I've tried this along with my doctor before, while drugs were in Phase 2 of trials and was denied by Vertex. However, maybe now that they are in their final phase, they may relent.. It may be worth a try for those of you who's backs are up against the wall and need the meds ASAP. At any rate, below is the response from the FDA...
Mag
Thank you for your message to the Division of Drug Information at the Center for Drug Evaluation and Research (CDER), within the Food and Drug Administration (FDA).
We sympathize with your situation and appreciate the time that you have taken to contact us.
Outside of a clinical trial, the only mechanism for a patient to legally obtain an unapproved drug is through a Physician Request for an Individual Patient IND (Investigational New Drug) application under Expanded Access for Non-emergency or Emergency Use ( commonly referred to as "compassionate use"): http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm107434.htm
Please note that the physician must be willing to undertake the necessary responsibility and adhere to the FDA's regulatory requirements, but the manufacturer must also be willing to make the drug available for the individual patient IND. The physician should first ensure that the manufacturer of the unapproved drug is willing to provide the drug. If the manufacturer agrees to provide the drug, the physician should submit an IND to the appropriate review division.
If the physician needs further general direction, he can reach this office at 1-301-796-3400 or 888-INFO-FDA.
Best regards,
Drug Information BLS
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration