The FDA has a very tough job. With respect to medicines, they require and examine documents that attempt to demonstrate that proposed medicines are safe AND effective. This is part of the approval (FDA –Approved) process. Now, since the new FDA Amendments Act, they have to monitor and implement safety measures for medicines after the approval process. They have to monitor and require safety plans for after medicines are approved, after they are on the market. As one way to do that the FDA has developed what they call REMS, Risk Evaluation Mitigation Strategies. Rightly so, the FDA is concerned about aftermarket safety of opioid medications.
There is a significant rise in misuse, abuse and diversion of opioid medications. The REMS process has just recently begun and it looks like we are headed for a new set of barriers to accessing pain medicines for people who need them. The new REMS requirements are heading in the direction of requiring all prescribers to be certified for prescribing each different opioid medication----a different certification for each different medication. Imagine if everyone needed to get a different drivers license for each town they drive through? Chaos, pure chaos. If prescribers have to do that to prescribe, they simply won’t prescribe and people simply won’t get their medicines.
The American Pain Foundation is working with a group of concerned pain organizations to meet with the FDA to improve this scenario. We do not need more barriers to accessing our medicines.
Published On: February 25, 2009