We will try to provide updates on the pergolide situation.
As of 04/29/07:
Since the FDA apparently isn't doing it's homework on how much
pergolide is out there in any form, I'd like as many people as
possible to call 5, 10 or more pharmacies in your local area, ask
them if they have any pergolide pills and if they do, how many, what
strength. Jot down the date, pharmacy name and how much, if any, they
have. Send that information to the "big 5" below, with a cc to me. If
you are uncomfortable doing that, please send it to me (drkellon@aol.com) and I'll
forward it identified only by your city/town.
The only legal source in the FDA's eyes is the pills. The sooner we
can document they are gone, or about to be, the better.
David J. Horowitz
Deputy for Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov
Stephen F Sundlof, D.V.M., Ph.D.
Director of the Center for Veterinary Medicine
Food and Drug Administration
240-276-9000 phone
240-276-9001 fax
stephen.sundlof@fda.hhs.gov
Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 phone
240-276-9060 fax
marcia.larkins@fda.hhs.gov
Virginia Behr
FDA - Ombudsman
Phone 301-796-0675
Fax 301-796-9883
virginia.behr@fda.hhs.gov
Andrew von Eschenbach
FDA Commissioner
phone 301-827-2410
Fax 301-443-3100
andrew.voneschenbach@fda.hhs.gov
____________________
As of 04/27/07:
Such as it is, here goes.
The Veterinary side of the FDA (CVM - Center for Veterinary
Medicine), did prepare a proposal for an interim solution. I spoke to
the officer (that's what they call them at the FDA, "officer") in
charge of that. He would not tell me what was in it but did tell me
that he had sent it over to FDA "main" for approval. The approval was
expected to have occurred by last Friday at the latest (that was the
announcement we were expecting) but never appeared. On Tuesday, he
said he was hoping to see it "soon".
Part of the problem is priority. They're a tad distracted by the
contaminated pet food fiasco (don't go there on this list please,
much as I'd love to..) but even more important is that none of the
immediate available options are very appealing to the FDA. Below is a
list of the possible solutions that I just put together for a Horse
Journal article:
1. The FDA could publish a specific exemption from the prohibition on
compounding from bulk drugs with regard to pergolide and horses with
Cushing's Disease. This would immediately free drug wholesalers to
supply compounders. Drug should still only be produced upon receipt
of a prescription from the treating veterinarian. This would be
entirely legal and there are precedents for issuing exceptions.
Certain chemicals used in treatments of poisonings have already been
granted exceptions. We favor this as a short term solution.
2. The former USA manufacturers of pergolide pills in this country
could be encouraged to resume production specifically for veterinary
use.
3. The FDA could allow importation of pergolide pills produced in
other countries.
4. A drug company could begin the drug approval process for pergolide
as a treatment for equine PPID. This is time consuming and expensive,
but preliminary communications with the FDA CVM staff in the division
of MUMS - Minor Uses and Minor Species - indicates they may be able
to help. This division was created to help fill the special needs of
relatively uncommon species, or uncommon diseases. While the number
of horses with Cushing's Disease is certainly not small, the market
size can't compare to the need for things like dewormers and
antibiotics. The program provides financial incentives and allows for
sales of the drug before the entire approval process has been
completed.
5. In the event the FDA does not offer even a short term solution
quick enough, and an owner/vet find themselves unable to source the
drug, the veterinarian can apply for a Medically Necessary Veterinary
Drug exception. Details for this application can be found at:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf/ Once approved,
this would enable the veterinarian to import drug to treat his or her
patient(s). Because of inherent delays in petitions being approved,
and a likely large volume of petitions once the supply begins to dry
up, you shouldn't wait until the last minute to get started on this.
===================
In speaking with the FDA on Tuesday, it was abundantly clear that
granting an exception for bulk compounding was the last thing they
wanted to do. The current compounding furor, with abuses on both
human and veterinary ends, haven't helped us any. Still, this would
be the quickest solution. The FDA would prefer to see 2. happen, but
no interest from that sector so far. Number 3. is probably the
solution that CVM proposed (I'm guessing at that), but FDA main
wouldn't be wild about that idea either.
Number 4. is something I'm actively working on, identifying companies
that are already making "specialty" drugs (smaller market than big
sellers like dewormers or antibiotics), small companies, companies
with experience producing drugs that are potent in small doses in a
loose powder form.
Number 5. is your safety net. There's no way to tell how much
pergolide is still out there, or how long it will last. Pharmacies
that seem to have a good supply now could find it disappearing
quickly as other pharmacies run out. If this drags on too long, you
could also easily be looking at a problem with black market drug of
god knows what quality and coming from god knows where. If the
availability of drug through approved suppliers doesn't change,
sooner or later you're going to have be highly suspicious of anyone
who claims they have no problem getting the drug. The FDA is not
interested in having to process a huge volume of these applications,
but may try to stall on doing anything until they actually start to
get them.
==========================
Until they have a solution in front of them that they like, the FDA
is going to drag its feet. We need to keep putting pressure on them.
All of you who cross-post and generate new signatures on the petition
are helping. Several members are also getting breed associations
involved and/or getting articles in magazines. I've been interviewed
by The Horse, Equus and got a request late yesterday from Horse
Illustrated. There will be an article in the next issue of Horse
Journal. Also trying to get a national news service to pick it up.
You can all also help by sending individual e-mails, faxes or phone
calls to these 3 people:
Food and Drug Administration
1-888-463-6332 - phone
cderombudsman@fda.hhs.gov
Dr. Stephen Sundlof
Director of the Center for Veterinary Medicine
240-276-9000 - phone
240-276-9001 - fax
stephen.sundlof@fda.hhs.gov
Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 - phone
240-276-9060 - fx
marcia.larkins@fda.hhs.gov
Phone, fax, e-mail or all three as often as you like.
By the way, in response to the reply from the FDA that some of you
got, basically saying it's not their problem and it's up to the
manufacturers to supply the drug, that's not true. No manufacturer is
obligated to make any drug. Few firms would be interested in
this "small" a market, compared to something that the entire equine
population uses on a regular basis.
The FDA does acknowledge that it has the responsibility to prevent or
alleviate both real and potential shortages of essential drugs. Read:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
This *is* their problem, but it's up to us to see that they deal with
it before even one horse runs out of pergolide.
Eleanor
_____________________
As of 04/05/07:
Pergolide, the most effective treatment for horses with Cushings and
the only thing that helps many of them has been taken off the market.
For details drop in on the Cushings group:
http://groups.yahoo.com/group/EquineCushings
If you have or had a horse with Cushings, or know someone who does,
please go to this site and sign the petition for drug manufacturers to
keep producing the drug for equine use:
Please also cross post this to all equine groups you are on.
Thank you.
Dr. Eleanor Kellon
____________________
According to the CBC at
http://www.cbc.ca/health/story/2007/03/30/permax.html pergolide has
voluntarily withdrawn the medication in both Canada and the United
States. In Canada, however the drug is still protected under patent,
and is sold by Shire Pharmaceuticals.
"It's going to be a matter of economics for the manufacturers. If the
market is big enough to warrant it, they may keep producing for
equine use."
"Cabergoline is a dopamine agonist in the same class as pergolide. It
is more potent and longer acting. We do have at least preliminary
information on its use in a small number of horses."
____________________
As many of you may know, pergolide (Permax) is being withdrawn from the
market due to some heart valve problems with a subset of the people who take
the medication. Pergolide is also pretty much the only available drug to
treat Cushings Disease in horses. Since most of this drug is ordered through
compounding pharmacies, it turns out the drug manufactures actually did not
know about the equine market for the drug. In an effort to keep this life
saving drug available for our Cushings horses, a petition has been started
to demonstrate to the manufacturer the demand for pergolide. If you have or
had a horse with Cushing's, or know someone who does, please go to this site
and sign the petition for drug manufacturers to keep producing the drug for
equine use:
http://www.ipetitions.com/petition/savepergolide/
Please take the time to sign and cross-post this information on any other
lists or bulletin boards that you frequent. Also, if your horse is on
pergolide, I think it would be helpful to note that in the comments section.
Feel free to ignore the request for donations at the ipetition web site
after you sign the petition:-)
_____________________
From Dr. Eleanor Kellon:
I'm already starting to get mails from people using the human generics
and Permax saying that their pharmacies are out. All three pill
producers have stopped manufacturing. It appears that the only way the
pills will be produced again is if one of the 3 manufacturers appeals
to the USDA for a special permit. If that happens, that single
manufacturer will be the only source of pill form pergolide. Anyone
currently using pills would be wise to switch to compounded.
*The most accurate way to dose compounded pergolide is in capsule form.
In addition, anyone making a switch to a compounder should make sure
that:
1. The compounder is fully licensed.
2. The compounder only uses bulk drugs that come from FDA approved drug
wholesalers. Ask for the name of their pergolide bulk drug wholesaler.
If it's not on the list below, don't use that compounder.
The petition is going strong, creeping up on 700 signatures
representing thousands of horses. In addition to signing the petition,
I would encourage anyone who feels so inclined to contact the
wholesalers directly by phone, fax or e-mail. When you do, be sure to
mention the name of your compounding pharmacy. One or more of the
wholesalers will recognize them as their clients and will be able to
check their sales records. As soon as a wholesaler confirms they will
continue to stock pergolide and keep the supply uninterrupted, we'll
take them off our contacts list. Also provide a link to the petition
when you contact them. This will be the quickest way to let them know
we have a need - a BIG need! Remember, the drug is out there. The human
market in the USA was very small compared to the rest of the world.
This is what I sent the wholesalers over the weekend and this morning.
Directly below that is a list of the FDA approved wholesalers who were
stocking pergolide and all the contact info I currently have.
Make your voice heard!
-------------------------------
I am a veterinarian and co-owner of the over 5000 member Yahoo Equine
Cushing's group. As you know, at the FDA's urging pergolide mesylate
has been removed from the human market. The three US suppliers of
pergolide tablets are no longer producing the drug. What you may not
realize is that bulk sales of pergolide to compounders are largely
going to the veterinary market.
Pergolide is the only effective pharmacological therapy for horses with
Cushing's Disease, pituitary pars intermedia dysfunction. I believe
that drug wholesalers are unaware of the size of the veterinary market.
It is critically important to keep pergolide available for veterinary
use. The FDA action does not impact off-label use in horses.
A web petition has been put up to collect signatures and comments
regarding the use of pergolide in horses:
The petition was put up noon on April 6. Despite the holiday weekend,
there are already 14 pages of signatures, reflecting the needs of
thousands of horses. This is only the tip of the iceberg. There are
currently 10 to 12 million horses in the United States, of which
approximately 10% are age 20 or older. It has been estimated that
virtually any equine that lives long enough will develop the
degenerative changes of dopaminergic neurons that leads to pituitary
dysfunction and Cushing's disease. This disease may begin much earlier
in some horses, in their teens. Pergolide is needed by these animals
for the remainder of their life.
We urge you to continue to stock pergolide mesylate. There is a market.
Owners that had been relying on Permax or generic human tablets are
already encountering shortages. There is an urgent need to keep an
uninterrupted flow of pergolide mesylate to compounders.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Co-Owner, Yahoo Equine Cushings
http://pets.groups.yahoo.com/group/EquineCushings/
=============================
List of Wholesalers and Contact Information
Gallipot
Barbara Jones CEO bjones@gallipot.com
Michael Jones President mjones@gallipot.com
2400 Pilot Knob Road
St. Paul, Minnesota 55120
800-423-6967
Fax 800-339-1596
Medisca USA
sales@medisca.com
661 Route #3, Unit C
Plattsburgh NY 12901
800-932-1039
Medisca Canada
sales@medisca.com
6090 Henri-Bourassa West
West Saint-Laurent, Quebec
H4R 3A6
800-665-6334
Spectrum Chemicals
4422 S San Pedro St
Gardena CA 90248-2027
bulk@spectrumchemical.com
sales@spectrumchemical.com
Annette Farioli
800-813-1514
Fax: 800-525-2299
Hawkins
800-375-0009
Letco Companies
sales@letcoinc.com
1316 Commerce Drive
Decatur AL 35601
800-239-5288
Professional Compounding Centers of America (PCCA)
9901 South Wilcrest Drive
Houston, TX 77099
customerservice@pccarx.com
800-331-2498
Fax 800-874-5760
