This past June I wrote a SharePost entitled, URGENT: FDA May Remove or Limit Access to Opioid Pain Medications. In it I told you about “Risk Evaluation and Mitigation Strategies” the FDA was developing in an attempt curb the misuse and abuse of opioid pain medications. At that time, the FDA was asking the public to comment on the REMS under consideration, but the final date they would accept comments was June 30, 2009.
Reportedly the FDA received more than 1,250 comments from individuals and groups. I know many of you wrote, as did I. Apparently our concerns made an impression because now the FDA has reopened and extended the comment period to October 19, 2010 “in light of continued public interest in this topic and to provide an opportunity for all interested parties to provide information and share views on the matter.”
I'd like to think this means the FDA is rethinking and reassessing the situation so the resulting REMS will not make life even more difficult for chronic pain patients. The truth is, no one really knows what is behind this extension. Two out of three recent FDA actions make me wonder whether the extra time will lead to more reasonable REMS or to such stringent regluations that it will be significantly more difficult to get needed opioid medications. Here are the three recent FDA decisions:
• Last July Onsolis, a new fentanyl product that can be absorbed through the mouth's mucus membranes, was approved for treating breakthrough cancer pain. However, the REMS program which accompanies it is so unbelievable restrictive and burdensome for physicians, patients and pharmacies that it is highly questionable whether it will ever be prescribed.
• In September, an FDA expert panel endorsed plans to introduce Exaigo, an extended-release form of hydromorphone, that is expected to receive final approval any day now. It's REMS program is only slightly less restrictive than that of Onsolis.
• On a brighter note, in August EMBEDA, a tamper-resistant extended-release morphine sulfate and naltrexone hydrochloride combination, was approved for the treatment of moderate to severe chronic pain. The “interim REMS” which accompanied it are reasonable – a medication guide and special communications sent to prescribers explaining the new drug.
As for which direction the FDA is leaning when it comes to opioids currently on the market, your guess is as good as mine. But if you want to have input into their deliberations, now is the time to speak up.
What You Can Do
Read my original SharePost: URGENT: FDA May Remove or Limit Access to Opioid Pain Medications and click on “View Comments” to see what other community members wrote in their letters to the FDA. Then go to “Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs” at regulations.gov, click on “Submit Comment” and share your own thoughts and opinions.
If you have any ideas for more effective ways to curb the misuse, abuse and overdosing of prescription pain medications that don't at the same time over-burden chronic pain patients and their doctors, I hope you'll feel free to share them. It's unusual for a government agency to reopen public comment, so I think we should take full advantage of this opportunity.
When you write to the FDA, please comment below to let us know – and feel free to share a copy of your letter if you'd like.
Published On: November 30, 2009