Comment Period Closing Friday, 6/25

[willing]

Eric mentioned this in another thread but it bears repeating : the opportunity to submit comments to FDA hearing FDA-2010-N-0107 on expanding early-access to DAA drugs is about to close. The hearing docket now includes a full transcript of the hearing held on April 30 and a number of interesting comments by drug manufacturers and advocacy groups. However only a couple of patient comments have been submitted.

Everyone has a different interpretation of this but I believe the most compelling comments will be from those most  at risk if this initiative accomplishes nothing : null and partial responders who will treat with telaprevir or boceprevir notwithstanding poor  odds and risk adding protease-resistant mutations to their existing challenges.

To submit a comment:
1) go to http://www.regulations.gov
2) click on "submit a comment" and enter the hearing id: FDA-2010-N-0107
3) select "submit a comment"

[Bill1954]

Thanks for your ongoing diligence with this, Willing. I can’t help but wonder if individuals are reluctant to comment; perhaps intimidated by the FDA? I dunno. Do you have, or do you know if one of the advocacy groups has an outline that patients could fill in blanks and submit? Obviously, it’d be better for them to receive individually crafted letters, but maybe we could impress/assault them with volume :o)?

Just passing thoughts.

Thanks again—

Bill

[willing]

thanks - there's a good post  by Eric on this at the end of thread:

http://www.medhelp.org/posts/Hepatitis-C/WIll-you-get-involved-politically-to-speed-up-new-treatment-access/show/1230113#post_5673752

the comment form requests a name but this is not checked and it doesn't appear it would be an obstacle to anyone wishing to remain anonymous. There does seem to be a delay between submission and display of a comment in the docket. Approval of boce/tela will be "good enough" for many, so the issue is mostly of importance to those who will be left-out: G3s, null-responders, etc.

[HectorSF]

Thanks for the reminder willing.

Hectorsf

[willing]

the full transcript of the April 30 hearing runs 280 pages and is available as file FDA-2010-N-0107-0028.pdf in the hearing's docket folder. For those curious about what the "powers that be" are thinking (or at least saying in public) on this subject it's interesting reading. Presentations by the lead medical officers at Merck, Roche/Genentech, Vertex and BMS are included along with comments on behalf of patients advocate groups  including AASLD and NATAP (Jules Levin).

Overall, it's pretty glum, IMHO (other than a reference by  Dr. Albrecht, Merck presenter, to  ribavirin as the "ugly sister" of combo tx (p. 171) - spoken like a patient). Acres of blah-blah-blah about need for safety/efficacy demonstrations. Most presenters were not even willing to accept the INFORM1 results as indicative that dual DAA tx will yield significant improvement. Sheer cow manure! I can certainly understand the need for careful preliminary testing of multi-DAA tx - who knows what evil sides may get triggered by say an r7128/boce combo. But to argue that the total combined antiviral effect is "speculative"  (ie less than at least the max of the two effects) is nonsense...