Are Generic Drugs Okay to Take?
Generic drugs provide significant cost savings to consumers compared to brand name drugs. But are these drugs really the same? Are they safe to take? When can my pharmacist give me a generic instead of the brand name prescribed by my doctor?
What are generic drugs?
Generic drug are copies of FDA-approved brand name drugs, usually made by another manufacturer. For example, the brand name drug, Lipitor® used for the management of high cholesterol has over 20 FDA-approved generic versions.
Generic drugs cost less than brand named drugs because their manufacturers do not have to spend money on research like it takes for original (brand-name) medicines to get FDA approval. Additionally, competition in the marketplace created by one or more generic products and the reduced need for advertising and marketing can also significantly reduce the price of these drugs.
How does the FDA approve generic drugs?
Brand name drugs are protected for a period of time from generic competition after FDA-approval. This allows them to recover some of the money spent on the research to get the drug initially approved. After this time period is up, a generic drug manufacturer may submit a request to the FDA to get authorization to make a generic form of the drug. They must demonstrate that the generic is considered equivalent (identical active ingredient, dosage form, route, strength and/or concentration) to the initial drug. The generic product may differ in characteristics such as shape, packaging, color, flavor, and preservatives.
Are generic drugs as safe as brand name drugs?
Generic drugs must be manufactured according to the same standards as brand name drugs. All manufacturing, packaging, and testing sites must pass inspections to meet these quality standards. If these standards are not met, then the FDA will not allow the product to be available.
How do you know if a generic drug is available and can be substituted for a brand name product?
Ask your pharmacist! The FDA requires that generic manufacturers provide information comparing their generic products to the original brand name drug for approval. The FDA makes this information available to pharmacists in an online database. Your pharmacist can check the information so that they can provide you with a suitable generic drug.
In this database, if the generic drug has demonstrated bioequivalence—the rate and extent to which the active ingredient is absorbed from the product and becomes available at the site of drug action—then it may be designated by the FDA with a Therapeutic Equivalence code beginning with the letter A. Drug products not considered to be therapeutically equivalent begin with the letter B.
How can I work with my pharmacist to make sure my medicine is safe and effective, but also affordable?
State prescription drug substitution laws vary—some allow automatic generic substitution, and others require it to be OK’d by the patient. Be sure to ask your pharmacist if your medication has a generic version available and if it can be substituted for your brand name drug.
Another consideration for you and your pharmacist to discuss would be the appropriateness of product substitution. For some conditions, small differences in the amount of drug in the bloodstream can make a difference in the medication’s effectiveness. Medications for management of seizures, warfarin, and thyroid medications are examples of this concern, but there are other drugs that require precise amounts to be effective.
Summary
The use of generic drugs has improved affordability of medications for many people. However, it is important to discuss availability and appropriateness of generic substitution with your pharmacist to achieve the best treatment outcome for your condition.