Our Ask An Angel correspondent is Arlene Petersen, Certified Senior Advisor and Life Care Navigation Specialist in the area of senior home care.
Q. My husband and I have an on-going difference of opinion about generic versus brand-name drugs. Is there a difference between the two?
A. My husband and I have the same, on-going discussion! I always thought the generic version of a brand-name drug was the same, but upon researching it, I learned some new things myself!
It is probably easy to agree that the one big difference between the generic versions of a drug and the brand-name is cost. The FDA states, generic drugs can cost 80 to 85 percent less than a brand-name.
Why the difference in cost? According to the Mayo Clinic, generic drugs are less expensive because the companies that make them don’t need to spend money on drug research and development, clinical trials, marketing, and advertising â as brand-name drug manufacturers do. These costs can run into the hundreds of millions of dollars for a single drug.
Once patents and exclusive sales rights of a brand-name drug have expired, generic drugs can begin to enter the market. A generic drug manufacturer needs only to understand the known chemistry of a brand drug and then develop a method for manufacturing a product that meets FDA standards.
The FDA lists their requirements on their website, fda.gov. Their requirements are listed as:
Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand-name.
Generic drugs do not need to contain the same inactive ingredients as the brand-name product.
The generic drug manufacturer must prove its drug is the same as (bioequivalent to) the brand-name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand-name product is used, the generic drug will work the same.
The FDA does realize that some variability can and does occur during manufacturing, for both brand-name and generic drugs. When a drug, generic or brand-name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
The FDA also has a link to check if your medication is available in a generic form. However, the easiest way to check on this is to ask your doctor or pharmacist.
Additionally, the question that is also asked is if a generic drug is safe to take. According to the Consumer Health Information Corporation, the answer is âusually yes.â
They state that a company must prove that its generic version of a drug is both safe and effective before it can be sold to the public. The company that made the original brand-name drug proved during years of testing that the drug is both safe and effective.
A company that makes a generic drug must show that its version of the drug is 80 to 125 percent âbioequivalentâ to the original brand-name drug. For example: a brand-name drug is taken, and it is found that 100mg of medicine reaches the personâs bloodstream. For a generic version of the drug to be considered safe and effective, the active drug in the tablet or capsule must release between 80 mg and 125 mg in the bloodstream. This difference isnât considered a problem in most drugs.
In essence, it is best to seek the advice and direction of your doctor and pharmacist before choosing a generic over a brand-name. Each time you refill your prescription, ask your pharmacist if the manufacturer has changed. Make sure you understand how and when to take your medication. Always report any reactions to your doctor and pharmacist.
Have a question for our angel correspondent? You can send our angel an email to apetersen@visitingangels.com or send your question via mail to Ask An Angel, 65 Woodbury St., South Elgin, IL 60177.
