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Petition Calls on FDA to Hold Makers of Generic Drugs Accountable

Generic prescription drugs

Gabriel Drapos was a freshman at Harvard when he was diagnosed with ulcerative colitis and had to have his large intestine removed. A generic form of the acne medication Accutane was to blame.

Karen Bartlett took the generic pain pill sulindac for shoulder pain. Within weeks, her skin began peeling off in clumps. Her lungs are permanently damaged, and she is legally blind.

Drapos and Bartlett were legally barred from holding the drug manufacturers responsible for their devastating injuries. That would change if a new petition is successful in finally convincing the Food and Drug Administration (FDA) to change its rules.

“We believe it is critically important that all prescription medicines, including generic drugs, carry current and accurate safety warnings,” reads the petition by Take Justice Back.

“People who are hurt by generic drugs should have the same legal rights as those who are injured by brand name versions of the same medications. Both brand name and generic manufacturers should be accountable for the safety of their products. If no one is accountable, no one is safe.”

Take Justice Back is a grassroots campaign of the American Association for Justice to restore accountability, promote safety and ensure Americans have access to justice.

Who is Responsible for Injuries?

Generic drugs account for more than 80 percent of prescriptions in the United States today, yet these manufacturers assume zero responsibility for the safety of their products.

The problem began long ago. The Hatch-Waxman Act of 1984 gave rise to today’s robust generic drug market and established the modern system for generic drug regulation. The law fast-tracked the approval process for generic drugs as long as they have identical ingredients to the name-brand drug. Essentially, generic labels have to match the labels of the brand names.

But what happens when manufacturers of generics discover side effects long after a brand-name drug has left the market? And who is held liable for injuries?

“There is the problem of suing for responsibility, but there is also the bigger problem of safety,” Allison Zieve, general counsel for Public Citizen, told Drugwatch.com. “There has to be a way to make sure there is adequate labeling on every drug.”

Even when the brand-name drug goes off the market, as happens regularly, the generic that remains can’t change the warning label. Public Citizen counted 434 generic drug products currently on the market for which no brand-name product exists. A Public Citizen report shows that at least 53 drugs approved more than 10 years ago by the FDA, required black-box warning labels within the last five years.

Zieve’s consumer advocacy group has been pushing the FDA to fix these issues for years. It may finally happen.

Supreme Court Sides with Generic Drugmakers

The U.S. Supreme Court twice has sided with generic manufacturers, essentially providing them with legal immunity. In its 2011 decision, PLIVA, Inc. v. Mensing, the high court ruled that these manufacturers could not be held responsible for failing to warn patients about side effects. Upholding their state law duty to warn would cause the manufacturers to violate federal law. Under the U.S. Constitution, federal law trumps state law whenever the two are at odds. So the court concluded that generics can’t be held responsible for failure to warn when they follow federal rules and wait until brand-name manufacturers change the warning labels.

In June 2013, in a follow-up decision — Mutual Pharmaceutical v. Bartlett – the court said generic manufacturers are also exempt from lawsuits that claim their products are defective.

FDA Rule Change Would Help Consumers

The FDA proposed a rule change on Nov. 8, 2013, to address the limitations of its current rules. The proposal would allow generic drugmakers to change the information on warning labels without waiting for the brand-name drug to do so. The deadline for the comment period was March 13.

The FDA said the new rules would speed the dissemination of safety information to doctors and patients by allowing generic drugmakers to use the same process as brand-name drugs to update their warning labels.

“That would be a huge improvement,” Zieve said. “Drug warning labels should be updated sooner, and the ability to hold the generics accountable when their drugs cause injuries will provide a significant incentive to make sure their labeling is adequate and current.”

Manufacturers of generics vehemently protest the rule change. They claim that consumers could be confused if the generic labeling differs, even temporarily, from the labeling on the brand name.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the benefits outweigh those concerns.

“This proposed rule reflects the Agency’s judgment that concerns related to temporary differences in labeling between generic drugs and their corresponding brand drugs are outweighed by the benefit to the public health, which would result from all application holders having the ability to independently update drug product labeling to reflect newly acquired information regarding important drug safety issues through CBE-0 labeling supplements,” Woodcock said in a statement to an April 1 congressional hearing.

“This proposed rule, if finalized, is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients.”

The rule would also eliminate the conflict between state and federal law. Generic manufacturers could no longer rely on the two Supreme Court decisions to shield them from failure to warn and defect claims.

Sign the petition today.