Comments Please on AAPHP Petitions to FDA

[Vocalek]

Victory! I did call the number and my comments are now posted!!

Please contact the FDA Division of Dockets Management at 301-827-6860 to inquire about the status of your comment.

If you left a comment and had selected "individual consumer", call the number above, give them your name and/or your tracking number and ask them to make your comments public.

 

[rothenbj]

Victory! I did call the number and my comments are now posted!!



If you left a comment and had selected "individual consumer", call the number above, give them your name and/or your tracking number and ask them to make your comments public.

It's starting to look like the only way they'll get posted is if you call.

 

[Mister]

It's starting to look like the only way they'll get posted is if you call.

A suggestion, and this is what I'm going to do when I call on Monday, every caller might while having them on the phone tell them that:

1) The regulations.gov site says in at least four places that comments submitted may be published and publicly available. No one who posts a comment has any expectation of it being hidden.

2) It is so clear that comments will be published that some people are not commenting. Which is fine, that's the way regulations.gov is supposed to work.

3) People who post a comment want their comment to be public. Regulations.gov is for that exact purpose.

4) Regulations.gov is also for enabling people to comment on other people's comments. How can they do that if some comments are hidden?

5) Hiding any comments will make the FDA look bad. Some people want to see what the public is saying and will be very unhappy to find that what the public is saying is being hidden. It really doesn't look good.

So in conclusion, please not only change my comment to be visible but please also change all other currently hidden comments to be visible.

This is my plan. If enough people do something similar maybe they'll get tired of us and give in

 

[rothenbj]

A suggestion, and this is what I'm going to do when I call on Monday, every caller might while having them on the phone tell them that:

1) The regulations.gov site says in at least four places that comments submitted may be published and publicly available. No one who posts a comment has any expectation of it being hidden.

2) It is so clear that comments will be published that some people are not commenting. Which is fine, that's the way regulations.gov is supposed to work.

3) People who post a comment want their comment to be public. Regulations.gov is for that exact purpose.

4) Regulations.gov is also for enabling people to comment on other people's comments. How can they do that if some comments are hidden?

5) Hiding any comments will make the FDA look bad. Some people want to see what the public is saying and will be very unhappy to find that what the public is saying is being hidden. It really doesn't look good.

So in conclusion, please not only change my comment to be visible but please also change all other currently hidden comments to be visible.

This is my plan. If enough people do something similar maybe they'll get tired of us and give in

Called them and got a woman that barely spoke English. Gave her the information she left for a bit and informed me she'd need to call me back since the system was so slow. The clock is ticking..... I hope not ticking me off.

 

[Mister]

I've made my call and tried a pitch to unhide all comments. My comments will be changed, but no luck on getting them changed in bulk. Can't hurt for others to keep trying though.

I was told that all comments can be viewed by anyone who comes to their offices and asks to see them.

I asked how many comments were on each petition including hidden ones at the present time and was told 330 on the reclassify petition, 193 on the press conference petition.

 

[LuckyCharm]

I've made my call and tried a pitch to unhide all comments. My comments will be changed, but no luck on getting them changed in bulk. Can't hurt for others to keep trying though.

Talk about government waste and inefficiency! Well, guess that means we all know what we need to do. If they'd rather field calls from every one of us and unhide our comments one by one rather than en masse, so be it.

I was told that all comments can be viewed by anyone who comes to their offices and asks to see them.

What sense does that make? If anybody can view the comments just by showing up, then it can't be our privacy they're concerned about. And even if that were their claim, how do they know it's me on the phone when I ask that my comments be unhidden? I could be my boss or my partner or just about anybody.

I asked how many comments were on each petition including hidden ones at the present time and was told 330 on the reclassify petition, 193 on the press conference petition.

Sheesh.... does somebody in that office just not have enough work on their hands, that they want to field calls from 330 different people, hunt down their comment, and unhide it? Why is there no option right there on the comment submission form to make the comment hidden or public? I strongly object to government employees using tax dollars to perform wholly unnecessary work.

~~Cheryl

 

[Janetda]

Isn't the point of this whole exercise to let your thoughts be known to the FDA. I think what is really important is whether or not someone at the FDA reads them and takes them into consideration.

 

[Mister]

LuckyCharm, I quite agree with all you said. It makes no sense at all.

Isn't the point of this whole exercise to let your thoughts be known to the FDA. I think what is really important is whether or not someone at the FDA reads them and takes them into consideration.

That is the point but I have a couple of big problems with comments being hidden.

1) Transparency. It isn't like the FDA has given people a lot of reason to be trusting. They should be transparent. And, if the media wants to see what is going on they should be able to see it.

2) The regulations.gov site includes as one of the bullet points where it says "On this site you can:", "Submit a comment on a regulation or on another comment". And there is a facility to comment on a comment. But that's pretty hard to do when they're hidden. What if there are anti comments in there which contain blatant lies but they're hidden?

 

[Janetda]

Good points Mister. I think I'm a bit dubious of the whole process though.

 

[Luisa]

I posted a comment on the FDA survey-80ad4f4e-it was never displayed on the FDA consumer comments page. Do you think it was ever posted? They only show 34 consumer comments. I wonder if others were never recorded.

 

[Mister]

I posted a comment on the FDA survey-80ad4f4e-it was never displayed on the FDA consumer comments page. Do you think it was ever posted? They only show 34 consumer comments. I wonder if others were never recorded.

Luisa, we have learned that most of the comments people have submitted have been hidden, supposedly to protect people's privacy. Doesn't make sense since the comment site is supposed to be for public comments, but that is what they've done.

You can contact the FDA Division of Dockets Management at 301-827-6860, tell them that you want your comment to be visible, and give them either your comment number or your name so they can find and fix it. And if you do this it wouldn't hurt to tell them that you think it is wrong for them to be hiding comments while you're at it

 

[miss MiA]

I remember that when filling out the comments forms, somewhere near the bottom beneath the answer slots it was noted which of the fields would be viewable publicly, which corresponded with an icon next to each of those fields. (Don't remember how they worded the publicly viewable part, i.e. if it only referred to website publication or not.) So I thought that was how they dealt with protecting privacy -- by not publishing certain fields, and giving you the pretty clearly noted choice not to fill certain ones in. Thus I was surprised to read later (only here I think; IIRC I skipped any fine print at the regulations.gov site itself) that apparently some of the fields that I believe I saw noted as being amongst those not made public, could in fact be made public -- such that we did need their 'protection' after all.

Don't know if I described that well and it made sense, but the point is meant to be that to me it looks like another inconsistency in regard to what they're saying now about the non-publications (in addition to the one about 'protecting' us even from stuff we knew would be made public).

 

[DC2]

I called and asked them to make my comments visible.

 

[rothenbj]

I've made my call and tried a pitch to unhide all comments. My comments will be changed, but no luck on getting them changed in bulk. Can't hurt for others to keep trying though.

I was told that all comments can be viewed by anyone who comes to their offices and asks to see them.

I asked how many comments were on each petition including hidden ones at the present time and was told 330 on the reclassify petition, 193 on the press conference petition.

Ditto for me. When I brought up the reason people post on this site is to have their comments viewable. He contended that people put private information it, but I can't believe many people put anything in that they don't want published. That is the purpose of the site, isn't it?

Anyway, I think mine are now visible, at least the one is. He told me both would be, but I haven't checked the July 22nd petition yet.

I really don't think the FDA wants all the support being published. They sure are making it difficult to get it done. On my first call, I told them I wanted them published. They called me back when I wasn't available so I had to call again and finally got somewhere.

I don't believe this should be a difficult process, but I suppose our stance has something to do with the lack of publishing. I wonder if those supporting the FDA stance had to call to get their comments posted?

 

[thorn]

Somebody should post a comment on there that tells others they have to call with confirmation number so it'll show up. And then get THAT post un-hidden.

 

[Vocalek]

Actually, you don't need to call as long as you do not select "Iindividual Consumer" as the Submitter Category. Those are the only ones that FDA has a policy of not displaying unless you ask. (Of course this policy is not made known unless you ask, "Hey, where's my comment?")

If you select anything else it will be posted without having to ask. From here on out, I am selecting "Consumer Group" as my category and listing CASAA as my organization. Of course your oganization can be anything you want it to be. "ECF" would work just as well.

 

[rothenbj]

Actually, you don't need to call as long as you do not select "Iindividual Consumer" as the Submitter Category. Those are the only ones that FDA has a policy of not displaying unless you ask. (Of course this policy is not made known unless you ask, "Hey, where's my comment?")

If you select anything else it will be posted without having to ask. From here on out, I am selecting "Consumer Group" as my category and listing CASAA as my organization. Of course your oganization can be anything you want it to be. "ECF" would work just as well.

Elaine, I'm not sure if that's true since I used the Drug company group as my submitter category to test what you were told. I had to make the call and the excuse was that he was way behind on his work. It still doesn't look like they are coming through very quickly.

 

[Vocalek]

Elaine, I'm not sure if that's true since I used the Drug company group as my submitter category to test what you were told. I had to make the call and the excuse was that he was way behind on his work. It still doesn't look like they are coming through very quickly.

Very interesting. They must be scrutinizing these comments on petitions more carefully than other documents. The two I posted on the FDA's call for comments on its own document on dissolvables showed up very quickly. FDA–2010–N–0123