Center for Drug Evaluation and Research

Index for 1998

• What You Say: Part III
• Plugging in the V-Chip at Work
• Expert's Update on Workplace Violence: Know Warning Signs
• When a Drug Isn't a Drug
• Alternative or Appropriate Dispute Resolution Gathers Steam
• Avoiding Conflicts of Intellectual Interest
• The Internet: Problems vs. Opportunities
• Feedback: A Valuable Commodity
• Better Internal Meeting Management—Just a MAPP Away
• Ombudsman's Annual Report
• What Is Customer Service?
• Holidays Throw Spotlight on Patient Access Questions

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What You Say: Part III

In the first two columns of this series, I discussed five of my top eight hindrances to communication between CDER and the world outside. They were a lack of accurate and timely information to applicants on the progress of their application; problems with setting up meetings; requests for information that seem unnecessary or personally motivated; rigidity in applying guidelines; and poor-mouthing to explain delays.

Working in the confidential world of trade secrets and proprietary information, we sometimes underestimate how much companies know about their competitors' products and research. We are surprised when an applicant challenges a guideline or a request for a new analysis or data by telling us their competitor's product got approved without such an analysis or data. To some applicants, the regulatory scheme should be simple: develop standards for proving the safety and effectiveness of a drug class, and apply the same standards to all other members of the class forever. The problem with that philosophy, of course, is that science constantly changes as we learn more about new drugs. Requirements that were not contemplated before become essential for a new application, and what seemed essential for the first member of a class may seem unimportant when the fifth one comes up for review.

Recognizing how such changes in the ground rules may be perceived by applicants is the key to communicating new requirements effectively. Care must be taken that new requirements are explained in light of new information, lest applicants come to believe that we are really favoring competitors already in the market by throwing added road blocks in the path of newcomers.

Closely related to the problems stemming from evolving science are those caused by changes resulting from divisional reorganizations or reassignments of reviewers. Needless to say, such an abrupt change may leave an applicant bewildered and angry when the result is conflicting advice or a different review outcome.

We are making strides in developing better consistency across divisions in the application of policies and practices. But continuity is equally important. We must honor advice and commitments made by previous reviewers of an application, unless to do so would lead to an unsafe or ineffective product on the market. Such commitments should not be made lightly, they should be documented, and they should be altered only for significant reasons, with the concurrence of the division director. In fact, the new legislation recognizes that we shouldn't deviate without appropriate justification and supervisory concurrence. It requires that we adhere to our guidances and that we seek public comment as part of the process for general guidance documents.

Finally, I want to make a plea for rationality in regulation. I have heard people say: "I know it doesn't make much sense, but the regulations require that . . ." The law and the regulations were written to make sense. If your interpretation of them does not make sense in dealing with a particular case, you should reassess the interpretation you're using. Discuss it with your colleagues and supervisor and get an opinion from the Chief Counsel's office. Even if you sometimes feel that you are just passing along guidance or recommendations to the regulated firm, please take responsibility for what you tell the firm. If the logic of what you are saying is not clear in your mind, it won't be clear in theirs. That is the essence of communication.

So that completes my list of communication mishaps. If you have some you would like to contribute to my list, please give me a call (4-5443) or e-mail me at MORRISONJ.

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Plugging in the V-Chip at Work

In a sleepy, up-scale bedroom community outside Los Angeles, a junior high school vice principal calls a faculty meeting. When about half of the teachers have arrived, he pulls out a .45 automatic and opens fire. He then goes around the school looking for teachers who weren't at the meeting. When the shooting ends, five teachers are dead and one is crippled for life.

That was my introduction to violence in the workplace. It occurred at the school I attended, but I wasn't there when the killings happened. I was there 15 years later, when he came up for his first parole hearing. The teachers for whom he searched unsuccessfully were very nervous. They recounted the story with the immediacy of yesterday's news.

Was this another case of a nice, mild-mannered guy who snapped and became a lethal maniac? That stereotype is a myth, perpetuated by news media interviews with neighbors and acquaintances after the fact, according to violence expert Dennis Davis. In his book, Threats Pending, Fuses Burning: Managing Workplace Violence, Davis says:

"Human behavior is not organized in such a way that a 'perfectly normal,' hardworking family man wakes up one day and suddenly decides to act out his rage in a manner that leads to the injury or death of others. There are always warning signs."

He explains that after the fact, coworkers and acquaintances are reluctant to say publicly that they knew the guy was weird and suspected that he might act violently. Such statements would beg the question: "Then why didn't you do something?"

It's easy to ignore the threat of violence if one believes that, like tornadoes, it occurs randomly and with little or no warning. There is a natural reluctance to talk about violence in the workplace. We think it won't happen here. After all, there are only about 1,000 workplace homicides a year out of a 100 million workers. And, let's face it, there is the fear factor. The Postal Service now has a rule that bringing a gun to work will mean the worker will be fired on the spot. But should the supervisor fire the worker before or after he is disarmed?

According to Davis, there are plenty of warning signs. They are known and easily recognized. Many of the warning signs are the types of lesser violence that are reported over a 100,000 times a year. There are many more that are not reported. When one includes that number, we are dealing with at least one incident per year per 1,000 workers. Based on averages, that would mean about nine reported incidents per year for FDA. We experienced a tragic episode a few years ago, when an FDA employee killed three people, but not at work.

So what are the warning signs, and what should organizations do to prevent violence in the workplace? Fortunately for us, Davis teaches a course on violence in the workplace for the Parklawn Training Center (PTC). The CDER EEO Staff, PTC and I are arranging for him to give a one-hour presentation as part of a regular CDER staff meeting in March. It will cover such subjects as spotting the warning signs and identifying preventative measures. As usual, it will be held in Parklawn and videoconferenced to WOC II and Corporate sites. I encourage everyone who has not already taken the PTC course to attend, especially supervisors and managers.

If we educate ourselves about the nature of violence, we stand a better chance of filtering it out of the workplace, just as the V-chip will one day filter out violent programming on TV sets in the home.

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Expert's Update on Workplace Violence: Know Warning Signs

As a follow-up to last month's column, I thought I would pass along some lessons learned from Dennis Davis, Ph.D. He is the expert on workplace violence who gave an excellent and provocative presentation at the March CDER staff meeting.

Dr. Davis described the three levels or stages of violence. Each level tracks a progression of behavioral changes. Since the nice guy who suddenly snaps and kills people is a myth, it is important to recognize changes in behavior and deal with the warning signs early. These warning signs point to a person who no longer cares about himself (90 percent of workplace violence is committed by men). "If an employee does not care about himself and the consequences of his actions," Dr. Davis said, "you should be concerned for yourself and for others around him."

The first stage may consist of a variety of hostile expressions, including dehumanizing others by name-calling or derogatory comments; challenging authority; being frequently argumentative; alienating others; swearing excessively; using sexually explicit language; and otherwise verbally abusing others. We don't ordinarily think of these as violence, but they can signal future trouble and should be taken seriously

Most such warning signs never escalate into more serious behavior, but supervisors should deal with them promptly and appropriately. Failing to discuss the inappropriate behavior with an employee, however, implicitly condones that behavior and encourages an escalation to more violent behavior. Documenting such behavior is important, Dr. Davis said, not for the individual's personnel file, but for the supervisor's reference should further action be necessary. If the acts are sufficiently serious, the supervisor should bring in experts and inform the second-line manager.

Second-stage behavior typically includes: arguing frequently and intensely; blatantly disregarding organizational policies and procedures; inventing gossip about co-workers or sabotaging their work; committing petty vandalism or theft of the organization's property; making verbal threats or unwanted advances and, more importantly, putting them in writing or e-mail; and blaming others for any problems the individual has at work.

If such behavior is observed by or reliably reported to supervisors, immediate action is essential. Experts should be brought in, and the person should be counseled. The Employee Assistance Program has experts who can advise supervisors on dealing with such situations. They are only a phone call away (3-HELP) and have a trained staff of psychologists who are glad to help and to offer suggestions about how to get troubled employees into counseling. The supervisor and the Employee Assistance Program should not be the only ones informed, however. Confidentiality restrictions prohibit the program's staff from disclosing the problem. Therefore, it's wise to notify others in the supervisory chain and Employee Relations.

The third level of workplace violence is one that no one wants to witness. It consists of displaying weapons, actual acts of physical violence and may include arson, rape, homicide or suicide. In the event of a third-stage incident, Dr. Davis advises that witnesses have three responsibilities: first, get out of harm's way; second, warn others to stay away; and, third, call the authorities.

It is good to have emergency response procedures, but the most effective approach is to practice prevention. That means not hiring people with a history of violent behavior (effectively done reference checks can prevent many different problems), keeping alert to possible warning signs of potential violence, addressing problems early and seeking professional help before a crisis occurs.

Dr. Davis acknowledged that it is often difficult for a supervisor to approach an employee who is behaving oddly on the job or who is becoming aggressive to others. However, the alternative is to ignore the situation and wait for an escalation in violence. A supervisor should avoid confronting the employee in a hostile way. A caring but firm tone in a private conversation will usually be effective in first-stage cases. Resistance to taking advice or orders can be overcome by a supervisor using examples from his or her experience rather than dictating behavior to the employee. If the employee reacts negatively to the supervisor's attempt to address the problem, further action is indicated.

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When a Drug Isn't a Drug

Responsibility for determining where FDA-regulated products belong rests with the Agency's Ombudsman, Amanda Norton. My job as the Center's Ombudsman includes being CDER's point person for intercenter jurisdiction. Before becoming involved with intercenter jurisdiction, I had little idea about the number and variety of products that fall into the gray areas between centers. Besides the 30 to 40 formal requests for designation filed with Amanda Norton's office each year, there are many informal questions from prospective applicants about which center should review their product.

Three intercenter agreements, developed and signed in 1991 by the three centers that review medical products, describe the rules for deciding product jurisdiction. Those documents, each one involving two centers, are helpful, but cannot describe every possible product. Anyone who does this work quickly develops sympathy for the regulatory affairs people in the industry who must decide which center has jurisdiction over their proposed product. Those of us inside the Agency have significant difficulty deciding where some products belong, and we have access to prior decisions about investigational products that cannot be disclosed to those outside the Agency.

We occasionally find products reviewed in CDER that belong elsewhere or are very similar to other products in another center. Correcting the misdesignation is very difficult when the product has already been approved or is far along in the review process. This article is my plea to staff in CDER for help in identifying products that really belong in another center.

Although product sponsors have the first opportunity to make the decision on jurisdiction, they may not be unbiased in their choice. If a product might arguably be a device or a drug, many sponsors prefer device status to avoid user fees and to be subject to what are perceived as less stringent requirements. Thus, sponsors often submit the product for review as a device and look to the Agency to tell them if they are wrong. Conversely, some drug companies would prefer that their products be regulated as drugs to benefit from exclusivity or because they are more comfortable with the CDER review process.

The consequences to the Agency and to sponsors of misdirected applications can be substantial, but they are less severe when the problem is identified early in the product's regulatory life. Whether misdesignation occurs by inconsistent Agency decisions over time or by a failure to recognize an error, the courts look unfavorably on the Agency when virtually identical products are regulated by different centers. A recent court opinion involving the assignment of some ultrasound imaging agents to Center for Devices and Radiological Health and others to CDER stated that assigning similar products to different regulatory jurisdictions is by definition arbitrary and capricious.

Later this year, I hope to distribute to the new drug project managers an algorithm that will help them decide when a product belongs in CDER.

In the meantime, if you see an IND for a product that seems to belong in CDRH or the Center for Biologics Evaluation and Research, or if the product appears to be a combination drug/device or partly composed of a substance that may be CBER's, please discuss it with your supervisor and let me know. Likewise, if you get a consult from another center for a product that you think really belongs in CDER, question it. Your instincts may well be right. Even if you are wrong, you will learn something about product jurisdiction, and you will earn our gratitude for being alert to possible problems.

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Alternative or Appropriate Dispute Resolution Gathers Steam

I was privileged to participate in the HHS ADR Forum held April 30 at NIH's Natcher Auditorium. The growing interest in ADR, which stands for alternative dispute resolution or appropriate dispute resolution, depending on who you talk to, is evidenced by the turnout for this conference.

Planners originally anticipated that perhaps 200 people would attend this forum for employees of the Department. Registration quickly grew to 500, the capacity of the auditorium, and more than 250 others had to be turned away. This is truly remarkable, considering that most people were unaware of what ADR stood for just a couple of years ago.

The program began with a plenary session. Among the speakers was Kevin Thurm, deputy secretary of HHS and the Department's chief operating officer, who observed that litigation, with its adversarial nature, frequently destroys relationships. In contrast, the purpose of ADR—whether it is conciliation, mediation or negotiation—is to seek a consensus that repairs and strengthens relationships.

John Settle (what an appropriate name!), who recently left government after 18 years at the helm of the Departmental Appeals Board, noted that ADR represents a new paradigm in how disputes are handled. He urged managers everywhere to adopt new approaches to avoid becoming obsolete. He used the analogy of the Swiss watch industry, which, when given the opportunity to adopt the quartz technology that was developed in Switzerland, chose to rest on its laurels as the world's best clock makers. Instead the technology was snapped up by Texas Instruments and Seiko.

The forum then broke up into a series of concurrent sessions, including:

• ADR 101, a discussion of the basics of dispute resolution.
• Negotiated Rulemaking, a briefing on how the Health Care Financing Administration used this relatively new process.
• ADR in the Workplace, a look at how ADR is being used at FDA and Government Accounting Office (with FDA's Kathy Vengazo discussing how the Division of Employee Relations uses ADR instead of formal disciplinary actions).
• Mediate Instead of Litigate, a demonstration of how ADR can be used as an alternative to litigation by the Federal Government (with Kay Cook from FDA's Office of Chief Counsel presenting).
• Role of Ombuds in Federal Agencies, with yours truly and Suzanne O'Shea talking about ombuds in FDA, along with ombuds from U.S. Information Agency and NIH in a highly interactive session.
• Real Life Experiences, ADR in the Medicare, Medicaid and Head Start Programs.
• New Directions in Federal ADR Initiatives, a discussion of the ADR and Negotiated Rulemaking Acts of 1996.
• Partnering: Exploring the Use of ADR in the Labor-Management Arena, a session that should be useful to FDA management in the coming months.

Finally, the forum concluded with a general question-and-answer session with the speakers.

I left the forum with a renewed sense of optimism that as the word spreads that conflicts in all arenas can be solved through ADR, we will see a more harmonious and productive atmosphere emerge. When we are willing to see that other people in whatever capacity they operate are not enemies but are just other people with different interests that have an equal right to be heard and respected, we will adopt the principles of ADR in all facets of our work and private lives. As John Settle said in his remarks: "I urge you all to bring ADR from the workplace into your homes and into your communities. You won't hear that said about GPRA or TQM."

If you are involved in a dispute with internal or external customers, consider ADR. Contact me by phone (4-5443) or e-mail (MORRISONJ), and I'll help or find the expert who can.

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Avoiding Conflicts of Intellectual Interest

Anyone who has been in the Center for more than a few days has been made aware of rules and regulations regarding standards of conduct and conflict of interest. Over the years, the FDA has placed great emphasis on financial conflicts, ethics and bribery awareness. To be sure, such an emphasis is warranted. Nothing is quite so damaging to the Agency as having one or more employees convicted of exchanging regulatory decisions for monetary or other favors.

However, in our zeal to protect our good name against financial misfeasance, we should not neglect potential conflicts of interest where financial gain is not involved. For example, if a reviewer of a drug belongs to an organization that publicly espouses a point of view for or against that particular drug or its therapeutic class, most people would question the reviewer's ability to perform an unbiased evaluation of that drug.

CDER MAPP 4641.3 covers outside activities and addresses active participation in an organization as evidenced by holding an office or otherwise prominently representing that organization. But is it reasonable to draw a distinction between the levels of participation in an organization? Or what about a reviewer with strongly held views that pose a conflict who does not belong to any outside organization? While the issue may be raised in the context of an outside activity, the problem really stems from an appearance of an intellectual conflict of interest.

In Title 45 of the Code of Federal Regulations, a section is devoted to standards of conduct specifically for the FDA. Section 735-101(a) states in part:

"Because of FDA's special regulatory responsibilities to the consumer and industry, its employees must be especially alert to avoid any real or appearance of conflict of their private interests with their public duties. Their actions must be unquestionable and free from suspicion of partiality, favoritism, or any hint of conflicting interests."

Conflicts arise when we, as private citizens, exercise our right to espouse causes that we believe but which also impact our work. In our public lives, we are commissioned by the American people through Congress to be unbiased evaluators of the safety and effectiveness of drugs.

The real or apparent intellectual conflicts cannot be dismissed by an assertion that scientific principles outweigh reviewers' subjective opinions or that the data speak for themselves. The plain fact is that the data do not speak for themselves. If they did, we would not need statisticians. No matter how much objectivity is built into the review process, the judgment of primary reviewers still weighs heavily.

When an advisory committee member has an apparent intellectual or financial conflict of interest, for example, when the member has pioneered the drug being discussed, we ask him to recuse himself or herself from the deliberations on the drug. We should demand no less intellectual honesty from ourselves.

There are many issues in our society that evoke strong feelings on both sides. Some of those issues involve drugs that we are asked to evaluate and to monitor. Abortion and contraception come immediately to mind. There are also many controversial issues related to treatment of drug and alcohol abuse, AIDS and animal testing. If we believe strongly in one or another side of an issue that may bias us with respect to a particular drug, class of drugs or methodology, we have an obligation to discuss the matter with our supervisor and to refrain from participating in any regulatory activity in which we might seem to have a conflict. Supervisors also have an obligation to assure that the work products coming from their areas of responsibility are free from bias or the appearance of bias.

Ultimately we are the only ones who can say for certain whether we hold views that, if known, may appear to bias us in performing our work on a project. There is a natural reluctance to raise such issues with our supervisor for fear that we might be viewed as less valuable to the Agency. But raising such issues strengthens the ethics of the Agency and actually makes those who come forward more valuable. An intellectually honest scientist is the most valuable asset the Agency can have.

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The Internet: Problems vs. Opportunities

Now that almost all of us have adapted to the emergence of electronic communication, it is a good time to reflect on its significance to our work. We are comfortable with e-mail, but working with the Internet plus localized variations like intranets and extranets takes electronic communication to another level. We are only beginning to see and experience the potential of this medium.

The Internet, originally created for scientists to communicate with each other, has long since been appropriated by the rest of the world. No one speculates anymore about when it will contain a critical mass of information and thus become useful to the average person. It reached that point some time ago. It is growing at an astounding rate—both in numbers of users and in the quality and amount of information, services, commerce and societal impact.

I can attest personally to the power of the Internet. After putting my Ombudsman page on CDER's site a year and a half ago, the volume of contacts I receive has more than doubled overnight. I get e-mails and calls from distant parts of the globe. Thankfully, I still remain undetected by most Web crawlers, so the people who contact me are generally limited to those who started in the FDA site. That keeps incoming e-mail to a manageable level and minimizes intrusions.

On the output end of things, the Internet has revolutionized the Agency's transparency. Now, instead of sending out material in response to individual Freedom of Information requests, we can make source documents and other information available to the world instantaneously.

As with all revolutionary advances in technology, the Internet has brought both promise and problems. To cite an oft-repeated litany, it seems that we are drowning in data, not all of which are accurate. In addition, it seems the total of letters, phone calls and e-mails to CDER is now larger than the volume of letters and calls we received in the past, meaning that e-mail is not just replacing conventional media but has opened communications with people who haven't contacted us before. That means a bigger workload, but it also means more opportunities to get our information out to where it will do the most good. It also means that we can save some costs in the way we operate.

We can distribute vital information worldwide, immediately and at minimal cost. If we can anticipate questions and put answers on our site quickly, we can possibly cut the number of letters, e-mails and phone calls we receive.

Each of us should take some time to think about what information we have and use daily that could benefit our constituencies, such as health care professionals, patients, the public, industry and other government agencies. Before I strike terror into Carol Assouad, who does an excellent job overseeing the CDER sites as part of the Medical Library, let me hasten to add that there are resource limitations on how much data can be added usefully to our servers and how quickly. Nevertheless, we should all contribute to planning what information appears on our sites.

I plan to follow this advice and post some guidance on intercenter jurisdiction for reviewers on CDER's intranet. If you have ideas for other information that you would like to see on our Web sites, I encourage you to tell the people who have access to the information, or tell me, and I will see what I can do to get it posted. Incidentally, that invitation goes for anyone reading this, whether you are in FDA or outside. Just send me an e-mail with your suggestions (morrisonj@cder.fda.gov).

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Feedback: A Valuable Commodity

One of the best ways to improve any process is to get feedback. Sometimes feedback comes from an expert who watches a process and makes suggestions, such as a golf pro watching a student's swing. Other times feedback comes from customers who suggest ways to improve products and services. At CDER we get both kinds of feedback.

We get feedback from the press, from Congress, from consumer groups, from industry groups and, it sometimes seems, from anyone who has ever taken medicines or eaten food. A series of meetings between FDA, the centers and our stakeholders is providing more feedback on important issues.

Feedback is effective when it is honest and accurate. On the other hand, it does little good to hear that we are doing a lousy job or a great job unless we know that the feedback is from a source who is able to evaluate our work fairly, accurately and without bias. The problem with much of the feedback we receive is that it can be distorted by false assumptions about what we do or false expectations about what we can do.

That is why I was impressed with a survey published last fall by Price Waterhouse, Improving America's Health II: A Survey of the Working Relationship Between the Life Sciences Industry and the FDA. This survey, a sequel to one published in 1995, was conducted by a group at the University of California at San Diego called Connect. While the survey was partially funded by a number of pharmaceutical and biotech companies and has some flaws, it is an honest attempt at identifying and tracking the key factors in FDA's product review processes.

The survey identified three areas in which the FDA review processes could be improved without jeopardizing patient safety: process guidelines, communications with applicants and submission quality. Questions in the survey dealt primarily with communications. Only 116 firms, including drug, device and biotech companies, responded. Thus, the answers to individual questions were often based on a small number of respondents and are useful mainly as qualitative indicators. Since this is the only such survey of which I am aware, qualitative data are better than none. Although comparisons are made in the report with the previous survey, the first one only queried West Coast firms while the second one included firms nationwide.

Most of the responses were generally favorable and could be predicted:

• Firms that had end-of-Phase II conferences generally found them helpful.
• Project managers and reviewers were seen as cooperative and knowledgeable.
• Accessibility to project managers was good, but a minority of respondents found it difficult to talk directly with reviewers.
• Overall communications with CDER were rated acceptable to excellent by all but a very few.

However, responses to one of the questions is cause for some concern. Although the vast majority of respondents did not experience changes in policy during the review process, those who did were asked why they thought the change occurred. The most common single reason cited was a change in CDER personnel. I think we are doing better in this respect, but this survey serves to remind us that we have a legal mandate to honor advice and decisions made by our predecessors in the review process. Hopefully, if another survey is conducted next year, it would find that changes in reviewers no longer result in changes in policy.

I have asked Connect to send me copies of both surveys. As soon as I get them I will make them available to the CDER libraries. They are worth a read, and I hope these surveys are the forerunners of larger, more detailed ones in the future.

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Better Internal Meeting Management—Just a MAPP Away

Whenever industry representatives talk about how CDER has improved over the past few years, meetings are usually mentioned. We are perceived as scheduling meetings in a more timely manner and running the meetings more effectively. Those of us who regularly attend internal CDER and FDA meetings would probably not find the same improvement in that arena.

Whether we work in the new drug review or other areas of CDER, we are under constant pressure to work more efficiently and effectively. While we have streamlined many of our processes, we will need to reduce the expenditure of resources even more. Where is the fat now? There is a fair chunk of it in internal meetings.

Wasting time in meetings is not a CDER invention. It seems to be universal. In a recent private sector survey, 80 percent of managers estimated that half their time spent in meetings was wasted. I would guess that a survey of CDER managers would yield about the same results. The biggest gripe I hear about internal meetings is that we often have the same meeting over and over again, because the first meeting failed to arrive at a clear decision or consensus.

The question, then, is: "Why can't we improve the effectiveness of internal meetings the same way we improved external meetings?" The answer is: "We can!" Why don't we then, and since everyone has the same problem, why hasn't it been successfully addressed in so many organizations?

I put the question to Bob Potter, an expert in meeting management who teaches a course on effective meeting management for the Parklawn Training Center. He believes that most managers do not think of meeting time as a resource to be managed. However, most supervisors and managers average about 35 percent of their time in meetings. If half that time is wasted, it represents more than a sixth of the salaries of CDER management. That is a substantial amount of money, not to mention the lost opportunity for doing other work while half the meeting time was being wasted.

Effective meeting management is not rocket science. That's unfortunate, since if it were, perhaps we would devote more time and attention to it. The basics for effective meetings are contained in the external meetings MAPP (4512.1) and other sources:

• Having clearly stated objectives for the meeting.
• Having the right people present and adequately prepared to discuss the issue.
• Keeping to a written agenda with realistic time allotment.
• Taking good minutes that record decisions made and that are circulated promptly to everyone in attendance.
• Assigning action items with due dates that are tracked and followed up.

For those who are new to running meetings or others who feel a little rusty on the subject, there are courses available from CDER's Division of Training and Development (contact Janice Newcomb, 7-1262, NEWCOMBJ) and from the Parklawn Training Center (3-6790). In addition, Beverly Compton of PTC highly recommends a book, How to Make Meetings Work: The Interaction Method, which is available at the PTC office in Parklawn, Room 16A-55. For managers who would like their staffs to get training en masse, both training offices are glad to bring training on site.

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Ombudsman's Annual Report

Well, it's that time again. The leaves are falling, a new fiscal year has begun, and it's time for me to give you feedback on the past year's ombudsing. There are some trends emerging, now that I have three years of cumulative data.

First, the number of cases overall declined somewhat from last year. There were just under 100 this year, due in part to a significant drop in contacts by CDER employees. In my first year, internal cases represented about a third of the total. Last year, it had dropped to a quarter; although, the actual number of internal cases was greater than in the first year. This year internal cases fell to a tenth of my workload. There are a couple of factors that aided in that decline. First, some chronic problems related to internal management were solved, which helped greatly. Second, the advent of the union may have focused complaints away from the Ombudsman mechanism, at least for those in the bargaining unit.

Another trend which bears watching is a recent surge in e-mail traffic from outside FDA. I don't track e-mail contacts by subject the way I do cases, but I have been receiving a steadily rising number of e-mails, primarily from consumers, patients and health professionals. That number has increased markedly in the last few months to an annual rate of more than 300.

I believe that the increase reflects the rapidly expanding use of the Internet and underscores the need for a more systematic way of handling electronic correspondence. I am not alone in experiencing such an increase. The CDER Executive Operations Staff has been receiving an increasing number of e-mails as well, but their volume is more than 10-fold mine.

To give you an idea of the reasons for complaints, both external (excluding all but a few e-mails) and internal, general categories are in the table.

Although I have refined the method of categorization over time, it is clear that the percentage of issues related purely to the timeliness of reviews or actions has dropped each year. When complaints about access are included, however, the numbers are more constant. It is often difficult to separate timeliness issues from access issues such as difficulty setting up a meeting or failure to respond to phone calls. Both affect the length of the process in question.

The percentage of cases involving disputed policies or decision making has remained pretty constant over the past three years between 30 percent and 40 percent.

Both the number and the percentage of complaints about poor advice or a lack of information have bounced around, but may be on the rise. That is ironic, since with CDER's Web site, there has never been more information available. The numbers indicate, however, that we need to produce still more guidance documents, and we need to make sure that we are all knowledgeable about their contents.

With respect to internal complaints, the relative numbers of those associated with systems as compared to personnel practices has been rising. There are a number of reasons for the change, but I think that improvements in CDER operations generally have raised expectations of folks regarding all the systems. I notice that CDER's people are less likely to accept inefficiency as a way of life and are quicker to complain.

Not all the complaints were about CDER systems. There is a trend toward complaints about Agency and Department systems, such as personnel and payroll, that account for much of the increased percentage. We should not forget, however, that the overall number of internal complaints is moving in the right direction.

I stopped tracking the alerts I get from CDER staff regarding problematic external interactions. These alerts have been increasing, and such information has been very helpful and much appreciated. The earlier in a process that I become involved, the easier problems can be worked out.

I want to thank everyone in CDER for the excellent cooperation and help during the past fiscal year. For those of you who are new to the ombuds process, please remember that my role is not to assign blame but to resolve disagreements and, if possible, prevent them in the future by revising procedures or plugging holes in our processes and communications.

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What Is Customer Service?

Customer service is a trendy concept. An Executive Order, No. 12862, mandates that we do it. But what is the "it," and who is our customer? The answers may vary greatly depending on the circumstances.

The FDA Customer Service Plan lists four types of customers: consumers, health professionals, other agencies and the regulated industry. During internal discussions about CDER's mission, vision and values, the term "customer" raised issues among staff who could readily see the consumer as a customer, but viewed the regulated industry as more of a stakeholder than a customer. Some used the term "compelled customer."

Our scientific education has conditioned us to believe that if you can name something and relate it to other named things, you know something about it. One might call it wisdom by taxonomy. What do we learn about customers or service by naming categories into which all people with whom we interact can be sorted? Not much. This categorization of customers may be useful for planning purposes, but it distracts us from an essential idea.

Let's take the consumer, whom we all agree is our ultimate customer. Which consumer is that? Is it the terminal cancer patient who wants access to highly risky experimental drugs and willingly accepts the risk that the therapy may be ineffective or harmful? Or is it the hypertensive patient who want assurances that the risks and benefits associated with the medicine he or she takes have been well-characterized by large clinical trials? Or is it the taxpayer who wants safe and effective drugs with a minimum of delay and expense?

It's all of the above and millions more. Each person is a consumer and each person has different needs and expectations at different times or in different circumstances.

Perhaps a better definition of a customer is the person with whom you are dealing right now. It may be an attorney representing a small manufacturer, a patient with a question about his or her medication, a representative in Congress who writes on behalf of a constituent, or it may be your co-worker in the next office who has a review she wants to discuss. Is there any reason to give one of these better service than another? I would guess that many in CDER would say that the representative would get better service, because, after all, Congress funds the Agency. It boils down to what you mean by "service."

Service does not imply immediate attention. When we are in a busy bank, we understand that not everyone can be accommodated immediately, so we wait and do not complain about the service unless the wait is excessive or unless our teller is rude or unhelpful. All of these breaches in customer service are difficult to define but easy to recognize when they happen to you.

Service allows for priorities, and it allows for queuing. "Service," like "customer," cannot be described taxonomically. It varies with each situation and with each customer. Inherent in the concept of excellent service are the notions of fulfilling needs and of meeting or exceeding customer expectations for quality, timeliness and courtesy. It also entails tailoring the response to the individual requirements of each customer and of each situation—flexibility. Excellent customer service requires that you mentally put yourself to be in the position of the customer—empathy.

In the example of competing priorities, the representative might wait while the co-worker's question concerning a review that is due that day gets answered. Or the attorney may wait for the patient because their calls arrived in that order. There are no hard and fast rules.

In addition to flexibility and empathy, excellent customer service requires tact, judgment and an understanding of the substantive issues at hand. When it occurs, the customer feels that someone in the organization genuinely cares that their needs are met and did all that was reasonably possible to meet them.

Feedback I get from people outside CDER is almost always positive about the professionalism and willingness of Center staff to be helpful. That is a great base upon which to build a first class customer service reputation. For further information about customer service, I recommend reading the FDA Customer Service Plan at http://www.fda.gov/oc/customerservice.

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Holidays Throw Spotlight on Patient Access Questions

One of the toughest jobs any of us face is telling a dying patient or his family member why he can't have access to a drug he believes is his last, best chance for survival. Maybe the holiday season makes them more memorable, but lately it seems that I've received more patient-access questions.

Thankfully, my job usually puts me in the positive position of trying to find a way to get needed drugs to patients rather than withholding them. When we are successful, the feeling of making a difference is terrific.

But often the problem is not simply one of access. Sometimes I know that a product is being promoted or used in a questionable manner, and an IND has been filed to lend an air of legitimacy. An IND also cloaks the product in secrecy, limiting what we can say about it.

One way out of this legal bind is used effectively by some project managers in CDER. They guide the inquirers by suggesting questions to ask of those who are promoting the fraudulent product:

• Where were the studies showing effectiveness of the product published?
• What are the credentials of those treating patients?
• Who is currently conducting studies of the drug?

Besides fraudulent products, there are other difficult issues relating to patient access. For example, a study may be on clinical hold—a procedure that prevents a sponsor from beginning a study because of unresolved issues related to patient safety or a lack of information. Such issues can't be discussed outside the Agency unless the sponsor chooses to make them public.

Sometimes the drug is approved in another country but not here. Since there are ways to import the product for one's own use if one has the resources or contacts with foreign physicians and pharmacists, difficult issues of equal access to such drugs arise.

Many of us in CDER deal with patient-access issues. Reviewing divisions, especially Oncology and Anti-Virals, and those who handle consumer questions and requests all face the issue often. Most people working in CDER will at some time be faced with questions about patient access. From my experience, CDER staff generally respond to such questions admirably, and patients and their families greatly appreciate a caring attitude from CDER staff.

At times, however, it is all too easy to merge into the gray fog of the organization, diluting responsibility for actions or policies. "After all," you may tell folks, "it is not I who took the action (or did not take an action), but the Center is bound by law and regulations to follow this path. If it were up to me, I would gladly do things differently."

For anyone tempted to use that old bureaucratic ploy, please remember CDER's mission to protect and enhance public health. We are all embarked on that mission, and we must all take ownership of it. If the mission statement is to be more than a facile sound bite, it must be translated into day-to-day, person-to-person interactions. It's very rare that laws or regulations mandate that we do things that, were we in our customer's shoes, would seem heartless and cruel. Laws and regulations generally have flexibility built into them.

Taking ownership does not mean shouldering the burden alone. Fortunately, there are excellent resources to help with patient access problems:

The FDA's Office of Special Health Issues is a source of information and help to patients with AIDS, cancer, Alzheimer's disease, chronic fatigue syndrome and other serious and life-threatening diseases and to their families. The staff does a terrific job, and they are advocates for patients, which is something we in CDER often don't have the time or mandate to do.

The OSHI staff can explain what it means to be in a clinical trial and can put patients in touch with NIH and other government and private sources of help. The Office of Special Health Issues can be reached at (301) 827-4460.

Within CDER, you can refer telephone inquiries to the Drug Information Branch and written or e-mail requests to the Executive Operations Staff. Both staffs can provide information on emergency INDs, personal importation and other issues related to experimental therapies, especially for disorders that OSHI doesn't handle.

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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