...
For such products (relating to tropical diseases) at the present time, there is little possibility of manufacture in the United States.
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From page 182... ...
There is perhaps one final aspect of United States regulations that should be mentioned, the regulatory influence on the availability of participants in the final and critical stage of research -- clinical pharmacology. The area of clinical research is the most difficult of all in the medicine research process; it is the stage where the pharmaceutical industry must turn over to outside scientists (with careful monitoring, of course)
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From page 183... ...
A recent study of health issues by the World Bank clearly documents a second important point -- that the most serious disease problems of the developing nations are by no means restricted to parasitic diseases. Even earlier, in 1969, a study published by the Rockefeller Foundation cited statistics showing that nonvector-borne diseases are consistently identified as the major health concerns by these countries themselves.
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From page 184... ...
It has not been possible for the private sector, as represented by the pharmaceutical industry, to stem that tide. Despite public retreat and foundation withdrawal, a significant amount of research directed toward parasitic diseases has been conducted by the industry, and with successful results.
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From page 185... ...
Integrated public health programs pose substantial logistical problems, and demand a great deal of management, organization and planning; in short, they are expensive. Because of lack of public funds to support such programs there has been a general underutilization of available drugs for treatment of tropical diseases.
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From page 186... ...
I, for one, from the United States industry would like to be a creative partner in that innovative thrust.
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From page 187... ...
In regard to the first of these, you may not be aware that last month the world's first Encyclopedia of Bioethics was published by the Kennedy Institute for the Study of Human Reproduction and Bioethics at Georgetown. This four-volume publication has 313 articles that address such contemporary problems as advertising by the medical profession, 187
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From page 188... ...
The key question, whether the United States Government should allow the export of useful but potentially hazardous substances not approved for marketing in this country, evokes strong views on both sides. On the one hand, there is concern that current export policy for some products can result in the "dumping" of inferior or even dangerous substances in countries poorly equipped to evaluate the potential risks involved.
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From page 189... ...
The Administration's new bill, The Drug Regulation Reform Act of 1978, which was given extensive study by committees of both Houses in the last session of the 95th Congress, would revise the current export rules applicable to drugs. Under the Act, two standards for export would apply to all drugs.
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From page 190... ...
The relative safety and efficacy of a drug or medical device is a composite judgment which must be made by each country based upon many factors, such as the status of the health care system in that country, patient compliance with dosage regimens, alternative therapies that may be available, and other specific characteristics of its population. Some diseases prevalent throughout the world -- especially in the tropics, where most of the developing nations are found -- are rare or nonexistent in this country.
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From page 191... ...
That understandable lack of foresight clearly handicaps our ability to help meet the therapeutic needs of developing nations. What we need is statutory authority to make useful drug entities and products available to foreign countries, to do so with due reference to the regulatory decisions of foreign governments, and without subjecting such countries to unreasonable risks from dangerous entities and products.
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From page 192... ...
Creation of similar research institutions in the developing countries will be required if science in those areas is to flourish in the 21st century. What are the constraints on involvement of the United States government and research community toward development of pharmaceuticals for primary use in other parts of the world?
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From page 193... ...
But the fact remains that money for research on tropical diseases has been meager compared to funds allocated for research on the health problems in the United States. For example the FY 78 budget for the National Institute of Allergy and Infectious Diseases (NIAID)
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From page 195... ...
CO rH i- H O rH ON •H •o f~ rH H -^- O P-^ i-~ ro 1n vO CO P-^ 3 f t M M M M M CU b ro vO l~> ON O CO M CO CO O 00 O en |
From page 197... ...
Perhaps the foremost obstacle in regard to developing drugs for tropical diseases is that we do not yet have the necessary scientific knowledge to solve many of the pressing problems. To mention only a few, we are ignorant about the host-parasite relationships in 197
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From page 198... ...
schistosomiasis; the metabolism of the leprosy bacillus; or mechanisms of replication of viruses causing the most prevalent infections. Dig deeply -- that is the key.
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From page 199... ...
"Among many critical issues, in addition to the perennial question of funds, I would single out these: At what level should the primary responsibility for directing research programs reside? Should it be with the individual scientist and his institution, or should it be in Washington?
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From page 200... ...
You know of course that when we run out of people to write a memo to, we write a memo "to the record." This regulation would go a long way to vitiate the mischief of administrative micro-management and provide a greater opportunity for managers to return to the regions of professionalism. The final constraint concerns limitations on the number of specialized medical scientists who are available to work on tropical medicine, and, hand in hand with this limitation, insufficient numbers of research institutions in the developing countries.
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From page 201... ...
For example: the centers in Mexico, Nigeria, and elsewhere under the auspices of the Consultative Group for International Agricultural Research -- a joint enterprise between Rockefeller and Ford Foundations. But, in a sense, the Rockefeller Foundation left the international health field too soon.
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From page 202... ...
Extend current United States research to the developing countries through "linkages" between United States investigators and those in the countries where tropical diseases prevail; 3. Assist in the establishment or strengthening of centers of excellence in developing countries; and 4.
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From page 203... ...
of the 200th anniversary of the United States. This phrase, "sure foundations," was taken from a longer statement by Thomas Jefferson.
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From page 204... ...
Government and Academic Laboratories for the Development of Preventive, Prophylactic, Diagnostic, and Therapeutic Agents for Selected Infectious Diseases. Conference on Pharmaceuticals for Developing Countries.
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From page 205... ...
Dr. Warren called for increased participation by the pharmaceutical industry in efforts to find new therapeutic agents for diseases endemic to developing countries.
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From page 206... ...
Sallam's comments about the profit potential for pharmaceutical companies in Egypt, as experienced by the Hoechst Company since the early 1960s. He also mentioned the company's schistosomiasis research in Egypt, an unusual achievement.
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From page 207... ...
the promotion and mislabelling by the pharmaceutical industry of particular antibiotics. These two situations have resulted in emergence of many resistant bacterial strains such as gonococci, pneumococci, salmonellae, and shigellae, some of which now respond only to a very few agents.
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From page 208... ...
He referred to the extensive networks of clinics being built by WHO in developing countries which represent important resources for clinical testing of new products. Would the pharmaceutical industry be prepared to contract for any testing in underdeveloped countries, perhaps coordinated by WHO?
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From page 209... ...
He accused many pharmaceutical companies, even so-called "good name" companies, of selling bad products to developing countries. He asked how quality control can be assured for developing countries lacking the minimum facilities to police all imports.
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From page 211... ...
The charts provide a profile of the health scenario in the developing world in facts and figures, in all its staggering gravity, but also its contradictory and irrational elements. Only the most essential data are reproduced in this document.
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From page 212... ...
If existence of an educated middle class is a crucial prerequisite to building an industrialized economy, developing countries may indeed be justified in devoting a disproportionate share of resources to their benefit. WHO, other UN agencies and political groupings are proposing that developing countries allocate resources increasingly to the social periphery of primary health care; for all practical purposes this is to take resources away from the private sector and channel them into the public sector.
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From page 213... ...
Any comparison between the industrialized countries and Africa would show even sharper differences.
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From page 214... ...
It is the public sector that is woefully in disorder from any vantage point. This applies to the medical infrastruture, medical care 214
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From page 215... ...
Figures vary more in low income countries but pharmaceutical expenditure rarely rises to US $2 and often accounts for up to 50 percent of total health care. Figures relate to 1975 or latest available year.
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From page 216... ...
DISTRIBUTION OF PUBLIC FINANCE IN SELECTED DEVELOPING COUNTRIES (1975) Country Category Total Nat'l Finance % Distribution Local Currency millions Education Health Defence Low Income Bangladesh a/ Ethiopia India Kenya a/ Sri Lanka c/ Tanzania c/ 6307 1049 174100 d/ 219 8150 6640 10.3 2.5 f/ 6.7 15.5 4.4 17.6 8.0 e/ 3.3 e/ 12.1 21.1 6.6 6.5 10.5 6.1 2.2 12.5 6.2 11.0 Middle Income Bolivia 6293 27.5 9.0 h/ 16.5 Brazil a/ 58556 5.0 1.0 14.0 Colombia a/ 46528 18.4 7.4 8.6 Dominican Rep.
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From page 217... ...
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From page 218... ...
They are developing strong initiatives in creating national welfare services in the health field that extend health care to the needy and underserved. If further proof were needed of the gross deficiencies of the public sector, it can be found in the use of drugs against tropical diseases.
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From page 219... ...
iiiooiiiiomvor-. |
From page 220... ...
Patents It has become fashionable in Third World countries to attack patent practices of the multinational drug producers. The proclaimed reason for this assault on patent rights is that industry is employing the international patent system to prevent local production and secure import monopolies.
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From page 221... ...
TABLE 6. PATENT PROTECTION FOR PHARMACEUTICALS IN SELECTED DEVELOPING COUNTRIES Country Patent situation satisfactory Patents legally possible, but worthless a/ Patents not allowed CENTRAL & SOUTH AMERICA Brazil Argentina Chile Venezuela Peru Ecuador Colombia Paraguay Uruguay Mexico Costa Rica a/Patents may be obtained which cover only the manufacturing process, they are not enforceable, their life is too short or other legal obstacles deprive the patentee of any real protection.
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From page 222... ...
TABLE 6. PATENT PROTECTION FOR PHARMACEUTICALS IN SELECTED DEVELOPING COUNTRIES Country Patent situation Patents legally Patents not satisfactory possible, but allowed worthless ASIA India + China + Taiwan + Philippines .
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From page 223... ...
This process will continue as research oriented pharmaceutical companies find it inadvisable to file patent applications in India. Trade Name Restriction A growing number of developing countries are abolishing or restricting trade names, and are requiring or encouraging prescription by generic name.
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From page 224... ...
There can be little doubt that because of the low-price levels, problems in transfer prices and in the remittance of dividends and royalties, developing countries do not carry their share of research and development costs of the multinational drug companies. These 224
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From page 225... ...
The little room for individual initiative left to drug companies is to be further reduced, virtually putting them in a strait-jacket. Until recently, Sri Lanka had practiced drug policies of this nature for a number of years.
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From page 226... ...
I recall my own experiences in the 1950s, when so many companies entered with courage and enthusiasm into Third World countries, taking pride in their operations and the value of their contributions to the economy and society, willing to venture high risks and long-term investments. Since those days of promise and achievement, the corporate spirit has undergone a profound change.
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From page 227... ...
It is within their power to create economic and social environments that will enlist the aid of the developed world. It is equally within their power to erect barriers to meaningful assistance.
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From page 228... ...
Now, I am Chairman of ACDIMA, "The Arab Company for Drug Industries and Medical Appliances", created to shoulder the responsibility for developing not only a pharmaceutical industry for the Arab World, but also the manufacture of all that is needed by the health service; namely, pharmaceutical raw materials, package materials, and medical appliances. Africa and the Middle East comprise 68 developing countries with a population of about 600 million: 400 million in Africa, and 200 million in the Asian Middle East countries.
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From page 229... ...
The question of branded versus generic drugs is very important to the majority of developing countries wishing to benefit from the availability of reasonably priced generic drugs of adequate quality. Second: the characteristics of the population Physical size, age distribution, mortality rate, urban concentration, culture, and traditions are important determinants of drug use.
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From page 230... ...
• Except for the countries of the Arabian Gulf, Libya, and perhaps Algeria and South Africa, African and Arab countries suffer -- to varying degrees -- from shortages of hard currency. Overall, drug consumption is growing relatively rapidly, with annual growth rates of 16 percent in Africa and 19 percent in the Middle East being recorded.
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From page 231... ...
The output of local manufacture is limited by difficulties in importing raw-materials, the cost of which is often greater than the price offered by overseas suppliers for finished products. The incentive to local production (costing about 15 to 20 percent more than the lowest tender price)
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From page 232... ...
Strengthen the links between the pharmaceutical industry and research centers. Investigate medicinal plants and other potentially useful natural resources.
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From page 233... ...
The company was established in March 1976, and has been collaborating with other countries and with UNIDO to begin implementation of essential projects for production of: • Pharmaceutical raw materials, including some antibiotics; and some synthetic bulk pharmaceutical chemicals. • Pharmaceutical packaging materials, such as glass containers and hard gelatin capsules.
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From page 234... ...
A factory for manufacture of antibiotics, previously estimated to cost about $40 million, will now require an investment of $90 million; worse, the pharmaceutical glass factory projected to cost a maximum of $45 million, is now estimated to require an investment of $128 million These costs are almost prohibitive for anyone, even for a group of developing countries wishing to embark on the manufacture of raw or packaged drug materials What can be done by the United States and the American pharmaceutical industry? I cannot add much to what Dr.
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From page 235... ...
UNESCO already regards temples, monuments, historic buildings, and other treasures as part of the human heritage, and pools money to preserve them as a source of enjoyment and nourishment for mind and soul; it is time for the world also to pool money and raise a fund through WHO, UNIDO or a new "International Bank of Health". In this way, the world can own discoveries and technologies in the health field, and make them available especially to developing countries, not gratis, but at prices adjusted to each country's purchasing power.
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From page 236... ...
I shall proceed as follows. First, thumbnail sketch of recent policy developments in the pharmaceutical sector in India and Sri Lanka; second, a discussion of the main problems as far as the availability of drugs is concerned; third, problems of drug distribution; last, the main conclusions.
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From page 237... ...
The overriding concern of the government continues to be promotion of local production, and to this end increasing attention is given to attracting advanced technology from abroad, by licensing where feasible and by direct foreign investment where necessary. The last two or three years have witnessed the following significant developments.
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From page 238... ...
is selling turnkey plant technical assistance and training services to Arab countries, Sri Lanka, and Bangladesh; Sarabhai Chemicals (a private firm) is setting up a turnkey multi-purpose plant in Cuba, under a contract awarded by UNIDO; and several possibilities of technical cooperation with Latin America are being explored, again under UNIDO auspices.
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From page 239... ...
In 1972, Sri Lanka set up a State Pharmaceuticals Corporation (SPC) to centralize all drug imports, to economize on their purchase and to replace the sale and use of drugs by brand names to generic names.JJ/ Sri Lanka was, and continues to be, dependent upon imports for the bulk of its drug needs; local production, by a few small local firms and five affiliates of foreign firms, was confined to the relatively simple formulation and packaging of a few imported pharmaceutical chemicals.
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From page 240... ...
While the achievements of reform in Sri Lanka were impressive, resistance from multinational affiliates, drug importers, and the medical profession continued, and the change of government in 1977 led to some emasculation of the activities of the SPC. Detailed information on the most recent developments are not available but indications are that a private market, with brand-named drugs, will be restored,^0/ and that the SPC will continue to function as the major importer for the state health services and possibly also (like CEME in Brazil)
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From page 241... ...
2. The area of local production of drugs contains a host of difficult issues, most of of which are general to the whole problem of industrialization in the Third World and not peculiar to this industry.
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From page 242... ...
Technology: The major constraint on further development of the pharmaceutical industry in India now is availability of new and complex technology. There are three ways to resolve this constraint: direct investment by foreign firms in production of bulk chemicals; licensing of technology by foreign firms of local enterprises, public and private; and indigenous development of process technology.
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From page 243... ...
3. The issue of drug imports can best be considered for the case of Sri Lanka, and may be subdivided into two components: import of finished pharmaceutical products, and that of intermediate pharmaceutical chemicals.
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From page 244... ...
The best solution here may be for both sides to recognize that compromise is required. Drug companies should accept that poor countries constitute a special case in that their need for innovation is low (except for specific tropical diseases)
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From page 245... ...
Sri Lanka has launched a thorough reform, with tremendous resistance from the medical establishment, but it is as yet impossible to evaluate the success of its attempt. Some other countries, like Afghanistan, are banning advertising of branded drugs altogether, but it is not clear what alternative channels of information dissemination will replace it.
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From page 246... ...
In another recent paper, I have tackled more directly what multinational drug companies may do to meet the aspirations and needs of the Third World,_16/ The most general conclusion I arrive at is that the "free market" system as it now exists is incapable of resolving the various conflicts that 246
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From page 247... ...
exist between drug multinationals and developing countries without substantial modification. It needs reform in terms of the number and prices of drugs it provides, of the assistance it gives to local production capabilities of less-developed nations, of the system of drug promotion and information dissemination, and of the importation and distribution of drugs.
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From page 248... ...
3. Of the total value of production of $980 million in 1976-77, bulk drugs accounted for 18 percent (of which 33 percent was produced by two public sector units, 60 percent by large private units and 7 percent by small-scale units)
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From page 249... ...
Lall, Price Competition and the International Pharmaceutical Industry, Oxford Bulleting of Economics and Statistics, February 1978, pp 9-22 10. See Scrip, 31 December 1977, p 18 11.
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From page 250... ...
The developing countries have come to realize increasingly that the conventional approach inherited from the industrialized countries is hopelesly inappropriate when it comes to meeting, within a reasonable period of time and from available resources, the basic health needs of their vast populations.
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From page 251... ...
This is the concept of "primary health care", of essential care made universally accessible to individuals and families in the community by means acceptable to them, through their full participation and at a cost the community and the country can afford. While these new ideas on primary health care, already implemented in a few countries, take root in other countries and help to break the present log-jam in extending medical care from the urban, elitist minorities into the vast rural populations, the whole problem of an adequate supply in the public sector of pharmaceuticals indispensable to meet the basic health needs of large populations is assuming a new social dimension.
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From page 252... ...
The concept of the selection of essential drugs to meet basic health needs of the population is so closely linked with the concept of primary health care, and so important, that you must forgive me for repeating some of these obvious statements.
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From page 253... ...
3. Again, as scientists, we would like to see that this process of selection of the drugs most suitable to meet basic health needs under severe economic constraints is, as far as possible, unbiased and based on adequate scientific data obtained in controlled clinical trials and/or epidemiological studies.
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From page 254... ...
In the public sector, expensive, imported pharmaceuticals of this type, irrelevant to basic health needs, may become a wasteful drain on a developing country's scarce resources for health care and could be replaced by cheaper items of local production, particularly herbal remedies. Finally, in developing countries there is also a growing demand 254
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From page 255... ...
This new program has broad objectives and is distinct from the Special Program on Research and Training in Tropical Diseases. The aim of WHO is to stimulate, through the new program, broad international cooperation among governments, both of developed and developing countries, interested United Nations agencies, development aid organizations, and pharmaceutical industries, in order to alleviate the situation in the public sector of those developing countries where large segments of the population do not have access to the most essential drugs, including vaccines, that are indispensable to ensure even a minimum of health care.
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From page 256... ...
It is envisaged that, at the request of a government, the Action Program could provide immediate help to improve the supply position where lack of essential drugs is the main constraint for development of a national program of primary health care. At the same time, adequate support could be provided for a comprehensive survey of the country situation which, in turn, could lead to further cooperation in strengthening national technical and managerial capabiities, in training personnel, in transfer of information and in building up infrastructures in the following six main areas: 1.
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From page 257... ...
Almost everything has been said on research and development of better tools for control of tropical diseases, but this discussion should not obscure other areas, such as clinical and epidemiological studies on safety and efficacy of existing drugs used under local conditions, development of appropriate technologies for drug formulation and packaging, including stability of the products under tropical conditions, and development of more heat-resistant vaccines, etc. While research and development of new and better drugs is crucial to progress in health care -- and the outstanding contribution of the 257
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From page 258... ...
Perhaps the new Action Program on Essential Drugs, outlined above, coupled with development of primary health care efforts in developing countries, could increase effective use of modern drugs, open new markets in the public sector for such drugs and, by the same token, provide incentives for research and development efforts of the industry more relevant to particular needs of developing countries. This new program of WHO is in its initial stages, and its success will largely depend on the political will of the governments of developing countries to tackle the problems in their own countries, and on the readiness of more affluent countries to work together in true partnership with the less affluent to define and implement a plan of action as part of social and economic development.
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From page 259... ...
Let me close by making a pledge to those of you working in the pharmaceutical industry who, I realize, deal with reality instead of hopes and theories. We shall do our best to stimulate mutual understanding and cooperation between governments and private industries in order that the fruits of your technology -- modern drugs, vaccines, diagnostic products and all the rest -- which are indispensable for modernization of health care and effective disease control in developing countries, get into the hands of more health workers for the benefit of a larger proportion of the world's population who, at present, are denied access to them.
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From page 260... ...
Current Concerns in Drug Development for Parasitic and Tropical Diseases Drugs currently available for treatment of parasitic diseases have limitations due to problems of toxicity, development of resistance to the drugs, and the fact that they are generally expensive.^,^/ In addition to better distribution of existing therapies, less developed countries (LDCs) need new drugs that are safer, more effective, and more easily administered for treatment of these diseases.
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From page 261... ...
Despite these apparent disincentives, certain pharmaceutical firms continue to be actively involved in research on drugs for parasitic diseases. The World Health Organization (WHO)
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From page 262... ...
1966 1977 13 8 yrs 9 yrs a/The following aspects of the United States regulatory process are particularly relevant to development of drugs for parasitic and other tropical diseases.
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From page 263... ...
The measure we have recently developed in some detail is the number of NCEs taken into human testing, and their subsequent progression through clinical and regulatory stages of drug development. This is a useful measure, since the point of entry into human testing represents a firm's decision that a compound is worth further testing and investment.
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From page 264... ...
Since data requested in the surveys are not publicly available and were provided under a confidentiality agreement with responding firms, results of the surveys are expressed in aggregate form without identifying any individual company or compound. Although the contribution of foreign-owned pharmaceutical firms to new drug development in this field is known to be substantial, complete data on the experience of these firms were not obtained in our investigational NCE survey; the investigational NCEs described in this paper represent only those developed by United States-owned pharmaceutical companies.
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From page 265... ...
Because of the small number of compounds in each specific category, all categories ar combined in this initial report. Countries in which NCEs were First Synthesized Table 1 lists the countries where the investigational NCEs for parasitic diseases were first synthesized.
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From page 266... ...
The IND filings are shown in Figure 2 as a function of time. The rate of IND filings by United States firms and their affiliates was fairly constant (i^e.., a total of one or two per year)
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From page 267... ...
20,27 46,73 (0) 18,30 33 9 13, 14 •These compounds had received NDA approval by the end of 1976.
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From page 268... ...
Once a company has decided that a drug is worth submitting for an NDA, that drug has high likelihood (88 percent) of eventually obtaining NDA approval.12/ For each of these drugs the IND phase was shorter than the NDA phase, in contrast to the pattern seen for NCEs in all therapeutic areas, for which the average IND phase was longer than the average NDA phase.
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From page 269... ...
Part II: Marketed NCEs for Parasitic Diseases This part deals with NCEs that have received NDA approval and are marketed in the United States by United States-owned or foreign firms. Within our data base of all NCEs that have received NDA approval in the United States from 1940 through 1978, 35 of the approximately 850 drugs are in the parasitic and tropical disease categories.*
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From page 270... ...
Part III: Antiparasitic NCEs Available from the CDC Because of the special position of the CDC with respect to drugs for tropical and parasitic diseases, the distinction between investigational and marketed drugs, and hence the significance of IND filing and NDA approval, is not as meaningful as for NCEs developed by industry. Information from CDC on their INDs in this area indicated that none were first testd in man in the United States.
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From page 271... ...
ANTIPARASITIC NCEs APPROVED FOR U.S. MARKETING SINCE 1940 Category and NCE a/ Year of NDA Approval Duration in Months of NDA Phase b/ Antiamebic Carbarsone 1944 Not Available (Carbarsone)
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From page 272... ...
(Cont'd) Category and NCE a/ Year of NDA Approval Duration in Months of NDA Phase b/ Amopyroquin 1966 (Propoquin)
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From page 273... ...
TABLE 5. ANTIPARASITIC DRUGS AVAILABLE FOR INVESTIGATION FROM THE CDC a/ Drug Disease Bayer 2502 Bithionol Dehydroemetine Melarsoprol (Mel B, Arsobal)
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From page 274... ...
J Richard Crout, Director of FDA's Bureau of Drugs, has said that FDA policies on regulations pertaining to acceptance of foreign data are not responsible for lack of any recent NDA approvals in this field since drugs for tropical diseases that do not occur in the United States could be approved on the basis of foreign data._17/ In addition to the current export policies referred to above, however, othe United States regulatory procedures may influence the level of R&D activity in antiparasitic drugs and drugs for other therapeutic areas.
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From page 275... ...
Provisions requiring release of data were discussed in hearings on the Drug Regulation Reform Bill of 1978. The activities and policies of several major United States and foreign pharmaceutical firms in regard to research on drugs for parasitic and other tropical diseases have recently been described by Behrman.j)
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From page 276... ...
.kj This factor must be taken into account when society considers creating incentives for the private sector to continue research in drug development for tropical diseases.
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From page 277... ...
The authors wish to thank the Center for Disease Control and the pharmaceutical firms that provided data for our study.
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From page 278... ...
Center for Research in Government Policy and Business, University of Rochester, GPB 77-10, August 1977 5. Hansen RW, Wardell WM: Regulation and competition in the pharmaceutical industry.
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From page 279... ...
Fed Reg 43:35210-35236, 8 August 1978 21. Standards for institutional review boards for clinical investigations.
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