Coalition Calls for Replacement of FDA Commissioner for Approving Hydrocodone Drug, Blames Agency for Opioid Abuse, Overdoses
Food and Drug Administration Commissioner Margaret Hamburg is being targeted as a failure by a coalition of anti-addiction activist groups who are calling for a replacement, Al-Jazeera reported.
The coalition wrote a letter to Secretary Sylvia Mathews Burwell, who oversees the FDA and sub-agencies under the U.S. Department of Health and Human Services (HHS), and said the FDA's approval of dangerous and high-dose opioid painkillers are causing overdose deaths and helping increase rates of addiction.
The Fed Up coalition told Burwell, that since coming on board in 2009 Hamburg has been making dangerous decisions which will continue to promote the current opioid crisis.
The coalition is convening its second rally in front of the White House on Sunday, according to the letter. They defended their concerns by citing specific examples of high-risk opioids.
"Last October FDA approved Zohydro, an easily crushed, high-dose hydrocodone product, despite an 11-2 vote by its scientific advisory committee to keep the drug off the market. This action led to urgent pleas from public health officials, consumer advocacy organizations, addiction treatment providers, medical experts, Members of Congress, several governors and attorneys general from 28 states, for FDA to reconsider its decision," the coalition said.
They said that Hamburgs approval of such chronic non-cancer painkillers (cncp) is "squarely at odds" with the Center for Disease Control (CDC).
"In the midst of public health crisis, Department of Health and Human Services agency heads should not be delivering contradictory messages to the public," the coalition said.
The FDA responded to the letter and told Al-Jazeera that they defended Hamburg and Burwell's actions and that both were working together with other agencies to fight opioid abuse.
According to the CDC, 46 people die in the United States every day from an overdose of prescription painkillers, andphysicians are a leading source of prescription opioids for the highest-risk users, Al-Jazeera reported.
We've become a society that thinks a pill is the answer to everything, and pharmaceutical industry has a huge influence on the FDA," said Judy Rummler, the president of the Steve Rummler Hope Foundation, a coalition member group.
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