New warning rule for users of generic drugs is left in limbo

Five years after the Supreme Court blocked most personal-injury lawsuits against makers of generic drugs, a rule designed to strengthen patient protections have stalled, leaving what consumer groups warn is a safety gap for millions of users.

After several delays, the Food and Drug Administration said last year it would to issue a new rule by the end of this month to require generic drug makers to update their warning labels in response to newly revealed risks. But the agency quietly said recently it had put off a final decision until early next year. 

“I am surprised, even shocked that it has taken so long and that this hasn’t been fixed,” said Allison Zieve, a lawyer for Public Citizen, the consumer-rights group that petitioned the FDA in 2011.

At issue are legal rules governing the nation’s most commonly used prescription drugs. 

More than 88% of the prescriptions dispensed in the United States are for generic drugs. The industry says consumers, insurers and hospitals save $254 billion a year by using these lower-cost, copycat drugs.

But these drugs also have what some advocates describe as a hidden risk.

Only makers of brand-name drugs have a legal duty to update their warning labels if they learn of new risks or side effects, the high court ruled in a 5-4 decision five years ago. By contrast, justices said that FDA rules forbid generic makers from acting on their own to update their warning labels.

The conservative majority reasoned that because generics must be the same as the approved brand-name drugs, their makers are not to free to add new warnings. At the same time, they ruled that generic makers may not be sued by injured patients who contend they and their doctors were not warned of a drug’s serious new risks.

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The 2011 decision in PLIVA vs. Mensing tossed out suits from two women who suffered crippling nerve disorders and facial disfigurements after taking a generic form of Reglan, a drug that treats acid influx. In 2013, another 5-4 ruling in Mutual Pharmaceutical vs. Bartlett tossed out a $21-million jury verdict in favor of a New Hampshire woman who was disfigured, badly burned and nearly blinded after she had a severe reaction to sulindac, a pill she took to relieve her shoulder pain.

Justice Clarence Thomas conceded these women had been dealt an “unfortunate hand” by a ruling that appears to “make little sense,” because their injury claims would have upheld had they taken the brand-name version of the same drug. But the FDA regulations stood in the way, he said, adding that “Congress and the FDA retain the authority to change the law and regulations if they so desire.” 

In response to public petitions, the FDA proposed to change its rule so generic makers would have the freedom and a legal duty to update their warnings to patients and doctors. But the proposal ran into fierce opposition from industry leaders who said it would be costly and possibly confusing. If several generic versions of a drug were being sold, doctors and pharmacists could be confused if their warning labels differed, they said.

Chip Davis, president of the Generic Pharmaceutical Assn., said he was pleased the FDA had delayed the rule again. It “carries significant cost consequences that would reverberate through our health system,” he said.

His group proposed instead that the FDA take over the task of updating warning labels. In the past, the agency has said its limited staff cannot constantly monitor the more than 11,000 drugs on the market. That responsibility has been left to the companies that sell approved drugs.

Sandy Walsh, a spokeswoman for the FDA, said the proposed rule change “remains under review.” The agency has “received a great deal of public input from stakeholders” and “is carefully considering the comments,” she said.

Consumer-rights advocates are upset by the delay and see a growing danger to public safety as generics take over the market. They say several hundred drugs are now sold only by generic makers, so no manufacturer has the legal responsibility to update warnings of possible new risks.

“Industry has screamed about this rule, and it looks as though they are bowing to the pressure,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group.  Under the court’s rulings, he said, the generic makers “face essentially no liability, and they are fighting to keep it that way.”

Lawsuits can provide compensation for people who have been injured, “but that is not their primary importance,” Carmone said. “Now, the generics have no incentive to engage in robust monitoring of the safety of their products, and there’s no accountability if they don’t. It’s critically important that they have a real incentive to promptly warn doctors and patients,” he said.

Twitter: DavidGSavage

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