Generic Drugs
Are Generic Drugs Really The Same?
by Christopher Bates, PharmD
Have you ever wondered if generic drugs are just as good as their brand counterpart? The best way to answer that question is to examine how the drug gets approval from the Food and Drug Administration (FDA). The FDA regulates all drug products manufactured and/or sold in the United States. The FDA assures that all drugs in the U.S. are safe and effective when used according to the directions for use.
Drug companies that manufacture brand name (new) drugs are responsible for providing information to the FDA that proves their drug is safe, effective and meets the high standard of quality that is set forth in regulations mandated by the FDA. This process is a long and expensive one. On average, it takes 10 to 15 years and up to $800 million to develop just one new drug.
On the other hand, drug companies that manufacture generic drugs (substitutes for brand name drugs) must prove that their drug is exactly the same as the brand drug. The generic drug must have the same chemical active ingredient, manufacturing process approval, labeling (intended use) and “bioequivalence”. Bioequivalence is defined as being able to produce the same amount of drug to the site of action where the drug produces its therapeutic effect. Bioequivalence is the most important factor when comparing 2 different drugs to see if the are equivalent. If 2 different drugs (brand vs. generic) are determined to be bioequivalent, then they will produce the same therapeutic effects.
When the FDA is reviewing a generic drug for approval, the generic drug must show that it is bioequivalent to the brand name drug before it will get approved. If a drug does not meet the FDA standards, then it will get denied and can not be used in the U.S.
All drug products approved by the FDA, both brand and generic, must meet the same high standards of quality. s a result of the FDA approval requirements, patients and healthcare providers can be assured that brand and generic products approved by the FDA will provide the same therapeutic effect to the patient.
Christopher Bates, PharmD
Christopher Bates, PharmD. is a registered pharmacist and a pharmacy manager for Walgreens. He is a member of the HealthCare Advocates Ministry at Christ Fellowship. He has served on the Mexico Mission Team. If you have questions or comments for Dr. Bates, please email or call the Healthcare Advocates Ministry at 799-7600 ext 2196.
