The United States Food and Drug Administration (FDA) acts as the caretaker of the public, working to help bring new drugs to market while protecting the health and safety of the American population. Drug companies create a mountain of paperwork and steps that required to successfully bring a drug to market, a costly endeavor that is possible only for the largest and most well financed companies. The biggest criticisms against the FDA are that it fails to bring promising drugs in a short enough amount of time, and that it turns a blind eye to helpful treatments shown in studies that don't follow its protocol. But the stakes are high. And doctors are taught to follow The Hippocratic Oath, which says, "I will¬†prescribe¬†regimens for the good of my patients according to my ability and my judgment and¬†never do harm¬†to anyone." So when another product was shot down by the FDA, despite visual benefits, one has to evaluate the entire picture to have a measured response. Alimera Sciences was notified by the Food and Drug Administration (FDA) that two more clinical trials would need to be conducted to proved that their new drug, Iluvien is safe and effective for diabetic macular edema. This ruling by the FDA will result in a multiyear delay if Alimera would choose to proceed with the new trials and would necessitate a large investment of capital which Alimera does not currently have. Iluvian is a tiny tube which is implanted into the eye and releases low daily doses of fluocinolone acetonide (a steroid) for up to three years. Laser treatments are the current standard of care to halt or slow leaking blood vessels in the retina. Side effects from the laser treatments include partial loss of peripheral and night vision. While Alimera believes that Iluvien has a manageable risk to benefit ratio, the FDA decided that the risks of side effects were substantial and the benefits of the drug did not outweigh those risks.
Is the FDA the Bad Guy when a Beneficial Drug fails to get approved?
- by Dr. Paul Krawitz
- 13 December, 2011