Anti-Opioid Abuse Groups Call for Resignation of FDA Head

By Victoria Kim 09/25/14

Physicians are calling for Margaret Hamburg to resign because of her agency's approval of the powerful painkiller Zohydro.

Margaret Hamburg.jpg
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Over a dozen groups concerned about the burgeoning prescription painkiller epidemic called for the resignation of the head of the Food and Drug Administration, Commissioner Dr. Margaret Hamburg, in a letter released on Wednesday.

Physicians for Responsible Opioid Prescribing, a 900-member advocacy group that petitioned (and were rejected by) the FDA to drastically restrict opioid use, and the National Coalition Against Prescription Drug Abuse, were among those who signed the letter addressed to Health and Human Services Secretary Sylvia Burwell, who oversees the FDA and other health agencies.

The FDA has been under intense scrutiny from public health officials, politicians, and law enforcement alike for approving a powerful new painkiller called Zohydro last October, against the recommendation of its own medical advisers.

“We are especially frustrated by the FDA’s continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths,” the letter read.

Zohydro is the first pure hydrocodone medication to be approved by the FDA. It is up to five times stronger than other opioid medications currently on the market. The fact that it is easily crushable is problematic, because it can be snorted or injected.

Critics of the drug fear the Zohydro’s potential for abuse and addiction. Since Zohydro’s FDA approval, members of Congress from West Virginia, Massachusetts, and Kentucky have introduced legislation to ban the drug, and attorneys general from 28 states have asked the FDA to revoke Zohydro’s approval or require that the pills be reformulated to make them harder to crush for snorting or injection.

Commissioner Hamburg, who has led the agency since 2009, has defended the drug’s approval by saying that it fills an important medical niche.

“Dr. Hamburg’s support for using opioids to treat chronic non-cancer pain is squarely at odds with efforts by the CDC to discourage this widespread practice,” the letter said.

Deaths associated with prescription painkillers like OxyContin and Vicodin have more than tripled over the last 20 years to an estimated 17,000 in 2011.

A Department of Health and Human Services spokesman, Tait Sye, said that opioid abuse “is a serious issue and one that the secretary is focused on.” 

“Secretary Burwell appreciates hearing from stakeholders on the important issue of prescription opioid abuse, and looks forward to responding to their letter,” Sye added.

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Victoria is interested in anything that has to do with how mind-altering substances impact society. Find Victoria on LinkedIn or Tumblr