Calling the abuse of prescription pain medications “a major health challenge for our nation,” the Food and Drug Administration has issued a draft guidance document designed to help drug companies develop opioid drugs with tamper-resistant formulas.
“The FDA is extremely concerned about the inappropriate use of prescription opioids,” said FDA Commissioner Margaret A. Hamburg, MD. “This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse.”
The FDA’s draft guidance outlines the types of studies drug makers need to test tamper-resistant technology, and describes how the FDA will evaluate the results of those studies. The document also offers a first look at the type of labeling claims the agency will allow.
Because the science is relatively new, the FDA said it will take a flexible approach to labeling abuse-deterrent products and will work with the pharmaceutical industry on establishing ways to evaluate their effectiveness.
“While prescription opioids are an important component of pain management, abuse and misuse of these products have resulted in too many injuries and deaths across the United States,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
“An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse.”
A 2010 report from the U.S. Centers for Disease Control and Prevention (CDC) documented a rise in overdose deaths that paralleled a 300 percent increase in the sale of prescription painkillers since 1999.
The CDC found that opioid painkillers were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. In 2009, the misuse and abuse of prescription painkillers was responsible for more than 475,000 emergency department visits, a number that nearly doubled in just five years.
Opioids can be abused in a number of ways, including crushing them in order to snort or dissolving them in order to inject. Tamper resistant formulas make the drugs harder to crush or dissolve, rendering the active ingredient ineffective if attempted.
“Our nation is in the midst of a prescription drug abuse epidemic,” said Gil Kerlikowske, director of National Drug Control Policy. “While there are no silver bullet solutions to this public health and safety challenge, abuse-deterrent formulations of powerful prescription opioids can make a difference in addressing this epidemic.”
But the FDA’s planned action is not without its critics.
The agency is not requiring drug manufacturers to develop tamdrug manufacturers per-resistant formulas, and it is unclear if the labelear ing requirements will make a distinction between abuse and addiction. Generic formulations will not be covered by the guidance, nor will other immediate-release generic opioids currently on the market.
“My greatest concern is the section on labeling, where FDA outlines the claims that drug companies will be able to make about their abuse-deterrent formulations,” said Dr. Andrew Kolodny, chairman of the psychiatry department at Maimonides Medical Center in New York and co-founder of Physicians for Responsible Opioid Prescribing.
“What’s missing here is a requirement by FDA that the label on these products state clearly that ‘abuse-deterrence’ does not render these products less addictive,” Kolodny told Pharmalot.
Kolodny warns that the drug abuse epidemic could become worse if doctors are misled to believe that these formulations are less addictive and develop a false sense of security about their safety when prescribing them.
However, the FDA said it plans on working with the drug companies to be careful about the language it allows in the labeling and how they can use that language in their marketing.
The FDA will next conduct a 60-day public comment period, followed by a two day public hearing where the agency will discuss both the document and the comments it received. No date has yet been set for that hearing.