Average FDA Approval Time for Regulatory Reviews

How long does it typically take the US Food and Drug Administration to complete the regulatory reviews of proposed new medications?

a. 306 days

b. 326 days

c. 346 days

d. 366 days

Answer: a

Is that faster than you thought? You’re not alone. Despite widespread perception that drugs drip instead of flow through the pipeline, the U.S. Food and Drug Administration (FDA) is doing an excellent job of balancing speed and safety in the review and approval of new medications, according to Joseph Ross, MD, MHS, an associate professor at the Yale School of Medicine. His recent review of therapeutic agents approved by the FDA and the European Medicines Agency (EMA) between 2011 and 2015 showed the FDA’s regulatory reviews were, on average, 60 days shorter than those done by the EMA. The results were published as Scott Gottlieb, MD, the nominee to run the FDA, implored the federal government to develop a faster drug approval process.

Dr Ross said the FDA is between a rock and hard place: The public and industry want drugs approved as quickly as possible, but only if they’re safe and effective. He pointed out that the FDA is already the fastest regulatory agency in the world and wondered why there is persistent pressure from the public, politicians, and industry to accelerate the review and approval of new medications.

It takes time and careful attention to approve safe and effective medications, said Dr Ross, who added that speeding up the FDA regulatory review risks undermining the process. He said it takes time to review pertinent clinical data and make evaluations to approve safe and effective drugs as quickly as possible, and the FDA is appropriately balancing those competing priorities. Dr Ross added that the FDA should not accelerate its approval of new drugs as long as the current process, speed, and regulatory pathway are not compromising patient safety.

—Dan Cook