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  • STAT News, Ed Silverman

Here’s one drug safety rule the FDA should enact — quickly

Next month, the Food and Drug Administration is likely to miss another target date for implementing a rule to improve generic drug safety. If that happens, the American public will lose.

The rule is important because it addresses a maddening quirk in the law.

Right now, brand-name drug makers can change product labels after learning about potentially harmful side effects. But generic companies cannot do the same thing — unless such a change has already been made to the corresponding brand-name drug.

The Supreme Court upheld this regulation six years ago and, as a result, patients who believe a generic drug label gave them inadequate warning of potential side effects cannot sue the generic companies for harm. To address this inequity, the FDA proposed a rule in 2013 to let generic drug makers independently change product labels. Fearing lawsuits, generic companies have repeatedly lobbied to delay the measure.

This time, the Trump administration ought to ensure the rule is enacted.There is good reason. Nearly 90 percent of prescriptions written in the United States are for lower-cost generics, according to the Quintiles IMS Institutes for Healthcare Informatics. If the rule does not go into effect, there may be times when labeling could be insufficient to warn about patients about risks. [...]

There is a technical term for where all this leaves consumers — out of luck.

Some attorneys have tried a clever workaround, though.

Since they can’t file lawsuits against generic companies, they have targeted brand-name drug makers. The theory is that these brand-name companies should know that consumers will rely on their labeling when they are prescribed a generic version of a drug. [...]

Read the full article here

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