FDA Will Soon Improve the Safety of Generic Drugs

Generic drugs are often preferred by both insurance carriers and patients alike when they are generally available. These drugs tend to cost both insurance providers and patients far less money than brand-name drugs once they hit the market. As a result, the majority of drugs purchased in America currently are generics. However, their prevalence has not made them safer than brand name drugs. In fact, generics are often labeled as either dangerous or defective drugs due directly to certain regulatory loopholes.

In an effort to address a particularly important regulatory loophole affecting generics specifically, the Food and Drug Administration (FDA) recently announced plans to grant the manufacturers of generic drugs permission to alter the safety labels of these drugs subject to far fewer conditions than these manufacturers are held to now.

Currently, generic drug manufacturers are only granted permission to change safety labels under two specific circumstances. First, if the manufacturer of a drug’s brand-name counterpart has changed the brand-name safety label, generic manufacturers must do the same. Second, if the FDA orders a generic manufacturer to change its labels, it must do so. There is currently no safety valve in place for a manufacturer of generics to change safety labels simply because new safety information has been made available.

As a result of this regulatory gap, patients taking generics have become subject to the mercies of the FDA and brand-name manufacturers rather than the companies which create the drugs that they take regularly. The FDA’s move to change this reality will hopefully improve patient safety and make generics a more reliable and informed product overall.

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