A poster on here several days ago mentioned researching if paper signatures could be combined with this online petition. I've not seen a follow up to that post. Do you know if that is possible? I want, as I think most here do, to help get to that 100k number. Thanks
Yo Fat Ed...It becomes an official statement with her name, Catherine Chew, her title, Acting Director Division of Drug Information, and her governmental division of the FDA - Center for Drug Evaluation and Research plastered to the end of the response email I sent to Dr. Janet Woodcock on November 14, 2013. Mine is dated January 6, 2014 at 8:40am. If it had been sent in December I would have posted it in December. And about your opinion, well you know what they say.
I don't know if it's definitive or not but I did receive it in my yahoo mail account, addressed to me:
CDER DRUG INFO
Dear Mr. Hanxxxxx,
I obviously changed the last few letters of my last name to x's. The email address that sent it was DRUGINFO@fda.hhs.gov
As you may know, we recently participated in a policy forum with the Duchenne community, including patients, parents, experts, and other stakeholders. Please know that we hear your frustration, and fully understand the dire urgency of the situation. We will continue to work relentlessly with the community to make safe and effective treatments for Duchenne muscular dystrophy available to patients.
Thank you again for taking the time to write to us.
Catherine Chew, PharmD
Acting Director, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
Thank you for your message to the Food and Drug Administration (FDA) about eteplirsen, a new drug under investigation for the treatment of Duchenne muscular dystrophy.
We recognize the huge unmet medical need in Duchenne muscular dystrophy, the devastating nature of the disease for patients and their families, and the great urgency to make new treatments available.
We understand that you feel that eteplirsen is highly effective. FDA’s ongoing analyses of eteplirsen and other drugs for the treatment of Duchenne muscular dystrophy are based on thorough and extensive assessments and discussion of all available data and information by a large multi-disciplinary team of FDA scientists. Many assessments are ongoing. Some of this information, in particular, information about the dystrophin biomarker, the natural progression of the disease, and the results from clinical studies, are not available to the public. We are prevented by legal regulations from divulging this information, or our assessment of this information, making it hard to understand FDA’s evolving position on these drugs. Please know that FDA has reached no conclusions about the possibility of using accelerated approval for any new drug for the treatment of Duchenne muscular dystrophy, and for eteplirsen in particular.
FDA is fully committed to make safe and effective drugs available for patients with Duchenne muscular dystrophy as soon as possible, and is actively engaged with all drug companies developing new drugs for Duchenne muscular dystrophy, including Sarepta Therapeutics, the company developing eteplirsen.