Regulatory Focus™ > News Articles > FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

Posted 19 May 2016 | By Zachary Brennan 

FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

The US Food and Drug Administration (FDA) again pushed back (from later this summer until April 2017) its finalization of a contentious rule that would allow generic drug companies to update labels like their brand name counterparts.

An FDA spokeswoman told Focus that the new date for the finalized rule is a “projected” date “that may be adjusted to reflect ongoing work,” though she could not offer any specifics on why this date was pushed back for this rule.

The proposed rule from 2013, when finalized, would allow generic companies to update their labels when safety events become known and ahead of FDA’s acceptance of such label changes, as brand name companies have done for three decades.

Currently, generic drug labels must mirror their reference products, and court decisions have limited the avenues for patients to sue generic companies when suffering from side effects. The situation is particularly tricky for a small subset of marketed generics (Public Citizen said in 2013 there are 434 such generics) that have no marketed reference products.

Debating the Final Rule

Generally, those advocating for the finalization of the rule, which was supposed to occur in July, claim it would be a step in the right direction for patient safety, as generic companies would have to better track side effects and patients would be able to sue generic drug companies if severe and unexpected adverse events occurred while using generics.

Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a statement on Thursday that FDA’s postponement of finalizing the rule is “plainly bowing to industry pressure and, in the process, prioritizing industry profits over patient health and safety.”

A Public Citizen report from 2013 found 53 drugs for which FDA required a new boxed warning – the most serious type of warning – after a generic entered the market. Of the 53, 11 are currently marketed only as generics. 

However, those opposing the rule, including the Generic Pharmaceutical Association (GPhA), claim the rule would expose generic companies to billions in new legal liabilities, while others say FDA should play a more central role in updating generic labels, particularly to ensure generic labels across different manufacturers are consistent.

Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute and former FDA official, told Focus: “FDA needs to bear more responsibility for updating the labels of old generic drugs and can take on that role, rather than foisting it onto generic drug makers in a way that will not only increase generic costs and expose them to the same sort of failure to warn suits that plague branded companies, but will undermine the generic model by creating incongruities between the labelling of the same generic drug, solely by virtue of the manufacturer and what CBE [changes-being-effected] supplements they happened to file. I think this is the most inefficient way to achieve what FDA purports to be their public health goal here, which is why I believe this was politically contrived, or at least politically influenced.”

Industry and law experts also don’t seem so sure that the finalization of this rule will necessarily decrease the number of adverse events linked to generic drugs. Even FDA Commissioner Robert Califf said in a recent Congressional hearing that it's well-known that doctors don't read drug labels.

Gottlieb added: “If the goal was simply to make sure generic labels are updated in a timely fashion as new information accrues, there were far more efficient ways for FDA to ensure that, and in a manner that would make sure that the generic labeling was consistent across different manufactured versions of the same generic drug.”

Shift to a Vaccine-Like System?

Rachel Sachs, JD, an academic fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, also told Focus: “In my view, it's worth taking a step back and figuring out what we want the rule to accomplish. If what we want to do is compensate patients who are harmed by generic drugs to the same extent as we compensate patients who are harmed by branded drugs, it's not obvious that the best way to do that is to change the labeling rule. Now, it might be the best way for the FDA to do that – labeling is the tool they have. But it might be that a system more like what we've set up in the vaccine context would be appropriate.”

What Sachs is referring to is the federal law that generally protects vaccine makers from lawsuits seeking compensation for injuries or deaths due allegedly to avoidable design problems, though patients can file suit in a special federal vaccine court established under the National Vaccine Injury Compensation Program.

“Basically, we've got a list of injurious side effects we know can result from these vaccines, and if you suffer from one as a result of getting the vaccine, you receive compensation. And so if what we care about is compensation, not just information, we might want a system that pays out precisely when you suffer a side effect we know about – and that's the vaccine system,” Sachs said.

There’s also the question as to how these generic label changes will impact patient safety.

“The idea behind a ‘failure to warn’ lawsuit is that the failure to warn somehow caused the injury that occurred, and if you had been warned, you would've behaved differently to avoid the injury. Sometimes it's possible to behave differently. But sometimes it isn't, really, or the patient decides that it's worth the risk,” Sachs told us. “So if the generic company updates its label to reflect side effect X, and the patient gets side effect X, it's relatively unlikely that the patient can sue. But they've still been injured by the product. And given that few doctors and patients read the product labels, I'm not convinced that permitting generic companies to change their labels on their own will have any significant effect on prescription patterns or on patients' choice of medications. If that's true, we're in exactly the same situation we were before – lawsuits against generic companies will just be thrown out on different grounds going forward. Admittedly, under the new rule generic companies would now have an incentive to keep track of side effects and there may be some effect on some doctors and patients.” 

And Public Citizen’s Carome told Focus that the tracking of such side effects is central issue for the finalization of this rule, particularly as the lifespan of drugs can last up to six or seven decades.

“This is a simple, common sense rule change that levels the playing field” between generic and brand-name drugmakers, Carome added, noting that brand-name drugmakers were the ones who initially came to FDA to request the ability to update their labels with new safety information.


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