We all know that just as every person is different, so too is every disease and every drug. And so we weren’t surprised by the results of a new study published in the Journal of the American Medical Association.

The study found that the FDA used a range of clinical trial evidence when approving 188 novel therapeutic drugs for 208 indications (uses) between 2005 and 2012. These results are entirely consistent with our regulatory mandate. We believe varying approaches to clinical studies to support drug approval is good news, not bad.

Data to support the approvals studied were based on a median of two pivotal trials per indication. A pivotal trial presents the most important data used by the FDA to decide whether to approve a drug.

But when the authors looked more closely, they found that more than a third of these drugs were approved on the basis of a single pivotal clinical trial, and other trials involved only small groups of patients for shorter durations. Of the approvals studied, the new drug was compared with existing drugs on the market only about 40 percent of the time.

 …