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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.

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  • It would make sense to allow generic drug companies to change the drug label independent of the brand name company.

    That being said, if generic companies were allowed to change the label based on their safety reporting there are a few unanswered questions.

    Would changes on generic drug labels be the result of pooled generic co. safety data or could safety data from a single generic co. be used to justify the label change?

    If the generic company has exclusivity and/or majority share of the generic market, then one would expect them to receive the majority of safety reports. That being said, generics may vary from the innovator so would there be anything in place to qualify whether or not the safety report is the result of the generic co.’s formulation and/or it involves quality control/manufacturing issues?

    Also, most patients don’t read or have access to the the actual drug label because the manufacturer bottle and PI are thrown out after the pharmacist puts the patients’ dispense in a pharmacy bottle. The patient then receives a pharmacy print out of the label summary written in layman’s terms.

    Does anyone track and/or is anyone responsible to ensure that the pharmacy print out complies with the label? I assume that this would be the responsibility of state pharmacy boards?

    What about liability on the part of the learned intermediaries such as pharmacists and prescribers? How would a generic drug company disseminate info about label changes to pharmacies, pharmacists and physicians/other prescribers?

    • Hi Anne

      All good questions. One argument, which I gather you’re wondering about, is the rule may cause a potpourri of labels could emerge as one generic company changes its labeling but others may not.

      The FDA would obviously have to address this, but the all or nothing mentality that results in nothing happening would defeat the purpose of the rule in the first place.

      One former FDA official, who now consults for generic companies, contends the FDA can make such a move. In any event, I can only imagine these would have to be sorted out as part of implementing the rule, if it goes forward.

      Thanks for writing in,

  • As Ed stated, the probability of winning one of these lawsuits is very low, so if I were a plaintiffs’ lawyer I would recommend the settlement route as an ultimate outcome.

    The blueprint is in an incident that occurred in Kentucky in 1989. A man named Joseph Wesbecker, with a long psychiatric history had been taking the new “miracle drug”, Prozac when one day he went to work with an AK-47, committed mass murder then committed suicide. The families of the victims sued Lilly for megabucks, and the trials were ultimately halted in 1995 when Lilly agreed to an undisclosed settlement. Given that Lilly’s revenues from Prozac were $1.7 billion as far back as 1989, the hit to their bottom line was probably not huge.

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