FDA Registration Of Neglected Tropical Disease Drugs And Its Impact On Developed Countries That Need - Thesis Example

• The burden of NTDs

NTDs consist of a set of infectious communicable diseases caused by varied groups of vector-borne protozoa, bacteria, and parasitic worms. Over 1.4 billion people across the globe, including an estimated 400 million children, are affected by one or more of the NTDs. NTDs cause approximately 534,000 deaths each year (Sabin Vaccine Institute). NTDs such as leishmaniasis, trypanosomiasis, and lymphatic filariasis cause significant health burdens in developing countries in the Middle East and Africa. Regionally, the NTD does not affect a large number of people even though they carry high morbidity and mortality. In addition, they also affect people’s social lives and productivity. However, opportunities to control them exist since they are typically endemic in limited areas. Second, they have simple diagnostic tests and low-cost treatments are available (Salaam-Blyther 17). Third, the primary health-care systems are generally underdeveloped and lastly, political commitments have been implied (Narain et al 206-210). A dramatic shift in U.S. policy has seen an accelerated move towards fighting tropical diseases in developing countries. In September 2007, the United States Congress passed the Food and Drug Administration ACT of 2007 that increased the funding for research and development of NTDs such as malaria, tuberculosis, leishmaniasis, and Chagas disease. A major provision in the Act consisted of the awarding of transferrable review voucher (PRV) to pharmaceutical companies that were granted Food and Drug Administration Approval for new biological and pharmaceutical treatments that target a neglected tropical disease (Grabowski and Ridley 3). FDA registration has made significant impacts on the developing and developed world.

• The Role of the FDA

The FDA regulates drug approvals to promote public health by keeping ineffective and unsafe drugs off the market. Because of these, the users of the drugs in both the developed and developing countries can think of a registered drug as one that has been proved to meet the standards of efficacy and safety. Despite the successive reforms to address the bias and the stringency of the FDA registration process, there is a growing body of evidence that suggests that FDA drug approval standards have become unusually strict than optimal socially (Ward).