Supreme Court case could impact future of generic drugs

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Generic drugs are the most prescribed and most affordable medications available, but the availability of those drugs could change if the Supreme Court decides to make the manufacturers liable for harmful side effects.

When a New Hampshire woman took a generic anti-inflammatory drug, sulindac, and the rare side effect she suffered can only be described as horrific.

“Sixty percent of her body was burned,” said David Frederick, attorney for Karen Bartlett. “She’s had 12 eye operations, is legally blind – all because she sought relief from pain from a shoulder.”

Before the case came before the Supreme Court, a new New Hampshire court awarded Bartlett $21 million, saying the maker of the generic drug should have had stronger safety labeling.

Phamacist John Hertig, Associate Director of the Purdue College of Pharmacy’s Center for Medication Safety Advancement, said the ruling causes him concern.

“I’m a little worried about giving a jury of my peers that power when the Food and Drug Administration already does that,” Hertig said.

Generic manufacturers argue that they followed all manufacturing and labeling guidelines provided by the FDA, and they said they are prevented from improving the safety of generic drugs because the FDA requires them to follow the exact warnings and ingredients of the brand name drugs they copy.

Since generics are so much cheaper, Hertig worries that lawsuits like this will have a chilling effect on manufacturers.

“We’re worried about future generic manufacturers providing needed drugs, maybe opting not to provide that drug because of a bad side effect profile,” Hertig said.

There’s a lot at stake for consumers. Roughly 80 percent of the prescriptions in America are generics. The cost of name brands is a big reason why. On average, name brands are four times more expensive.

John said generics remain a great option for consumers, but he said this case proves that patients should take precaution before taking any drug.

“The best way to at least avoid that or be aware, is to have that discussion with your physician,” Hertig said. “Have that discussion with your pharmacist, fully understand what the potential ramifications are of taking your medication.”

The Supreme Court is expected to rule on this case by June.

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