Saturday, December 6, 2008

Hi Team Iplex,

Hi Team Iplex,

I have attempted to explain the process by which Iplex will be distributed in the USA. I am still unclear about out of country delivery of Iplex, and will follow up with Christine O’Neal first thing Monday to try to establish what the protocol for members of Team Iplex outside of the USA will be.I have set first to explain some of the language, which may be unfamiliar to some of us, with links and definitions. For those of you in the pharmaceutical industry, please jump in and fill in any missing links, and please feel free to try to simplify my definitions if you see a way to explain this more clearly. In brief, as many of us are aware, Iplex will be available in the USA by a process called a single patient IND, also commonly called Compassionate or Emergency use. This is a process which sounds very complex, but in reality is nothing more than a lot of paperwork, don’t be alarmed or frightened by it, it’s just paperwork…One of the first questions I have had is cost. When a drug is accessed by a single patient IND the FDA allows the drug manufacturer to recoup reasonable costs only. When I spoke to Christine Friday, she indicated that cost had not yet been set. I have no idea at this time what the monthly costs will be. Many also want to know about insurance reimbursement. At this point, I feel that insurance reimbursement is highly unlikely. I do not know of any insurance company that will pay for any of the costs associated with a single patient IND – that includes associated MD visits, labs, etc. I wish I had better news to report, but this is the unfortunate facts of the matter. A Single patient IND (again, AKA compassionate/emergency use) requires the approval of an IRB. Most of us aren’t familiar with what an IRB is. Here is a brief definition, as supplied by a Wikipedia link and my definition.Institutional Review Boards (IRB's): http://en.wikipedia.org/wiki/Institutional_review_boardEvery hospital/teaching facility that does research involving human subjects must have an IRB that initially reviews/approves proposed research. An IRB protects the ethical interests of humans involved in trial studies. Before it will approve a single patient IND, the IRB will determine that a our risks are reasonable in relation to anticipated benefits – as Iplex is already FDA approved, and has passed rigorous safety testing in other diseases, this shouldn’t be a very complex process. The FDA has already approved this process for Insmed, so their role should be simply shuffling of papers, I don't expect lengthy reviews on their end.Now, many of you may have physicians who are not affiliated with a teaching hospital, or do have a physician who conducts research and has association with an IRB, but who won’t write for Iplex, and are curious about what you can do to access an IRB. Fortunately for those of you, there are independent IRBs. One of the larger independent Institutional Review Boards that may be accessed by physicians not within the realm of academia is Western, their website is here http://www.wirb.com/. There are fees associated with this service, I cannot comment on the pricing, but would suggest you contact Western, or do a web search to locate any independent IRB. Your private physician may also be familiar with an independent IRB, and already have a established relationship with one?So, in summary, here is the process for a Single Patient IND, there are several forms which will be filled out, submitted to the FDA by your doctor, once all of the t’s are crossed and the I’s dotted, the drug will be shipped to your doctor. In my experience with government bureaucracy – it is important the forms be filled out completely and accurately. This is what you should expect your doctor to submit to the FDA.Request for a single patient IND for Compassionate or Emergency Use should be stated at the top of the correspondence. Brief Clinical History of the patient including the diagnosis, the disease status, prior therapy, response to prior therapy and the rationale for requesting the proposed treatment. Proposed Treatment Plan including the dose, route, planned duration, monitoring procedures and modifications (e.g. dose reduction or treatment delay) for toxicity. Reference a published protocol or journal article if appropriate. Drug Supply Reference Statement which would name the supplier or manufacturer and a statement that a Letter of Authorization to cross reference an appropriate IND of the supplier or Drug Master File (DMF) of the manufacturer is included. The treating physician must contact the supplier or manufacturer for such a statement. Informed Consent Statement that states that informed consent and approval of an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment. There are some IRBs that have specific procedures for approving emergency requests. Investigator Qualification Statement that specifies the training, experience, and licensure of the treating physician. The first two pages of a Curriculum Vitae (a fancy name for resume) typically contain this information and are usually sufficient. FDA Form 1571 completed with the treating physician listed as the sponsor. Form 1571 and other forms can be downloaded from the Internet. Contact telephone number and facsimile number. If the request is approved, an IND number will be issued by the FDA and the treating physician will be contacted by phone or fax with a letter to follow. The IND is considered active upon issuance of the number. The IND sponsor (treating physician) will then contact the drug supplier and provide the IND number. The supplier may then ship the drug directly to the treating physician.Please feel free to email or call me if you want me to try to explain better. I have never been accused of being a good teacher, I apologize if this isn't as clear as it could/should be - but will be happy to answer any questions to the best of my ability.Andrea--"Being deeply loved by someone gives you strength, while loving someone deeply gives you courage." Lao Tzu Taoist Philosopher,600 BC-531 BC

2 comments:

Anonymous said...

hi drew pals in nj do you think you are going to get this if so can you give me some help my dr andrews at columbia in nyc said no so looking to get this maybe you or someone reading this can help tried to contact wirb like the blog said they said they cant help
thanks rich horling
cars51391@aol
908 380 7391

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