WASHINGTON, D.C. -- 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 Dr. Margaret Hamburg, 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 against the recommendation of its own medical advisers.
The new letter is the first formal call for new leadership at the FDA over the issue.
"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," states the letter, which is addressed to Health and Human Services Secretary Sylvia Burwell, who oversees the FDA and other health agencies. The groups signing the letter include Physicians for Responsible Opioid Prescribing, a 900-member advocacy group that petitioned the FDA to drastically restrict opioid use. The FDA rejected that petition last year.
Deaths linked to the addictive medications, including OxyContin and Vicodin, have more than tripled over the last 20 years to an estimated 17,000 in 2011, the most recent year for which the Centers for Disease Control and Prevention reports figures.
The CDC has called on doctors to limit their use of the medications to the most serious cases of pain, such as cancer patients and end-of-life care. But the vast majority of prescriptions written in the U.S. are for more common ailments like arthritis and back pain.
Hamburg has supported broad use of the drugs, noting that 100 million Americans reportedly suffer from chronic pain.
The letter to HHS says the commissioner and the FDA are out of step with efforts by the CDC and other parts of the federal government.
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