From the 7/25 Show – Commissioner Margaret Hamburg’s Waterloo

On July 23 the FDA held a public meeting concerning the “extended release” (aka – OxyContin) products under the guise of creating new “safety guidelines”. The guidelines were presented under the auspices of REMS – Risk Evaluation and Mitigation Strategy. REMS was initiated in 2007 to bring greater information to the public if a “DRUG’S BENEFITS OUTWEIGH ITS RISKS”.
The radio show revealed the hypocrisy and continuing disingenuous efforts by the FDA. Thousands dying, tens of thousands addicted and millions dependent and the FDA continues to allow the unencumbered marketing of the long term opioids for “moderate to severe pain”. The lunacy of the public meeting was missed by all in the media. The psychological, emotional and brain altering results from the opioids should have been the first order of discussion at the meeting. The inept and insincere efforts of the “corrupted” FDA officials leading the proposals and meeting should have been revealed. The quote by John Jenkins, the director of the FDA’s office of new drugs, said “the agency’s plan was designed to address legitimate use of the drugs, not deliberate abuse”. Volumes can be written on Jenkin’s misunderstanding of “legitimate” use, but to publicly state that abuse is not under the auspices of the FDA’s concerns should immediately create the dismissal of Jenkins.
Margaret Hamburg, the Commissioner of the FDA, is allowing the ineptness of Woodcock, Throckmorton, Rappaport, Jenkins and Hirsh to be remembered as the most ineffective FDA Commissioner in History. Millions of individuals and families continue to be affected by the inaction of the FDA and the clock is ticking on revealing Hamburg’s ineffectiveness in representing the safety of the American people. The fiasco of the July 23rd meeting was a glaring reminder of Hamburg being out of touch. Hamburg should become familiar with Napoleon at Waterloo.