Manufacturers of pharmaceuticals create drugs and sell them in bulk to wholesalers, who then distribute them to pharmacies. This process requires complex logistics and packaging methods to ensure that medicines are delivered on time and in good condition. Patients can then go to a pharmacy to pick up their prescriptions. Additionally, pharmaceutical companies are attempting to restrict access to samples for generic drug testing.
Generic drug manufacturers need to be able to purchase samples of brand-name products for bioequivalence testing. This is because they must demonstrate that they can manufacture a bioequivalent product that meets current Good Manufacturing Practice (CGMP) standards. These manufacturers do not need to conduct clinical trials like the original pharmaceutical company did. One study found that organizations that had received grants from pharmaceutical companies often supported the companies' positions, while groups that had received minimal funding focused their advocacy on potential drug side effects.
By making an acquisition, a large company can bring a drug to market faster or distribute it more widely than a small business could. 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 also devote some of their R&D 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 designed to reward pharmaceutical companies for their innovations and protect consumers is 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 this period, 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&D. For established pharmaceutical companies, current revenue streams from existing products also provide an important source of funding for their R&D projects.
Direct-to-consumer pharmaceutical advertising (DTCPA) has grown significantly over the past few decades and is now the most prominent type of health communication that the public encounters. Pharmaceutical companies are using tactics to make their temporary monopolies semi-permanent.
