WASHINGTON — Companies that make generic drugs, the medications most Americans buy, are fighting to kill a proposed federal regulation that would require them for the first time to warn patients of all the known health risks of each drug they sell.
The proposed rule change by the Food and Drug Administration "would be nothing short of catastrophic," said Ralph G. Neas, president of the Generic Pharmaceutical Assn., an industry trade group. It could raise healthcare costs and "create dangerous confusion" for doctors and patients, he said.
At issue is a legal loophole created by Supreme Court rulings that drew a sharp distinction between brand-name drugs and lower-cost generics, which are the same products but usually are marketed under their chemical names.
In 2009, the high court confirmed drug makers could be sued if they failed to warn patients that a brand-name drug carried a serious potential health risk.
The decision upheld a $7-million jury verdict for Diana Levine, a Vermont violinist whose lower arm was amputated after she was injected with an anti-nausea drug made by Wyeth. The drug sometimes caused gangrene if injected into an artery.
But the Supreme Court majority flipped when confronted with a generic drug that also caused a horrible side effect.
Last year, a 5-4 ruling tossed out a $21-million verdict awarded by a lower court to Karen Bartlett, a New Hampshire woman who was disfigured, badly burned and nearly blinded after she had a rare, but previously reported, reaction to a prescription painkiller.
Had Bartlett taken the brand-name drug Clinoril for her shoulder pain, she would have won her claim. But her pharmacist gave her the generic drug sulindac. And at the time, the product label did not warn patients or their doctors of the rare reaction, known as Stevens-Johnson syndrome.
Nonetheless, the court ruled generic makers were shielded from lawsuits such as Bartlett's.
Justice Clarence Thomas, who cast a key vote, reasoned that because federal regulations say generics must be exact copies of the approved brand-name drugs, their makers cannot revise or update warning labels when new risks come to light. And so, he said, they cannot be sued for failing to warn consumers.
The dissenters said this made little sense. "Nothing in the court's opinion convinces me that … Congress intended these absurd results," said Justice Sonia Sotomayor.
In November, the FDA proposed to fix the problem by allowing generic makers to change their warning labels when reports of new problems arise.
"In the current marketplace, approximately 80% of drugs dispensed are generic drugs," the agency said. "Accordingly, there is a need for [generic drug producers] to able to independently update product labeling to reflect certain newly acquired safety information."
The proposed rule change would extend legal liability as well. Any company that makes generic drugs would have an "independent responsibility to ensure its product labeling is accurate and up-to-date," the FDA said.
The proposal met fierce opposition from the generic drug industry. Its members said they "cannot support a proposed rule that undermines public health merely to facilitate litigation against generic drug companies by the plaintiff's bar."
Neas, who heads the industry group, noted that generics had lowered many Americans' healthcare costs. A study by the independent IMS Institute for Healthcare Informatics said generics had lowered healthcare costs by $1.2 trillion over the last decade.
Neas formerly led the Leadership Conference on Civil Rights and the liberal advocacy group People for the American Way, and he was credited with helping organize a national campaign that helped derail the Supreme Court nomination of Judge Robert Bork in 1987.
Neas described his group's fight against the proposed rule change as a national public education campaign.
"Our aim is to get the facts out there," he said. "This will go for some time. I don't believe this [proposed] rule benefits anyone in the healthcare system."
The FDA had planned to complete work on the proposal after hearing comments through January. It agreed to postpone the deadline until March in response to complaints from the generic drug makers.
But the rule change has the backing of congressional leaders who follow health policy. They include Rep. Henry A. Waxman (D-Beverly Hills), cosponsor of the 1984 Hatch-Waxman Act, which is credited with spurring the widespread adoption of generic drugs.
"Patients should have the same rights to seek compensation if they are injured by a drug, regardless of whether it is a brand-name or a generic," Waxman said in an interview. "It doesn't make sense," he said, to have patients' rights depend on which version of a drug they took.
A growing number of drugs are sold only as generics. That shift argues for changing the federal warning rules, said Dr. Michael Carome, director of Public Citizen's Health Research Group, a nonprofit organization.
"Many potential hazards are not discovered until years after drugs have been on the market," he said. "The proposed rule would remedy this public health problem" by requiring generic makers to disclose new safety risks as they are known, he added.