No. In many clinical trials, approved drugs are used as concomitant therapy for subjects during the trials but are not part of the clinical trial evaluation. For example:

• patients may be required by a protocol to take certain approved drugs as concomitant therapy before or during the trial (e.g. patients may receive antihistamines for immune response concerns in a clinical trial to study a recombinant protein, in order to mitigate potential risks of participation in the trial; or all patients may receive concomitant therapy before randomization to either the investigational drug or placebo) or
• patients may be permitted by the protocol to continue taking certain approved drugs as concomitant therapy during the trial because such drugs are not likely to interact with the study drug(s) or otherwise confound the results of the trial (e.g. pain medications for patients in a clinical trial to study a drug intended to treat cancer) or because discontinuing the drug might adversely affect the patient.

In accordance with 21 CFR 312.8, a sponsor must obtain prior authorization from FDA to charge for its investigational drugs, including investigational uses of its approved drugs. However, FDA regulations do not require a sponsor to obtain prior authorization to charge for its own approved drug when that drug is used as concomitant therapy for an approved use and is not part of the clinical trial evaluation.

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