FDA/CMS Summit Demonstrates Need For Innovative Hiring Solutions
By Rob Wright, Chief Editor, Life Science Leader
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When Janet Woodcock, M.D., kicked of this year’s FDA/CMS Summit for biopharmaceutical executives, the FDA’s director for the Center for Drug Evaluation & Research (CDER) did so by recapping what was achieved in 2015, as well as sharing her lengthy list of priorities for the coming year. According to Woodcock, the challenge to successful implementation of various priorities is analogous to keeping an airplane flying while at the same time trying to fix or improve whatever isn’t working. And though she and her team have done admirably in piloting the organization for the past several years, I wonder how long they can continue to do so. For despite CDER’s significant accomplishments last year (e.g., first biosimilar approval), one priority that hasn’t moved — at all — is the organization’s glaring need for staffing. From a PowerPoint released at the conclusion of last year’s summit, at the bottom of slide four you see a 2015 front burner priority listing of “Improve staffing” that notes over 600 vacancies at CDER.. One year later, Woodcock stated that CDER still has 600 vacancies – (see slide 10 of this year’s presentation)! Now, one could argue that CDER, like most organizations, probably had its share of routine turnover. Perhaps the agency hired more than 600 people last year. But at an organization that employs approximately 3,200 civilians, 600 vacancies represents trying to fly and fix the CDER plane with about 20 percent less staff than you need. Constant pressure in other industries to do more with less has been shown to increase employee burnout. If the CDER employee hiring needle hasn’t moved at all in 12 months (probably longer), perhaps it is time to start asking about what needs to change, because the current approach isn’t working, and employee burnout could further exacerbate the problem.
What Is The Definition Of Insanity?
Albert Einstein is credited with having said that the definition of insanity is doing the same thing over and over again and expecting different results. Perhaps this is one of the reasons for CDER’s inability to fill its employment void. According to Kay Holcombe, SVP of science policy at BIO and panelist at the FDA/CMS Summit, no matter how lofty the goals are for the Prescription Drug User Fee Act they cannot be achieved unless the FDA can staff up appropriately. Though Holcombe says there are a few provisions that could help the FDA with this challenge in the 21st Century Cures Act, the agency is up against an administration issue in terms of working with the U.S. Department of Health & Human Services (HHS) and getting HHS to agree to hire the people they need at a salary commensurate with their expertise and competitive to the private sector.
Another thing the FDA is up against is its extraordinarily stringent conflict-of-interest requirements. For example, if the FDA wants to hire someone who is or has worked in industry, this individual has to divest all financial industry holdings. “That includes people who have been in the industry for a long time and whose 401(k)s are invested very heavily in FDA-regulated industries,” Holcombe noted. This can be a very difficult decision. For even if a person is willing to take a slightly lower salary in the spirit of public service, experienced talent facing the prospect of having to divest their financial future places the FDA and CDER at a decided disadvantage when it comes to recruiting top talent. Though Holcombe shared that nobody seems to know how to address this situation, I would like to propose a possible solution.
Can We Get Government To Think And Act Outside The Box?
If we consider the roots of public service, it is rendering of a service that is in the public interest. If we go away from the notion of the career politician, but think about how folks in days gone by used to take a hiatus from their private sector vocation as a means of serving the public for a few years, and eventually returned to their jobs, how might we facilitate this notion at today’s FDA? First, we need to eliminate the barrier of people having to divest their financial futures. Second, we need to be able to pay these people at a competitive salary that doesn’t break the government bank. Third, we need to create a means whereby industry is willing to part with some of its top talent.
Why not create an industry-sponsored FDA public-service internship program? Here is how it could work. Let’s say someone from industry is interested in gaining or enhancing their government drug-reviewer experience. These people would be allowed to apply for a position as an intern with a specified term limit (e.g., two to three years). If accepted, the intern’s investments would be placed into a temporary trust that they would not be able to make any financial moves within until their public service is completed. Further, as this is a public-service position, the person’s salary, benefits, and so on could be paid by their employer — similar to a college professor being given a paid sabbatical. Other stipulations could be created, such as the individual not being allowed to work on a product sponsored by their company. When I ran this idea past a legal mind, in true lawyer fashion they said, “You could have the person work on a competitor’s product just to slow it down.” I am skeptical that high-character individuals would think of such things, but other stipulations could be devised to prevent this from occurring. Now you may be wondering why industry would want to participate. For starters, the person would be able to bring back a wealth of knowledge to share with their company and peers . In addition, such a program might provide intellectual stimulation to prevent employee burnout. However, perhaps the government could provide some additional incentives that could make such a program even more appealing (e.g., tax credits). If industry isn’t willing to pay the entire salary and benefits, other compensation-sharing models could be developed.
While I am sure there are plenty of road blocks (e.g., non-disclosure agreements) which would need to be addressed to make such a program a viable option to filling CDER’s employment void, where there is a will to make a positive change, it seems certain that we can find a way. But if we continue to approach the problem without trying to come up with new and innovative solutions, it is likely the CDER’s 600 vacancy gap will not remain a constant, but likely get wider.