Print“This is nothing less than a grave menace to the public health.”
The U.S. Food and Drug Administration has the authority, the ability, the means, the mission, and the mandate to manage the healthcare risks and benefits inherent in the products they regulate on behalf of the American public. That’s why opponents of preemption of state liability lawsuits are running scared.
Their latest attempt to muddy the waters of FDA labeling authority comes in the form of a leak of internal agency documents. Staff of Rep. Henry Waxman, D-California, claim that internal FDA documents show that career officials oppose agency regulations that weaken consumers' ability to sue drugmakers.
"Much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," the report quoted Dr. John Jenkins, who oversees FDA's new drug reviews, as saying. "We know that such an assumption is false."
Nobody ever claimed that any FDA label is fully accurate. Such an assumption is indeed false, but nobody has ever said otherwise. What supporters of preemption do say is that the FDA carefully considers the scientific evidence relating to any proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. Those who support preemption believe that a drug’s FDA mandated label deserves deference from courts and juries applying state tort law.
Jenkins is right, but that doesn’t make preemption wrong.
Jane Axelrad, an associate director for policy at the agency, provided a second “smoking gun” statement. She wrote, "We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary," she said. "To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information."
Axelrad is right too. But that doesn’t change the argument for preemption. Of course drug companies would prefer to minimize risk information – and they make their arguments based on sound science. Sometimes the FDA agrees, other times they do not.
The “leaked” documents being aggressively peddled to the media do not change the sound legal and public health argument for preemption a whit. What it does show is that there is a robust and collegial debate within the agency on this matter. Taking these conversations out of context, as is now being done by members of Waxman’s staff, just shows how desperate they are – and how weak their arguments are.
October 31, 2008
http://www.burrillreport.com/article-preempting_innovation.html
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