Thanks to Senator Andy Hill Right to Try legislation is dead for this year. No, I don't know why one person has the audacity to block a vote on legislation in that manner, limiting the voice of the people. I think he thought it would pass and that's why he did it and he believed he wouldn't face political repercussions. He just got sworn in for another term last year so maybe 2020 pay attention to his ambitions.
So to regroup and think about other angles on this, the FDA in February 2015 announced that they had submitted a draft revised Expanded Access form; that plus they were shortening up the form review period to 30 days.
FDA blog: A big step to help the patients most in need (Feb. 4, 2015)
http://blogs.fda.gov/fdavoice/index....-most-in-need/
The travesty is that it took an FDA regulator's own wife dying of cancer for these revisions to happen.
F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval
http://mobile.nytimes.com/2016/01/03ś/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-ap...
So I decided to contact the FDA to see about this revised firm and what the status of it is. Surely anything that improves the process and cuts down on the amount of time required of practitioners the better, right? I just heard again last week that it is too complicated the current form and process. Yeah, that's a great excuse - it takes too much time.
The FDA replied to my email today, just one day after I sent it in:
Thank you for writing to the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.
Our current process along with all necessary forms for Expanded Access (Compassionate Use) can be found here
http://www.fda.gov/NewsEvents/Public...m#How_To_Apply
Additionally, please refer to the
Individual Patient Expanded Access Applications: Form FDA 3926 (Draft Guidance for Industry).
As part of the rulemaking process on proposed rules, there is an opportunity for the public and other stakeholders to submit comments on the proposed rule by visiting the regulations.gov webpage here: http://www.regulations.gov/#!docketDetail;D=FDA-2015-D-0268, and click on “Comment Now.” You may submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please make sure to reference the docket number for your comments.
When finalized, draft Form FDA 3926 is intended to provide a streamlined alternative for submitting an investigational new drug application (IND) under ยง 312.23for use in cases of individual patient expanded access.
Once the comment period and the review process is complete, the form and Final Guidance will be posted on the FDA website. It is unknown how long this process will take.
We appreciate you taking the time to contact us.
What to do? Submit comments? The only ones there earlier today were from last Spring. Spread the word to patient advocacy groups? Sure, put the pressure on the FDA. Contact the media? Sounds like a great addition to the Right to Try story.
Debate Over Right-to-Try Laws in the States - NPR
http://thedianerehmshow.org/shows/20...-in-the-states