Top FDA Officials Say Preemption Policy Based on "False and Misleading" Information

Wednesday, March 11, 2009 by: David Gutierrez, staff writer
Tags: FDA, health news, Natural News

(NaturalNews) Internal FDA documents have revealed that top agency officials strongly objected in 2006 and 2008 when the Bush administration took steps to enshrine a "preemption" policy for drugs.

Under the preemption doctrine, FDA approval becomes the final word on the safety of a drug. This means that even if an FDA-approved drug has caused severe injury to consumers, no lawsuits can be filed in state courts about it.

In 2006 and 2008, the FDA sought to strengthen its preemption policy by requiring drug companies to get agency approval before making any changes to the safety section of drug labels.

At the time, top FDA officials blasted these changes as "naive to what actually occurs in practice," and said they were based on "false assumption," "false and misleading" assertions" and "gross overstatement."

"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," objected Office of New Drugs head John Jenkins. "We know that such an assumption is false. ... We know that many current approved drug labels are out-of-date and in many cases contain incorrect information. ... It is unwise to suggest that FDA approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information."

The internal objections were recently revealed in a report issued by the Committee on Oversight and Government Reform. The report notes that the new preemption rules may have already led to consumer harm. It cites the case of when Glaxo sought to change the label of its breast cancer drug Tykerb to warn of the potential for pneumonitis or interstitial lung disease, but the FDA delayed on approving the change for three months. The FDA delayed for the same amount of time when Johnson & Johnson sought to add warnings of the potential for liver toxicity to its antibiotic Levaquin.

The FDA eventually required all antibiotics in the same class as Levaquin to carry warnings about the risk of liver damage.

Sources for this story include: www.pharmalot.com.