Manufacturers create drugs and sell them wholesale to wholesalers, who in turn sell drugs to pharmacies. In this process, wholesalers use complex logistics and packaging methods to receive and deliver medicines on time and in good condition. Patients can go to a pharmacy to pick up their prescriptions. Another way pharmaceutical companies are thwarting generic drugs is by restricting access to samples for testing.
Generic drug manufacturers should be able to purchase a sample of a brand-name product for bioequivalence testing. This is because they have to demonstrate that they can manufacture a bioequivalent product following current Good Manufacturing Practice (CGMP) standards. These manufacturers don't need to conduct clinical trials like the original pharmaceutical company did. One study found that organizations that had received grants from pharmaceutical manufacturers often supported companies' positions, while groups that had received minimal funding focused their advocacy on potential drug side effects.
By making that acquisition, a large company could bring a drug to market faster than the small business could have, or could distribute it more widely. There may be competing drugs in the same therapeutic market, and companies can introduce other new drugs to that market, provided that they do not infringe patents on existing drugs. Pharmaceutical companies devote some R%26D resources to finding new effective combinations of existing drugs, such as with the latest HIV treatments and preventive measures, or new drug delivery mechanisms, such as insulin pumps. The system aimed at rewarding pharmaceutical companies for their innovations, but eventually protecting consumers, is systematically breaking down.
In response, communication channels have been opened between pharmaceutical companies and regulators long before filings to help ensure that companies collect all the relevant data needed for a successful filing. The patent prevents other companies from copying it for 20 years and covers many aspects of a drug's intellectual property, including its manufacture, formulation and, in some cases, its use. During that time, they can maintain higher prices on a patented product than they could otherwise, which makes new drugs more profitable and therefore increases the incentives for pharmaceutical companies to invest in R%26D. For established pharmaceutical companies, current revenue streams for existing products also provide an important source of funding for their R%26D projects.
Direct-to-consumer pharmaceutical advertising (DTCPA) has grown rapidly over the past few decades and is now the most prominent type of health communication that the public encounters. Pharmaceutical companies are currently using a set of tactics to make their temporary monopolies semi-permanent.