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Day two of David Pecker testimony wraps in NY Trump trial; Supreme Court hears arguments on Idaho's near-total abortion ban; ND sees a flurry of campaigning among Native candidates; and NH lags behind other states in restricting firearms at polling sites.

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The Senate moves forward with a foreign aid package. A North Carolina judge overturns an aged law penalizing released felons. And child protection groups call a Texas immigration policy traumatic for kids.

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The urban-rural death divide is widening for working-age Americans, many home internet connections established for rural students during COVID have been broken and a new federal rule aims to put the "public" back in public lands.

FDA Proposes Simpler Updates for Generic Drug Labels

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Monday, April 7, 2014   

FRANKFORT, Ky. - According to Allison Zieve, an attorney with the watchdog group Public Citizen, most people are not aware that when they take a generic drug, they may have unwittingly given up some of their legal rights. She explained that that's the result of a 2011 Supreme Court ruling.

"If the labeling on a generic drug has failed to advise you of a safety risk, the Supreme Court has held you cannot sue the manufacturer for failing to warn you, unlike (the situation with) a brand-name company, which you could sue."

Zieve said the original FDA rules covering generic vs. brand-name drugs were written years ago, but now the agency is proposing a change that would make it easier for the makers of generic drugs, in many circumstances, to modify their labels when new information becomes available.

The update would allow label changes to add details such as newly discovered risks or side effects, without going through a government approval process.

"Now, rather than having a very small part of the market, generics have a huge part of the market, 84 percent of prescriptions filled," Zieve said. "So, the FDA rule is really a very important and overdue recognition that generic manufacturers need to be able to take responsibility for labeling."

Zieve pointed out that most people don't really choose whether they get generic drugs or not; that decision is often made by a doctor or pharmacist.

Often, generic drugs are much less expensive than name-brand drugs, which has accounted for their popularity. Zieve said people shouldn't feel that generic drugs are less safe than brand-name drugs, but it's wise to get the latest information about risks and side effects.

"The number of drugs that this has affected over the years is probably not huge," she said. However, the lawyer added, "The number of patients that have suffered because of the lack of adequate warnings is much bigger."






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