FDA Issues Tamper Resistant Guidelines

FDA Issues Tamper Resistant Guidelines


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prescription pain medications  “a major health challenge for our nation,” the Food and Drug Administration has issued a draft guidance document designed to help drug companies develop opioid drugs with tamper-resistant formulas.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 “This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse.”

The FDA’s draft guidance outlines the types of studies drug makers need to test tamper-resistant technology, and describes how the FDA will evaluate the results of those studies.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.

Authored by: Richard Lenti

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Donna Ratliff

I know from experience and by hearing from many of my members of organisation FFPCAN- fight for pain pain care action action network, that unfortunately that many reformulated pain medcines are not nearly as effective against chronic intractable pain as the original ones. They may be bioequivent but they are horrible on releasing the proper medication they once did. I’m sorry to report this, but thet are just not good medicines.
Doctors need to know this and I see that with pill mills gone. Meaning rogue doctors that hand pain medicines right of the office had caused many problems. I think that where all the problems started. So if doctors only prescribed these original un reformulated pain medicines to patients with legitimate docmented pain. Most of these problems would not be happening and chrinic pain patients would be relieved suffering! Many patients with REAL pain have switched to methadone. These medications disolve and work well and release the medicine properly.these hard as rock meds don’t disolve before passing through the digestive system.stomach upset! No pain relief for many . We need generics! We need pain medicine that will really work! Reformulated oxycontin needs to be prescribed at least 3 times a day possibly 4! When eating meals after dosing, even a hour later stops the med and it quits working!

I have screened my members. Done background public checks on them and they are legitimate patients.I would like to hear what established patients opinions on these reformulated medicines. Are working for you as well as the orginal? Please share your thoughts
I feel It that, certain pharmaceutical. Companies are trying to monopolise the opioid markets. Greed because the patients are running out! This is not constitution to do this! Legitimate patients deserve effective pain relief. These 2 other reformulated meds are awful! I don’t know anyone that would waste money on paying for these anymore.
Sorry but I’m speaking the truth! Too many Real patients have complained! Come on patients tell your story and the truth!!!!!!! They need to STOP catering addicts!!!!! And give legit patients that are not addicted pain relief!
We’re not getting quality anymore! Because of a minority of addicts! thisis not fair! Its down rigjt inhumane! Austria and other countries have access to good pain care medicines! America is the only one making a stink! With pill mills gone- we need North Caolinas Project Lazurus here in Florida and accross Nation!!!!!!!!! It has been proven to work and the FDA is impressed! Over 69% of overdoses have been down for a yyear now and still decreasing! Government do your research!!!!!!! Stop the inhumane suffering!