I think there are some good people at the FDA. There are also some not so good people.
My wife suffers from young onset Parkinson's. She's blown through Requip and Mirapex, two Dopamine Agonists that helped her function until the side effects became worse than the symptoms.
One of her primary meds today comes from Canada. We keep "expecting" it to get approval from the FDA, but no dice. It's approved everywhere in the world, but here. We buy it outside of our health plan.
A new, miraculous drug from Israel, called Rasagiline, shows significant improvements in PD patients and appears to stop progression of the disease. This is HUGE. Yet, the FDA is sitting on it. See the following article...
Rasagiline Effective as Monotherapy for Early Parkinson's Disease: Presented at ANA
Once again, we circumvented the FDA (or attempted to). We ordered the Israeli drug through a Canadian pharmacy with our neurologist's prescription. Because we're ordering it for personal use, with a prescription, and the drug is not sold in the U.S., the FDA cannot legally stop us from buying it. Too bad no one told them.
We were blocked and the drug was embargoed and returned to Israel. We fought and fought, but ended up unable to get past the FDA. Below is the letter my wife fired off to a number of FDA bureaucrats...
First, I would like to apologize that this letter is so long. But I am writing because I believe you have a Compliance Officer who is extremely incompetent & derelict with regard to the duties of her job. Not only did I have a horrible experience in trying to deal with her, but now that I complied with all requirements & she supposedly “released” my drug to me, it has never arrived at my house. I believe it is important that you have all of the facts with regard to this case, as I have outlined in this letter.
I am only 43 years old & I have Parkinson Disease. In the four years since I was diagnosed, I have taken every single prominent drug available here in the USA & approved by the FDA for Parkinson’s. I have had adverse reactions or medically unacceptable side effects from every single one of those drugs. There is only one drug I have been able to take – Sinemet. It is the one drug that Parkinson’s specialists know works, but that needs to be saved for as late in the disease as possible because of the side effects it will begin to cause within a few years of being treated with it on a regular basis. Without the drug, I am essentially non-functional. And with drug, I am functional now, but face a certain reality that it’s effectiveness will begin to deteriorate within a few years, & the side effects will become as much of a problem as the disease itself. There are “newer” & supposedly “better” drugs for PD on the market now & approved by the FDA. However, my body has rejected all of those.
In July, my neurologist, a well-known specialist in the field of Parkinson Disease, suggested that I go ahead and process the paperwork to purchase rasagiline from Israel via a reputable Canadian pharmacy. Rasagiline has not yet been approved by the FDA, & when it is, it will be called Azilect. It was released by Teva Pharmaceuticals in Israel last spring after years of research & development. My doctor already has several patients who are on it with no problems & it was his opinion that I would be a very good candidate as well. He was also hopeful that it would help me with symptoms that continue to break through even on my current medications, as well as possibly reduce the dosages that I need. We had hoped to wait until it was approved by the FDA, but it is taking entirely too long. My husband & I decided to go ahead and purchase the drug. We could purchase enough for three months, & hopefully by the end of that time, rasagiline would be approved & I would be able to purchase it here in the USA, through my health insurance.
On August 3, 2005, I processed my paperwork & prescription through Total Care Pharmacy, Ltd. – a licensed Canadian pharmacy. It was supposed to take three to five weeks for me to receive the drug through the mail. On September 1st, instead of my drug, I received a form letter from the FDA, stating that my order, shipped from Barak Pharmacy in Tel Aviv, had been detained on August 24, 2005 for the following reason:
FD&CA Section 505(a), 801(a)(3); UNAPPROVED NEW DRUG The article appears to be a new drug without an approved new drug application. Drug is available in the US and, therefore, not permitted for personal importation.
Not only does this statement appear to contradict itself, but the second half clearly is false with regard to the drug I was trying to import. The letter then told me that I had until September 14th to provide documentation that would enable the drug to be released to me, although it did not tell me what documentation I needed to provide. It did give the name & contact information for the agent responsible for my case: [SUPPRESSED NAME OF HEARTLESS UNCARING BUREAUCRAT], Compliance Officer for the District Director of Customs at the FDA office in Jamaica, New York.
After conducting some research, I discovered that under the FDA's Personal Importation Policy, FDA has authorized its inspectors to use their enforcement discretion to allow U.S. residents to import certain products under certain limited conditions. I’m sure that I don’t need to tell you what those conditions are. It was all new to me, but from what I read, my situation clearly met the conditions for personal importation. It was also clear that because [HEARTLESS UNCARING BUREAUCRAT] did not even bother to find out that this drug is NOT available in the US, I believe she improperly used her discretion in the detainment of this drug.
But this was only the beginning of my nightmare. I tried contacting [HEARTLESS UNCARING BUREAUCRAT], as the letter I received told me I could do. I tried contacting her repeatedly by email, telephone messages & FAX for almost two weeks without any response. On September 13th, I tracked down & called you, [BOSS OF HEARTLESS UNCARING BUREAUCRAT], because I understand that you are [HEARTLESS UNCARING BUREAUCRAT'S] supervisor. Your assistant called me the same day, which I appreciated. Then [HEARTLESS UNCARING BUREAUCRAT] miraculously called me the very next day, which was the deadline for me to present evidence that my drug complied with the law. The first thing that [HEARTLESS UNCARING BUREAUCRAT] did was to whine to me about her huge backlog of cases & how she just couldn’t get to all of them right away. Here I am, being denied a medication I need, & she wants me to feel sorry for HER! I have to admit that I gave her a piece of my mind, letting her know that maybe she would not have such a large caseload if she bothered to find out that the drug is not available in the US.
At first, she argued with me that the drug IS available in the US. But she finally looked it up & confirmed that she had been wrong. She then proceeded to tell me that my drug may have been one that had been sent to the lab for analysis. So before I could even try to claim the drug, I needed her to find out if it had already been partially destroyed, even though the date for me to claim the drug had not yet passed. Fortunately, she was able to locate the drug in tact that same day. This was the only thing she did in this entire case that showed any sense of urgency or compassion on her part. I guess the lab has a huge backlog too, & the drug had not been touched. She phoned me after that with instructions on the exact documentation I needed to provide in order to claim my shipment.
I had already sent her a detailed letter explaining why I was importing this drug, & I had Faxed a copy of my prescription. According to what I had read, this information was all that I should have had to provide. However she said that I had to have a letter from my doctor in addition to my letter & the prescription. The letter would have to explain why my doctor wants me to take a drug not available in the USA. I don’t know why the notice I received in the mail didn’t just explain what I needed to provide for documentation, but at this point, I just tried to comply by letting my doctor know that I needed a letter as quickly as possible.
It only took a couple of days for me to get the letter from my neurologist. On Friday, September 16th, I Faxed his letter, along with my prescription, and a letter from me, to [HEARTLESS UNCARING BUREAUCRAT]. Since it was Friday, I didn’t expect her to receive the FAX until the following Monday. On Monday, the 19th, I emailed [HEARTLESS UNCARING BUREAUCRAT] to follow up on my FAX. She claimed she had not yet received it & that she would not receive the FAX until it had been logged. On Tuesday, I Faxed the whole thing again with an urgent note to get it to [HEARTLESS UNCARING BUREAUCRAT] ASAP. On Wednesday, I emailed her again. She did not reply. Finally on Friday, the 23rd, I received the following email from [HEARTLESS UNCARING BUREAUCRAT]:
[My Wife], this package will be mailed out to you on 9-26-2005 by Investigator [BUREAUCRAT]. Sorry for the inconvenience and have a nice weekend.
At that point, the FDA had been holding my drug for a month. To her, it was just a mere inconvenience.
On September 29th, I received another notice from the FDA. This time it stated that my drug had been denied & would be returned from where it came. When I finally stopped hyperventilating, I checked the dates on the letter, it appeared that it may have gone out before [HEARTLESS UNCARING BUREAUCRAT] released my shipment to me. Since it could have been an automatically generated letter, I emailed [HEARTLESS UNCARING BUREAUCRAT] asking her to confirm that the drug was, in fact, in route to me. She responded that it had been shipped & that any letters I might receive before I get the package should be disregarded. However, she also added the following:
Please do not say to your friends you received your drugs from FDA. Your drugs were released to you on the basis that it is not available in the USA and you submitted the necessary paperwork.
The emphasis in the above quote is hers & not mine. In other words, she has admitted in writing that the drug is not available in the US & therefore was detained under false pretenses. It also confirms that I turned in all of the required paperwork.
I wish that I could say that my story at least has a somewhat happy ending – that being my having finally received the prescription released to me by [HEARTLESS UNCARING BUREAUCRAT]. However, it has now been three weeks since my drug was supposedly released & mailed to me. Even the US Postal Service can get a package from Jamaica, NY to Dallas within that amount of time. However, it has STILL not arrived. I suspect it was either destroyed or returned to Israel. If it was mailed, I doubt it was done with any kind of tracking on it. Of course there’s always the possibility it is just sitting in Investigator [BUREAUCRAT’S] office in a pile, whoever Investigator [BUREAUCRAT] is. I have no idea why [HEARTLESS UNCARING BUREAUCRAT] didn’t make sure this package was mailed herself. I even offered to pay to have it over-nighted to me – an offer she never acknowledged.
The FDA & the federal government would have me believe that they are somehow protecting me by denying entry of pharmaceuticals from outside of the US. In this case, they are doing me harm by withholding it. My doctor has several other patients who also had rasagiline confiscated for the same bogus reason, although I don’t know who the officers were in those cases. Apparently, I am the only one who bothered trying to wade through the FDA’s red tape. But if my drug was being detained for illegitimate reasons to begin with, why was I forced to jump through hoops in order to try & claim it? Or better yet, why was [HEARTLESS UNCARING BUREAUCRAT] not capable of checking first to see if the drug should have been detained at all? To me, my rights as a US citizen have been improperly denied due to the neglect, if not outright abuse of personal importation policy, by Officer [HEARTLESS UNCARING BUREAUCRAT] on behalf of the FDA.
I am writing in defense of my rights, as well as the rights of all the Parkinson’s patients I know of who are also being denied the importation of the same drug. I guess I have no choice now, but to wait for FDA approval. I certainly don’t want to try importing the drug again & risk repeating this nightmare. I realize there is probably nothing you can do to help me at this point. And while it won’t change the outcome of my case, or help my medical situation one single bit, I personally hope you toss [HEARTLESS UNCARING BUREAUCRAT] out on her tail. Maybe then I will have saved someone else from having the same experience, & would at least know that all of my time & trouble hasn’t been completely for nothing. Please let me know if there is anything else I can provide which will enable you to properly investigate this case.
I understand what the FDA is trying to do. Still, these are real people they impact. It is real damage they're doing.
Here is the FDA approval process...
http://www.phrma.org/newmedicines/newmedsdb/phases.pdf
That's a sad story. I personally believe that the FDA should allow unapproved drugs to be sold, with a notice telling the patient that the drug has not yet been approved.