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Trial lawyers helped FDA with rule opening generic drug firms to lawsuits

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Paul Bedard,Washington Secrets,Supreme Court,FDA,Pharmaceutical Industry

The association that represents America's trial lawyers played a special role in the Food and Drug Administration's process of developing a new rule that opens the door to suits against generic drug makers, a potential financial bonanza to lawyers -- and a $4 billion hit to consumers and the government.

In a letter to a House committee, the FDA singled out the trial lawyers group, the American Association for Justice, as the only one officials met with as they drew up the rule. In the same letter, the FDA said that it typically doesn’t meet with stakeholders while drawing up new regulations.

And at a House Appropriations subcommittee hearing Thursday, FDA Commissioner Margaret Hamburg called the process “open,” and said the agency met with drug makers “as well.”

But Rep. Kevin Yoder, R-Kan., said it was surprising that the FDA said the process is typically closed to those involved, but in this case trial lawyers were given special access.

“I just found that odd that in your letter you would say that was the only group you met with,” he said.

The admission raised new concerns that the administration is doing the bidding for trial lawyers who want access to generic firms.

The rule change follows a Supreme Court decision barring suits against generic drug firms accused of providing insufficient label warnings. The 5-4 decision restricted suits for so-called design defect or drug-safety complaints, arguing that generic makers have to use the same labeling as the original drug maker. As a result, only the makers of brand-name drug can be sued.

Several Senate Democrats have been pushing for a change.

But the shift to let generic firms change safety labels could be costly. The Generic Pharmaceutical Association recently released a study that said the rule could cost $4 billion, mainly because generic firms would have to expand their legal teams to fight product liability lawsuits.

“The analysis finds that generic product liability would increase annual spending on generic drugs by $4 billion, or $1.16 per prescription for the roughly 3.4 billion generic prescriptions dispensed in the U.S. each year. Of this, government health programs would shoulder $1.5 billion, and private health insurance and the uninsured would bear $2.5 billion. Given expected increases in pharmaceutical spending, the economic impact of the proposed rule would increase over time,” said the study.

Paul Bedard, the Washington Examiner's "Washington Secrets" columnist, can be contacted at pbedard@washingtonexaminer.com.