ext 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.

“The way things stand now, generic companies won’t face lawsuits, so they have less incentive to make timely updates to their labels,” explained Allison Zieve, director of the litigation group at Public Citizen, which had petitioned the FDA to propose the rule. “But the status quo is bad for safety and public health.”

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.

Such a case is under way this month in a Chicago federal court, where GlaxoSmithKline is being sued by the widow of a 57-year-old attorney who struggled with depression. He took a generic version of the Paxil antidepressant and later jumped in front of a train. Paxil, like other similar drugs, had a warning added to the label a decade ago about an increased risk of suicidal thoughts in young adults, but it does not warn of that risk for those over 24.

Wendy Dolin’s lawsuit contends that Glaxo was aware of a heightened suicide risk among older adults, as well, but failed to update its label — which meant that the generic manufacturer could not update its label, either.

“Glaxo left a defective label in place and they’re the only ones that could have changed it,” said Michael Baum, an attorney for Dolin. “Right now, people don’t know what they get when they buy a generic. They’re saving money, but giving up right to file suit unless a case like this proceeds.”

With very few exceptions, this legal tactic of suing the brand-name company has largely failed.

Over the past decade, more than 100 similar cases have been tossed by courts around the country, according to the Drug & Device Law blog. One lawsuit succeeded in a federal court in Vermont and there were two victories in a California state court, although one of those is now on appeal before the California Supreme Court.

Whether the Dolin case succeeds remains to be seen, but even if it does, it may not apply beyond Illinois.

“The reason most courts have rejected this claim is because, under state product liability law, a plaintiff has to sue the manufacturer or seller of the product that caused the injury,” explained Richard Oetheimer, a partner at the Goodwin Procter law firm.

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

If the FDA misses its April target for enacting the rule, the process could drag on indefinitely.

And that’s especially true since the Trump administration seems averse to issuing new regulations. Moreover, its nominee to head the FDA, Dr. Scott Gottlieb, has many ties to drug makers through his consulting and venture capital work, which may make him less inclined to enact rules that might open companies up to lawsuits.

Nonetheless, the Trump administration should green light the rule, or risk being labeled as hindering consumer safety.

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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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