U.S. and state health regulators called on Congress on Tuesday to strengthen federal oversight of compounding pharmacies as lawmakers prepared for two days of hearings on a deadly fungal meningitis outbreak linked to a compounded steroid.
But the main federal regulator, the U.S. Food and Drug Administration, said in a statement to Reuters that it faces legal restrictions in regulating drug compounders such as the New England Compounding Center. The Massachusetts pharmacy was at the center of the outbreak that has infected 438 people, including 32 who have died, in 19 states.
The chief public health officer for Massachusetts also urged immediate congressional action to bolster federal oversight of the little-known, lightly regulated compounding industry, which is primarily overseen by state pharmacy boards.
“It is clear that the patchwork of disparate state regulations is not enough to keep the public safe,” Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, said in written testimony filed with a U.S. House of Representatives oversight panel.
Lawmakers hope to shed light on why regulators failed to act against NECC despite multiple problems dating back to 1999. They also are focusing on whether new legislation may be needed to grant FDA clear authority to police the drug compounding industry.
“FDA’s authority over compounding pharmacies is more limited by law and needs to be strengthened,” said the federal agency’s statement to Reuters. “We look forward to working with Congress to prevent this from happening again.”
Those sentiments were echoed on Tuesday by a new report from the minority Democratic staff of the oversight and investigations panel.
“Legal authority over compounding has been complicated by court decisions that have cast doubt on FDA’s authority to regulate compounders,” the report said. “Compounders operate in a regulatory gap between state-regulated pharmacies and federally regulated drug manufacturers.” …
Earlier this month, the state fired board director James Coffey and board counsel Susan Manning for failing to act on the Colorado complaint.
The Massachusetts pharmacy board was left to oversee NECC’s operations in 2003 when state and FDA officials agreed that its activities did not constitute a manufacturing operation that would need to meet stringent federal standards for safety and efficacy, the FDA acknowledged on Tuesday.
The decision was originally disclosed on Monday by a House Republican staff report. …
The “FDA, Fatally Didn’t Act” title is mine. The Reuter’s title for this article was “Meningitis outbreak spurs calls to strengthen FDA”. We don’t need an FDA that is some kind of new Gestapo, but neither can we survive as consumers if it is a skulk of foxes falsely guarding America’s hen houses. The perversion and wimpification of the FDA did not happen by accident. It was the direct result of intentional action over decades “by an alliance of corporations, lobbyists, right-wing think tanks and the politicians of both major parties.” (link) This is why we have an FDA that causes death by deregulation.
The compounding industry should learn from the GMO food and pesticide industry. If you don’t get your people into the FDA, you can’t cover up the deaths that result from deregulation of deadly products. Duh.
In 2009, President Obama appointed Michael Taylor as a senior adviser for the FDA. Consumer groups protested the appointment because Taylor had formerly served as a vice president for Monsanto, the controversial agricultural multinational at the forefront of genetically modified food. – washintonpost
Obama also made Monsanto lobbyist, Islam Siddiqui, the US Ag Trade Representative and nominated Monsanto defender, Elena Kagan, to the US Supreme Court, among other “industry over the people” moves.
With Obama appointed Monsanto friend Elena Kagan now on the Supreme Court, expect no justice for obviously criminal conflicts of interest in FDA appointments. That means more and more unlabeled deregulated GMO food products out there to disable your immune system.