Center for Drug Evaluation and Research

Index for 1996 and 1997

• To See Ourselves as Others See Us
• Timeliness, Policy Emerge as Top Complaints
• CDER Transformation in Full Bloom
• A Holiday Story from CDER
• When the 'R' Word Rears Its Ugly Head
• Shakespeare's Advice on Career Development
• Building a Career . . . Part Deux
• Learning from Our Successes
• CDER Transformation—Thoughts on Virtuosity
• CDER and FDA Leadership Development Programs
• There's No Substitute For A Caring Manager
• Mediation—Ready for Prime Time
• Innovations Award—Nothing Succeeds Like Success
• Another Year of Ombudsing
• What You Say—Part I
• What You Say—Part II

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To See Ourselves as Others See Us

Well, I've been on the Ombudsman job for over five months. I have talked with folks from the industry and from CDER about the way we interface, and, working with the Office of Training and Communications (OTCOM), I plan to do much more of that. It seems like a good time to share with you some of what I have learned, and I'll continue to do that periodically in this column.

Naturally, from my position as Ombudsman, I hear about and investigate only the cases where there have been serious miscommunications, delays and problems in our operations. If the cases and examples I get were reflective of CDER's normal functioning, we would not have been able to meet our user fee goals. Having said that, I believe we can learn much from our outlying cases, and if we can prevent future problems from happening, we can rob our critics of those prime examples they love to cite. We can also do our jobs better if we understand the problems faced by those with whom we interface.

I am always surprised to hear from knowledgeable people outside the agency that they are frequently mystified about how we operate, why we do many of the things we do or ask the questions we ask. The term "black box" is used by some of them to describe the drug review process. Clarity in communications, timely meetings and scientifically justified requests for additional data, when necessary, are high on the priority list of the people I have talked with. The new MaPP (Manual on Policy and Procedures), "Formal Meetings Between CDER and CDER's External Constituents (#4512)," issued on March 7, covers meetings with external customers and should be of great help in improving communications. (The MaPP will be placed on Internet.) Clearly, the regulated industry and applicants have an insatiable need for solid information about our policies and procedures. The Good Review Practice (GRP) guidelines are eagerly awaited outside the Center as a means of improved consistency in reviews and of a better understanding by the applicants about what we are looking for in submissions.

As science and policies evolve, as procedures change with new technologies and as personnel in reviewing divisions, in CDER management, and in the Commissioner's and the General Counsel's offices leave and are replaced, those who deal with the agency need up to the minute information about these changes. (I have found that need to be shared by our own staff.) In the new drug review area, firms find that, because the life-cycle of an NDA is long, experience gained with one application may no longer be valid when the next one is ready to be submitted. There is no way to avoid the inevitable shifts in the regulatory landscape.

However, we can be sensitive to the serious problems an applicant faces when

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Timeliness, Policy Emerge as Top Complaints

I have been "ombudsing" for a year now, and I'm asked frequently about the nature of the complaints I get. Naturally, the confidential nature of my contacts makes it difficult to get very specific, but now that I have a year's worth of data, I can give you a reasonably clear picture.

This analysis is based on 71 complaints or issues in 59 contacts. I included only those involving substantive complaints or issues. The ratio of contacts from outside the Center to those from within runs roughly 2:1. That is not too surprising, since the ratio of the population of the outside world to Center employees is even larger than that (about 3,000,000:1).

The complaints can be sorted into the following categories with corresponding frequencies:

Timeliness is the most frequent complaint from outside. The 34% figure is really understated, because many of the complaints about priorities are aimed at speeding up our processes. This is expected. Even though we have made tremendous progress in shortening review times, expectations have also been raised. Many complaints about timeliness relate to the new drug area, but others relate to activities throughout the Center. All of us can reduce the number of timeliness complaints by not promising anything we can't deliver. A careless estimate of a completion date by us can lead a company to use it in making costly business decisions.

Next to timeliness, I hear most about disagreements with policies, actions or decisions. About a third of the time, the problem stems from miscommunication and misunderstandings. When coupled with the third category, dealing with bad or lacking information, it is clear that we can prevent many complaints by getting more and better information out. I suspect that CDER's new Web site and the anxiously awaited internal CDERnet will significantly help improve understanding of our policies and procedures.

Another piece of advice I would give is to make sure you cite policies accurately, and if you think a policy doesn't make sense, don't pass it along until you understand it and find an interpretation of it that makes sense in the particular context you are working with.

It should be no surprise that over half of the internal complaints relate to poor personnel management practices. With the Federal work environment changing constantly, often not for the better, our supervisors and managers need to be aware of the impact on our people of bad press, dwindling opportunities for promotion to management positions, and the threat of downsizing. We can improve morale with honest positive and negative feedback, delegated responsibilities for meaningful work and expressions of appreciation for excellent performance.

One of the pleasant surprises of the Ombudsman's role for me has been the number of times I have been alerted by CDER staff to developing problems with external interactions. Please continue to let me know when you see a problematic interaction developing. This year I have been alerted to a systems problem in personal drug imports, multiple cases of deteriorating relations with companies and consultants, and problems with internal FDA investigations.

I also appreciate hearing about problems with administrative systems that are not serving our needs as they should. Don't assume that everyone knows about a problem you see and that no one cares. Send me an e-mail at MORRISONJ or call me at 594-5443. Together we can make CDER a better place to work.

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CDER Transformation in Full Bloom

So often we are too close to the trees that we miss seeing the forest. An excellent example of that cliché is CDER's transformation process. In my job as ombudsman, I see plenty of trees, in the form of calls, e-mail and letters, mostly complaining about what is wrong with our systems and people's behavior. I believe it is essential that I periodically take the time to step back from the trees and view the broader landscape.

One such opportunity came in the form of the Fall Planning Meeting. It was a marathon event lasting some 10 hours, but those of us who managed to sit through all the presentations were rewarded with a view of the Center that revealed some remarkable changes since the previous sessions. Incidentally, if you missed the live presentation, shortly there will be tapes of the sessions available through the library.

A lot has happened in the past six months to change CDER's outlook. It was only in March that CDER's senior managers first got together during a go-away to form the Change Team and drafted CDER's mission, vision and values statements. Since that time, the Change Team has begun to function cohesively, working together toward commonly set goals. If you compare the presentations at the fall planning sessions to those in the spring, you will see much more attention was paid to how the goals for each office align with those of the Center, and you will see many more references to cross-organizational activities.

Without much fanfare, CDER has moved from the initial phase of its transformation, that of establishing its vision, mission and values, to setting its goals and getting down to the nuts-and-bolts work of seeking results based on the broad goals. Currently, the Change Team, augmented by the Leadership Fellows, has identified six general results and specific projects and actions to accomplish those results. The results are:

• A highly satisfied, productive and efficient CDER staff.
• Improved efficiency of the drug regulatory system.
• Improved quality and timeliness of drug development and review.
• Expanded international harmonization.
• Improved communication of essential drug information to consumers, patients and health professionals.
• Increased internal and external awareness of CDER's work and the value it adds to society.

The working groups have met and will meet again Nov. 20. As the planning for these results efforts becomes firmer, additional people from throughout CDER will be recruited to help. If you want to be a part of this transformation process, and I certainly recommend that you do, keep watching your e-mail, the Pike and the new CDERnet for more information.

Speaking of the CDERnet, which was unveiled Nov. 5 (reachable by typing "www" in the address box for those of you with Microsoft Internet Explorer), that intranet site and CDER's Internet Web site are further evidence of the Center's transformation. I can personally attest to the power of the Internet in expanding communications. Since my Ombudsman page went on-line last month, calls, letters and e-mail to me from outside have tripled. Not only am I getting more industry complaints and suggestions, but I am also getting questions and requests for assistance from consumers, patients and health professionals. Progress has a price, but I am enjoying the challenge.

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A Holiday Story from CDER

Lest you believe that the lot of an Ombudsman is an endless litany of complaints and woes, it is not. On occasion I am privileged to observe CDER at its best, and at this time of year it is especially appropriate that I share one such story with you. This story could be called "A Tale of Two Fathers." In early November I was contacted by a man in the Midwest whose son was suffering from metastatic malignant melanoma, a particularly aggressive form of cancer. His son had been started on a chemotherapy mixture of three drugs two months earlier, but the hospital pharmacy was now unable to locate one of the drugs, dacarbazine. He had talked with the manufacturer but was told that a supplemental application was pending with FDA, and they couldn't promise delivery of the drug until the first quarter of 1997. His son needed to continue the chemotherapy soon, and he asked if there was anything I could do.

I checked with the Division of Oncology Drug Products, and Leslie Vaccari, a project manager, soon filled me in on the history of the supplement and the difficulties the firm had in finding a supplier. The division had worked long and hard in the face of diminishing supplies of the existing product to help the company find a new source of supply for the active ingredient. They had also received calls from patients and their families, and they had encouraged the firm to submit a supplement in a timely manner so that supplies of the newly manufactured product could be shipped quickly. In fact, Leslie told me, the supplement would be approved that very day. The night before the son of the reviewing chemist, Steve Koepke, had been in a serious car accident. Nonetheless, Steve came in after spending the night at the shock-trauma unit to make certain that the supplement would be approved.

Once I determined from the company that supplies would be moving in a few days, I called the father of the boy with cancer. He expressed his and his family's gratitude for the support they received from CDER. There are doubtless scores or hundreds of other families across the country who owe a similar debt to the folks in Oncology. Most of them will never know whom to thank.

So for them, I'll thank Steve, Steve's supervisor, Eva Tolgyesi, Leslie and all the dedicated people at the Division of Oncology Drug Products. I'm glad to report that Steve's son is doing well. Happy holidays to all.

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When the 'R' Word Rears Its Ugly Head

Most of us at some time in our lives have been in the uncomfortable position of being accused of doing something we didn't do. When that situation arises, it is often impossible to prove that we didn't do a particular thing or, if we did it, that didn't do it with the alleged motive. Such is the nature of defending ourselves or our organization against charges of retaliation. Unfortunately, CDER has had to do just that before Congress in recent years.

In the context of a regulatory agency, retaliation is usually defined as a regulator taking action, or not taking action, to the detriment of a regulated individual or company in reprisal for some previous action by that individual or company. Even an implied threat to retaliate is considered retaliation.

To use an example that might occur in CDER, Company A submits an NDA to CDER. There follows a scientific dispute about the review, which the company appeals to the office level, and the office director agrees with the company. A subsequent NDA that Company A submits to the same review division receives a not approvable letter citing numerous deficiencies requiring a lot of time and money to resolve. Company A charges that the division was overly picky on the second application in retaliation for the company's appealing the earlier dispute. The division maintains that its deficiency letter was entirely appropriate.

Obviously, there is no real defense that anyone in the division can offer to erase the perception of retaliation in the minds of the applicant and of those who want to believe that retaliation is part of the way we do business. The only way I know to reduce the likelihood that anyone will allege retaliation is to build trust by incorporating three simple customer service principles in all our contacts.

First, from my observation, the most important principle of good customer service is expeditious response. Nothing gets relationships off to a worse start than failing to return phone calls promptly or not answering letters. In addition, stating an approximate time in which a substantive answer can be expected, if one cannot be given right away, and meeting that time frame proves that our word is good and that we can be trusted.

CDER has already done much to establish a track record in timeliness. The entire Prescription Drug User Fee Act implementation has improved our relations with the public and with the regulated industry enormously. We need to extend that success to all aspects of our work.

Second, the response should be fair, reasonable and well thought out. If we give a quick response that is inappropriate, requires further explanation or seems inconsistent with other decisions, we convey a careless attitude and undermine our own credibility.

Third, the manner in which business is conducted should convey an understanding and caring attitude. This factor is more difficult to measure than the first two because it is subjective. It involves much more than a pleasant voice on the phone or a well-written letter. Customers look for evidence that the person they are dealing with understands their problem and cares about the outcome.

Everyone who comes to us has a problem, whether it is a company that needs our approval to market a product or a consumer who has had a bad experience with a drug product. If we respond to all our contacts promptly, take the effort to understand each person's problem and provide a fair, reasoned answer in a timely and appropriate manner, I guarantee you that charges of retaliation against CDER will be only bad memories.

For more information about retaliation, please refer to FDA Commissioner David A. Kessler's memo to all FDA employees dated June 29, 1995, available on the Internet at: http://www.fda.gov/cder/commis.htm.

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Shakespeare's Advice on Career Development

About a third of the issues brought to me concern internal CDER matters. Often the immediate cause of the complaint is not the real problem. Unfortunately, as in many scientific organizations, the press of technical work in CDER often becomes overriding, and we don't take enough time to attend to the human side of the enterprise. As a result, talented people sometimes find themselves underutilized or placed in positions for which they are not best suited or for which they have not been adequately prepared.

The problems that result from unwise management of human resources are tremendously destructive to the fabric of any organization. In CDER we are working through the transformation process to improve the way we manage all of our resources. But in the meantime, there are some things you can do to improve your lot in life if you find yourself in one of these career blind alleys.

To quote Shakespeare, "The fault is not in our stars, . . . but in ourselves that we are underlings." In Julius Caesar, Shakespeare described a support group run amok. Today, as in ancient Rome, assassination is never a viable remedy for problems with management. But there are other ways by which you can take charge of your own situation.

One method is to participate in a developmental program, such as the CDER Leadership Fellows Program or the FDA Leadership/Executive Development Programs. The CDER Leadership Fellows Program is in the midst of its maiden voyage, with 28 fellows working on projects that will make significant changes in CDER. A date has not been set for opening the next application process.

The FDA Leadership/Executive Development Programs are about ready to announce openings for the next two-year cycle. have a particular interest in the FDA programs, because I have been for many years the CDER representative to the FDA Management Development Committee, which oversees the programs and makes the selections. These programs are open to GS-13s to 15s and are highly competitive. They have evolved from the old FDA Mid-Level Program, and they offer a rich mix of course work and tailored developmental assignments to different parts of the FDA, including the field.

If you are interested in applying to the FDA Leadership or Executive Development Program, keep an eye out for the official announcement, coming probably in early spring. If you have questions about how to apply, please contact the OTCOM representative who will be identified in the upcoming announcement. For those who may want to talk about how they might fare in the competition or other aspects of the programs, I would be happy to serve as a resource. Please call me (4-5443) or e-mail me (MORRISONJ).

While these two developmental programs apply specifically to people in grades GS13-15, a wealth of other programs target different groups. One in particular is the Center's new Secretary Certification Program sponsored by OTCOM.

Developmental programs are only one aspect of personal and professional development. I always encourage applicants to the programs to develop their own plan and to consider acceptance to one of the programs a nice bonus but not essential to their career progression. In my next column, I will discuss other approaches people have used to get a career unstuck. I invite everyone to share techniques you have used or have seen others use successfully. Give me a call or send an e-mail, and I'll include the best ones in my column.

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Building a Career . . . Part Deux

Last month, we discussed how leadership and other developmental programs can sometimes cure the "my career has fallen and it can't get up" syndrome! But there are other ways you can jump start a stalled career.

For most people, career growth doesn't just happen; it is the result of considerable planning and self-analysis. The key is to take control of your future, do some real soul-searching about what you want out of life and from your career (there are plenty of self-help books to guide you), and then develop a strategy for attaining your career goals with realistic milestones. You should reassess your goals and plans annually.

In the old days, career growth and progressive promotions through the managerial ranks were synonymous. Today, we live in a different world. Management is one career track, and it is still a rewarding one for those who have appropriate talents and skills. But don't automatically assume that management is for everyone.

I believe that there has never been a time in CDER when there were more opportunities to demonstrate leadership and to develop your career. The matrix management structure and the transformation effort in CDER have resulted in a proliferation of subject-matter coordinating committees, subcommittees, transformation results teams, and subgroups that are producing significant procedural and policy changes.

When the FDA Management Development Committee interviews candidates for the Leadership Development Program, we ask about the person's ideal job in the agency. From the answers we get, it is clear that many people have the mistaken impression that there is a group somewhere in FDA that sits around all day and makes all the policy. It is true that some organizational units have the word "policy" in their names, but policy is made throughout the agency and throughout CDER. If you see a need for a policy or procedure in your work, chances are there is a group working on it that would welcome your help. If there isn't such a group already, why don't you start one? Just discuss it with your supervisor first and with your colleagues, and you may find it is easier than you thought.

While the financial and recognition rewards structure has not kept pace with the reality that management and leadership are not necessarily vested in the same people, things are changing. For example, as her CDER Leadership Fellows project, Nancy Smith, Director of the Division of Biometrics III, has been doing some outstanding work in developing a non-supervisory career pathway for reviewers from new hire through what is called the master reviewer level.

If you want to take a look at the draft, go to the CDERnet (just type "Bambi" at the Internet address prompt, then click on Master Reviewer Program). I believe that the same type of management and technical dual career pathways will come to pass in the regulatory and administrative areas as well. Perhaps you can make it happen.

CDER has made great strides in improving communications, and you will see even greater progress in the future. If you need information about any of the CDER committees or who is on them, you will soon be able to find the information quickly. The CDER internal Web site, CDERnet, will become the central place for all information needed by center staff. The site was created only a few months ago, but is growing rapidly so keep watching it for the information you need in your career planning.

You can also get information through networking and mentoring. By developing contacts with people who have progressed along the routes you see yourself going, you can profit from lessons they have learned. CDER is developing a mentoring program for new hires, and it is in effect in some review areas. But even if you have been around CDER for a while, you can find opportunities to be mentored by more senior staff. Remember the rule for career building: Your career is your own; take responsibility for its growth and development.

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Learning from Our Successes

It is just as important to learn from our successes as to learn from our mistakes. Since my aim is to make the job of Ombudsman obsolete because there is nothing left for anyone to complain about, it is worthwhile to study those areas in CDER where we don't get complaints; for example, the PDUFA (Prescription Drug User Fee Act) area of the new drug review.

One of the biggest sources of complaints from the outside is the timeliness of CDER processes. And yet, I get very, very few complaints about the time taken to review an NDA that was in the PDUFA system. Oh, I get complaints about other aspects of the new drug development process; whether they should be subject to user fees for some supplements, whether requiring a more costly study is justified, why it takes so long to schedule a meeting, and the like. But once a drug is in the NDA review process under PDUFA, I just hear the sweet sound of my phone not ringing.

Is that because applications get reviewed so fast that it boggles the minds of applicants? Not really. Even though we have cut review times in half over the past few years, it still took about 15 months last year from submission to approval.

I believe that the most important reason for the lack of complaints about PDUFA reviews is their predictability. User fee goal dates are set, and everyone knows what the goal date is for a given application. Not only that, everyone knows that CDER will meet or beat that date with the same certainty that we require for clinical studies (95% confidence or better).

Therein lies the key to our success. In the non-PDUFA world, where I still get many complaints about timeliness, I would guess that about half would not arrive at my door if there were a way for the complainant to know exactly when to expect a response. The more forthcoming we are about the exact status of a review, the fewer the causes for complaint.

I know it's easier said than done. With declining resources and shifting priorities, it can be a nightmare to predict a date when a review will be completed. But on the positive side, I would point to the success we have had with PDUFA and say that not all of that success was due to an increased staffing level. Review times had begun to drop before the new employees came on board.

A critical element in achieving a reputation for delivering results in a timely manner is having a mind set that places a high priority on setting and meeting realistic timeframes. Once adopted, this behavior applies to all interactions within CDER and with outside contacts. I try to use it in my work, and for each caller I give a time by which I expect to deliver an answer. I then try to get the answer by the date promised. If I can't, I call anyway to tell what has happened up to that time. People will forgive a reasonable number of missed due dates if they feel you are honestly trying your best to get the work completed.

The cardinal rule of customer service is not to overpromise. Nothing destroys credibility so much as giving an estimate and not meeting it, then giving another estimate and not meeting that. After a while, excuses, no matter how valid they sound, will not be accepted. If you find yourself giving overly optimistic estimates, try adding a fudge factor. I tend to be too hopeful, so I often double my first assessment before I predict a due date.

Not only will you build credibility by giving estimated dates and meeting them, you will gain skill at making time estimates. You will even derive a sense of satisfaction from your newly developed expertise.

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CDER Transformation—Thoughts on Virtuosity

The CDER transformation is gaining momentum. Changes, both large and small, are now occurring with such rapidity that it is often difficult to keep up with them. One of the larger changes to be unveiled recently is the CDER Virtual Journal (vJ). The internal forum in which CDER scientific and regulatory staff can communicate freely about the issues that confront us daily has been needed for a long time. In case you haven't yet seen it, you can do so by accessing the CDERnet (type CDERnet at the address prompt in Internet Explorer).

I might quibble about the name. The word "virtual" connotes something almost as good as the real thing. For example, the movie Virtuosity, with Denzel Washington, features a virtual reality that flirts with but ultimately is separate from reality itself. However, the first issue shows the vJ to be a real journal in the best sense of the word. It is filled with relevant, important and timely articles on issues that affect us all. The vJ's premiere issue not only demonstrates the medium, but it sets a high standard for content.

Janet Woodcock's lead article on science, law and public policy reminds us how infrequently we have taken the time to discuss the philosophy of drug regulation and how important it is to understand the basis for what we do. It is a "must read." Bob Temple's scholarly review of the history of drug regulation can make you an instant expert on the subject. Other articles include such wide ranging subjects as carcinogenicity testing, meta analysis, drug advertising, bioequivalence, clinical trial design, the review of an NDA, and much more. They demonstrate that, if we all participate, a forum like the vJ allows us to learn about and to discuss openly and frankly the unique scientific issues that we face. Such a forum can not only inform but can also build more consistency and rationality into our work as well.

To be able to conduct such a discussion within the security of CDER's firewalls is a welcome change from the goldfish bowl in which we usually work. But the vJ is too valuable to hide it from public view. The many people who produced the vJ are also working on a companion version for the CDER Word Wide Web site. A forum that provides for an ongoing dialogue with patients, health care providers, the regulated industry, other regulatory bodies around the world and our many other stakeholders would be of inestimable value.

Not only is the vJ itself impressive, but the way it came into being epitomizes the CDER transformation. It originated in the Good Review Practices' (GRP) Track 2 Committee organized by Julie Carlston and Debbie Henderson. With the proactive nurturing of Nancy Smith and Zan Fleming plus the support and talents of Steve Wilson, Grant Williams, Jack Pevenstein and a host of people from all over CDER, it has become a reality—not a virtual reality. It was not budgeted or allocated FTEs, but it grew from the grass roots of CDER. The vJ is truly a model of how the transformation is changing the environment and culture of CDER. It brings to mind the original meaning of virtuosity.

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CDER and FDA Leadership Development Programs

In my February column, I advocated taking charge of your career development and cited two structured ways to do that: the CDER Leadership Fellows and the FDA Leadership Development (LDP) programs. Since the Fellows program has announced about 20 openings for its second class beginning in the fall, and with the FDA LDP announcement due out this month, I thought it would be useful to discuss them further. They both have "leadership" in their titles, a natural source of confusion, and they both are aimed at identifying and developing future leaders. However, they are quite different.

The Fellows program is newer and is run out of the Office of Training and Communications' (OTCOM) Division of Training and Development under a contract with the Council for Excellence in Government, which facilitated the initial phase of CDER's transformation. The CDER Fellows remain in their current jobs more or less full time, but they meet periodically for facilitated training experiences and discussions. In addition, they each select a project to develop and complete, preferably in collaboration with other CDER or agency staff. A wisely chosen project can lead to considerable visibility in CDER and to a sense of accomplishment at a level usually reserved for senior managers.

Both the CDER Fellows and the FDA LDP are geared to the modern concepts of leadership in a matrix management system. Leadership no longer equates to supervisory or management titles. In fact, the FDA program changed its name a few years ago, substituting "Leadership" for "Management." The LDP grew out of what was known as the "Mid-Level Program." Compared with the Fellows, the FDA LDP is more time-intensive and requires some geographical flexibility. The LDP entails training and developmental assignments, generally consuming 12 months, to be completed within the program's 18-month span. While participants keep their current jobs, they spend only about a third to half of the time actually in their offices. They generally complete four developmental details of 30 to 90 days duration each during the program. Most of these details are outside their home organization (e.g., Center). It is a requirement that all headquarters-based participants serve at least one detail in an FDA field office and field participants must come to headquarters for one assignment. However, these are the minimum requirements, and in the group that just graduated, assignments carried some as far away as Europe and Latin America.

The LDP is more highly competitive, with only about 15 slots available every two years from throughout the agency. It is run out of the FDA's training division but is guided by an agencywide committee, chaired by Sharon Smith Holston. The committee has representatives from each Center, the Office of Regulatory Affairs, EEO, and other Commissioner-level components. This committee interviews the candidates and makes the selections.

Graduates of both programs are enthusiastic supporters and are glad to talk about their experiences. Before applying to any developmental program, it is wise to talk with some graduates to get a firsthand view of how it helped them, what they liked most and least about the experience, and to find out if it is right for you.

Although the last day for applications to the Fellows program for FY '98 was June 16, career development is an ongoing pursuit. It is not too early to think about next year if you are interested. As of this writing, the application period for the LDP has not been announced, although it should be opened in June. Be sure to watch for the announcement, if interested. The LDP comes around only every two years, so if you miss this opportunity, you'll have to wait until 1999. Selections for the Fellows program will not likely be known before the applications for the LDP are closed, but there is no bar to applying to both programs, although it would be impractical to participate in both simultaneously.

For more information about the CDER Fellows program, contact OTCOM's Janice Sheehy or former CDER Fellow Mary Lambert. For LDP application, contact Sarah Thomas in CDER's Training Division. As CDER's representative to the FDA Leadership Development Committee, I encourage CDER employees who are considering applying to the LDP to contact me directly for more details about the program.

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There's No Substitute For A Caring Manager

In my annual feedback column last October, I commented that over half of all internal complaints related to poor personnel management practices. Now, we all know about the decades of oppressive and sometimes dumb personnel rules and regulations that left government managers chafing and new hires perplexed. But that is not what I was referring to when I wrote about poor personnel management practices. I meant practices that individual managers in CDER chose to use to manage their people and their work.

Has anything changed in the eight months since that column? Well, with a new office structure for information systems management, a new review division created, departure of some managers and reshuffling of others, there has certainly been a change in the landscape. In addition, managers at all levels have been given a new tool for self-evaluation: the 360-degree assessments that we all completed recently. In that process, CDER managers and supervisors received feedback from their subordinates, peers and supervisor on a wide range of management performance factors. Information was also provided about where each of us stood with respect to norms established by thousands of other managers. In general, we fared well in most areas compared with a government norm. However, just being better than average is not where we should want to be.

I wish I could report that internal complaints have dropped off and that a new era in management brilliance has swept CDER to new heights of productivity and élan. Alas, I cannot. If anything, I am hearing reports that there are areas in CDER with significant morale problems. And while we continue to improve our Prescription Drug User Fee Act (PDUFA) performance, there are signs of increased stress.

As we gear up to implement whatever changes will come with the PDUFA reauthorization and its companion FDA reform legislation, it is essential that we make sure that we are most effectively using the resources we have. Our most valuable resource is people. We have been fortunate that the PDUFA increase in CDER staffing coincided with a weak job market that allowed us to recruit some really talented individuals. As demands on us increase, we cannot afford to squander the time and talents of our people. But that is exactly what we do when we fail to ensure that we have matched the right jobs to the right people. It is also what we do when we distract staff from their work by employing ill-conceived management practices.

We in CDER care almost universally about our public health mission, about consumer protection, and about our work. This caring attitude is one factor that binds us together and makes CDER a great place to work. However, we sometimes get so busy with the technical aspects of our work that we forget to care enough about our customers closest to home—the people with whom we work daily. In supervisors, this neglect often takes the form of the "thank you" not said or the constructive feedback not given, but we can improve this situation.

The 360-degree assessments provide valuable feedback to supervisors and managers. It's been a few months since we formally reviewed those assessments. We need to take them out again and look at how we were perceived in areas such as giving information, feedback, and appreciation to our staffs. In addition, we need to ask ourselves how effectively we communicate both positive and negative aspects of our staffs' performance. However much feedback our staffs think we give, if it is not honestly or effectively given, it misses the mark. We need to set specific managerial goals for ourselves, such as giving each person we supervise feedback every week or taking time to improve our own management skills. Above all, if we as managers do not create an environment of respect for all staff members, problems will surely occur.

If you sense that the climate in your work environment is strained, you may want to discuss it with someone you trust. There are many solutions to personnel problems, but the earlier they are identified and addressed, the more likely a successful outcome. If you want to discuss personnel issues, my door is always open, not only to employees with complaints, but also to managers seeking solutions.

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Mediation—Ready for Prime Time

All of us at CDER have, at one time or another, experienced problematic interactions, either inside the Center or with our outside contacts. These interpersonal disputes can be among the most time-consuming issues we deal with. Despite the Center's extensive efforts at improving management and supervisory practices, difficult interactions continue to surface.

I have my own theories about why we run into such problems. In this politically correct world, we have become accustomed to interacting with our coworkers, supervisors and subordinates as well as with our outside contacts through stylized relationships that are based on certain assumptions. In our communications we tend to assume that we know what other people expect and need, but we dare not ask them directly, lest we violate some ill-defined borderline between appropriate and inappropriate interactions. Instead we seek to wrap every sentence in mumble-speak so that no one knows what we are really thinking, and everyone plays the game of inferring what each of us really means. After a while, we lose sight of even our own needs and expectations.

In addition, most of us are so busy with the technical side of our work that we don't take enough time to really listen. Even when our well intentioned communications suddenly provoke unexpected responses, we too often choose to ignore them rather than engaging in a meaningful dialogue to find out what prompted the response.

Whatever the cause of a problem interaction, if you are a party to one of them, you need to know how to deal effectively with it. There are a million ways to prevent problematic interactions from occurring, but if you get into a situation in which failed communication escalates into a real problem, is there a viable solution?

Not only is there a solution, but it is becoming more available to us. The mechanism is mediation. Mediation is simply a structured, confidential conversation between two people, facilitated by a trained mediator, with the aim of coming to a mutually accepted agreement. It is widely used in communities for everything from family disputes to reducing gang violence. It is also being used increasingly as an alternative to litigation. It is highly successful, with agreements achieved in more than 90 percent of the cases.

If this seems somehow familiar, I have written about mediation before, and I have offered to mediate disputes within CDER and between our staff and outside contacts. I have not been overwhelmed with requests. However, things are changing.

The FDA EEO Office has just given a one week training course in mediation to more than 20 people from all parts of the agency. The plan is to use mediation routinely as part of the EEO process for resolving complaints. I'm hoping that as mediation becomes a part of the EEO process it will spill over into other areas and become recognized as a valuable tool in resolving all types of disputes. As people use mediation, they will find it to be a safe environment in which they can turn negative or hostile feelings about their working situation into positive and productive relationships. I won't kid you; it is not always painless, and it does take some real thought and work by the parties involved. But the rewards are great, and it can be a turning point in a career stalled by misunderstandings.

If you want to find out more about EEO mediation in CDER, talk with Margaret Bell (4-6645). And, as always, I'll be glad to answer your questions about mediation in general (4-5443).

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Innovations Award—Nothing Succeeds Like Success

With the many posters floating around the various CDER sites and the kudos coming our way, we in CDER have reason to be proud that we are the primary factor in FDA's being recognized as one of the finalists in the 1997 Innovations in American Government Award, sponsored by the Ford Foundation and Harvard's John F. Kennedy School of Government. Whether we wind up as winners or just finalists, we have won. In addition to the $20,000 prize already gained, we have achieved recognition as being in the vanguard of a new era in government.

When the CDER transformation was rolled out last year, many of you may remember that one of the exercises was to write a headline for the Washington Post of whatever date it was in the year 2000. There were quite a few people who suggested something like, "CDER Wins Malcolm Baldridge Award." Although the criteria are different for the Innovations in American Government Award, who among us would have predicted we would be finalists for such a prestigious award just one year later?

It is just as important to analyze one's successes as well as one's failures (and it's a lot more enjoyable). The Innovations Award is based largely on our success with new drug reviews and in exceeding user fee goals. It is easy to say that the Prescription Drug User Fee Act (PDUFA), which authorized a hefty increase in resources to CDER and CBER, is the reason we performed in such an outstanding manner. But such an analysis would be superficial and only half right. If you look at the statistics, you will see that the time to first action on NDAs started to fall before we accrued benefits of any increase in resources.

Our review times fell initially because we set goals to which we were committed. Other aspects of the award, such as accelerated approvals, came about independently of either additional resources or PDUFA. In fact, one can find many examples of projects that are infused with additional resources but fail because they are poorly managed. So my analysis of our success leads me to conclude that progress comes from measuring critical processes of an organization (or better yet, measuring outcomes), setting strategic goals, finding better ways of doing the job and then implementing them. Incidentally, this is not my original idea. You will find exactly this prescription in every reengineering or management book and in the application for the Malcolm Baldridge Award. There is a lot of verbiage around these principles, but the message is basically the same.

What is the payoff in all this for those of us who are toiling in fields not fertilized by PDUFA funds? The answer is that this system that led to the Innovations Award can be scaled down to any working unit, even down to the individual working alone. If you don't have extra funds coming in to cover the expense of measuring what you do, that's OK; this system comes with a built-in resource benefit.

As you identify ways to do things better and faster, you gain more time. With extra time, you can measure other processes and save even more. As you become more efficient, you can actually do some of those things you always wanted to but couldn't because you didn't have the time. You will enjoy your work more. You will be noticed for your better work or faster service. You will start to get awards for your performance. You will be innovating. People and organizations will come to you for advice and use you as a benchmark of excellence.

Think about it. Are there things you do that could be done more efficiently and more effectively? After all, we work for an award winning, innovative organization. We have an image of excellence to uphold.

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Another Year of Ombudsing

It doesn't seem like a year has passed since I prepared my first annual report (see October 1996 Pike), so that must mean that I'm having fun. This year has been busier than last, which I credit to the Ombudsman's page going up on CDER's Web site.

It's always difficult to decide what constitutes an ombudsman's "case," because one issue or problem may generate many contacts from the client, and one client or contact may bring several issues or problems. To give you a feel for the increase in my workload, however, I can say that last year I reported 71 complaints from 59 clients. This year I was contacted by an estimated 135 clients involving many more than 200 contacts.

The mix of issues changed to some extent, however. Because of th‍e Web site, I received many e-mails in addition to the usual phone calls and letters. Some of these e-mails presented general problems or complex issues rather than complaints about CDER's action or inaction. I hear more now from consumers and health professionals than I did last year. As you might expect from the increased business, the ratio of external to internal cases rose from FY 96's 2-to-1 to more than 3-to-1 during the fiscal year just ended.

I decided to array the analysis somewhat differently this time, following the natural grouping of cases involving complaints about CDER actions:

Last time I included a category of priorities or inconsistencies, which accounted for 22 percent of the complaints in the external category. However, it is often difficult to separate challenges to policies or decisions into those where inconsistency among divisions is involved and those where it is not, so I folded that category into either policy/decision challenges or timeliness/priorities, depending on the gist of each complaint.

I heard fewer complaints about timeliness in PDUFA review areas as the old application backlog was eliminated and as applicants have come to believe that goal dates will be met. I also believe that we are getting better in eliminating inconsistencies among reviewing divisions. Some non-PDUFA areas have dealt effectively with backlogs. The Office of Compliance has eliminated the backlog in issuing Certificates of Free Sale. These are now a source of user fee funds, thanks to a new law and a lot of dedicated effort. However, timeliness remains a consistent concern in other Center activities. It will continue to be of concern, requiring us to learn to work smarter and more efficiently, often with fewer resources.

Policy, decisions and priorities continue to be a major area of concern. We reduce such complaints by documenting our policies and practices better, getting more MaPPs published, including more policy documents on our Web site, making sure that we articulate our policies and decisions clearly and that we follow those policies that have been published.

Internally, management issues continue to be the primary concern, with an increased effort needed to ensure that supervisors and managers spend the time and effort necessary to improve personal interactions and the working climate. That means, among other things, providing effective positive and negative feedback to employees and foreseeing and heading off potential personnel problems. It also means improving our methods of recruitment and orientation as well as analyzing the information we are already getting from the 360-degree evaluations and satisfaction surveys.

It seems that CDER folks are complaining more about management and administrative systems that are based outside CDER. That may signify that CDER administrative systems are improving faster than FDA and HHS systems. Clearly, though, such systems in general are improving.

Finally, I received fewer alerts from CDER divisions about problematic interactions with outside contacts. Please remember that such alerts are very helpful in smoothing out problems before they become critical. And, as always, I appreciate getting feedback from inside or outside CDER about systems, problems and suggestions for making things work better. Just e-mail me (MORRISONJ) or call 4-5443.

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What You Say—Part I

How many times have you been certain of what you meant to say, but the party to whom you were speaking didn't take it in the way you expected? It may happen more frequently than you think. I hear about problems of miscommunication all the time, but I get only those cases where someone received a message that provoked them enough to contact me.

In recent sessions of the New Reviewers' Workshop, I have given examples of communications with regulated industry that miss their mark. In this and subsequent columns, I'll share some of these examples and others that pertain to how well we communicate in CDER.

First, there is this one—which I still hear sometimes—that all we can say to an applicant is that the application is "under review." For many years, we were instructed that such information was all we could impart. If there is a single type of communication, or lack thereof, that causes more problems than any other for CDER, it is the failure to keep applicants or other stakeholders apprised of what is happening with the paperwork they have submitted.

I firmly believe that we would receive fewer calls and questions and more good will if we let people know where their application is and when each segment of the review is expected to be completed by the members of the team and their supervisors. So long as you give reasonable estimates and really make a good faith effort to meet them, you will gain credibility and significantly improve CDER's reputation for fairness and efficiency.

Second, the meetings MAPP (4512.1) has helped, but it has not eliminated the problems with scheduling meetings. It seems that it still takes too long to get meetings scheduled in the views of those we regulate who have a lot riding on our decisions. Some of the scheduling problems lie with the overcrowded calendars we all have and the demands created by PDUFA due dates and other pressing work. However, we can get out of this box if we simply stop assuming that all problems are solved by meetings. From my experience, very few are.

Perhaps the issue that is presented by the applicant or by the internal indecision can be resolved by telephone or e-mail. Some issues can be settled by the skillful use of a short consensus paper that is used as the basis for reaching mutual agreement. Many alternatives to meetings are more efficient and effective. Try them, you'll like the way they can free up time on your calendar.

In communicating with one another, it is always important to keep in mind that the relative positions of the people communicating greatly affect how the communication is received.

Just as a supervisor talking with a subordinate should be careful in choosing words that will be listened to for any nuance of threat, disapproval or praise, those of us who work in a regulatory agency must be cognizant of the effect our words have on those we regulate.

Dr. Woodcock likes to use the example of how you would react to an IRS auditor and perceive his or her words. The analogy is a good one to keep in mind. I'll continue this discussion of communications in the next issue of the Pike.

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What You Say—Part II

In my last column, I discussed two significant hindrances to communication with the regulated industry: not keeping applicants informed of the progress of their applications, and slowness or unwillingness to set up meetings. This month, I'll give you more examples of problems in communication I've seen in CDER.

Many new reviewers do not appreciate the havoc that ensues from a casual request for more information in an application. In the New Reviewers Workshop session on industry interactions, we bring in a representative of the pharmaceutical industry to address and dialogue with the participants. Most of them have stories to recount about CDER requests that caused some real headaches.

In general, companies treat each request seriously. If it is easy to provide, there is never any hesitation about answering your questions. However, if it entails additional work to answer, the company has to decide whether the requested data are reasonable, how much it will cost to provide the information, and how long it will delay the process. Unless it is onerous and time-consuming and clearly unwarranted by the review requirements, most firms won't balk. I have heard of questions that took several hundred thousand dollars and several months to answer, but the applicant complied, even when the basis for the request was not clear or when the information was not viewed as useful in evaluating the safety or effectiveness of the product. My advice is always to be careful about what you ask for, how you describe it and to clear even minor requests through supervisors.

Nothing enrages applicants more or destroys our credibility faster than a request that is viewed as arbitrary and motivated by personal interest rather than as necessary for establishing the safety and effectiveness of the product. Even legitimate questions or requests for additional data, if the reasons for them are not clearly stated, can appear arbitrary and capricious. Please remember that the Administrative Procedures Act prohibits government actions that are arbitrary and capricious.

The best way to avoid the appearance of asking for information out of personal interest or intellectual curiosity is to publish a guidance that informs everyone of our requirements and the bases for them. But slavish adherence to a guidance that does not make sense in a particular case will absolutely drive applicants crazy. There is a fine line between following guidances for the sake of consistency and blindly insisting that the methods suggested in guidances be followed, even when the applicant prefers to use an equally valid alternative method. Guidances are recommendations, not requirements. Of course, alternatives suggested by the applicant should be reasonable, valid and appropriate.

Old habits are hard to break. Before PDUFA, it was fairly common for CDER staff to explain delays to applicants in terms of a lack of resources. Such explanations seemed reasonable when meetings were held in small conference rooms with distressed tables and an eclectic array of ugly chairs. But times have changed. Particularly when dealing with applicants covered under PDUFA, explaining that a lack of resources is delaying an application, even if true, is not well received. No one believes the government doesn't have enough money, especially representatives of a company that just forked over $200,000 in user fees. So keep your credibility and swallow those excuses about a lack of resources before you utter them.

I'll give you the last three of my top eight problems with communications in an upcoming column. In the meantime, have a great holiday season.

News Along the Pike
CDER Office of Training and Communications (HFD-210)
Parklawn Building, Room 12B-31

Editor: Norman "Joe" Oliver

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