Anyone who has insurance has probably run into a situation where a generic drug is filled even though the prescription was written using the brand name. Most prescription pads have a checkbox for the doctor to give his/her approval for a generic brand to be used. So what are generic drugs and are they safe?
FDA Approval Standards
There is a division of the FDA that works specifically with generic brands. The drug must go through rigorous testing before it is FDA approved. From the FDA website, some of the things that the FDA requires are for a generic brand:
- The active ingredient is the same as the brand name drug. This must be the ingredient that is effective against the illness or condition it is being used to treat.
- The active ingredient is the same strength.
- The drug must meet the same batch requirements for identity, strength, purity, and quality.
- The drug information label must be the same as the brand name. (The exception to this is if the brand name is approved for more than one use, the generic label will not include unless it does the same.)
- Any inactive ingredients that are not found in the name brand must be acceptable.
- The drug must last for at least the same amount of time as the brand name drug.
- All patents or exclusivities must be addressed.
The FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand name counterparts. Generic brands may contain other inactive ingredients such as fillers or preservatives, but must work in the same way and provide the same clinical benefit as its brand name version.
Why is the generic brand so much cheaper? Because the brand name company invested time and millions of dollars to create the drug in the first place. The FDA does not require the generic brand to repeat costly animal and clinical research.
Most insurance companies now insist that if there is a generic drug, that it be given to the patient. However, if a doctor believes the brand name drug will benefit the patient better and/or treat several diseases that a generic counterpart could not, the doctor could provide documentation to the insurance company explaining why he/she has written the prescription for only the brand name drug.
Don’t be afraid to use generic drugs. The FDA Generic Drugs Program conducts a rigorous review to make certain generic medicines meet the same standards as their brand name counterparts. The FDA also conducts almost 3500 inspections a year of the generic medicine’s manufacturing plants and continues to monitor drug safety after the generic medicine has been approved and brought to market.