Anyone Else See a Problem with This?
The Wall Street Journal has an article on FDA’s rejection of bifeprunox, a schizophrenia drug from Wyeth. The company plans to resubmit its application with more data and believes the product will eventually be approved. All in all, a pretty standard story, but here’s the passage that really caught our eye:
“Just 20 percent of new drug applications are approved during the FDA's first review cycle, [Wyeth] says.
“The FDA puts the number at about 25 percent for standard applications, though the percentage varies from year to year. Ultimately, about 75 percent of new drug applications win marketing approval, the agency says.”
In other words, FDA’s own statistics indicate that two of every three drugs that are ultimately approved suffer from some sort of regulatory delay. These delays can be caused by just about anything from manufacturing problems to disputes over labeling. Withholding approval until these outstanding issues are resolved is clearly the right course of action.
However, the majority of long-term delays are caused by what boils down to a conflict over interpretations of clinical trial data. Given that an application was submitted, we can assume that the sponsor believed its clinical trials demonstrated an acceptable level of safety and efficacy. Nonetheless, FDA’s most common response is to tell the sponsor to get more data. This means higher development expense and lost sales revenue for the company and delayed access to new therapies for patients. Additional clinical trials also reduce the population available for other studies and raise, or should raise, ethical concerns about treating a control group with placebo when a safe and effective option is available.
Keep in mind, we’re talking about drugs that are eventually approved. If the goal of FDA review is to identify which drugs are safe and effective, then denying these drugs on the first round amounts to a false negative.
It is undoubtedly true that some trials are poorly designed, some manufacturers try to slip less than conclusive results past regulators and sometimes issues arise after an application has been submitted that warrant a request for additional information. But if two out of three drugs which are, in fact, safe and effective have to go back for further testing, then there’s something wrong with the approval process. The standards are either unclear, poorly communicated or subject to overly variable interpretation.
Neither FDA nor the clinical trials industry are in their infancy. Surely, at this point, there is some way to ensure that a higher portion of safe and effective drugs are approved during the first round.