Generic Drugs: Safe, Effective, and FDA Approved
What is the difference between a generic prescription drug (generic or generic drug) and a brand name prescription drug (brand name drug)?
The short answer is, "All the money you save." The only real difference is just the name and price - and generics cost less. A brand name drug is a new drug that is discovered to treat a medical condition. It has undergone research and development, then U.S. Food and Drug Administration (FDA) review and approval, prior to bringing the new brand name drug to market. Once a brand name pharmaceutical manufacturer has discovered a chemical that has potential to become a new brand name drug, they will usually get a patent for the drug. Most drug patents are generally protected for 20 years. The patent protects the company that first makes the drug. The patent doesn't allow anyone else to make and sell the drug. When the patent finally expires, other drug companies can start selling the generic version of the brand name drug. But first, they must test the generic drug and the FDA must approve it. The FDA says that all prescription drugs must work well and be safe. Generic drugs use the same active ingredients as brand name drugs and work the same way. The FDA puts all generic drugs through a rigorous, multi-step process to ensure that they are the therapeutic equivalent of their brand name counterparts. That means that a generic drug can be substituted and it will produce the same clinical effect, and meet the same safety profile, as well as other standards, as the brand name drug.  Back to Top
Generic formulations undergo a rigorous FDA approval process.
Here are just some of the FDA standards and practices that generic manufacturers must follow: - A generic drug must be the bioequivalent (performs in the same manner) of its brand name counterpart.
- A generic drug must pass the FDA's review for both active and inactive ingredients.
- The manufacturing facility of the generic drug must pass FDA inspection.
- The generic drug must have the same active ingredients and be available in the same strength and dosage form as its brand name counterpart.
- The label of the generic drug must include the same information found on the packaging of its brand name counterpart.
- Finally, the FDA continues to monitor the generic drug for quality control after it has been approved.1
The FDA ensures your generic drug is safe and effective before it goes to market. In most cases, the average person cannot tell the difference between a generic drug and a brand name drug, other than its size, color or shape. They look different because trademark laws in the U.S. do not allow a generic drug to look exactly like other drugs already on the market. Back to Top
Your generic drug is safe and effective. The FDA has the results to prove it.
When it comes to any prescription drug, most people ask themselves, "Is it safe? Will it work?" When it comes to a generic drug, however, the first question people often ask themselves is, "How can it be as good as the brand name drug if it costs so much less?" The FDA ensures that your generic drug is safe and effective. All generic drugs are put through a rigorous, multi-step approval process. From quality and performance to manufacturing and labeling, everything must meet the FDA's high standards. It makes it tough to become a generic drug in America, so it's easy for you to rest assured. Gary Buehler, Director of the FDA's Office of Generic Drugs, understands the impression that consumers have about generic drugs not being as good as brand name drugs. "Most people," he says, "believe that if something costs more, it has to be better quality. In the case of generic drugs, this is not true. The standards for quality are the same for brand name and generic products." Back to Top
Why are generic drugs less expensive?
Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, invest in the initial research and engage in the development and testing, the costs to bring the generic drug to market are less. But they must show that their product performs in the same way as the brand name drug. All generic drugs are approved by the FDA. For you, that means generic drugs contain the same active ingredients, have the same potency and quality as their brand name equivalent, but are available at a much lower cost.* Back to Top
Are generics as safe as brand name drugs?
Yes. The FDA says that all prescription drugs must work well and be safe. Generic drugs use the same active ingredients as brand name drugs and work the same way. Generic drugs may look different in size or color, and their names are different (they are referred to by their chemical names instead of brand names), but the FDA has set for them the same standards for quality and effectiveness as their branded counterparts. All generic drugs are put through a rigorous, multi-step review process that includes a review of scientific data on the generic drug's ingredients and performance. The FDA also conducts periodic inspections of the manufacturing plant and monitors drug quality – even after the generic drug has been approved. Back to Top
Are generic drugs as effective as brand name drugs?
Yes. The FDA requires that generic drugs must be as high quality, strong, pure, and stable as brand name medicines. Still, there are many misconceptions or myths about generic drugs. Some of these are widely believed - by consumers as well as many health professionals. Back to Top
Myths and Facts about Generic Drugs
Myth #1: Generics are not as safe as brand name drugs.
Fact: The FDA requires that ALL prescription drugs be safe and effective. The fact is that generic drugs use the same active ingredients as their brand name counterparts. The FDA monitors reports of adverse drug reactions and has found no difference in side effects between generic drugs and brand name drugs. Myth #2: Generics are not as potent as brand name drugs.
Fact: Generic drugs must have the same quality, strength, purity and stability as their brand name counterparts. It must be shown that generic drugs work the same in the body and have the same risk-benefit profile. Myth #3: Generics take longer to act in the body.
Fact: The FDA requires that the generic drug deliver the same amount of active ingredients in the same amount of time as the original, brand name drug. Myth #4: Brand name drugs are made in modern manufacturing facilities and generics are often made in substandard facilities.
Fact: The FDA conducts about 3,500 inspections a year on all pharmaceutical facilities, including the facilities of generic manufacturers. Substandard facilities are not permitted by the FDA. Back to Top
What is the best source of information about generic drugs?
Contact your physician, pharmacist or other health care professional for information about generic drugs. If you still have questions about drug safety or effectiveness, the FDA has set up a toll-free hotline at 1-888-463-6332. Back to Top
Good news for consumers.
Many brand name drugs are about to lose patent protection, which means more generic drugs will be coming into the marketplace. According to the Congressional Budget Office, Americans save between $8 billion and $10 billion every year by choosing generics1. We recommend taking a proactive approach to reducing your own health care costs. Ask your physician to prescribe a generic drug or allow substitutions at the pharmacy. If no generic equivalent exists for a brand name prescription drug that you are taking, consider asking your physician if there is a generic alternative** available to treat your condition. It's up to YOU to insist upon lower-cost generic drugs. The more you know about generic drugs, the better prepared you will be to make sound health care choices. Back to Top
Generic Prescription Drugs - The Same Quality and BIG Savings.
It is often assumed that well-known brand name drugs reflect a higher level of quality than generic products in today's consumer-driven culture. For example, many believe that when you pay more for a "designer" name, you expect a superior product. However, prescription drugs are different from general consumer products. In the case of prescription drugs, the standards of quality are the same for brand name drugs and generic drugs. The generic drug is just as safe and effective as its brand name counterpart. The FDA makes sure of it. When the patent on a brand name drug expires, other drug manufacturers can make and sell the same drug. This same drug is sold under its chemical, or "generic," name. Like their brand name counterparts, all generic drugs are tested and approved by the FDA before they can be sold to consumers. Back to Top
FDA-approved generic drugs are just as safe and effective as brand name drugs.
To be sure, a catchy name may do a better job of helping promote a new drug than its chemical name. Zantac sounds friendlier than "ranitidine HCl." Dyazide is easier to say than "hydrochlorothiazide" and "triamterene." But the power of a prescription drug lies in its chemical formulation, not in the name. The generic version works just like the brand name drug in dosage, strength, performance and use, and must meet the same quality and safety standards. All generic drugs must be reviewed and approved by the FDA. Most importantly to you, the consumer, research shows that you can save between 30% to 80%* when you fill your prescriptions with generic drugs instead of brand name drugs. Back to Top
How much money can you save?
To determine how much money you can save using generics, compare your generic copay or cost share to the brand copay/cost share, then multiply the difference by how many prescriptions you might fill and refill per year. This will give you an idea of how much you can save per year by choosing generic drugs. See our example below. Example
A person purchases a one-month supply of a maintenance prescription drug 12 times per year. For the brand name drug, he/she will pay $600. For the generic drug, he/she will pay $120. The person will save $480 a year, which is equal to 80% savings.
| | Brand Copay | | | | | Drug X 1-month supply | | | | Brand = $600/yr. |
| | Generic Copay | | | | | Drug X 1-month supply | | | | Generic = $120/yr. |
| | Savings with Generic | | | | Per Rx # | Refills/Yr. | % Savings/Yr. |
| | Drug X 1-month supply | | | | |
The perception that the substantial cost savings between a generic drug and its equivalent brand name drug is based on a difference in safety, effectiveness or quality is simply not true. A generic drug may be a different color or shape, but every generic drug is put through a rigorous, multi-step review process by the FDA that includes a review of scientific data on the generic drug's ingredients and performance. Back to Top
So why do generic drugs cost less?
Generic drugs cost less because their manufacturers do not have to spend the hundreds of millions of dollars it takes to complete research and development on the new, original drug. The brand name drug manufacturer makes that investment, along with the millions of dollars needed to market and advertise the new drug. Therefore, it costs the generic manufacturer less to develop the same drug. The savings are passed on to you! Back to Top
1 www.fda.gov *The amount of your savings will be based on your prescription drug coverage. Source: Generic Pharmaceutical Association's Web site: www.gphaonline.org. **A "generic alternative" is a therapeutic alternative utilizing a generic drug to treat the same condition.
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