In April, the Food and Drug Administration is expected to review a rule that governs changes in labelling for approved drugs and biological products. But based on previous reports, it is also expected that the FDA would avoid enacting the rule.

Currently, brand-name drug makers are allowed to update product labels after learning about potentially harmful side effects and generic companies are only allowed to do so afterwards.

In a 2011 case, the Supreme Court upheld this regulation, therefore patients who insist that a generic drug label failed to warn of all potential side effects, cannot sue the generic companies for harm.

Generic companies constantly thwart the rule

The case saw two patients developing tardive dyskinesia after being prescribed a Reglan-equivalent - a drug commonly used to treat digestive tract problems - from their pharmacists for several years.

The patients sued the generic manufacturers, who argued that federal statutes and FDA regulations required the same safety and efficacy labelling as Reglan, for metoclopramide (the generic). The Supreme Court then remanded the case.

In an attempt to address the inequity, the FDA proposed a rule in 2013 to let generic drug makers independently update product labels. However generic companies feared lawsuits and have repeatedly lobbied to delay the measure - three times since 2013, raising questions about whether the rule will ever become reality.

They are concerned that the rule will allow lawyers to find ways to make them appear negligent if they do not update newly learned safety information to labels quickly enough.

Rule is important for patient safety

Due to cost-effectiveness, nearly 90% of prescriptions in the United States are for generics, according to the Quintiles IMS Institutes for Healthcare Informatics. If the rule is not enacted, the US might see many repeats of the 2011 case.

“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.”

Some attorneys targeted the brand-name drug makers, based on the assumption that these companies should know that patients rely on their labelling even though they are prescribed the generic-equivalent.

Targeting brand-name companies instead

Such is the argument for a case in a Chicago federal court, where GlaxoSmithKline (GSK) is being sued by the widow of a 57-year-old attorney who consumed the generic version of the Paxil antidepressant and later committed suicide by jumping in front of a train.

Paxil and other similar drugs have put a warning on the label a decade ago, about an increased risk of suicidal thoughts in young adults, but does not warn of the same risk for those over 24.

The widow, Wendy Dolin, argued that GSK was aware of the risk for those among older adults, but failed to update its label, therefore 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 the right to file suit unless a case like this proceeds."

Trump administration needs to green light the rule

This workaround of suing the brand-name company in Dolin's case is not the first and has not been largely successful.

In the past decade, more than 100 similar cases have surfaced around the country, with only one successful lawsuit in a federal court in Vermont and two in a California state court - although one is now on appeal before the California Supreme Court.

Dolin's case is still awaiting verdict, and even if it is successful, the verdict 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 Oethiemer, a partner at the Goodwin Procter law firm.

This leaves consumers dependent on luck.

If the FDA does not enact the rule next month, the length of the process could be indefinite - especially if the Trump administration is hesitant to issuing new regulations.

Not to mention, the potential head of the FDA, Dr Scott Gottlieb, is attached to many pharmaceutical companies through his consultancy and venture capital work, making him protect the companies from lawsuits, according to his interests. MIMS

Read more:
Will an expedited FDA drug-approval process result in a win-win situation?
The effects of different pill shapes and sizes - and implications of these for pharmacists
Will Trump's FDA pick be able to lead the agency according to the Republicans' promises?

Sources:
https://www.statnews.com/pharmalot/2016/05/19/fda-generic-drugs-safety/
http://www.raps.org/Regulatory-Focus/News/2016/04/13/24750/Updated-Congress-Looks-to-Force-FDA-Into-Rewriting-Major-Generic-Drug-Labeling-Rule/
https://www.statnews.com/pharmalot/2017/03/20/generic-drug-label-fda/
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AG94
https://www.supremecourt.gov/opinions/10pdf/09-993.pdf