Call to Action: the FDA Needs to Hear From You!


The FDA has reopened the public comment period for developing Risk Evaluation and Mitigation Strategies (REMS) that would regulate opioid drug availability. Comments will be accepted until October 19, 2010. Many drugs that are routinely prescribed for IC would be affected by these regulations and access to these drugs could be severely limited.

The FDA stated that the deadline was extended “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.” Practitioners, researchers, and the general public are encouraged to submit comments and concerns about these regulations so that the FDA will have adequate and accurate data to fully assess the situation.

You have until October 19, 2010 to submit comments to the FDA: Title: “Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting; Reopening of Comment Period.” Docket ID#: FDA-2009-N-0143.

Submit written comments to: Division of Dockets Management (HFA-305); Food and Drug Administration; 5630 Fishers Lane, rm. 1061; Rockville, MD 20852.

Submit electronic comments by going to regulations.gov and clicking on the “Submit Comment” tab.
For further information call 301-796-3448; or e-mail: OpioidREMS@fda.hhs.gov.





Posted November 19, 2009