You are the CEO of Biobigtech, Inc. (BBT), a Delaware corporation HQed in the NC Research Triangle which specializes in cutting-edge "orphan" pharmaceuticals for rare and specialized diseases. It is a very lucrative business thanks to your federal income (half of the company's gross profit comes from a combination of Medicare/Medicaid payments and various federal grants and price supports for orphan drugs), but recently, BBT has run afoul of the Food & Drug Administration (FDA) with some of its directed marketing to physicians regarding claims about the capabilities of BBT's top-selling product, Xaxitol. FDA has regulatory authority over all marketing of prescription medications, such as this one, under the Food, Drug & Cosmetic Act (FDCA). It has sent BBT a warning letter about the sales force making "unsubstantiated claims" that Xaxitol can make patients feel better in as little as 3-5 days without going into any more depth about the subject; FDA points out that according to your own data, submitted in drug trials, less than one-tenth of one percent of test subjects felt better in between 3-5 days; the overwhelming majority actually felt worse on a subjective (personal opinion) scale for the first two months of taking the medication before feeling some relief from both their disease and the side effects of the medication. FDA also objects to your using anecdotal (non-scientific) subjective data to make these claims rather than hard science, and reminded BBT in its warning letter that its "full disclosure" (or "fair balance") rule imposes a duty upon drug manufacturers to disclose all known benefits and risks of a drug in marketing and representation to the public at all times.

You are upset by the warning letter, believing that this is America and you should have a right to say what you want, within reason, about Xaxitol. The stakes are high in this fight, however, because if you don't take all the corrective action FDA demands within 30 days, you run the risk of having Xaxitol declared unqualified for Medicare/Medicaid, and all federal grants for all drug projects within the company may be suspended or canceled as well for failure to comply with a corrective order. Half of your company's income can be gone overnight.

Identify and discuss at least three elements of planned response (or what you would at least consider as options) from the material (Chaps 1-5, plus 11) we have completed in the course to this date and describe how it fits in to your response thinking to the FDA as CEO of BBT.