PDA

View Full Version : FDA Discontinues Investigational New Drug (Veterinary) Paperwork


We Hope
10-07-2009, 10:32 AM
http://www.avma.org/onlnews/javma/oct09/091015h.asp

JAVMA News October 15, 2009

"The Food and Drug Administration's Center for Veterinary Medicine is no longer accepting requests nor issuing letters facilitating veterinarians' personal importation of foreign animal drugs that are not approved for use in the United States.

"The FDA had previously issued letters stating it did not object to the importation by licensed veterinarians of small amounts of unapproved animal drugs for specific patients and in special circumstances, such as when the drug posed no threat to human or animal health and there were no adequate drug substitutes available.

"Veterinarians seeking to import these types of foreign animal drugs are instead directed to FDA's guidance on the Coverage of Personal Importation, which is available at :"

http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf

When we needed Caninsulin for Lucky, it was not yet approved (Vetsulin) for use in the US, so we needed to go through this type of paperwork before he could receive it.

It appears that if the situation was happening today, and Vetsulin wasn't yet in the US, we would be able to make the arrangements with Intervet alone.

From this, it would also seem that if a vet wanted or needed 100% bovine insulin for a diabetes patient, he/she would only need to contact Pfizer about their Insuvet Neutral (R), Lente, or Protamine Zinc (PZI) insulins.

This should make getting a drug you need a lot easier and faster; while I wish this system was in place when Lucky needed Caninsulin, I'm glad to see that it will now be easier for others to import needed drugs.

Kathy

eyelostit
10-07-2009, 07:21 PM
Thats good news, I remember when I talked to the vet years back about one of the cushings drugs and it appeared to be a big project to even get the drug.

We Hope
10-07-2009, 07:32 PM
Dolly,

I think that was trilostane and it was approved for use this year under the name Vetoryl.

I remember a loophole in the import process here. It was approved for human use but not for animals, so you could purchase and import it under its human brand name, but if you wanted to import it as Vetoryl then, you had to go through all of the red tape. ;)

eyelostit
10-07-2009, 07:54 PM
Well thankfully all that is over for our pets

labblab
10-08-2009, 08:06 AM
Dolly,

I think that was trilostane and it was approved for use this year under the name Vetoryl.

I remember a loophole in the import process here. It was approved for human use but not for animals, so you could purchase and import it under its human brand name, but if you wanted to import it as Vetoryl then, you had to go through all of the red tape. ;)
Hi Guys,

I just wanted to pop over from k9cushings and add a bit of history about this issue :). I started treating my Cushpup with trilostane five years ago, prior to its approval here in the U.S. I was scared to death about doing anything "wrong" by importing it from the U.K., so I spent a lot of time researching the FDA directives. And this is what I discovered.

It has actually been the case that, for at least a decade, the FDA has openly stated that even though it is technically illegal, they will refrain from seizing medication imported by private individuals under certain specific conditions (regardless of whether or not the medication is intended for human or veterinary use). The conditions generally include factors such as: there is no approved version of the drug available in the U.S., the drug is being imported by a private individual for personal use only (no resale), and the quantity ordered is very small -- not to exceed around a 90-day supply.

When ordered by private individuals, there has been no "red tape" or formal application involved. The internet pharmacy will probably require presentation of a valid prescription. But aside from that, there is no prior approval or paperwork needed. Here is the FDA's policy statement that discusses the importation of drugs for personal use:

http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm

The reason why people (like me) were originally importing the human version of trilostane was because that was the only version that "Masters Marketing" (the primary U.K. internet pharmacy) was supplying at that time. Neither form of trilostane -- human or veterinary -- was approved for use in the U.S. That was why the FDA was allowing it to be imported in either form (because it was not available in the U.S.). As soon as Masters started stocking Vetoryl (the veterinary version), then that was the version of trilostane that folks started importing for their dogs. But now that Vetoryl is receiving FDA approval, importation of trilostane in any form for veterinary use must cease.

The situation was different for vets, however. If they wanted to personally import a non-approved drug for resale to a patient, they had to submit a written application to the FDA and receive a specific import waiver. That WAS a lot of work and a lot of red tape for everybody (probably including the FDA!). So I believe it is that aspect of drug importation that the FDA is discontinuing -- the importation by vets via a written import waiver. It looks as though the policy re: importation by individuals for personal use remains unchanged. And that actually has always been the easier and usually less expensive process, anyway. The main issue has been finding a supplier for the drug you need. For instance, initially the manufacturer of Vetoryl would only sell directly to vets. It was during that time that Masters was supplying the human version of trilostane (Modrenal) to U.S. customers. I don't know how this issue relates to diabetic medications, as far as finding foreign pharmacies/manufacturers that can supply the non-FDA-approved product that you may be seeking.

But I hope this helps make some sense of a very confusing situation!

Marianne

We Hope
10-08-2009, 08:58 AM
It has actually been the case that, for at least a decade, the FDA has openly stated that even though it is technically illegal, they will refrain from seizing medication imported by private individuals under certain specific conditions (regardless of whether or not the medication is intended for human or veterinary use). The conditions generally include factors such as: there is no approved version of the drug available in the U.S., the drug is being imported by a private individual for personal use only (no resale), and the quantity ordered is very small -- not to exceed around a 90-day supply.

When ordered by private individuals, there has been no "red tape" or formal application involved. The internet pharmacy will probably require presentation of a valid prescription. But aside from that, there is no prior approval or paperwork needed.

Neither form of trilostane -- human or veterinary -- was approved for use in the U.S.

At one point in time, trilostane was FDA approved for human use.

http://newdruginformation.com/Modrastane_2.htm

"New Drug Application (NDA) Number - 018719
The FDA assigned number to Modrastane."

http://www.drugs.com/cons/Trilostane.html

Drugs.com Trilostane

"This product was withdrawn from the U.S. market in April 1994."

When we determined we needed Caninsulin, we went to both FDA and Intervet. Both sources told us the only way to import it was to make the IND-personal use application. Intervet helped us file the IND request, as they told us there was no way to get the Caninsulin into the US without it, no matter who ordered it.

I had them seize an order of Caninsulin because it was not approved before they allowed our IND. It was an order which would have been in keeping with small quantities, but their reason was that the drug was not approved for use in the US. I made the order, not my vet--it was still gone.

It would seem that it depends upon the drug you're trying to import; I know people who import beef and pork insulin for their personal use. They are allowed to import up to six months worth of insulin, but the paperwork which has to be re-done every time they need to place an order is still problematic. Many times, even with all of the paperwork in place, their insulin is still held up by red tape.

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm173909.htm

Q-5. "How does FDA determine whether it will allow me to import beef or pork insulin for my personal use?

A. "FDAs decision to use enforcement discretion is made on a case-by-case basis.

Q-6. "How do I request approval to import beef or pork insulin for my personal use?

A. "In order to help FDA decide whether to use its enforcement discretion to allow you to import beef or pork insulin, FDA recommends that you send to your foreign supplier the following documents along with your beef or pork insulin order:

a signed statement that the product is for your own personal use;

the name, address, and phone number of the U.S.-licensed physician or practitioner who is responsible for your treatment with this drug;

shipping documentation information required by the U.S. Department of Agriculture (USDA) to assure compliance with their requirements.

You should request that your foreign supplier include with your shipment a copy of the above documents. The inclusion of these documents with your shipment of beef or pork insulin will help FDA to decide whether to use its enforcement discretion to allow importation of your beef or pork insulin. If you have questions for the FDA regarding the import of beef or pork insulin, please contact William Nychis at 301-796-3298.

"Q-8. How much beef or pork insulin can I import?

"A. You may only import beef or pork insulin for your personal use. You may not sell the product to others. In the case of beef or pork insulin, FDA may allow you to import for your own use up to a six-month supply."

Kathy

labblab
10-08-2009, 11:12 AM
Hi Kathy,

Yes, you are exactly right that trilostane was approved at one time for human use in the U.S. What I should have said was that there was no approved form of trilostane available on the U.S. market (for either humans or animals) by the time that I was personally ordering trilostane from the U.K.

I also think you are totally right that the FDA makes its enforcement decisions on a case-by-case basis. I did not mean to imply that every drug can be personally ordered without any difficulty or risk of being seized. But rather that the FDA's selective enforcement policy relating to individual importation has been in place for quite some time, even though many vets have not been aware of it.

The FDA policy to which I am referring relates specifically to the importation of unapproved drugs. That was the area that I had been researching because of my interest and concern over trying to import trilostane. Here is a related quote from the link I gave earlier:

That said, FDA's guidance for coverage of personal importations of unapproved drugs identifies several factors that should be considered by FDA personnel when determining whether to exercise enforcement discretion and refrain from taking action against the importation of unapproved drugs. The General Guidance Section states that FDA should consider not taking enforcement actions against such importation:

"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country."

So it is definitely true that people need to be aware that there is always a risk of seizure associated with importation, and that the FDA reserves the right to inspect and block any shipment. However, as I said above, I think many vets have been unaware that personal importation of unapproved drugs has even been an option for owners. For those of us who had been ordering Vetoryl prior to FDA approval, the FDA's policy was a god-send. Of all the folks who ordered from Master's during these past several years, I am unaware of any shipment that was actually confiscated (one member's shipment was opened, but then was forwarded on to her). And in order to conform with the FDA's policy, I merely filled in the requested information on Masters' ordering form (attested that I was ordering for personal use only, and provided my veterinarian's contact information).

But I have had no personal experience with ordering anything other than trilostane. I just know that, in that case, it was going to be a huge hassle for my vet to obtain a formal import waiver. Whereas, for me as an individual, it was a simple matter for me to order the drug directly.

Marianne

We Hope
10-08-2009, 11:40 AM
Marianne,

At the time we were in need of this, there was quite a "heavy hand" policy with regard to certain drugs. Insulin happened to be one of them.

Since Canadian prices were (and still are) cheaper, many people on fixed incomes were taking their chances by ordering from Canadian pharmacies for their own needs. Some of them had their insulin seized. (Quite a bit of this was Lilly insulin made in the US for the Canadian market.) When I needed a back up vial of the discontinued Iletin II Lente (in case there were supply problems), you couldn't buy a vial at all in the US, but you could still obtain them in Canada.

Knowing that the "hammer" was down, I ordered from a Manitoba pharmacy, but asked them not to label the package as insulin, and explained why. It went through without anyone getting "curious".

We were told that there had been only one previous IND-personal use approval for Caninsulin; it was for a dog who'd been a resident of another country. The approval was made to allow the treatment to continue. If we were denied, I considered taking Lucky temporarily to Canada so he could begin treatment with it and then re-applying for the IND under the same conditions, if that was to be the only way he could get what he needed.

With the help of Intervet, Lucky was approved and became the first US patient who was not either part of a previous trial or a previous user of Caninsulin. I can't say enough good things about them; before 24 hours were up after the initial "help!" e-mail to their Netherlands headquarters, we heard from the person in charge of the pending approval (as Vetsulin) in the US. The IND papers were filed that afternoon.

This was the only option we had and for those who need drugs where this is or was their only chance, I'm glad there are a lot less hoops to jump through before that happens! :)

Kathy

labblab
10-08-2009, 04:27 PM
This was the only option we had and for those who need drugs where this is or was their only chance, I'm glad there are a lot less hoops to jump through before that happens! :)

Kathy
Kathy, you are probably about ready to slap me silly at this point. But what I'm not seeing is any substantive change to the FDA's written policy re: personal importation that makes things any more or less easier for individuals to bring in unapproved drugs. All that I am seeing from the JAVMA article is that the FDA is no longer going to issue import waivers to vets. But the referenced regulations re: personal importation of unapproved drugs seem to be identical to the same policies that have already been in place for some time (case-by-case review with no guarantees, but with exceptions granted under certain circumstances). But I definitely may be missing something here...:confused: Are you maybe talking about informal, unwritten policies?

Marianne

We Hope
10-08-2009, 05:37 PM
Marianne,

When we were working on this, while I saw what was in place at the "human" side of FDA, no matter how I searched CVM, I found nothing on their site that detailed what one did for a veterinary drug.

We wound up contacting the CVM Ombudsman to get the information. It was the Ombudsman who told us we needed to (at the time) make the request in the form that we did. We began working on this when we realized we needed some information that only the pharmaceutical company could provide in order to make it.

This was when Intervet was contacted and they told us we needed to follow these procedures and would assist us with the filing of the paperwork.

If the disappearance of the need for IND-personal use-veterinary paperwork means that it will be easier to obtain a needed drug from elsewhere by whoever needs to do this, I still think it will be a benefit, if for no other reason than it eliminates the waiting period while CVM considers your case.

Kathy

labblab
10-09-2009, 04:48 AM
Gotcha! :) And you're right, I've been relying on the "general" importation policies as opposed to having found any specific CVM guidelines. So it is reassuring to confirm from the JAVMA article that the general guidelines do also govern the importation of drugs for animals. Thanks for finding and posting this info!

Marianne