A citizen petition has been filed with the FDA regarding the application for the the new MS therapy Lemtrada. If you would like to comment on this matter, you can do so here. Before you submit your views, please read these tips for submitting effective comments.
What comments would be especially helpful and relevant? So far, the process has been run by regulators whose specialties are far afield from the treatment of MS. To fill this hole, neurologists, especially those treating MS patients, should consider commenting. MS patients should also make sure that their voices are heard.
Why now? The comment period began after the FDA's complete response letter (CRL) was issued on December 27th, 2013. There are two reasons. First, it is important that the record indicates the views of those most impacted by MS so that these views are taken into account in the future.
Secondly, there is an appeal process. Where does the appeal stand? So far, the Lemtrada decision has been delegated to the Division director, who is an implacable foe of this drug and its sponsors. The Director of the Center for Drug Evaluation and Research, Dr. Janet Woodcock, will weigh in on the appeal. So, any views submitted in reaction to the Citizen Petition could make a difference when this appeal is taken up at the higher level within the FDA.