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Whitfield Bryson & Mason

Generic Drugs: Are They Truly Equal?

For many decades, prescription drug manufacturers spent vast amounts of money to develop new drugs, and reaped huge profits in return. Because of their innovation, they were protected from imitators by patent laws. In time, however, the United States legislature passed the “Hatch Waxman Act” to limit the time for which a drug maker could claim exclusive marketing and profit. After this de facto monopoly period, a competitor could make a “bio-identical” drug that could directly compete with the original drug. These drugs became commonly known as “generics” and, since they always cost less than the original, became the favorites of health insurance companies.

Patients, of course, have long wondered whether these “generics” are truly the equivalent of the brand name drugs they were designed to compete against. They have been told by their physicians, pharmacists and insurers there is no difference whatsoever. Unfortunately, the last few years have proved there is a massive difference between generics and brand name drugs: Liability of the manufacturer for damages caused by dangerous side effects!

Because the Hatch Waxman Act prevents the manufacturer of a generic drug from distinguishing itself in any way from the original, the United States Supreme Court has ruled that the maker of a generic drug may not change the warning label from the FDA approved original label even if the generic manufacturer knew or should have known of dangerous side effects that were not included in the original warning label. Unfortunately, this means that someone taking a generic drug will actually have less rights than one taking the equivalent brand name drug when it comes to a court of law. This immunity from the duty to warn of known dangers is currently being re-examined by our legislature, and WBM will be on the front line of this fight.