| As the U.S. Food and Drug administration (FDA) has put it, to get FDA approval, a generic medication must: contain identical active ingredients as the trade name drug (inactive ingredients may vary), be identical in strength, dose form and route of administration; meet the same batch requirements for identity, potency, quality and purity; be produced under the same established standards of FDA's Good Manufacturing Practice regulations compulsory for original medicines. To put it differently, their pharmacological effects are exactly the same as those of their brand name versions.
Although generics are chemically identical to their brand name versions, they are commonly sold at substantial discounts from the brand name price. According to the Congressional Budget Office, generic medications save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generic medicines.
The principal reason for the relatively low price of generic medications is that competition goes up among producers when medications no longer are protected by patents. Manufacturers spend less money on creating a generic medication, and are, thus, able to sustain profitability at a lower price to consumers. The costs of these generic medicines are so low that many developing countries can easily afford them. For example, Thailand is going to purchase millions of doses of the generic version of Plavix, a blood-thinning medicine to prevent heart attacks, at a cost of 3 US cents per dose from India, the leading manufacturer of generic medicines.
Producers of generic drugs do not incur the cost of medication discovery, and instead are able to reverse engineer known medicine compositions to allow them to manufacture bioequivalent versions. Manufacturers do not have to prove the safety and potency of the medications through clinical trials, because these trials have already been carried out by the brand name firm.
Generic medications may at times be molded differently than trade name versions, such as a generic pill versus a brand name bolus. Nevertheless, they have the same active ingredients and are manufactured under the same standards as brand name medicines. |
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