Marketplace, December 22, 2004
The White House says the Food and Drug administration is doing a "spectacular" job. Really? The FDA didn't respond to warning signs that block-buster painkillers like Celebrex and Vioxx increased the risk of heart attacks. Worse yet, its own drug-safety officer says the agency suppressed his research showing the apparent dangers of Vioxx. Belatedly, the FDA is now looking into the potential risks of Naproxin, an ingredient in many over-the-counter pain relievers. The FDA also failed to warn the public that antidepressants increase the risk of suicide among children who take them.
"Spectacular?" I don't think so. In fact, one might conclude that the Food and Drug Administration is failing in its core mission to protect consumers from harm. It's a toothless tiger.
Meanwhile, new legislation is winding its way through Congress that would prevent people who are hurt by drugs approved by the FDA from winning large damage awards against companies that made them. FDA approval would shield drug makers from having to pay anything more than $250,000 even when it's proven that they negligently caused someone more than $250,000 of harm. Congressional sponsors understand this cap on damages will end lawsuits against drug companies because personal-injury lawyers won't want to take on the risks and costs of such cases. If this bill passes, companies like Pfizer and Merck, now facing a flood of lawsuits because of Celebrex and Vioxx, won't have to worry.
So we've got an FDA that's not protecting consumers from harm, and pending legislation that makes it almost impossible for people who are hurt by drugs approved by the FDA to sue for damages. The question must be asked: How is the public going to be protected if the FDA remains weak and if private lawsuits are cut off?
You might ask the same question all over government these days. Pick an agency - not just the FDA, but the Securities and Exchange Commission, the Consumer Product Safety Commission, the Federal Trade Commission, and so on. They're supposed to protect the public. But they're all understaffed, their budgets have been whacked, and many of them are in the pockets of the very companies and industries they're supposed to regulate.
At exactly the same time, Republicans are clamoring for what they call "tort reform." Tort reform is a nice way of saying that people who are harmed by companies shouldn't be able to sue them and collect damages.
They can't have it both ways. Either regulatory agencies have to be made tougher and more independent, and given the resources they need to protect the public, OR we've got to rely on courts and private lawsuits to make sure companies have every financial incentive to protect the public. Absent both - tough regulators and the threat of private lawsuits - the public is at serious risk. If you're worried about Celebrex and Vioxx, you ain't seen nothin' yet.
