5 Common Questions About Generic Drugs
By Mathew K. Hupila
Summer Intern, Consumer Health Information Corporation 2008
Class of 2010: Creighton University School of Pharmacy and Health Professions
Dorothy L Smith, Pharm.D.
CEO and President
Consumer Health Information Corporation
Every day people come into the pharmacy and ask questions about generic drugs. This makes a lot of sense since so many people are receiving prescriptions for generic drugs instead of the original brand name drugs.
It is estimated that 46% of the people in the United States take at least one prescription drug. This means that there were 3.3 billion prescriptions dispensed in 2006. The total cost of all of these prescriptions was $192 billion. The average cost to fill one prescription with a brand name drug is approximately $111.02, while a generic prescription averages $32.23. This means that you would have to pay over THREE times as much for a brand name drug than as a generic one!
Many patients go to their pharmacists every day and ask if there is any way they can lower their costs to purchase prescription drugs. One common way that patients try to save money is to take generic drugs instead of brand name drugs. Using generic drugs instead of brand name drugs can save $8-$10 billion each year.
Some of the most common questions people ask about generic drugs are the following.
1.) What are Generic Drugs?
A generic drug is a copy of a brand name drug. To be sold, a generic drug must be “bioidentical” to the brand name drug. This means that the generic drug must be proven to be the same as the original brand name drug in the following ways:
• dosage form (tablet, capsule, liquid, etc.)
• strength (same amount of drug in both)
• how it is taken (by mouth, injection, etc.)
• how the medicine gets into the bloodstream and works in the body
The manufacturer must prove that their generic drug meets these requirements before the Food and Drug Administration (FDA) will approve it and allow it to be sold to the public.
2.) Why are Generic Drugs Cheaper Than Brand Name Drugs?
A brand name drug has to go through 10-15 years of research and testing in animals and people before it can be sold to the public. During this testing, the company making the drug must prove that it is safe and effective for people to use. All of this testing can cost over $1 billion. Once the new drug is approved, the company that made and tested it receives a patent. This means that no other company can make the drug until the end of the patent, which is usually 10-15 years after the drug is released.
When a patent for a brand name drug expires, any other company can copy the drug and sell a generic version. These other companies must only prove that their product is the same as the brand name drug. This means that generic drug companies do not have to spend as much time and money because they do not have to invent or test the drug for safety and get FDA-approval. This is why generic drugs cost less.
When a patent for a brand name drug expires, there are usually a number of companies that begin to make a generic version of the drug. Since there is more than one company making the drug, the price is lowered even farther due to competition between all of the different generic drug makers.
3.) Are Generic Drugs as Safe and Effective as Brand Name Drugs?
The short answer to this question is “usually yes”. 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%-125% “bioequivalent” to the original brand name drug. For example: a brand name drug is taken and it is found that 100mg of medicine reaches the person’s 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 80mg and 125mg reach the bloodstream (80-125%). This means that some companies might make generic versions that have 80mg reach the bloodstream and other companies might make generic versions that have 125mg reach the bloodstream. This difference isn’t a problem in most drugs. There are a few drugs, however, in which this can be an issue.
For example, some drugs are only safe and effective when the amount of medicine is within a small range in the bloodstream. This small range is called a “narrow therapeutic window.” This means that a small change in dose can cause a large change in the way the drug acts in the body. Below the therapeutic window, the drug is not effective. Above the therapeutic window, the drug could be harmful because too much drug is getting into the bloodstream. It is critical that the medicine be given in a dose that falls in the safe and effective range.
Let’s say a person is taking one of these drugs with a narrow therapeutic window. They have been taking a generic version of the drug that is 80% bioequivalent to the original brand name drug. After a few months, their pharmacy orders a generic version of the same drug that is made by a different company. This new version is 125% bioequivalent to the original brand name drug. This means that the new version of the drug could contain as much as 45% more active drug than the old version.
There are only a few drugs that have narrow therapeutic windows that need to be worried about. Some of these drugs include:
• Warfarin (used to prevent blood clots)
• Theophylline (used to improve breathing in people with asthma and other lung diseases)
• Phenytoin (used to prevent and treat seizures)
• Clonidine (used to treat high blood pressure)
• Quinidine (used to keep your heartbeat normal)
• Levothyroxine (used to treat low thyroid activity)
If you are taking one of these drugs it is very important to talk to your pharmacist to find out the name of the company that makes your generic drug. If you notice that your pharmacy has switched brands for your generic drugs (if your medicine looks different than normal), discuss this with your pharmacist and doctor and learn what signs to watch for to make sure you are still at the correct dose.
4.) If This Generic Drug is the Same as the Brand Name Drug, Why Do They Look Different?
Just because two versions of the drug do not look the same does not mean they act differently in the body.
There are laws in the United States that say that a generic version of a drug cannot look the same as a brand name version. The company that makes the generic version of the drug can make it whatever color, shape, or flavor they want as long as the amount of active drug remains the same as the brand name drug.
5.) How Do I Know if There is a Generic Version of the Drug that I Take?
There are a few different ways to find out if there is a generic version of the drugs you take.
• The easiest way is to ask your pharmacist. They will be able to tell you if there is a generic version of a drug available or when a generic version will most likely become available. Another way is to look it up yourself.
• The FDA has a website that lists all companies that make both brand name and generic drugs: http://www.fda.gov/cder/ob/default.php. By using this website, you can search for the drug you take to find out if there are any generic versions available.
Generic Drugs are Helpful, But We Still Need Brand Name Drugs
Generic drugs are cheaper than brand name drugs because the manufacturer does not have to spend money to discover and test the drug. However, without this research and testing, new drugs would never be discovered. Generic drugs can help save money, but if new brand name drugs aren’t developed, there will not be any new drugs available to help treat diseases. There is a place for both in our healthcare system.
Be careful switching from one generic drug to another. ALWAYS talk to your doctor and pharmacist before switching from a brand name drug to a generic drug or to a different brand of generic drug.
© 2008 Consumer health Information Corporation. All rights reserved.