Research Suggests That FDA Approvals Are Not “Too Slow”

A recent analysis in The BMJ found that a popular claim—that FDA drug approvals are too slow as a result of excessive bureaucratic regulation—may be unwarranted.

“Empirical analyses have shown the US Food and Drug Administration gets drugs to market faster than other major regulators,” Thomas A Marciniak, MD, a retired medical team leader at the FDA, and Victor Serebruany, MD, of the HeartDrug Research Laboratories at Johns Hopkins University, wrote in their analysis. “Still the agency finds itself the perpetual target of criticisms that it is too slow.”

Drs Marciniak and Serebruany sought to determine the speed at which the FDA approves cardiorenal drugs, and whether such approvals could be sped up while maintaining patient safety. They noted that the FDA’s cardiorenal division is notorious for being the Agency’s “least efficient” or slowest in terms of approvals.

In their analysis, Drs Marciniak and Serebruany explained that the excessive time between application and approval is often the fault of pharmaceutical companies, not the FDA.

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“This crude depiction ignores industry's contribution to the clock after clinical trials are completed but before the FDA receives the formal application,” they wrote.

They reviewed the submission and review timelines for 15 new cardiorenal drugs that took place between 2011 and 2015.  Results showed that timelines varied significantly, with a standard deviation of 1 year.  Some drugs took as little as 4 months from the time clinical trials wrapped to the time the drug was submitted to the FDA for approval, while others took as long as 51 months.

The researchers explained that during this time, pharmaceutical developers take time to analyze data and write a final trial report. However, they pointed to the drugs that only took 4 months as proof that this process does not need to take excessive amounts of time.

When the researchers examined the FDA’s portion of the approval process, they found much less room for improvement. Results showed that the standard deviation for the FDA’s scientific review and decision to approve timelines was only 2 months.

Drs Marciniak and Serebruany also pointed to resubmissions as a cause for an excessive time-to-approval. They noted that the blame for this time burden could be the fault of both the FDA and the drugmakers.

“On the one hand, the drug sponsor should have identified the trial problems before submission and acted on them,” they wrote. “On the other hand, closer collaboration between the sponsor and FDA during the initial submission might have facilitated first round approval.”

—David Costill