A coalition that includes physicians and addiction specialists are calling on the Obama administration to remove and replace FDA Commissioner Margaret Hamburg, arguing that under her leadership, the nation’s painkiller abuse epidemic has gotten worse.
The letter released today by more than a dozen groups — under the banner organization Fed Up! — includes Physicians for Responsible Opioid Prescribing and the National Coalition Against Prescription Drug Abuse.
The letter, which is addressed to HHS Secretary Sylvia Burwell, criticizes the FDA for approving new, high-dose opioid medications “that are fueling high rates of addiction and overdose deaths.”
The FDA came under fire last October after it approved hydrocodone bitartrate (Zohydro), even though one of the agency’s own advisory committees recommended against doing so. Zohydro is the first extended-release, pure form of hydrocodone ever approved.
While the CDC has called on physicians to limit the use of opioid analgesics to only the most serious cases, Fed Up! argues that Hamburg supports broader use of the drugs.
The letter also criticizes the FDA for approving opioid medications that are designed to deter abuse. They cite the July approval of Targiniq, which combines oxycodone with the naloxone. The latter drug is designed to blunt the pleasurable effect of oxycodone when snorted or injected.
The groups say Targiniq can still be abused simply by chewing on it.
Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency’s policies have contributed to a national epidemic of prescription painkiller abuse.
In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Margaret Hamburg, MD, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro (hydrocodone bitartrate) against the recommendation of its own medical advisers.