On Friday, the FDA reversed its decision from two weeks prior to withdraw the drug midodrine from the market following strong protests from patients. The FDA approved the drug, manufactured by Shire Pharmaceuticals, through its accelerated approval policy in 1996, but initially decided to take it off the market when Shire failed to provide followup studies proving its efficacy. Midodrine is used to treat postural orthostatic tachycardia syndrome, which causes a severe drop in blood pressure from blood pooling in the legs when standing up, leading to fainting and dizziness.
“It seems that the FDA will yield to consumer pressure, so if you want a drug to be approved or re-approved, just have your colleagues march on the FDA,” ACSH's Dr. Elizabeth Whelan sarcastically remarks.
ACSH's Dr. Gilbert Ross also expresses concern over consumers’ ability to directly affect FDA policy. “While I have nothing against allowing midodrine to remain on the market, I’m concerned that this particular drug and these particular groups can have an effect on this supposedly stringent regulatory authority of the FDA. It seems rather arbitrary to grant this reintroduction into the market while withholding approval for other drugs that, while not yet shown to be safe and effective for large numbers of patients, may benefit for smaller populations.”
