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Articles by Daniel Berger MD published in Positively Aware
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FDA Says NEW-FILL Personal Use On Hold
Daniel S Berger MD
However, after several months of smooth sailing with primarily trained plastic surgeons at a small but limited number of centers around the US, almost by surprise, the FDA interceded and halted its use. A recent comment made by an un-named HIV practitioner was it appears that the FDA managed to find a loop hole vehicle by which to interfere with personal wishes of individuals who suffer from the devastating facial atrophy side effects of antiretroviral therapy. Clearly it was the FDA themselves whose policy allows treatment for personal use, given that a drug is approved outside the US.
The October 26 action of the FDA halted all further distribution of New-Fill in the U.S.; therefore, the buying club DAAIR was in effect ordered to not release any more product for shipmentthis included shipping New-Fill to those that had already initiated treatment and were still in the process of having the 3-7 administrations needed for NewFill to be completely effective. Ultimately, through lobbying efforts of DAAIR with the FDA, DAAIR is guardedly confident that it can fulfill all shipments of product for those patients previously initiated into treatment with New-Fill prior to October 26th; however, at this time cannot ship product to anyone who would have started the procedures post 10/26/01.
The FDA decision was made by a small group of Directors within the FDA, from such areas as Personal Use and the division of Compliance. The FDA based their decision to halt distribution of New-Fill not because they found fault in issues regarding its safety or effect but rather due to the technical terms of their guidelines of allowing availability. Originally, New-Fill was allowed to be accessed by PWAs under the personal use guidelines. These guidelines permit use of drugs not yet approved here (but approved in other countries) and for the treatment of one of several qualifying illnesses determined by the FDA. Persons suffering from these illnesses (such as PWAs) can import a drug into the U.S. for their individual personal use. The powers to be within the FDA had then decided, upon further examination, that since New-Fill required the expertise of a trained physician and/or plastic surgeon that it no longer should be considered a personal use drug. Moreover, they maintain that it does not remain in full control of the individual utilizing the product so the FDA felt they can re-categorized New-Fill as a medical device.
The FDA does not allow for medical devices to be imported for personal use---all medical devices must be approved prior to use. The example the FDA gave was as follows: This situation would be similar to an artificial heart that was available in Europe but not yet approved for use in the U.S.we, the FDA, would not allow anyone to import that artificial heart and subsequently would not authorize any surgeon to transplant said deviceif that individual wants to access that artificial heart they must travel to Europe and have the procedure done there. The FDA did acknowledge that they would consider a treatment-IND (Investigation New Drug) protocol for New-Fill (a clinical trial)---this however, typically is itself a large administrative burden that can take minimally 3-6 months to complete and usually done by the sponsoring pharmaceutical company.
Many medical specialists can state with confidence that this indeed is not a devise. Yes it requires someone to inject the product, but linking this to heart transplant surgery is quite a stretch. The product comes in a vial such as many other drugs and is simply reconstituted with sterile water or saline, like other drugs. It is drawn in up a syringe and injected. This is not rocket science to perform and does not require any sophisticated or mechanical devises or apparatus.
At this time, DAAIR is still lobbying with the FDA to re-instate the program; they remain confident that it can fill all necessary prescriptions for product to those that had initiated treatment prior to 10/26/01. They should lobby the government for a further inspection of this issue. This vial of unreconstituted drug clearly is not a medical device. If the FDAs edict is left to stand, many affected persons will be wronged and deprived of a medication that can potentially change their quality of life and allow for more individuals to be transitioned back to the work force. If left untreated many patients with severe facial wasting will likely continue in their life of social stigma, slowly progressive downward spiral of low self-esteem, depression and the ultimate affect on daily work performance.
During this writing pans are being set up for a meeting with the FDA. During this meeting Martin Delaney of Project Inform, myself with other interested parties hope to make some sense out of all of these issues. I will try to keep you all posted on this web site as well as in my column in further issues of Positively Aware.
What can be done? Patients can lobby and write their governmental officials regarding FDAs controversial action Additionally, AIDS activists can moblize and encourage further discussion with the FDA. At this time the common belief is the FDA has not truly understood the product, in its entirety. Did other political distractions somehow intruded in its use, i.e. other companies competing with New-Fill for plastic surgery that may have caused the wrongly placed furor?