The U.S. Food and Drug Administration should require manufacturers of generic drugs to promptly update warning labels when they learn of new side effects, the healthcare advocacy group Public Citizen said in a petition filed Monday.
At present, generic makers are prohibited by regulations from changing labels unless they have FDA approval, or unless the brand name maker has updated the label first.
But generic drug sales have skyrocketed, the group says, and their manufacturers have a wealth of information about issues related to effectiveness and safety. In fact, 90% of prescriptions for drugs with generic equivalents were filled with a generic rather than the brand-name drug, the group said.
"We think it's a really big regulatory gap that threatens the safety of drugs and therefore the safety of patients that generics can't update their warnings in the same way as brand name companies," argues Allison Zieve, director of Public Citizen's Litigation Group.
"Because of this, injured patients have no recourse and there's no one for them to hold accountable if, as happened in a case last spring, a patient was severely injured. The patients suffer in two ways."
According to the group's petition, rules say that responsibility falls on brand name manufacturers to re-label their products when they learn of potential harm, and generic makers to follow suit.
But since generic makers selling most of the products, the generic makers hear about issues regarding side effects and effectiveness first, Zieve says. "The name brands no longer have the incentive to be paying as close attention. They're making a fraction of the money and selling a fraction of the prescriptions, yet they're the ones with the responsibility," she explained in a telephone interview.
When generic makers learn about potential side effects from their products, the FDA now requires them to tell the FDA about each instance, but not to immediately change their labels. The FDA has limited resources to monitor each safety event, Zieve says.
According to Public Citizen's petition, "some generic drugs may be associated with adverse events that do not occur with the name-brand drug," as in a case with Budeprion XL, "an example of a generic drug with side effects not associated with Wellbutrin XL, its brand-name counterpart." In that case, the generic manufacturer should have had an obligation to warn patients.
Asked for a response, a spokeswoman for the FDA said in an e-mail Monday that "the FDA will review the petition and respond directly to the petitioner once our review is complete."
The issue came to a head in June when the Supreme Court, in PLIVA v. Mensing, ruled that patients harmed by inadequate warnings on generic drug products can not sue generic makers for damages, but people who take brand name versions of the same drugs can.
"In that case, the Supreme Court considered whether the restrictions imposed by federal law on the ability of generic drug manufacturers to alter labeling preempts state common law claims against a generic manufacturer based on failure to warn of hazards associated with its product," Public Citizen said in its petition.
"The Court concluded that 'it was impossible for the manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same,' " the petition said.
Zieve said that other similar cases which have not reached the Supreme Court involved the drug metoclopramide, the generic equivalent to Reglan, which is used to fight acid reflux but which provoked instances of tardive dyskinesia, involuntary movements in patients treated for long periods of time with a medication.
"Over the past few years there were a bunch of cases where the generic drug company argued, 'you can't sue us because we don't have the ability to change the label, so you can't sue us for a failure to warn,' " she said.
Jennifer Fuson, spokeswoman for the American Association for Justice, said many similar situations have occurred, but one that has been repeatedly documented involves propoxyphene, a generic substitute for Darvocet, but which caused arrhythmias and other heart problems. Both were recalled by the FDA in 2010.
Asked for comment, a spokesman for the Generic Pharmaceutical Association referred to a statement released after PLIVA v. Mensing.
"GPhA believes the High Court has appropriately recognized that current law leaves generic manufacturers with no alternative but to make certain that its products have labeling that is identical to the labeling of the reference brand product," said GPhA executive director Bob Billings.
"As the Supreme Court recognized in this decision, assessing liability based on label content that is beyond the control of the generic manufacturer places the generic manufacturer in the impossible position of defending the content of a label that they are required by law to use, but prevented by law from changing."
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