Jamaican scientists Dr. Henry Lowe and his research team have developed a break-through drug for the treatment of acute myeloid leukemia (AML). Dr. Lowe has now received an orphan-drug designation for his discovery from the Food and Drug Administration (FDA) in the United States. The news was made public by Dr. Lowe, who has characterized the development as historic and noted that it offers Jamaica the potential for receiving over US$250 million over a three-year period just from the US market. According to Dr. Lowe, this is the first time anyone from a developing nation has accomplished the feat of beginning with the isolation of a bioactive molecule to ultimately provide a new drug from scratch that is then recognized by the FDA. He noted that the FDA is the top regulator and approval agency of foods and drugs in the world, Dr. Lowe is well known for using Jamaican plants like ball moss and cannabis in his cancer research. He received notification of the FDA approval in June of 2017. The FDA sent a letter to Dr. Lowe’s company Flavocure Biotech stating that it decided to grant the request for the orphan-drug designation under the provisions of the Federal Food, Drug and Cosmetic Act’s Section 526. It is significant that the FDA designation as approved is “broader” than that proposed by the firm in its request. The US Orphan Drug Act (ODA) permits granting a special status to drugs or biological products designed to treat rare diseases or conditions upon request by a sponsor.