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.

6 comments

  • catlady10

    I worry about what's in generics and why they are so much cheaper. I wonder about the true strength of the medication. And as far as talking to your doctor about it, what a joke. They get paid to prescribe them most of the time. It's all a big business deal.

    • Gat273

      "I worry about what's in generics and why they are so much cheaper"

      Generics are cheaper because the people who make them don't have the R&D costs of name brands.

      However a better reason is generics don't have the costs associated with advertising which is the real reason "scripts" cost so much. Do you think the pill companies absorb that cost?

      "They get paid to prescribe them most of the time. It's all a big business deal."

      Source this please.

      Most doctors prescribe generics to save their patients money. How many times have you seen doctors pass out free generic samples to their patients as they do for non-generic meds.

      • anon

        You are correct about why generics are cheaper than prescription medicines- they don't pay advertising costs, or some Hollywood star to pitch their products. Polident- Florence Henderson; Depends- June Allyson; Wilford Brimley, B.B.King, & Patti LaBelle- OneTouch Diabetes monitors;other name brand products as well. True, these aren't prescription medications, but they are name-brand items people buy for treatment or control of various ailments. Those commercials? The companies pay big bucks for them & pass it on to the consumer in the form of high prices.

        I've never had a bad reaction from a generic drug, either prescription or OTC. Allergic reactions I don't count because that's different from an adverse reaction like the article described. If generics contain the same medicine in the same strength & use the same fillers as required by the FDA, an atypical reaction like the woman in the article had is not going to happen to most users. Possibly the batch was tampered with or something. I wonder if the medicine she didn't take was tested? The generic manufacturers are already printing the same warnings as the name-brand manufacturers; did the name-brand manufacturers disclose this type of rare adverse effect on their labels? Probably not, if it wasn't a known adverse effect.

    • Bruce Lancaster

      I worry about that too. When I had some trouble with an ineffective generic, I decided to do some reading. It turned out that the rules for that particular generic from the FDA only required them to have 60% of the stated dose in each tablet. For all other generics outside the class of the one I had trouble with, the FDA rule says the generic can be 80-125% of the actual labeled dose. They give them 45% wiggle room (to be fair – the top end of 125% is really just to accommodate drugs made from naturally occurring ingredients such as antibiotics because even the name brand manufacturers can't keep their doses from exceeding by a good bit when the ingredients are fresh and then losing a little as they degrade). The other thing that is a concern is the fact that a large portion of the available generics are being made in Mexico now.

  • catlady10

    Doctors get their free med samples from the drug reps who are getting them to prescribe a certain med.

  • SMG

    Enough. Generics have a purpose but they are not without their issue. Fortune magazine published a great article in their February 2013 issue entitled "Are Generics Really the Same as Branded Drugs?"

    Here is the link to the article: http://management.fortune.cnn.com/2013/01/10/gene

    Please, take the time to read the article. It's eye-opening. Your news channel has a responsibility to report the whole truth. Why does Fox59 continually want to only show one side of the story?

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