THE PROS AND CONS OF GENERIC MEDICINE
According to the US Food and Drug Administration (FDA), a generic drug is a medication that is identical, or bioequivalent, to a brand name drug in dosage structure, safety, strength, route of administration, quality, performance characteristics and intended use. In other words, while generic drugs are chemically similar to the original patented medicine, they are often sold for far less. Statistics show that “generic drugs save consumers an estimated 8 to 10 billion USD a year at retail pharmacies”, www.ndrugs.com. The FDA touts generics as the way to go in the provision of qualitative yet affordable medicines to the consuming public.
Yet the perception that generic drugs are inferior to their original counterparts, still exist in certain quarters. This belief finds solid ground in that the development of a new drug is a very complex process, which involves not just the research and development of the chemical, but also clinical trials and all of the regulatory processes to get the drug approved for human consumption. However, it must be stated that generic medicines also pass through stringent controls and tests, in order to maintain the quality, strength, purity and stability levels of the generic in comparison to the patented version.
The FDA however believes that the costs of developing new drugs can be channeled into the manufacture of generic medicine, as a way of combating the steep and rising cost of prescription medicine in America.
Facts about the Process path for Generics
In case you would like to know the details regarding the approval process/production of generic medicine, the following tips can guide you:
1. FDA stipulates that all generic drugs have the same quality and level of performance as their brand name equivalent.
2. Research reveals that generics work just as effectively as brand name drugs.
3. When it comes to pricing, a wide gulf exists between generic and brand name drugs. On average, the cost of a generic drug is generally 80 to 85 percent lower than that for a brand name product.
4. Rest assured that the affordability of generic medicine does lower its quality and performance.
5. The FDA participates actively and closely monitors all stages involved in the production of generic medicine. It also keeps tabs on adverse events reports for generic drugs.
6. The FDA leaves no stone unturned in making sure all regulated products — including generic drugs — are safe and fit for human use.
However a few points of worry exist, especially with regard to the requirements for approving a generic drug:
1. The FDA requires that manufacturers input between 80% to 125% of the brand name drug activity into a generic medication. There creates room for variability if you get your generic from different vendors. While one producer may pack 80% of “effective” drug component, another one may opt to have up to 120%.
2. Components of generic drugs other than active ingredients are not required to be identical. This stipulation could mean that the formulation could affect how the drug is delivered to the user’s blood stream.
3. With regard to regulatory controls, the FDA admits that some generics somehow missed being tested. Cases exist where some generics have had to be recalled from the market.