This post was written by Abby Miller, PharmD candidate.
Have you ever found yourself standing in the aisle at the drugstore holding products and asking, if store brand acetaminophen is as good as Tylenol® or you could swap generic ibuprofen for your typical Motrin™? How do we know if off brand drugs are as safe and effective as the brands we know on the market? In this post, will take a closer look at the regulations in place and what consumers need to know about medication purchases.
A history lesson
In 1938, the Food and Drug Administration (FDA) passed a law that required manufacturers to prove the safety of a drug. However, this law did not require manufacturers to prove efficacy. During that time, medications were used, with some resulting in unwanted and sometimes serious side effects. As a result, in 1962, the FDA enacted a new law named the Kefauver-Harris Amendment and required manufacturers to show that drugs were safe and effective.
This might prompt the question: Are generic drugs held to the same standards as brand name drugs?
The process of bringing a drug to market is a long one. Before a new drug can begin clinical trials, the company/researchers have to submit what is called an Investigational New Drug Application. When an application is approved, clinical trials, during which safety and efficacy data is collected and analyzed, can begin. When the data is finalized, the researchers/company sends in a New Drug Application to the FDA. This is when the FDA goes through data with a fine-tooth comb to check for safety and efficacy.
Years down the road, when a drug is eligible to be marketed under a generic label, the company manufacturing the generic product submits an Abbreviated New Drug Application (ANDA). ANDAs were created under the Hatch Waxman Amendment in 1984 and require the manufacturer to show that the medications are therapeutically equivalent. This means that the generic drug is prepared with the same active ingredient at the same strength, administered the same way, with the equivalent safety and efficacy. If a drug is tested and found to meet these requirements, then and only then, may the generic product be marketed and sold.
So, shoppers can rest assured that a strict, time-consuming and detailed process is in place and overseen by the FDA to ensure that brand and generic drugs are safe and effective. The generic ibuprofen that you pick up from a pharmacy has the same active ingredient as Motrin™ and is just as safe and effective as the original medication.