If all goes well, in 2014 the medical community and patients will know whether midodrine hydrochloride really works to treat symptomatic orthostatic hypotension. This knowledge will come 18 years after midodrine's approval and 4 years after the US Food and Drug Administration (FDA) threatened to remove the drug from the market because no postmarketing studies had been conducted to prove the medication's efficacy.
This long journey to proving efficacy gives ammunition to critics of the FDA's drug approval process, who argue that regulatory loopholes allow medications whose true benefits are unknown to be available to patients.
Mitka M. Trials to Address Efficacy of Midodrine 18 Years After It Gains FDA Approval. JAMA. 2012;307(11):1124-1127. doi:10.1001/jama.2012.291