Are Brand Name And Generic Drugs Different?
October 20, 2014
Nearly 80 percent of prescriptions used by Americans are generic drugs. During the next several years, the use of generic prescription drugs is expected to increase even more. This is partially due to several popular drugs being scheduled to lose their patents. The following are some facts about generic drugs.
The Food and Drug Administration requires generic drugs to be of the same quality and perform the same as drugs with brand names. To be approved by the FDA, a drug must meet several strict standards related to strength, identity, quality, potency and purity. During the process of manufacturing, some variability occurs in both brand name and generic drugs. Only differences that are very small are allowed by the FDA. If some batches of the drugs are significantly different, they will not be approved. However, generic drugs are required to have the same strength, dosage, active ingredients and administration routes as the drugs they are designed to mimic. Inactive ingredients need not be the same.
All manufacturers must prove that their drugs are the bioequivalents of the brand name substances they are designed to be similar to. To determine this, patients' blood samples are collected. The blood is tested to see if it contains the same amount of the drug between brand name and generic products. If the amounts are the same, the drug will work the same. This standard has been applied to all generic drugs. Every form of generic packaging, manufacturing and areas for testing must meet the same strict standards as those set in place for brand name drugs. In many cases, generic drugs are made in the same manufacturing plants as their brand name counterparts.
Studies show that generics work as well as brand name drugs. Researchers analyzed the data from nearly 40 clinical trials where brand name and generic cardiovascular drugs were compared. They concluded that the two types of drugs worked the same. The average difference in the rate of absorption with generic and brand name drugs is less than four percent.
The FDA does not permit a difference of more than 45 percent in a generic drug's effectiveness. The FDA studied over 2,000 people between 1996 and 2007. During their studies, they looked at the absorption rates of brand name and generic drugs in the human body. Some generics absorbed slightly more than the average rate of less than four percent, but they were required to perform about the same in the body as their brand name counterparts.
Brand name and generic drugs differ greatly in price. Generic drugs usually cost between 80 percent and 85 percent less than brand name drugs. In 2010, experts said generic drugs saved Americans about $3 billion per week overall.
There are plenty of benefits to using generic drugs. In addition to these benefits, keep in mind that generic does not mean lesser quality. Manufacturers sell generic drugs cheap because they do not have to pay for the costs of multiple clinical trials. The FDA is in charge of evaluating drug safety after approval. If reports are submitted, they must be reviewed carefully. The FDA strives to ensure all brand name and generic drugs are safer. They also keep track of reported side effects that occur when people switch drugs. The FDA hopes that manufacturers of generic drugs will investigate the circumstances surrounding any problem reports. However, they do not have the resources for independent clinical trials similar to those performed by brand name drug manufacturers. To learn more about this topic, discuss concerns with an agent.