Trial Lawyers Helped FDA with Rule Opening Generic Drug Firms to Lawsuits
Bedard, Paul, Examiner (Washington, D.C.), The
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. …