FDA approved drugs are raising concerns for officials. There is no question that opioid use in the last two decades has skyrocketed. Between 1999 and 2010 alone, overdose deaths from prescription painkillers quadrupled. The upward trend (and downward spiral) is nothing short of disturbing, and this past September, more than a dozen anti-addiction groups brought it to the attention of President Obama.
FDA Approved Drugs: Federal Frustrations
On September 24,FedUp, a coalition to end the opioid epidemic, issued a letter to Sylvia Mathews Burwell, Secretary of Health and Human Services. The signers included governors, state health officials and state legislators, as well as a group called Physicians for Responsible Opioid Prescribing, an advocacy organization with 900 members.
In the letter, FedUp says that “immediate, coordinated and comprehensive federal action” is needed to effectively address the current opioid addiction crisis. And, it points to failed leadership as a direct cause.
“We are especially frustrated by the Food and Drug Administration’s (FDA) continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths,” the letter reads. “After careful consideration we have come to believe that without new leadership at FDA the opioid crisis will continue unabated.”
FDA Approved Drugs That Are Dangerous
FedUp goes on to speak to two recent drug approvals as recent examples of the FDA’s callousness and clear reasons for a changing of the guards.
“Last October FDA approved Zohydro […] 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. Even Attorney General Eric Holder reported that he was ‘a little baffled’ by the decision to approve Zohydro.”
Along with government officials, many news outlets – includingThe New York Times,Fox News andForbes – highlighted the drug’s high potential for abuse and addiction, but Secretary Burwell spun a different story. In anApril 2014 speech, she defended Zohdro, saying it was needed to help the “estimated 100 million Americans living with chronic pain.”
FedUp continued to make the case against the FDA and Secretary Burwell in its letter, pointing to another drug approval with even more alarming details.
“FDA approved Targiniq without convening a scientific advisory committee meeting. The decision by FDA to bypass the advisory committee violated its own policy.[…] We believe that FDA bypassed its advisory committee because it wanted to avoid the same controversy it faced after approval of Zohydro. Yet it is precisely when approval of a drug is controversial that scientific advisory committee meetings are called for.”
Citing to a 2012 study, FedUp also mentioned in its letter that the United States – which makes up only about 5% of the world’s population – consumes 84% of the world’s oxycodone and 99% of the hydrocodone supply. In the face of these statistics, along with soaring overdose rates and an addiction plague, FedUp presses for an administrative intervention.
Getting Help for Addiction
The White House’s response has not yet been officially published, but news outlets covered FedUp’s story coast to coast, which has at the very least started critical conversations.
If you’re dealing with an addiction to painkillers, opioids or any other FDA approved drugs, or looking for help for someone you love, don’t be afraid to start the conversation. Not sure how? The Watershed can help. Give us a call today: 1-800-861-1768.Tags: Anti-Drinking ADs, dangerous drugs, FDA