Demystifying Generic Drugs: 6 Things You Should KnowDecember 09, 2016
Generic drugs can provide consumers with great cost savings, but many worry they are not as effective as brand-name drugs. According to Janet Engle, of the University of Illinois at Chicago College of Pharmacy, such fears are misplaced.
The U.S. Food and Drug Administration has strict guidelines for generics. In order to be considered equivalent to its brand-name counterpart, it must:
- contain the same active ingredients as the innovator drug (inactive ingredients may vary)
- be identical in strength, dosage form and route of administration
- have the same use indications
- meet the same batch requirements for identity, strength, purity and quality
- manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products
Let’s look at six common concerns consumers have about generic drugs.
- 1. Are generics as good as brand-name drugs?
Yes. Generic drugs contain the same the same active ingredient, strength, dosage form and route of administration as brand-name drugs so the side effects are the same, Engle says.
- 2. How do you know when to use generic and when it’s important to go with the name brand?
"Generally it is advisable to go with the generic equivalent because of the cost savings," says John Norton, director of public relations, National Community Pharmacists Association. "Many states and health plans actually mandate that switches be made from brand to generic whenever possible."
Some consumers still insist on brand-name medications, falsely believing they are better than the generic counterparts. Your best bet is to talk to your doctor or pharmacist if you have any concerns about the safety or efficacy of the drug.
- 3. Which are safer – name brands or generics?
The FDA approval process is designed to ensure there is no difference in the safety of the brand and generic versions.
- 4. How difficult is it to have a generic drug approved?
"In order to have a generic drug approved, a drug company must submit an abbreviated new drug application (ANDA) for approval to market the generic medication," Engle says. "The ANDA must contain the data that proves the generic meets FDA's requirements. The FDA reviews this information and may request additional information before it will approve the generic equivalent."
- 5. How common are generic drugs in the marketplace?
The FDA process to approve generic drugs - that are generally 30 percent to 80 percent cheaper than brand-name drugs - is lengthy and complex. Generic drugs now account for 88 percent of U.S. prescriptions, according to the American Pharmacists Association. That number is likely to grow - there are about 4,300 generic drugs awaiting approval, some dating back to 2009.
- 6. Is the approval process for generic drugs exactly the same as that for brand-name drugs?
The process is simpler than those for new drugs that may enter the marketplace, Engle says.
Generic drug manufacturers are not required by the FDA to repeat the very costly clinical trials required of new drugs. Generally, generic manufacturers do not also need to spend money on advertising and marketing of the drug because that has been done by the brand-name company also saving money, she said.
What else you need to know
Although generics are recommended in most cases, Engle suggests consumers consider these tips:
- If you have a question about using a branded drug instead of a generic, talk to your pharmacist, who can help you decide if switching to a generic drug (if allowed by the prescriber) or sticking with a brand-name drug is a good idea in your particular case.
- Pay attention to the brand of generic medication you receive and try to stay with the same brand each time you refill a prescription.
- Make sure you are taking the medication correctly and not skipping any doses or taking too much.
- If you believe your generic is not working correctly, talk to your doctor about switching back to the brand-name drug to see if there is a change. It may be your disease state is worsening and neither brand nor generic will work the same. Do not stop taking your medications without talking to your doctor or pharmacist.
- Keep in mind the majority of generics work exactly the same as branded drugs and can save you a lot of money.