Voucher Program to Encourage New Drugs for Tropical Diseases
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Over the past 50 years, the development of new drugs for the treatment of tropical diseases, covering nearly one billion people has geschmachtet because it is not profitable for the remaining producers West. But that could change with what is called a voucher programme, the United States medication major manufacturers financial incentives for the development of drugs for diseases that are rarely seen in developed countries. VOA’s Jessica Berman reports. Last year, the United States drug makers, which some say, could be an enormous financial benefits. The United States Congress, the Food and Drug Administration permission to give what she called a gift for all pharmaceutical companies, the approval given to a new tropical medicine. The list of eligible diseases include tuberculosis, malaria and Schistosomiasis in association with other diseases, worms and parasites. The gift card is a producer of an expedited review of Experimental Medicine, believes that the company could be what we in the industry as a “Blockbuster” drug. Previous Blockbuster also Viagra for erectile dysfunction and Prozac for the treatment of depression. Timothy Cote is director of the FDA office that oversees the admission of products for diseases affecting humans under 200000 in the United States. “Drug sales [a] typical Blockbuster can between $ 3 billion and $ 10 billion to $ 12 billion, with a ‘b’ billions of dollars per year in the areas of distribution,” Cote. “So, c That is faster than check the value of financial compensation, if you bet $ 5 billion turnover and allows you to control the speed of the review process for six months, which is positive 2.5 billion dollars, which was a lot of money. ” The average length of the review process by the FDA last between 10 and 18 months. Under the proper regulatory program of the United States, the Authority of authorisation for research applications medicines Blockbuster, within six months. Cote said the accelerated review in no way compromise security. “It does not alter the review,” he said. “This is not to guarantee a permit. It says only that we saw on the speed of some other drugs. Well, this cheque will be useful for most products Blockbuster, the great market potential in the future. ” Despite these guarantees, the Harvard University Medical School, Professor Aaron boiler think domestic sport to develop drugs for tropical diseases, for a gift certificate for a bad idea. Kessel back to the house just released a study by colleagues from Harvard University, who said that the United States, regulators, emotion, the pressure for the approval of new drugs in a part of shorter duration, medicines, which were approved are five times more frequent in Du market for safety reasons. The researchers also found that more than four percent of new drugs, which had found its way to allow consumers to a star, the black box warning added to ensure the safety of the package. Caldron of the house, said the financial attractiveness of one may not be good to attract companies with experience in the development of drugs for tropical diseases. “A company that can really well in the cardiovascular system, medicines will try to give early feedback evolution of the tropical disease in the world, and perhaps not as good as the other manufacturers, which may anti-infective products” , said the domestic boiler. James Geraghty is vice president of Genzyme Corporation, a biotechnology company that develops new drugs, and to benefit from purchase orders. Geraghty, the FDA said the program will not be the safety of the drug, the processing industry. “Expedited inspection did not, we do not always have the intention, which in any lowering of standards,” he said. “Only a system of prioritization and accelerating the review of the importance, for reasons of public health, in any case reduced standards of verification.” Harvard’s domestic boiler think there are better ways to promote the development of new drugs for neglected diseases, including frontal obligations of developing countries in the West from other makers to purchase large quantities of tropical products, once they are developed. The voucher program is scheduled during the month of September force. |