What's the difference between brand and generic medicine?
Since the early days of medicine use, certain people, organizations, and agencies have worked to make sure that our medicine is safe and effective. In America, that agency is the Food and Drug Administration (FDA). One of the biggest and most defining actions of the FDA is the allowance and standards of generic medication.
Read on to find out
- Where generic drugs came from in the first place.
- How generic drugs are regulated and how that compares to brand drugs.
- Are generic drugs safe? Are they effective?
- Why you hear a different opinion from everybody.
- How your pharmacist can use generic drugs to improve your health and reduce your costs
First, where do ANY drugs come from?
Before a new drug is dispensed from your pharmacy it goes through a very long journey. The journey starts with a new discovery and takes, on average, 10 to 15 years.
- The discovery. Some new drugs are found by accident, some are specialty designed. They all start with a new idea and a desire to make people healthier.
- The tests. Starting with healthy animals and moving on to healthy humans, the chemical is given in many ways in many doses to see what it does and how safe it is.
- More test. It didn't kill the rat and doesn't give humans cancer? Great! Now it's tested in the sick people it could help and the treatment dose is found.
- Initial paperwork submitted to the FDA. To be prescribed or dispensed, the FDA must review and authorize it. Needless to say, this takes a lot of time.
- More paperwork submitted to the FDA. And again, and again. This includes tests called "Cmax" and "AUC" (more later).
- Approved! Now the drug can be marketed, prescribed, dispensed, and used. They also have proprietary license to the brand name of the drug for marketing purposes.
The shortened journey for a generic.
Since generic drugs aren't new drugs, they skip really far ahead in the process.
- The discovery, tests, more tests and initial paperwork submitted to FDA are all skipped!
- More paperwork submitted to the FDA. The application for a generic drug is call the Abbreviated New Drug Application (ANDA). All that the generic has to prove is that it has the same "pharmacokinetics" as the brand drug. To do this, they measure the "AUC" and the "Cmax".
- Approved! Now the drug can be marketed, prescribed, dispensed, and used.
A primer on "Pharmacokinetics."
There are two fields of study that tell us what a drug does when taken.
- Pharmacology is all about what a drug does. Drugs with the same active ingredient and the same dose will have the exact same pharmacology.
- Pharmacokinetics is what the body does to a drug. Even if drugs have the same active ingredient, their pharmacokinetics can make them very different.
Imagine for a moment that two drugs have the same pharmacology, meaning they are the same drug. But one is a pill and the other is a shot. When taken, the pill will have a weaker effect than the shot because our bodies natural defenses (stomach acid, etc.) will destroy part of the pill but the shot goes right into our body. For example, a 10 mg pill and a 10 mg shot would have very different effects, because the pill only really gives 5 mg. That's a big difference.
(These numbers are illustrative only, the amount of a pill our body rejects is highly variable)
Pharmacokinetic terms and ideas
What it is
The study of drug levels and travel in the body
10 mg taken by mouth gets 50% absorbed, then the liver clears it out in 8 hours
Area under the curve (AUC)
How much total drug gets into the body
10 mg taken by mouth gets absorbed 50% for a total exposure of 5 mg
Cmax (Maximum concentration)
The maximum amount of drug in the blood at a single point
After 2 hours, 10 mg taken by mouth is at it's highest concentration in the blood, and the liver reduces it from there
Good manufacturing practices
The FDA is in charge of making sure that any company that makes a drug does it safely. They make rules that define
- The environment. All factories, big or small, must be clean and properly managed.
- The process. The creation of a drug must adhere to the most current standards. No scrapping bacteria off Petri dishes.
- The variability. When making or extracting chemicals, it's impossible to produce 100% consistent results 100% of the time. The FDA allows for a +/-20% variance from batch to batch.
- The documentation. Paper trails exist en mass for everything related to health care, including the making of drugs.
All drugs makes, brand or generic, foreign or domestic, big or small, must adhere to all FDA regulations in order for their drugs to be available in the United States.
There are no differences in the rules for generic or brand drugs.
No doubt you've heard of or experienced drug recalls. Your pharmacy gets drug recall notices every week. These recalls usually require the pharmacy to return drugs, but sometimes require patients to as well.
Nearly all of these recalls are due to failed quality controls. All drug makers have to randomly test their product every so often to ensure it continually meets high standards. If they detect anything that makes their drug less effective or less safe, they recall any drug from the same batch.
As discussed earlier, the quality of generic drugs should not be a concern. Generic drug makers have to adhere to the same high standards as brand drug makers. The FDA does not distinguish between the two.
Although drug makers do get in trouble for sub-standard quality at times, there is no more likelihood that a generic drug maker will be at fault than a brand drug maker.
The other ingredients
Generic drugs must prove that they have the same active ingredients as brand name drugs. However, they do not have to have the same inactive ingredients (also called excipients). In fact, due to copyright law, they cannot have the exact same make-up as a brand drug. This is also why generic drugs look different, since the brand drug size, shape, and markings are all proprietary.
There may be any number of other individual reasons for a person to want or not want a certain thing from their medication. Your pharmacist is the best resource to help you make sure your desires are met.
Just remember that a brand name is not inherently "better" in any one way than a generic. They are just another choice on your list.
Some examples of reasons to select a particular form of a drug include:
Some people have an intolerance or sensitivity to certain chemicals. More common examples are dyes, gluten, animal products, and those that cause allergies. In these cases, the formulation of the drug that includes those ingredients should not be used. That may be the generic form, or it may be the brand form. It may be one generic form but not another. If you are sensitive to a particular chemical, you need to ask your pharmacist for a full listing of ingredients and work together to find one that does not have the chemical you are sensitive to.
Some drug makers pride themselves on adhering to certain ethical or religious standards. They may avoid testing on animals or using animal byproducts. They may use manufacturing techniques that are environmentally sustainable. They may avoid political corruption or be big into social services. Check out the websites for the drug maker to see what they offer.
Food for thought
How does a company ensure that a Lipitor made 5 years ago is the same as a Lipitor made today? Match the active ingredient, the AUC, and the Cmax.
How does a company ensure that a generic atorvastatin made today is the same as a Lipitor made today? Match the active ingredient, the AUC, and the Cmax.
When going through approval, a generic drug does not have to prove that it works. It just has to prove that it does what the brand drug does. The burden of proving effectiveness stays with the brand drug.
To be the same as a brand, a generic has to have the same active ingredient, the same dosing form, and the same pharmacokinetics. These requirements were chosen because drugs that share these characteristics will produce the same effect. It's the same requirements for different batches of a brand drug.
The actual difference between brand and generic drugs comes down to politics and economics. The act that defined generics was put in place to save healthcare dollars. The act that allowed for proprietary brand was designed to reward drug makers for new and innovative drugs. The drug industry, "Big Pharma," controls billions of dollars and has many representatives all over the country, including Washington, your clinic and pharmacy, and all forms of media.
The drug industry is rich with opportunities for bad professionals just looking to make a buck. It's not common, but it does exist.
- Our healthcare system is reward-for-service. The more services provided and the more complicated that services, the better compensation is received.
- Prescribing and dispensing records can be bought and sold. Drug makers pay lots of money to see the patterns of their drugs and their competitors.
- Gifts still exist. Although the days of golf outings and 5 course dinner are gone, drug makers still provide incentives for people willing to take them.
- It's a grey area. When an answer isn't clear, it's easy to make an opinion sound like a fact.
Even those people who are trying to do their best and avoid bias and pandering are subject to it. There is no way around it.
- Many continuing education opportunities are sponsored by drug lobbyists. Even if they are good, high-quality courses it does seem like a conflict of interest.
- Different professionals see things from different angles. When these view clash, it often comes down to posturing rather than working together.
- Prime-time commercials are soaked with drug ads.
- They may be relying on information from a bias source. No one can know everything independently, and sometimes the sources we trust may not be so trustworthy.
- Everyone, including professionals, is subject to bias. Everyone.
- Standard practice changes. Older professionals may cling to out-dated ideas while new professionals may actively ignore them.
The bottom line
The studies provide conflicting data. The rules are set by politicians and lawmakers. The drug industry is huge and rich. Professionals learn different things and experience things from different angles. There is no clear right answer.
Most professionals just want to do what they think is best for their patient. Few actually provide sub-optimal care for financial gain.
In the end, you need to make the decision that is right for you. But you also need to understand what that decision means. You need to talk to your healthcare professionals and get their opinion and buy-in. If they don't agree, get a new one. You need to be your own advocate.
Your pharmacist can help you understand and make decisions about your drugs.
- Brand and generic availability. They know what generics are available, and when future generics will become available.
- Price differences. Want to know how much your brand or generic drug will cost? How about alternatives? Your pharmacist can give you the no-insurance price and run a dummy claim through your insurance to see what's covered.
- Consumer information. Most pharmacists have access to official articles from the FDA and other agencies that talk about brand and generic issues.
- Another professional opinion. Your pharmacist sees a lot of people use a lot of medicine. They know who sticks with generics and who sticks with brand, and often their reasoning. Use their professional experience to make your decisions.
Questions and answers
Here are some common questions I hear and my answers to them. Work with your pharmacist to get their take on your questions to make sure you get what you need.
- Generic drugs don't work. There is no overarching similarities between generics to base this claim on. Many drugs aren't even available as brand anymore. The FDA regulates all drugs the same, brand or generic.
- Generic drugs have less active ingredient in them. The variability allowed for generic drugs (+/-20%) is the same allowed between batches of brands. Creating chemicals isn't easy, and all companies are allowed this variance. In reality, the variability is only +/-5%.
- Brands work better for narrow-therapeutic drugs. It's not the brand that works better, it's the consistency. Jumping from brand to generic or generic to a different generic may slightly change the effect of certain drugs. This is not an argument for brand, however, just an argument to stick with one and dose it correctly.
- Generics are lower quality. The FDA doesn't care if a company makes brand or generic drugs, they are subject to the same rules. It doesn't matter if the drug is made in Jerusalem or New Jersey, the rules are the same.
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Brandon Y is a community pharmacist working in Minnesota with over 10 years of experience in pharmacy. He welcomes comments and questions. Find more great pharmacy tips here.
The information provided on this page is intended for general educational and informational use only. It is not specific, personalized healthcare advice for you. For healthcare advice regarding your particular situation, talk to members of your healthcare team.