Let's file a class action suit against the FDA

C

cfbites

New member
I wonder if we could file a class action suit against the FDA to get their attention for the approval of Aztreonam?

This is a great drug and it needs to be available to all with cf. The FDA is potentially harming thousands of cf patients by not approving it.

At the very least, it might gain publicity for cf and show the FDA what this disease is truly like.

That's my crazy thought for the day.
 
C

cfbites

New member
I wonder if we could file a class action suit against the FDA to get their attention for the approval of Aztreonam?

This is a great drug and it needs to be available to all with cf. The FDA is potentially harming thousands of cf patients by not approving it.

At the very least, it might gain publicity for cf and show the FDA what this disease is truly like.

That's my crazy thought for the day.
 
C

cfbites

New member
I wonder if we could file a class action suit against the FDA to get their attention for the approval of Aztreonam?

This is a great drug and it needs to be available to all with cf. The FDA is potentially harming thousands of cf patients by not approving it.

At the very least, it might gain publicity for cf and show the FDA what this disease is truly like.

That's my crazy thought for the day.
 
C

cfbites

New member
I wonder if we could file a class action suit against the FDA to get their attention for the approval of Aztreonam?

This is a great drug and it needs to be available to all with cf. The FDA is potentially harming thousands of cf patients by not approving it.

At the very least, it might gain publicity for cf and show the FDA what this disease is truly like.

That's my crazy thought for the day.
 
C

cfbites

New member
I wonder if we could file a class action suit against the FDA to get their attention for the approval of Aztreonam?
<br />
<br />This is a great drug and it needs to be available to all with cf. The FDA is potentially harming thousands of cf patients by not approving it.
<br />
<br />At the very least, it might gain publicity for cf and show the FDA what this disease is truly like.
<br />
<br />That's my crazy thought for the day.
 
S

saveferris2009

New member
Definitely do some investigation prior to filing a law suit against the FDA (if that's even possible - i'm not a lawyer so idk).

Has the FDA ever approved an antibiotic with only 28 days' worth of placebo controlled data? It's important to have a sound, logical case otherwise you'll just be wasting your time.

The FDA has an obligation to us all (both CFer's and non-CFer's) in the US to only approve drugs that have been demonstrated by hard science that they work - not just anecdotal patient experience. Otherwise people would turn around and file suit against the FDA and/or the manufacturer for approving a drug WITHOUT sufficient efficacy data.
 
S

saveferris2009

New member
Definitely do some investigation prior to filing a law suit against the FDA (if that's even possible - i'm not a lawyer so idk).

Has the FDA ever approved an antibiotic with only 28 days' worth of placebo controlled data? It's important to have a sound, logical case otherwise you'll just be wasting your time.

The FDA has an obligation to us all (both CFer's and non-CFer's) in the US to only approve drugs that have been demonstrated by hard science that they work - not just anecdotal patient experience. Otherwise people would turn around and file suit against the FDA and/or the manufacturer for approving a drug WITHOUT sufficient efficacy data.
 
S

saveferris2009

New member
Definitely do some investigation prior to filing a law suit against the FDA (if that's even possible - i'm not a lawyer so idk).

Has the FDA ever approved an antibiotic with only 28 days' worth of placebo controlled data? It's important to have a sound, logical case otherwise you'll just be wasting your time.

The FDA has an obligation to us all (both CFer's and non-CFer's) in the US to only approve drugs that have been demonstrated by hard science that they work - not just anecdotal patient experience. Otherwise people would turn around and file suit against the FDA and/or the manufacturer for approving a drug WITHOUT sufficient efficacy data.
 
S

saveferris2009

New member
Definitely do some investigation prior to filing a law suit against the FDA (if that's even possible - i'm not a lawyer so idk).

Has the FDA ever approved an antibiotic with only 28 days' worth of placebo controlled data? It's important to have a sound, logical case otherwise you'll just be wasting your time.

The FDA has an obligation to us all (both CFer's and non-CFer's) in the US to only approve drugs that have been demonstrated by hard science that they work - not just anecdotal patient experience. Otherwise people would turn around and file suit against the FDA and/or the manufacturer for approving a drug WITHOUT sufficient efficacy data.
 
S

saveferris2009

New member
Definitely do some investigation prior to filing a law suit against the FDA (if that's even possible - i'm not a lawyer so idk).
<br />
<br />Has the FDA ever approved an antibiotic with only 28 days' worth of placebo controlled data? It's important to have a sound, logical case otherwise you'll just be wasting your time.
<br />
<br />The FDA has an obligation to us all (both CFer's and non-CFer's) in the US to only approve drugs that have been demonstrated by hard science that they work - not just anecdotal patient experience. Otherwise people would turn around and file suit against the FDA and/or the manufacturer for approving a drug WITHOUT sufficient efficacy data.
<br />
<br />
 
J

just1more

New member
I just have to say, while I have heard great things here....

If they really don't have any more research behind it than Amy stated, it needed rejected.

To argue otherwise, is to state that since cystics are *pick your word to describe* there is less of a need to protect them and validate their meds.

I for one, would hate to add another abx only to find out too late that it has side effects that weren't properly documented, such as killing what is left of my son's liver.

Just my .02 worth.
 
J

just1more

New member
I just have to say, while I have heard great things here....

If they really don't have any more research behind it than Amy stated, it needed rejected.

To argue otherwise, is to state that since cystics are *pick your word to describe* there is less of a need to protect them and validate their meds.

I for one, would hate to add another abx only to find out too late that it has side effects that weren't properly documented, such as killing what is left of my son's liver.

Just my .02 worth.
 
J

just1more

New member
I just have to say, while I have heard great things here....

If they really don't have any more research behind it than Amy stated, it needed rejected.

To argue otherwise, is to state that since cystics are *pick your word to describe* there is less of a need to protect them and validate their meds.

I for one, would hate to add another abx only to find out too late that it has side effects that weren't properly documented, such as killing what is left of my son's liver.

Just my .02 worth.
 
J

just1more

New member
I just have to say, while I have heard great things here....

If they really don't have any more research behind it than Amy stated, it needed rejected.

To argue otherwise, is to state that since cystics are *pick your word to describe* there is less of a need to protect them and validate their meds.

I for one, would hate to add another abx only to find out too late that it has side effects that weren't properly documented, such as killing what is left of my son's liver.

Just my .02 worth.
 
J

just1more

New member
I just have to say, while I have heard great things here....
<br />
<br />If they really don't have any more research behind it than Amy stated, it needed rejected.
<br />
<br />To argue otherwise, is to state that since cystics are *pick your word to describe* there is less of a need to protect them and validate their meds.
<br />
<br />I for one, would hate to add another abx only to find out too late that it has side effects that weren't properly documented, such as killing what is left of my son's liver.
<br />
<br />Just my .02 worth.
 
S

saveferris2009

New member
Just to clarify: Azli side effect profile is fine. Side effects aren't the issue - the med has been out for years and years.

it's just a matter of if this med, in this delivery system (nebbed instead of IV) is effective in the dose studied <img src="">
 
S

saveferris2009

New member
Just to clarify: Azli side effect profile is fine. Side effects aren't the issue - the med has been out for years and years.

it's just a matter of if this med, in this delivery system (nebbed instead of IV) is effective in the dose studied <img src="">
 
S

saveferris2009

New member
Just to clarify: Azli side effect profile is fine. Side effects aren't the issue - the med has been out for years and years.

it's just a matter of if this med, in this delivery system (nebbed instead of IV) is effective in the dose studied <img src="">
 
S

saveferris2009

New member
Just to clarify: Azli side effect profile is fine. Side effects aren't the issue - the med has been out for years and years.

it's just a matter of if this med, in this delivery system (nebbed instead of IV) is effective in the dose studied <img src="">
 
S

saveferris2009

New member
Just to clarify: Azli side effect profile is fine. Side effects aren't the issue - the med has been out for years and years.
<br />
<br />it's just a matter of if this med, in this delivery system (nebbed instead of IV) is effective in the dose studied <img src="">
 
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