Posted to EC List by Dr. Kellon May 3, 2007 Msg #91069
Answers for the "13 Questions" in the request letter.
Answers in [brackets]. You can cut/paste this into a word file so most of the information does not need to be retyped for printing on letterhead.
To:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary Division of Compliance, HFV-235
7519 Standish Place
Rockville, MD 20855
Fax: (240)276-9241
Re: Medically Necessary Personal Veterinary Imports
Please determine the following in the initial contact:
How did the veterinarian learn of this product?
[Pergolide has been the drug of choice for Cushing's in equines at least 10 years.]
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
[1-5 are obvious]
5. Name of drug
[Pergolide]
6. Drug family or class
[Dopamine agonist]
7. Name and address of drug supplier
[You will have to have picked out a pharmacy in another country
before this question can be answered and the application submitted.
Fairly easy to do on line. You don't have to actually place an order
or open an account, etc. They just need to know where it will be
coming from. Be prepared to be shocked at these prices.
See list below for suppliers.]
8. Legal status of the drug in the foreign country
[Legal]
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
[Need to specify the strength of the pills you are importing and
how many pills each time - e.g. a 100 count bottle of 0.5 mg generic
pergolide pills.]
10. Disease condition to be treated
[PPID/Cushings]
11. Reason why an approved human or animal drug will not treat the
disease condition
[There are no approved human or animal drugs other than pergolide
which are known to adequately treat the condition.]
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
[Veterinarian needs to answer "yes" to all three questions.]
13. Please include your email address.
[Veterinarian's email address]
Example Suppliers for Question 7:
http://www.rxcarecanada.com/Permax.asp?prodid=1348
http://www.smartmed.ca/canada_drugs/buy_pergolide_canada.asp
http://www.1drugstore-online.com/showprice.asp?name=pergolide&bysearch=ok
http://goldpharma.com/?show=search&search_srt=Parkotil&affiliate=1629522380&ref=search
Thursday, May 3, 2007
Medically Necessary Veterinary Imports Request
Summary of Fax Cover Sheet:
From: Michael Zimmerman; (michael.zimmerman@fda.hhs.gov)
Re: Request Import Drug
Notes: Attached is a copy of the 13 questions that must be answered to consider your request to import medication for your patient(s). Please answer each question as thoroughly as possible and fax your completed request back to our office. Please call if you have any questions. Thank you.
Address and Question Sheet:
Please submit letter to:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary
Division of Compliance, HFV-235
7519 Standish Place
Rockville, Maryland 20855
Or fax to 240-276-9241
Questions: (240)276-9202
Please determine the following in the initial contact:
How did the veterinarian learn of this product? If there is
any indication the product has been actively promoted in
U.S. markets it will be refused entry and an import alert will
be issued.
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
5. Name of drug
6. Drug family or class
7. Name and address of drug supplier
8. Legal status of the drug in the foreign country
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
10. Disease condition to be treated
11. Reason why an approved human or animal drug will not treat the
disease condition
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
13. Please inlude your email address.
ALL REQUESTS MUST BE SIGNED BY THE VETERINARIAN AND BE ON LETTERHEAD
Please allow 3-4 weeks for processing.
Revised February 1, 2007
[Go to version formatted as letter]
From: Michael Zimmerman; (michael.zimmerman@fda.hhs.gov)
Re: Request Import Drug
Notes: Attached is a copy of the 13 questions that must be answered to consider your request to import medication for your patient(s). Please answer each question as thoroughly as possible and fax your completed request back to our office. Please call if you have any questions. Thank you.
Address and Question Sheet:
Please submit letter to:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary
Division of Compliance, HFV-235
7519 Standish Place
Rockville, Maryland 20855
Or fax to 240-276-9241
Questions: (240)276-9202
Please determine the following in the initial contact:
How did the veterinarian learn of this product? If there is
any indication the product has been actively promoted in
U.S. markets it will be refused entry and an import alert will
be issued.
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
5. Name of drug
6. Drug family or class
7. Name and address of drug supplier
8. Legal status of the drug in the foreign country
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
10. Disease condition to be treated
11. Reason why an approved human or animal drug will not treat the
disease condition
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
13. Please inlude your email address.
ALL REQUESTS MUST BE SIGNED BY THE VETERINARIAN AND BE ON LETTERHEAD
Please allow 3-4 weeks for processing.
Revised February 1, 2007
[Go to version formatted as letter]
FDA and CVM Q/A
Q - What is MNVD (or MNVP)?
A - MNVD stands for Medically Necessary Veterinary Drug
CVM Policy Guide 1240-4170 outlines the policy for MNVD Product Shortage Management.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
"Medically Necessary Veterinary Product (MNVP): A product is considered to be an MNVP if it is used to treat or prevent a serious disease or condition, or needed to assurethe availability of safe food products of animal origin and there is no other available source of that product of alternative drug that is judged by CVM's veterinary staff to be an adequate substitute. Inconvenience and non-therapeutic uses are insufficient basis to classify a product as an MNVP."
"It is Agency policy to attempt to prevent or alleviate shortages of MNVPs. An MNVP shortage may involve an actual or potential shortage of a drug product."
The document goes on to outline Responsibilities and Procedures.
Q - What is the MNVD form?
A - There is currently a shortage of the legal generic pergolide tablets in the United States. There is a rapidly dimishing supply of bulk pergolide available for compounding, which is actually not legal under current policies. In order to ensure that an equine patient's medication (pergolide) continues uninterrupted, it may be necessary to import generic pergolide tablets from non-US sources.
This is not actually a "form" but
a) a fax cover sheet referring to "Request to Import Drug" and
b) a second sheet, "Medically Necessary Personal Veterinary Imports", listing the 13 questions that must be answered by the attending veterinarian on letterhead with the veterinarian's signature. A separate request must be made for each equine.
In separate articles you will find:
- The list of questions
- "Standard" answers to the 13 questions
- A list of non-US suppliers of generic pergolide tablets (for question #7)
These are also available in PDF either at the Equine Cushings List files
http://pets.groups.yahoo.com/group/EquineCushings/files
or by requesting copies by entering a comment at the end of this article.
A - MNVD stands for Medically Necessary Veterinary Drug
CVM Policy Guide 1240-4170 outlines the policy for MNVD Product Shortage Management.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
"Medically Necessary Veterinary Product (MNVP): A product is considered to be an MNVP if it is used to treat or prevent a serious disease or condition, or needed to assurethe availability of safe food products of animal origin and there is no other available source of that product of alternative drug that is judged by CVM's veterinary staff to be an adequate substitute. Inconvenience and non-therapeutic uses are insufficient basis to classify a product as an MNVP."
"It is Agency policy to attempt to prevent or alleviate shortages of MNVPs. An MNVP shortage may involve an actual or potential shortage of a drug product."
The document goes on to outline Responsibilities and Procedures.
Q - What is the MNVD form?
A - There is currently a shortage of the legal generic pergolide tablets in the United States. There is a rapidly dimishing supply of bulk pergolide available for compounding, which is actually not legal under current policies. In order to ensure that an equine patient's medication (pergolide) continues uninterrupted, it may be necessary to import generic pergolide tablets from non-US sources.
This is not actually a "form" but
a) a fax cover sheet referring to "Request to Import Drug" and
b) a second sheet, "Medically Necessary Personal Veterinary Imports", listing the 13 questions that must be answered by the attending veterinarian on letterhead with the veterinarian's signature. A separate request must be made for each equine.
In separate articles you will find:
- The list of questions
- "Standard" answers to the 13 questions
- A list of non-US suppliers of generic pergolide tablets (for question #7)
These are also available in PDF either at the Equine Cushings List files
http://pets.groups.yahoo.com/group/EquineCushings/files
or by requesting copies by entering a comment at the end of this article.
PERGOLIDE CRISIS - STATUS
Posted to EC List May 2, 2007 Msg #91035
A member ... got a copy of the instructions for filing a
medically necessary veterinary drug application today. I just put it
in the files and a notice should have gone out to everyone.
[Note - if you are not an EC List member and would like to request a copy
of this please enter a comment at the end of this article.]
This is the "safety net" pathway we've been talking about that lets
individuals get permission to import the drug until (if) the FDA
finds a solution to the shortage. Gotta tell you the fact they've
made a policy reversal on accepting these could be a bad sign. It
might mean they're hopelessly deadlocked on what to do about our
problem.
The application process isn't terribly long or complicated and I'll
post the answer to all the questions on there so your vets can
complete it in no time flat. Even if you still have some left, or
think you could get some (illegal) compounded drug, **ASK YOUR VET TO
FILE THE APPLICATION NOW**. Lord only knows what the "normal"
turnaround time is, and if it comes to hundreds or thousands of these
applications - well, you can imagine...
There was a "grapevine" rumor that today was to be the day for the
FDA announcement. In view of that, I waited to call the FDA again.
Not too surprisingly, no announcement. We have updates on adding
hydrogen peroxide added to fish water, but nothing on our horses.
They haven't even officially issued a press statement to the effect
that they are working on the problem.
Will let you know what, if anything, I can find out from the FDA
tomorrow.
Otherwise, we must step up the pressure. Keep going with the media
contacts, organizations, etc. but bear in mind no one, including the
government, can make them do anything. Public pressure and bad press
can. Don't waste too much time on special interest groups except to
send an alert and request for signatures on the petition. Don't do
anything that takes your time and energy away from directly
contacting the FDA by phone, fax, snail mail, e-mail. The news media
campaign is worthwhile, but they'll be slow to act. They have to
research it first. First reaction is likely to be to toss it into the
trash can so volume of requests will be important to even start that
process. Don't let a day go by without contacting the FDA and PLEASE
we need more regional pergolide pill in pharmacies information. It
doesn't matter if your horse actually has Cushing's or not. It
doesn't matter if you have a stash of compounded pergolide or your
compounder says they do. The FDA is supposed to be concerned with
**legally available** drug. Document that you have no legally
available source.
They're stalling on this, trying to get a feel for how
genuinely "urgent" the situation is, hoping for some company to step
up to the plate to resume manufacturing so they can avoid having to
issue an importation or compounding exemption, but in the process
they're putting our horses in a very real danger of having a gap in
their treatment at the highest risk time of the year.
Priorities right now are:
- Document there is no legal available source in your area
- Encourage your vets to submit the medically necessary veterinary
drug information for your horse
- Continue to pressure, DAILY, the FDA and news media
Eleanor
A member ... got a copy of the instructions for filing a
medically necessary veterinary drug application today. I just put it
in the files and a notice should have gone out to everyone.
[Note - if you are not an EC List member and would like to request a copy
of this please enter a comment at the end of this article.]
This is the "safety net" pathway we've been talking about that lets
individuals get permission to import the drug until (if) the FDA
finds a solution to the shortage. Gotta tell you the fact they've
made a policy reversal on accepting these could be a bad sign. It
might mean they're hopelessly deadlocked on what to do about our
problem.
The application process isn't terribly long or complicated and I'll
post the answer to all the questions on there so your vets can
complete it in no time flat. Even if you still have some left, or
think you could get some (illegal) compounded drug, **ASK YOUR VET TO
FILE THE APPLICATION NOW**. Lord only knows what the "normal"
turnaround time is, and if it comes to hundreds or thousands of these
applications - well, you can imagine...
There was a "grapevine" rumor that today was to be the day for the
FDA announcement. In view of that, I waited to call the FDA again.
Not too surprisingly, no announcement. We have updates on adding
hydrogen peroxide added to fish water, but nothing on our horses.
They haven't even officially issued a press statement to the effect
that they are working on the problem.
Will let you know what, if anything, I can find out from the FDA
tomorrow.
Otherwise, we must step up the pressure. Keep going with the media
contacts, organizations, etc. but bear in mind no one, including the
government, can make them do anything. Public pressure and bad press
can. Don't waste too much time on special interest groups except to
send an alert and request for signatures on the petition. Don't do
anything that takes your time and energy away from directly
contacting the FDA by phone, fax, snail mail, e-mail. The news media
campaign is worthwhile, but they'll be slow to act. They have to
research it first. First reaction is likely to be to toss it into the
trash can so volume of requests will be important to even start that
process. Don't let a day go by without contacting the FDA and PLEASE
we need more regional pergolide pill in pharmacies information. It
doesn't matter if your horse actually has Cushing's or not. It
doesn't matter if you have a stash of compounded pergolide or your
compounder says they do. The FDA is supposed to be concerned with
**legally available** drug. Document that you have no legally
available source.
They're stalling on this, trying to get a feel for how
genuinely "urgent" the situation is, hoping for some company to step
up to the plate to resume manufacturing so they can avoid having to
issue an importation or compounding exemption, but in the process
they're putting our horses in a very real danger of having a gap in
their treatment at the highest risk time of the year.
Priorities right now are:
- Document there is no legal available source in your area
- Encourage your vets to submit the medically necessary veterinary
drug information for your horse
- Continue to pressure, DAILY, the FDA and news media
Eleanor
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