Full article reprinted from "The Pink Sheet" December 14, 2009
The last two fiscal years have seen great gains in the number of new employees hired in FDA's Center for Drug Evaluation & Research, but the result is a relatively under-experienced staff: 38 percent of employees in both CDER and the Office of New Drugs have less than two years of on-the-job experience. Read on...
Full article reprinted from "The Pink Sheet" December 14, 2009
For an agency that has been severely understaffed in recent years - to the point where reviewers were encouraged to miss user fee deadlines to manage their workloads - the additional hires and the new funding that paid for them was a welcome relief for both FDA and industry.
But CDER also depends heavily on institutional knowledge and the expertise of its review teams to approve and regulate new drugs and biologics. And so while a more fully staffed agency is good news for FDA and its stakeholders, over the short term it means relatively inexperienced review teams.
Managing the influx of new hires is a significant challenge for senior CDER officials. "We've seen a significant net increase in our staffing over the last couple of years, probably pretty unmatched in government right now, except maybe the Defense Department," Office of New Drugs Director John Jenkins said during a keynote address at Elsevier Business Intelligence's FDA/CMS Summit for Biopharmaceutical Executives on Dec. 3.
"There are a lot of new people, which is good. There are also a lot of inexperienced reviewers, which means it's going to take time for them to come on board and really have a full impact," Jenkins acknowledged. "The full impact of all these new staff will probably not be seen for a couple of years."
Tight Quarters At White Oak
The change in staffing over such a short period of time appears unprecedented - at least for the current CDER leadership. Over the last two years, CDER has seen a 34 percent increase in the number of full-time equivalents, or 760 new hires. The Office of New Drugs has swelled by 26 percent, or 193 full-time equivalents.
In fact, the staffing increase is so extreme that CDER is overflowing its space in FDA's White Oak, Md. facility, just four years after the center's review teams moved onto the new campus.
"While we have a beautiful new campus at the White Oak facility, CDER space is now full," Jenkins said. "We've had this great recruiting success, and we're out of space. So as we continue to bring on board new staff with any increased funding, we're struggling to figure out how to manage that. There's even discussion about having people double up offices."
Experiencing Inexperienced Reviewers
But apart from the physical challenges posed by the influx of new hires, there are significant management hurdles to overcome. CDER reviewers learn on the job from their peers, so while new hires are being trained, many drug sponsors could be working with individuals who are reviewing their first applications.
"This is a bit of a new phenomenon for us. To have so many new staff at one time is something that we weren't fully prepared for," Jenkins admitted. "We're really trying to catch up on the idea that we have a lot of people we need to train."
While CDER has always had structured training for new hires, "it has been scattered and not a curriculum that new people follow," Jenkins said. Much of the training is practical experience, a "watch it, learn it, do it" model. Depending on the review team, a new person "may learn to do it well, or may learn to do it not so well."
There are many interactions between a project manager and a drug sponsor that "occur in isolation" and are not vetted by upper management. So unless senior officials happen to hear about it, "there can be not-so-great advice being passed along," Jenkins acknowledged.
CDER is trying to become more systematic in its training processes, but it is difficult given the number of new hires. "We have a lot of new people out there on the front lines," Jenkins said. "We have to do what we can to train them."
While CDER gets its new hires up to speed, drug companies can also do their part, Jenkins said. "If a project manager is telling you something that is so different from anything you've ever heard before, you've got to have the guts to speak up," he advised. "And if you're not getting success, you need to go to a higher level."
"We do have a dispute resolution process, and I've presented data before that show that for our dispute resolution process, about a quarter of the time we grant relief to the party that is disputing our action. So we can change our mind if we see good arguments for why we made a mistake."
A Silver Lining For Drug Sponsors?
While industry should expect to deal with inexperienced reviewers for the foreseeable future, there is one silver lining: the new hires are coming on at the time when OND is changing the process by which it reviews product applications, and the new hires are adapting more quickly to the process.
Overall, the "21 Century Review Process" is good news for industry: the "good review management practices" are intended to smooth out reviews of new applications that historically have been jammed into the final months before a user fee deadline. Jenkins expects that implementation of the new process will ultimately result in more first-cycle reviews.
The program has ramped up significantly since it was first piloted in FY 2008 with one application per review division. In fiscal 2009, the process was used to review all novel NDAs and BLAs (about 30-35 applications). This past October, CDER started adding all efficacy supplements requesting an expanded indication (120-150 applications).
When it comes to implementing the new review process, experience isn't necessarily playing in industry's favor. The new hires are adapting quickly to the earlier review milestones, Jenkins said, while the legacy employees are having a harder time adjusting.
"Change of such a complex process is very hard, and we've found that our more experienced staff have more trouble changing than our less experienced staff, because they are used to doing it one way, and now they are being asked to do it a different way," he said.
On the other hand, reviewers with less experience may be more conservative in their regulatory decision-making than reviewers who have been through the process more often. As reviewers gain more experience, they tend to have more confidence about their decisions, and may be more likely to accept an idea from a drug sponsor that is a bit out of the box.
- Kate Rawson
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