Generic drugs contain the same active ingredients, in the very same strength, as brand-name drugs. When a medicine is first developed, the pharmaceutical company that discovers and markets it receives a patent on its new drug. The patent usually lasts for 20 years, to give the originating company a chance to recoup its research investment. After the patent expires, a generic version of the drug may become available. Generics are marketed under the drug’s chemical, or “generic,” name and meet the same FDA quality and effectiveness standards as the original.
Some brand-name manufacturers charge customers higher prices in the United States than they do in other countries, where drug prices are regulated. Drug research is costly, and patent protection gives brand-name manufacturers at least 20 years to recover those costs — costs that generic manufacturers do not have. Brand-name manufacturers collectively spend billions of dollars in marketing new drugs to doctors and the public; they send their representatives to visit with doctors in their offices; and they pay for physicians’ trips to meetings and conferences to talk about their drugs with other doctors. Generic manufacturers rarely spend money on advertising and marketing — another important way they keep their costs down.
FDA-approved generic medicines work in the same way and provide the same clinical benefit and risks as their brand-name counterparts. A generic medicine is required to be the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken. Generic medicines also have the same risks and benefits as their brand-name counterparts.
The FDA Generic Drugs Program conducts a rigorous pre-approval review to make sure generic medicines meet these requirements. In addition, FDA conducts inspections of manufacturing plants, ensuring compliance with the agency’s regulations on good manufacturing practices.
FDA staff monitor approved brand-name and generic drug products to make certain that medicines at all levels of the supply chain, from the active pharmaceutical ingredients that provide therapeutic effect, to the final products being sold to consumers, are safe, effective, and high-quality. In the event of reports of negative patient side effects or other reactions, the FDA investigates and may require changes in how medicines (both brand-names and generics) are used or manufactured. FDA will also communicate any information to the public as warranted.
Generic drugs may not often be identified as important policy forces, but they have nevertheless greatly influenced the public’s health and the pharmaceutical industry. Though much in the way of public good has already been generated (i.e., better access to generics through lower cost and greater competition), generic drug policy will remain an important aspect of our healthcare system. For example, strict tort liability for generics and drug shortages are ongoing issues that are still developing. Additionally, the continually changing incentives and rules regulating the generic market will likely produce unforeseeable issues. Hence, it is imperative that we keep a keen policy eye on generic drugs to identify such changes in time to adequately respond to them.
For more information about generic medicines Contact your doctor, pharmacist, or other health care provider to discuss generic medicines. For more information from FDA, you can also:
Visit the FDA Generic Drugs Program web page.
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