Why is it important in Pharmaceutical Industry? What’s the relevance of this allegation in a country like the USA where it seems everyone knows everything except the workers? How come people in other parts of the world are not concerned about this threat to mankind as it affects the lives of many?
A great deal of the drug discovery work in the pharmaceutical industry is done on rats and other animals as drug development cost is so high, and it is difficult to test drugs on humans. For example – insulin, which is manufactured from glucose, was isolated from cattle and is now one of the most extensively used drugs in the world. There is a great controversy whether this drug is harmful for humans or not. The argument is on whether the animal models used in the process of discovery have been precluded from being representative of humans because they are innately resistant to insulin.
The other big accusation against the US Food and Drug Administration (FDA) is that it is doing more harm than good to the pharmaceutical industry. The FDA regulates the manufacture of prescription drugs but it lacks the power to control the marketing of commercialized drugs. Some of the biggest drug companies claim that they are entitled to hike up the prescription drug costs by 20 percent in order to make more money. The FDA has, on several occasions, blocked these high drug prices citing the fact that the market is flooded with low-priced generic versions of the patented drugs. However, there is no legal provision that allows the FDA to dictate the price of a patented drug.
Many pharmaceutical companies are also up for sale due to the rising costs of patented drugs. Many feel that the introduction of generic versions is unjustified since they are not able to recoup the R&D costs that they have invested in the development of their drugs. Hence, there is a misconstrued belief that the introduction of generic versions would adversely affect the profits of valeant pharmaceuticals. However, there is nothing in the nature of patents which prevent a patent holder from offering a generic version of a patented product. The idea that the public good is threatened by patented products is not true.
Another big accusation against the US Food and Drug Administration is that it is doing little to stimulate research into new drugs. The law allows pharmaceutical companies to monopolize any business including the distribution of medicines and the research into new drugs. Since the introduction of patent laws in 1980, there has been a drastic reduction in the number of new drugs introduced every year. In addition, there is no legislation which grants exclusive rights to the drugs hence they can be sold off the shelves without restrictions. This allegation against the FDA is completely false, as it has allowed innovative pharmaceutical companies to come up with cost effective medicines that can fight against all kinds of health problems.
Another accusation against the FDA is that it is failing to regulate the import of cheap generic drugs from abroad. As there is no official regulation for the drugs, the importer can freely decide to sell medicine at low prices hence there is a huge demand for fake drugs. The FDA has established measures to check and curb such practices. A list of over two hundred and twenty importers of branded and generic drugs is now maintained. If any drug manufacturer tries to ship medicine without following the rules and regulations, then he will be punished. Moreover, the penalties are heavy and this serves as a deterrent method to other companies that might try to abuse the system.
Another major accusation against the FDA is that it is promoting chemical drugs rather than using herbal remedies for diseases. Even though herbal cures are effective, they are not covered by the patents and hence can’t be sold as over-the-counter drugs. On the other hand, synthetic drugs are completely safe. However, many of them don’t have the US Patent on their works thus the generic versions can’t be sold as OTC drugs. Thus, instead of providing patients a chance to obtain inexpensive medications, the FDA is actually working against the interests of the patients.
The final accusation against the FDA is that it is responsible for the unnecessary deaths due to prescription drugs. The number of premature deaths due to pharmaceutical drugs has increased many folds during the past few years. However, all this has not deterred the pharmaceutical giants who are still fighting vigorously to hold on to their monopolistic control over the medical industry. The patent laws must be changed or else these companies can make unlimited profits by selling a medicine that doesn’t even cure the disease!