Regulatory Focus™ > News Articles > FDA’s Jenkins on Decline in New Drug Approvals in 2016: Not due to Standards Shift

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Posted 04 November 2016 | By Zachary Brennan 

FDA’s Jenkins on Decline in New Drug Approvals in 2016: Not due to Standards Shift

With less than half the number of new drugs approved in 2016 (19 so far) when compared to 2015 (45 total), John Jenkins, director of the US Food and Drug Administration’s (FDA) Office of New Drugs, told attendees Friday at a Prevision Policy conference in Washington, DC, that the decline has not been due to a shift in the agency’s standards or policies.

“There are fewer applications in front of us to act upon,” Jenkins said, noting that although he cannot discuss individual applications, a handful of the complete response letters (CRLs) issued in 2016 were due to good manufacturing practice (GMP) deficiencies and the need for FDA to conduct inspections.

Very few of the CRLs for new molecular entities were because of a failure to demonstrate efficacy, he said. Jenkins also noted that five approvals in 2015 had goal dates in 2016, so that’s another factor in the lower approval rate.

But Jenkins did say that there has been an uptick recently in the number of applications received, meaning the number of approvals could increase in 2017.

As far as staffing woes at FDA (upwards of 800 vacancies) and its impact on the agency’s ability to approve new drugs, Jenkins said he doesn’t think the decline in approvals is related to a manpower issue.

However, as he’s said previously, “There’s no doubt the breakthrough therapy program has increased our workload.”

He pointed to the almost 400 breakthrough requests FDA has seen over the first four years of the program, including over 50 approvals while noting that a unique feature of the next iteration of the Prescription Drug User Fee Act (PDUFA VI) will hold the agency accountable to hiring the people needed to do the work.

In terms of FDA’s ability to adapt quickly under its current framework, Jenkins said the agency is flexible, and that comment was echoed later in the conference by Richard Pazdur, acting director of FDA’s Oncology Center of Excellence (OCE), who said that with cancer treatments, the agency is intimately involved with applications even before they come in. Sometimes, he added, the office knows what it will do with an application even before it comes in.

And on the topic of patient engagement, Jenkins said he’s seeing a shift toward patient meetings FDA can participate in, provide guidance for and best practices for convening them. In addition, FDA needs to collect data and opinions on these meetings, analyze it, and interact with other regulators and industry to ensure they have a positive impact on drug development.


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