A draft guidance that the Food and Drug Administration published Tuesday could revive a debate about a drug approved last year to enhance the female libido. At the time of the approval, many observers questioned the FDA’s decision and doubted that the drug actually works. Now, some of the same critics are wondering whether or not the product, called Addyi and nicknamed the “female Viagra,” would even live up to the agency’s newly proposed criteria.
For instance, the draft guidance suggests that patients participating in clinical trials should frequently record key signs and symptoms “to minimize inaccurate responses resulting from problems” with a patient’s ability to recall past feelings. The guidance doesn’t specify just how long the recall period should be, but it hints that a shorter one is more desirable. “The longer recall period may increase noise in the assessment making it more difficult to detect or interpret change during a trial. With a longer recall, it is also possible that subject recollection could be more heavily influenced by other experiences or by more recent experiences,” the guidance says.