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Petition FDA to reduce ESWT costs

Posted by Scott R on 1/05/02 at 15:31 (068840)

If someone's interested in etitioning the FDA to get ESWT costs down, here's some info. This can be a group effort since I have 6,000 email addresses.

Citizen Petitioning of the FDA:
http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=10&SECTION=30&YEAR=2001&TYPE=TEXT

Here are the general ideas that need to be presented, but backed by more facts and knowledge than I possess:

Section A, Action Requested:
Approve ESWT machines in a more efficient and cost effective manner to lower ESWT costs.

Section B, Statement of grounds:
ESWT is safe as demonstrated in studies, but especially by virtue of ESWL which is more internal and higher power, and yet still considered safe. ESWT is very effective at least to some degree for all machines. Surgery, being the only alternative, is very dangerous and that the reluctance of HMOs, etc, to pay the high costs of ESWT make surgery the only alternative. In effect, FDA not helping to bring costs down is destroying some citizens' ability to walk. Current costs are currently around $5,00o, but could be $500 if more competition were allowed.

Sections C and D are not required.

They are requireed to make a determination in 180 (90?) days.

Other interesing links:
Class II exemptions:
http://www.fda.gov/cdrh/modact/exemii.html

But FDA considers ESWT class III, eventhough ESWL is class II
class III info:
http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg300-700.html

Re: Petition FDA to reduce ESWT costs

Dr. Zuckeman on 1/05/02 at 16:59 (068854)

Would be great if we could get a few thousand signed petitions. The foot is now in our hands. Lets see if this will work. Brian Do you have any comments about this . Pauline any imput.
Dr. Z

Re: Petition FDA to reduce ESWT costs

Pauline on 1/05/02 at 16:59 (068855)

God Scott, the last link you posted talkes about the steps they can take. First the warning letter which Norland got. I remember you having this on the site, but then they go on to talk about Recall and Seizure.

Are we going to wake up a sleeping dog? Right now Dr. Z and others still have the machine and can continue to use it, we just can't mention the name. It's obvious they know about the site so if lots of petitions
start rolling in, will it reflect back here and more action taken?

Lot's of people depend on this site.

Re: Petition FDA to reduce ESWT costs

Dr. Zuckeman on 1/05/02 at 19:20 (068869)

You are right lots of people depend on this site and on gettng proper treatment at a reasonable cost. The only sleeping dog that needs to be woken up is the public and how big companies are controlling our health costs. The FDA does have the choice but won't act unless they think the public is watching what they do. I say let the petition roll in. The FDA omnibus person's name and fax number will be posted on this board on monday.

This is the person who represents the interest of the public to the FDA
Change is always hard but can be done.

Re: Petition FDA to reduce ESWT costs

Scott R on 1/05/02 at 21:12 (068882)

I wasn't talking about the O. It's probably a lost cause because the regulations specifically state they will hold a grudge against devices that have previously been in trouble.

Re: Petition FDA to reduce ESWT costs

Pauline on 1/05/02 at 22:08 (068884)

Dr.Z,
You've said Pods see most of the foot cases in the U.S. so I would think they probably have the most access to people with foot problems. Perhaps petitions in every physicians office would collect these signatures faster.

We could also try the door to door stuff with our own neighbors, but with winter it's more difficult to do this outdoor type of collection.

What do some of the others think?

Re: Petition FDA to reduce ESWT costs

Scott R on 1/06/02 at 07:14 (068896)

If you read the link, you'll see that a petition to the FDA doesn't mean a bunch of people sign it. They aren't swayed very easily by popular opinion (otherwise they wouldn't have outlawed tryptophan, a safe amino acid that used to be prozacs only competitor and chitosan, one of the few ways to safely lower choleserol and thereby a major threat to several hugely popular heart drugs). Arguments that work within their regulations and in the direction of what they might personally want to happen combined with plenty of direct contact with patients is the best way.

Re: Petition FDA to reduce ESWT costs

Christine F on 1/06/02 at 09:14 (068922)

Ok, let me get this straight,if FDA aproves this device then insurance co. will cover the treatment? I aploigize for being young and inexperienced but I don't fully understand. And if it has such a higher success rate than surgery is cost the only reason why all pf sufferers have not gotten this treatment?

Re: Petition FDA to reduce ESWT costs

Dr. Zuckeman on 1/06/02 at 09:29 (068925)

Cost is one of the main reason why ESWT isn't covered by insurance

Re: To Scott

Pauline on 1/06/02 at 10:04 (068932)

I was answering Dr.Z question to me as to how we could get thousands of signed petitions. I still think the Pods have the best chance of getting the most signed petitions because they have lots of people comming to their offices. Distribution centers like this would seem to me to be the best answer to the question he asked me.

Re: To Scott

Jen R on 1/06/02 at 10:44 (068941)

Dr. Z & Scott,

I'm sure that those of us who have been following ESWT for awhile cover a rather large geographical area. Not sure the best way to attack the petitioning idea...but if I can be of any help...I'm more than willing to offer my services.

Jen R

Re: To Scott

dave on 1/18/02 at 08:03 (070364)

I think that pettitioning is a great idea. It seems that someone has full control over the cost of the treatments. I wonder how or why it only cost $125.00 in other countries. I believe that for most the cost here in the states is out of reach for most. I will be having the procedure done soon. The cost to me is irrelavent. I have been in agony to long.

Re: Petition FDA to reduce ESWT costs

Dr. Zuckeman on 1/05/02 at 16:59 (068854)

Would be great if we could get a few thousand signed petitions. The foot is now in our hands. Lets see if this will work. Brian Do you have any comments about this . Pauline any imput.
Dr. Z

Re: Petition FDA to reduce ESWT costs

Pauline on 1/05/02 at 16:59 (068855)

God Scott, the last link you posted talkes about the steps they can take. First the warning letter which Norland got. I remember you having this on the site, but then they go on to talk about Recall and Seizure.

Are we going to wake up a sleeping dog? Right now Dr. Z and others still have the machine and can continue to use it, we just can't mention the name. It's obvious they know about the site so if lots of petitions
start rolling in, will it reflect back here and more action taken?

Lot's of people depend on this site.

Re: Petition FDA to reduce ESWT costs

Dr. Zuckeman on 1/05/02 at 19:20 (068869)

You are right lots of people depend on this site and on gettng proper treatment at a reasonable cost. The only sleeping dog that needs to be woken up is the public and how big companies are controlling our health costs. The FDA does have the choice but won't act unless they think the public is watching what they do. I say let the petition roll in. The FDA omnibus person's name and fax number will be posted on this board on monday.

This is the person who represents the interest of the public to the FDA
Change is always hard but can be done.

Re: Petition FDA to reduce ESWT costs

Scott R on 1/05/02 at 21:12 (068882)

I wasn't talking about the O. It's probably a lost cause because the regulations specifically state they will hold a grudge against devices that have previously been in trouble.

Re: Petition FDA to reduce ESWT costs

Pauline on 1/05/02 at 22:08 (068884)

Dr.Z,
You've said Pods see most of the foot cases in the U.S. so I would think they probably have the most access to people with foot problems. Perhaps petitions in every physicians office would collect these signatures faster.

We could also try the door to door stuff with our own neighbors, but with winter it's more difficult to do this outdoor type of collection.

What do some of the others think?

Re: Petition FDA to reduce ESWT costs

Scott R on 1/06/02 at 07:14 (068896)

If you read the link, you'll see that a petition to the FDA doesn't mean a bunch of people sign it. They aren't swayed very easily by popular opinion (otherwise they wouldn't have outlawed tryptophan, a safe amino acid that used to be prozacs only competitor and chitosan, one of the few ways to safely lower choleserol and thereby a major threat to several hugely popular heart drugs). Arguments that work within their regulations and in the direction of what they might personally want to happen combined with plenty of direct contact with patients is the best way.

Re: Petition FDA to reduce ESWT costs

Christine F on 1/06/02 at 09:14 (068922)

Ok, let me get this straight,if FDA aproves this device then insurance co. will cover the treatment? I aploigize for being young and inexperienced but I don't fully understand. And if it has such a higher success rate than surgery is cost the only reason why all pf sufferers have not gotten this treatment?

Re: Petition FDA to reduce ESWT costs

Dr. Zuckeman on 1/06/02 at 09:29 (068925)

Cost is one of the main reason why ESWT isn't covered by insurance

Re: To Scott

Pauline on 1/06/02 at 10:04 (068932)

I was answering Dr.Z question to me as to how we could get thousands of signed petitions. I still think the Pods have the best chance of getting the most signed petitions because they have lots of people comming to their offices. Distribution centers like this would seem to me to be the best answer to the question he asked me.

Re: To Scott

Jen R on 1/06/02 at 10:44 (068941)

Dr. Z & Scott,

I'm sure that those of us who have been following ESWT for awhile cover a rather large geographical area. Not sure the best way to attack the petitioning idea...but if I can be of any help...I'm more than willing to offer my services.

Jen R

Re: To Scott

dave on 1/18/02 at 08:03 (070364)

I think that pettitioning is a great idea. It seems that someone has full control over the cost of the treatments. I wonder how or why it only cost $125.00 in other countries. I believe that for most the cost here in the states is out of reach for most. I will be having the procedure done soon. The cost to me is irrelavent. I have been in agony to long.