Brandon practices as a community pharmacist in MN. He started as a pharmacy tech in 2003 and received his PharmD in 2011 from the U of M.
Since the early days of drug development and manufacturing, certain organizations and agencies around the world have worked to make sure that our medicines are safe and effective. In America, that agency is the Food and Drug Administration (FDA). Some of the FDA's most defining contributions include their allowance of and standards for the approval of those generic drugs.
In this article, we will cover
- What Are the Steps in the Drug Development Process?
- How Are Generic Drugs and Brand-Name Drugs Regulated?
- Are Generic Drugs Safe to Take?
- Are They Effective?
- Why You May Hear Differing Opinions
- How Pharmacists Can Help You Know When to Use Generic vs. Brand-Name Drugs
1. What Are the Steps in the Drug Development Process?
Before a new drug is dispensed from your pharmacy, it must first go through a long journey of tests, more tests, and lots of paperwork before it gets approved by the FDA. The entire process—from discover to approval—takes an average of 10-15 years.
- The discovery. Some new drugs are found by accident, while some are specially designed. They all start with a new idea and a desire to make people healthier.
- The tests. Starting with just cells, then healthy animals, and then healthy humans, the chemical is delivered in many ways in many doses to see what it does and how safe it is.
- More test (clinical trials). It didn't kill the rats and didn't give people cancer? Great! Now, it's tested in the target patients to determine its efficacy and the appropriate dosages.
- Initial paperwork submitted to the FDA. In order for a drug to be prescribed or dispensed, the FDA must first review and authorize it. Needless to say, this takes a lot of time.
- More paperwork submitted to the FDA. This includes tests called "Cmax" and "AUC" (more on this later).
- Approved! Now the drug can be marketed, prescribed, dispensed, and used. The manufacturer also gets a proprietary license for the brand name of the drug for marketing purposes.
The Process for Generic Drugs Is Markedly Shorter
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!
- 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-name drug. To do this, they measure the "AUC" and the "Cmax."
- Approved! Now the drug can be marketed, prescribed, dispensed, and used.
2. How Are Generic and Brand-Name Drugs Regulated?
Defining 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, 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 certain 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 will recall all drugs that come from the same batch tested.
3. Are Generic Medications Safe?
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 branded drug makers. The FDA does not distinguish between the two.
Although drug makers do get in trouble for sub-standard quality at times, and both generic and branded drug manufacturers are susceptible to this.
What Makes Generics Different?
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-name drug's size, shape, and markings are all proprietary.
4. Are Generic Drugs as Effective as the Brand-Name Drugs?
How does a company ensure that a Lipitor (atorvastatin) 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 the approval process, a generic drug does not have to prove that it works. It just has to prove that it does what the brand-name drug does. The burden of proving effectiveness stays with the brand-name 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.
Understanding How Drugs Work
There are two fields of study that tell us what a drug does when taken.
- Pharmacology tells us what a drug does. Drugs with the same active ingredient and the same dose will have the exact same pharmacology.
- Pharmacokinetics describes what the body does to a drug. Even if drugs have the same active ingredient, their pharmacokinetics may be different, meaning one drug may not be as effective as another.
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 the body's 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 Definitions
|Term||What it is||Example|
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
5. Why Are There Differing Opinions on Generic Drugs?
There may be several reasons influencing an individual's choice of 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" than a generic. They are just another choice on your list.
Common reasons to select a particular form of a drug over another include:
Sensitivities or Allergies
Some people have an intolerance or sensitivity to certain ingredients. Common examples are dyes, preservatives, gluten, and animal products. 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 branded 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 ingredients 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 advocate social services. Check out the manufacturers' websites to learn more about their philosophies.
The actual difference between brand and generic drugs often 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 to make a quick buck. It's not common, but it does exist.
- Our healthcare system is reward-for-service. The more services provided and the more complicated the services are, the better the compensation is.
- Prescription and dispensing records can be bought and sold. Drug makers pay lots of money to compare the sales performance of their drugs and their competitors' drugs.
- Gifts still exist. Although the days of golf outings and five-course dinnesr are gone, drug makers still provide incentives for people willing to use them.
- It's a grey area. When an answer isn't clear, it's easy to make an opinion sound like a fact.
Even well-meaning professionals who are trying to do their best to 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, there can be a conflict of interest.
- Different professionals see things from different angles. When differing opinions clash, it often comes down to preserving reputation rather than working together to find the best solution.
- Prime-time commercials are saturated with drug ads.
- Doctors may be relying on information from a bias source. No one can know everything. We all depend on other sources of information, but sometimes, the sources we trust may not be so trustworthy.
- Everyone, including professionals, is subject to bias. Everyone.
- Standards in practice are constantly evolving. Older professionals may cling to outdated thoughts and practices, while new professionals may actively ignore them.
6. How Can My Pharmacist Help Me?
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.
Frequently Asked Questions About Generic Drugs
I hear these questions quite often, so I wanted to give you a quick answer here in case you have the same curiosities. However, it is still best to go to your pharmacist about any questions you may have to make sure you get what you need.
- Do generic drugs work as well as brand-name drugs? There are no overarching similarities between generics to accurately answer this. Many drugs aren't even available as brand anymore. The FDA regulates all drugs the same—branded or generic.
- Do generic drugs have less active ingredients than brand-name drugs? The variability allowed for generic drugs (± 20%) is the same as that allowed for batches of brand-name drugs. Creating chemicals isn't easy, and all companies are allowed this variance. In practice, the variability is only ± 5%.
- Don't brand-names work better than generics 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, you may notice a slight change in a drug's efficacy. However, this is not an argument for brand-name drugs; just an argument to stick with one and dose it correctly.
- Are generics lower quality than branded drugs? The FDA doesn't care if a company makes brand or generic drugs. Both are subject to the same rules and regulations. It doesn't matter if the drug is made in Jerusalem or New Jersey—they're held to the same standards.
The Bottom Line
There is no clear-cut answer. 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.
Most professionals just want to do what they think is best for their patient. Few will 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.
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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.
This content is for informational purposes only and does not substitute for formal and individualized diagnosis, prognosis, treatment, prescription, and/or dietary advice from a licensed medical professional. Do not stop or alter your current course of treatment. If pregnant or nursing, consult with a qualified provider on an individual basis. Seek immediate help if you are experiencing a medical emergency.
© 2013 Brandon Young