One More Week Of Anxiety: PDUFA Delayed
1 CommentBy Ed Silverman // June 14th, 2007 // 12:01 pm
Are you surprised? The House Energy and Commerce’s health subcommittee postponed the mark-up, which was to have begun today, after Republicans reportedly complained about some provisions. Instead, this won’t happen until Tuesday.
A key point of contention is language that would forbid pre-emption, which essentially gives drugmakers some immunity against product liability claims, because the FDA has already deemed a product to be safe. An exception would occur when, say, a company knowingly hid or falsified info that would have led the FDA to make a different decision about approving a drug.
Republicans argue the bill would open the door to still more state-level lawsuits against drugmakers and undermine the FDA’s authority. “It is a gift, if you like, to file suit in state courts,†Mike Burgess, a Texas Republican tells Congressional Quarterly (subscription may be required).
The issue is very hot. A Texas state court judge recently caused a furor when he dismissed a Vioxx lawsuit, citing the pre-emption rule, effectively putting nearly 1,000 Vioxx cases on hold. That move prompted legal experts to predict the issue would soon make its way to the Supreme Court.
Democrats insist they’re not trying to encourage lawsuits. “It’s not that we’re looking to change the status quo,†says subcommittee chairman Frank Pallone, a New Jersey rep. “But right now people might have remedies under state law already, and we don’t want to pre-empt that.â€
The bill’s language was initially included at the request of the American Association for Justice, the lobbying group for trial lawyers lobbying group, Public Citizen and other groups, according to Gerie Voss, the AAJ’s regulatory counsel. “PhRMA has taken every opportunity they can to stall,” Voss tells Pharmalot.
The medical device makers lobby called the provision a deal breaker in what is considered must-pass legislation. “It’s extremely troubling from our perspective,†Chris White, general counsel for AdvaMed, the industry’s lobbying group, tells CQ.
Brin Frazier, a spokeswoman for committee Democrats, says the language would remain only in the draft bill’s drug safety section. That would exempt device makers, who have enjoyed federal pre-emption since 1976.
Laurie
If the FDA has determined a drug to be safe due to incomplete, altered, inaccurate or fabricated information WHY should the drug companies be given a free ride for LYING?? If the preemption remains in PDUFA, the drug companies have no reason to tell the truth. We have seen so many cases of “questionable” data in clinical trials recently, that to allow preemption to stand is an unbelievable insult to the American people.