Medicine and money: name brand vs generic prescriptions

It is a long and complex process for a new drug to make it onto the market and available to patients. It can take up to 12 years to make this trip from lab to the grocery store. Out of 5,000 compounds that go to pre-clinical testing, only five will make it to human trial. From those five trials, one drug is approved on average. The process is very expensive in terms of time and money.

Pre-clinical testing can take around four years and includes laboratory and animal studies to assess the safety and biological activity. At a minimum, a pharmacological profile is established and toxicity of the drug in at least two animal species. There may also be a short-term study up to three months depending on the use of the drug. If the application is approved by the Institutional Review Board, it goes to clinical trials. There are three phases of trials. Phase one lasts around a year and involves between 20 - 80 healthy volunteers. This phase is to determine a safety profile, safe dosage range and how the drug is handle by the body. Phase two trials are controlled studies of 100 - 300 volunteers who are patients with the disease the drug is targeting. Taking about two years, the drug's effectiveness against the disease is studied. Phase three lasts about three years and may involved 1,000 - 3,000 patients in hospitals and clinics. These patients are closely studied by physicians to identify any adverse reactions and how effective the drug may be against the disease or condition.

After the studies are completed and data is compiled, an application is made to the Food and Drug Agency (FDA) for a new drug. Once the studies are reviewed and if the drug is approved, physicians can begin prescribing it to patients. The drug company must still make periodic reports to the FDA about reactions and other information.

The above-mentioned research and trials are what people pay for with a brand name drug; a reimbursement to the drug company for at least part of the cost of development. A drug company is given a 20 year patent on their drug. Some drugs are given an extension with a successful application to the FDA. Once a patent is close to expiring, generic companies apply for the right to sell generic versions. Because these companies did not have the developmental expense, they can sell the generic version at a much reduced cost.

Generic drugs are just as safe and effective as their name brand counterparts. They are required to have the same active ingredients. They look different because the style of the name brand drug is part of its trademark, which is protected. The facilities of both the manufacturer and generic makers are strictly controlled and inspected, the quality is the same. About 50 percent of brand-name firms make copies of their own and other company’s products to sell as generic. This is part of the free market and helps to keep drug costs down for consumers.