The head of the Food and Drug Administration says her agency is considering a change in the labeling requirements for opioid painkillers –- a move that many pain patients fear will make opioid analgesics harder to get.
In a speech this week at a national drug abuse summit and on her blog, FDA commissioner Margaret Hamburg called the abuse of prescription drugs “a public health crisis of enormous and devastating proportion” and said her agency would take a number of steps to prevent abuse, including “modifying opioid labeling.”
“We recognize that some are calling for further limitations on the use of these products, particularly in the context of non-cancer pain, including limiting the recommended duration of treatment; setting a maximum daily dosage limit; and restricting the use of these drugs to patients with severe pain,” Hamburg said.
“If additional improvements could make the labels more effective, it’s important we explore them as part of our overall efforts to improve the safety of opioids.”
The FDA is under increasing pressure from Congress and some public health officials to take stronger measures against prescription drug abuse. In 2010, over 16,000 people died from overdoses associated with opioid painkillers.
Recently the U.S. Drug Enforcement Agency sent a letter to the FDA expressing support for a citizen petition filed last summer by Physicians for Responsible Opioid Prescribing (PROP). The petition calls for major changes in the way opioid drugs are labeled and prescribed.
The DEA letter expressed concern about the slow pace of FDA action to address prescription drug abuse.
“DEA previously requested FDA to consider additional regulatory measures such as restrictions on prescribing, marketing practices and clinical indications for these opioid products,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control.
“The DEA hopes that FDA will implement suitable measures, such as labeling revisions, to help mitigate the adverse impact on the public health resulting from abuse of these products.”
The FDA currently approves most opioid analgesics for “moderate to severe pain.” The PROP petition would eliminate the word “moderate” and would restrict opioid prescriptions to no more than 90 days for severe non-cancer pain. Doctors would still be able to prescribe opioids “off-label” for pain patients, but critics contend many physicians would be unwilling to do that.
In her speech to the National Rx Drug Abuse Summit, Hamburg called the development of tamper resistant drugs “a clear and pressing public health priority,” but said more evidence was needed to see how well they work. Tamper resistant formulas are harder for drug abusers to crush or dissolve for snorting or injecting.
“We all know from sad experience that sometimes it is just a matter of time before those who are dedicated to abusing an opioid will find a way to do so even if it requires overcoming the latest abuse-deterrent technology,” Hamburg said. “Given these issues, it is essential that every abuse-deterrent claim be grounded in science and that they really work.”
In January, the FDA allowed Impax Laboratories (NASDAQ: IPXL) to begin selling a generic version of Opana (oxymorphone) that is not tamper-resistant. And this month generic crushable versions of OxyContin (oxycodone) are also expected to reach the market.
Under a bipartisan bill recently introduced in Congress, generic painkillers would be required to have tamper resistant formulas if one is available.
“We require drivers and passengers in cars to wear seatbelts, why is the FDA not requiring these technologies that can protect people – especially children and teenagers – from easily tampering with and illegally using these drugs?” Rep. Bill Keating (D-Massachusetts) asked during the keynote speech at the drug abuse summit.
Keating, who had a private meeting with Hamburg at the summit, is co-sponsoring the Stop the Tampering of Prescription Pills (STOPP) Act, which would require the FDA to stop generic painkillers from coming on the market unless they are tamper resistant.
But Hamburg said the agency already has the authority to do that.
“We have concluded that, if FDA finds a new formulation to be abuse deterrent, then the Agency has the legal authority under the Food, Drug and Cosmetic Act to require that generic versions of that product have abuse-deterrent formulations as well,” she said.
“In addition, under certain circumstances, we believe that we would have the authority to refrain from approving non-abuse deterrent formulations of that drug and to initiate procedures to withdraw non-abuse deterrent versions already on the market.”