Center for Drug Evaluation and Research

Index for 2002 and 2003

• New Year's resolutions
• If you don't know the rules, who does?
• Conspiracy theory
• Risk management is our job
• Annual report: Process issues remain on top of complaint list
• Some last thoughts from the old ombudsman, in with the new

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New Year's resolutions

Admittedly, New Year's resolutions are not exactly innovative fodder for a column at this time of year. I have my personal list, which I'm not sharing; but this one is a list of resolutions for my work life. If you like them, feel free to borrow some or all of them.

I resolve in 2002 to:

• Change the public's image of government. Not by fiat, not by using PR, but by doing simple things better, faster and more thoroughly than the public expects. I want people who contact me to be startled by how fast I return their calls, answer their e-mails and give them useful assistance or information. It's also satisfying to hear the transition in people's attitudes as they go from expecting bureaucracy to finding help.
• Take time to listen and to care. I'm required by my job to care about others' problems. I aim to do that better this year. The world would be a lot better and my job would be easier if everyone took time to empathize.
• Improve my environment. I don't mean clean up my office; although, that would be a change. I mean noticing the little things that impede doing my job and changing them. It may be seeing a need for a particular type of data that isn't on the CDER Web site and doing something about it. Whatever the impediment, it's often surprising how simple it is to remove the small annoyances we put up with daily.
• Resist the urge to overpromise. This is a hard one for me. I tend to underestimate the time it will take me to do a given task. I'll try to compensate in advance by adding a fudge factor into any time frame I promise as a completion date. People are impressed and grateful for work done within the promised time. They get annoyed at delays. I can prevent those annoyances by making realistic promises.
• Take responsibility. When something goes wrong, my first instinct is to look for a logical cause that is outside of my control. I need to remember that people don't expect perfection from human systems. They'll trust me more in the long run if I own up to mistakes and problems, whether they are mine or belong to the Agency. People accept an admission that an error was committed. They get angry at anything that smacks of blame shifting or lame excuses.
• Keep an open mind. I generally pride myself on having an open mind. But those pesky biases creep back in if I don't work diligently at keeping them out.
• Learn. Continuing education sometimes gets forgotten in the press of daily work. But in this job, I either learn new skills and knowledge or I become obsolete. I want to devote some part of each day to learning—not gossip or rumors—but real stuff.
• Value my colleagues. I often have reason to be proud of the people who work for CDER. Although I get lots of complaints, when I look closer, I frequently find that my colleagues did all that could be expected of them and more. I'm proud to be associated with CDER, and I need to celebrate it more.
• Enjoy my job. None of us knows what will happen next. Sept. 11 certainly brought that message home. So in the precious time I have here and now, I need my work to be enjoyable. I'm fortunate to say that mine is enjoyable, satisfying and meaningful. If it becomes less than that, it's time to find something that is enjoyable.

May this year be your best ever.

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If you don't know the rules, who does?

Every time I go through the annual agony of doing my taxes, I marvel at the arcane minds of CPAs and of the programmers who devise tax software. I frequently wish there were a software program called FDA Rules for Dummies. Let's face it, keeping up with the changes in the laws, regulations, guidances, MAPPs and policies we work with every day is a Herculean task. It is made somewhat easier by the information contained on FDA's Web site and other Internet resources.

Unfortunately, with the increasing exodus of staff with institutional memory, those of us who are left have fewer people we can go to for easy answers. That leads, inevitably, to an increasing number of problems caused by either ignorance of the rules or a lack of experience in interpreting them. That, in turn, leads inevitably to an increased business for the ombudsman.

There are some critical rules that can make a big difference to consumers and to those we regulate if they are ignored or improperly interpreted by CDER staff. Some examples include the rules for:

• Fast track or accelerated approval.
• Pediatric testing and exclusivity.
• Orphan product exclusivity.
• Importation of drugs for personal use.
• Drug manufacturing and quality standards.
• Patent certification for generic drugs.

There are numerous others as well.

No matter what we do or how we do it, there are more people looking over our shoulders than ever before. The news media daily make the public and us aware of our impact on the public health, drug costs and the financial markets. While that has always been the case to some extent, in recent years the public awareness of our activities has increased. The anthrax attacks last fall have also heightened the public's awareness of and expectations for our role in drug regulation.

Whether we are dealing directly with the regulated industry and the public or whether we are scientific reviewers or researchers tucked safely away in labs and offices, none of us can afford to be ignorant of the rules under which CDER operates.

These rules create public expectations that affect our organizational priorities and how we accomplish our mission. Ultimately, they affect how each of us does our work.

Realistically, we cannot individually know every law, regulation, guidance and policy that guides the Center. However, we must have a general knowledge of what rules exist, where they are written and who to ask for advice about their application.

It is also helpful for us to know our larger environment and a little about the forces that impact the Agency. Above all, I urge everyone to be honest about the extent of his or her knowledge. It is no sin to say you don't know. However, winging it can land you in deep trouble.

Fortunately, we have some good resources to help us keep abreast of the rules, policies and environment. The FDA Web site has been improved by replacing its original search engine with Google. Just remember that you sometimes have to search the FDA and CDER sites separately, since you may get some different hits with each.

You can search the Food Drug and Cosmetic Act, other laws enforced by FDA and FDA regulations by going to the Reference Room heading on FDA's Internet home page at http://www.fda.gov/.

The FDA intranet, available to FDA employees only, has a way to keep abreast of the latest news via the Clips, put out daily by the FDA's Office of Public Affairs at http://intranet.fda.gov/clips.

Of course, CDER's Web site has all the guidance documents, MAPPs and policies you need to refer to. The CDER weekly report, circulated by e-mail and posted on the CDERnet lists updates in regulations and other new documents.

Unless we make these resources part of an ongoing learning effort, however, they are of little avail. And, as always, I strongly recommend that if you don't feel fully up to speed on an issue, regulation, guidance or whatever, please ask someone who is.

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Conspiracy theory

On the heels of every rash of overblown promises by companies or individuals touting panaceas for the world's ills, comes the day of reckoning. In the day of reckoning for promising drugs comes the epiphany that FDA thinks they don't work—or at least haven't been shown to work. The day of reckoning is soon followed by the day of deflection and the conspiracy theory.

Now, I'm not thinking of any specific case, because there are more than enough examples in the media. It has become commonplace for the beleaguered company, whose stock price rocketed on whispered results of testing for a new drug that would cure cancer, stroke or hangnails, to blame FDA when it all falls apart.

The Web chat rooms are then soon filled with speculation about how big competitors and FDA conspired to block the drug. When the conspiracy theorists get really going, they may include the AMA in the cabal, since if all diseases were cured, doctors would be out of business. Sometimes the conspiracy is given credence by the news media, usually through less than thorough fact gathering.

Face it—we all believe what we want to or are conditioned to believe. We need our heroes and we need our villains. Heroes should be individuals acting in the face of insurmountable odds. Villains should be powerful people or organizations over which the public has virtually no control. That is where FDA comes in. If you are sick, it is more comforting to think that a cure for your illness is out there. It is just FDA that stands in the way of your survival. That leaves the door open for individuals to fight FDA and its co-conspirators, to get the drug released and the patient cured. That allows the helpless to take hope and to take action. It is not comforting to find that the company or people pushing the drug company stock lied, that there isn't any cure and that the patient will die (or that the investors were scammed out of their money).

FDA gets blamed either way. If we approve a drug that is later found to have unexpected side effects, we are criticized as being too fast and sloppy, in the hip pocket of industry or worse. If we fail to approve a drug, we are accused of being overly bureaucratic, stupid and causing the financial markets to collapse.

We in FDA should accept as inevitable that our organization and we as individuals will occasionally be painted as villains. It's the price we pay for taking action in the arena of public health. But it is necessary for all of us to be careful about what we say and to whom.

Further, if we see a drug that is yet to be approved but is being promoted by the sponsoring company far beyond its therapeutic value, we should convey that information to CDER's liaison with the Securities and Exchange Commission—Debbie Henderson, director of the Office of Executive Programs. The SEC has the authority to take action if the promotion is coming from the company and if the company has not truthfully informed stockholders. We should also alert DDMAC, because, if the promotion is coming from the company, it may be illegal.

Patients, patients' families, investors, stock analysts and reporters should do their homework and not believe pie-in-the-sky promises of a breakthrough drug that is just around the corner if only FDA would get out of the way. True breakthroughs do happen. Unfortunately, they happen far less often than people hope for. When they do occur, FDA is usually willing and able to speed them through the review process. Everyone should recognize that FDA cannot legally disclose information about pending applications.

What are purported by rumor mills to be leaks from FDA almost always come from within the company, the researchers or elsewhere. If anyone has substantial evidence of an FDA employee leaking information, report it to the FDA's Office of Internal Affairs (7-0243). It is a crime, punishable by dismissal and perhaps prison for FDA staff to leak such information. Conspiracy to break the law is a crime, and, fortunately, is also one rarely committed by FDA employees.

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Risk management is our job

One truth has been etched in my brain since I became an ombudsman seven years ago: You cannot please everyone.

Often the mistrust of governmental risk-benefit decision-making and risk management stems from a natural dichotomy between societal risk/benefit and individual risk/benefit.

For example, a mentally competent citizen may want to be able to make informed decisions about a full range of risks that he or she may assume. That position suggests that even risks that appear unreasonable for society at large should be available to individuals, but with sufficient information for them and health care professionals to make intelligent decisions.

Government generally sees its role as protecting the health and welfare of society as a whole. However, a substantial segment of the public expects to be protected from what they personally would consider unreasonable risks. Moreover, there is such a wide variation in the risks individuals are willing to accept that whatever decision the government makes regarding acceptable risk is doomed to attract criticism.

By eliminating risks that are unreasonable for the majority of its citizens, a government appears paternalistic to that subset of the population who want to make their own decisions and for whom the benefits may outweigh the risks in particular instances.

When the government makes decisions for its citizens, it automatically imposes value judgments that do not reflect the views of everyone. For example, when faced with evaluating a new drug that shortens life but improves the quality of life, conventional wisdom usually favors prolonged life over quality improvements. However, some terminally ill patients may not agree.

These reasons and more underscore the importance of CDER's risk management initiative. Without some clearly stated operating principles in risk-benefit decision making, CDER policy makers will be second-guessed by the press, the public and health care professionals. The worst scenario, as we have observed, is a risk-benefit decision altered post facto in the wake of media pressure. It is imperative that CDER clearly state the bases for its risk-benefit and risk management decisions and to make its decision-making transparent.

In theory, it is wise to allow the public to determine the amount of risk that is acceptable to them. However, which public should determine acceptable risk? Is it the public that won't tolerate the miniscule risk posed by saccharin? Or is it the public that downs a myriad of prescription drugs they buy online without consulting a physician?

Increasing the responsibility for risk-benefit decisions of individuals and their health care professionals, if the Center takes that course, requires more useful information about drugs than is currently available in labeling. It also means a willing acceptance of that responsibility by the public and health care professions. So far, there does not appear to be a public consensus to accept such increased responsibility.

Clearly, CDER's increased emphasis on risk management is most welcome. Part of our job will be educating the public and health professionals about the true risks and benefits associated with drugs. It also means that we need to come to a consensus within CDER about how we define acceptable risks for society. To that end, it is incumbent on each of us in CDER to understand the principles of risk management and to engage in learning opportunities and discussions within CDER and in other forums.

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Annual report: Process issues remain on top of complaint list

In my last annual report before leaving for pastures, greener or otherwise, I was hoping I could report that we had made significant progress in eliminating some of the more troublesome problems of the past.

Alas, that was not to be.

The number of cases and complaints rose moderately this past year, as did e-mail traffic. Of some concern was a significant rise in internal complaints, which, while still low, may reflect the cumulative effect of turnover in CDER's middle management, coupled with stress brought on by the increasingly tight timeframes of PDUFA II. Many reviewers and managers in CDER have felt pushed to their limits of capacity for workload and look forward to the added resources and realistic goals contained in PDUFA III.

As has been my custom, I tabulated external complaints according to six categories by percentage of total complaints. I compared the figures with three previous years to show trends better.

There are some trends worth noting. Unfairness became less of an issue, and timeliness bounced up, as did unhelpful interactions. I think these changes are further evidence of the workload stress that accompanied the last year of PDUFA II. I'm happy to report that complaints about uncivil interactions have dropped, and that the category was composed of the less offensive "unhelpful" variety of interactions.

Difficulty gaining access to CDER staff, in the form of meetings denied, phone calls not answered and late responses to correspondence (as well as delayed meeting minutes), has continued at an undesirable rate. At times this past year I have been snowed under, and I can sympathize with staff who just can't find the time to respond. But we really need to devote an extra effort to being more responsive. The people who try to contact us deserve better.

I plan to write one more column before I leave, but I would be remiss if I did not take this opportunity to thank the many people in CDER who have made my seven years as Ombudsman a truly rewarding experience. Janet Woodcock is at the top of my list, because she has strongly supported and appreciated the ombudsman function. The Center has made great strides under her leadership and will continue to do so in the future. I have received universal cooperation and help from CDER management and staff, for which I have been most grateful. Even the vast majority of those who have found themselves the subject of complaints have been forthcoming and cooperative, and, I hope, they have found it helpful that the role of the ombudsman is to listen to all sides of an issue and to get it resolved without recrimination or assigning blame.

All this thankfulness naturally leads to the question: "Why am I leaving?" Because it's time. In my 37 years with the FDA, I have never spent more than seven years in any one position. So it feels right for me to exit at this time. I don't know exactly what I'll be doing next year, but I have more goals and interests than I have time. Even after I depart, the people in CDER and their mission will always have a special place in my mind and heart.

We will be working to make the transition to a new ombudsman as smooth as possible, so stay tuned for more information.

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Some last thoughts from the old ombudsman, in with the new

In this, my final column and the first Pike issue of the new year, I'll give you some parting thoughts and introduce my replacement. I could write a book about the changes I have seen in drug regulation since I joined the agency in 1965. Trying to leave you with some meaningful thoughts in a 700-word column is challenging, but here goes.

In 1965, medicine was very paternalistic. It wasn't uncommon for physicians to tell terminal cancer patients that, "there is always hope." And patients believed them, because they wanted to. The FDA had just been revamped to include effectiveness as well as safety in the evaluation of new drugs, and clinical studies were regulated in the wake of the thalidomide tragedy. Fundamentally, the system was designed with the FDA acting as a funnel with a filter through which all products must pass before reaching the market. But later that model started to fall apart.

The public became more educated, and the news media began routinely reporting preliminary results of pharmaceutical research. People demanded more candor from their physicians. As they became aware of potential treatments for life-threatening diseases, they realized that they did not have time to wait until the normal drug development process had been completed. When the AIDS epidemic reached a critical point, its victims became the militant vanguard of patients demanding treatment with drugs based on only preliminary signs of effectiveness and safety. While the FDA adjusted its rules accordingly, the demand for new, inadequately tested treatments increased. Patients learned how to research the medical literature themselves. Soon, patients with no alternatives demanded treatments that had been shown to work only in animals.

The end of the twentieth century saw the rapid adoption of the Internet, a new technology with the potential to change society as dramatically as did the printing press and movable type more than five hundred years earlier. In a few short years, the Internet went from a means for scientists to communicate to a common forum for international communication. It has changed the rules. Anyone, from Bangkok to Bimini with a hundred dollars can set up a Web site and accept credit card payments. And as yet, no government has been able to regulate the transcontinental flow of information and products moving with speed and relative anonymity.

The FDA's legal model of a filter preventing dangerous or ineffective drugs from reaching the consumer has been breached. While the legitimate drug industry needs the regulatory framework as much as the FDA needs companies to adhere to it, we cannot ignore the challenges posed by drugs marketed through the Internet.

The key to drug regulation now and in the future is information. Whoever has the most useful and informative Web site will be in the best position to influence the public's health care decisions. CDER has a good Web site now, which is a tribute to the staff who keep it up. However, we need to do much more to make it user friendly and to upgrade its content and timeliness.

The CDER site needs to go beyond the information contained in drug labeling. It needs to include a compendium on drugs and drug usage, perhaps through links to other sites as well, and it needs to explain the risks and benefits of drugs in language that the lay public can understand. That will require multiples of the current resources being put into the site. If CDER does not expend that additional effort, however, other organizations or commercial entities will become the premier sources for information about drugs. And that would be unfortunate indeed.

So much for the old Ombudsman. It has been a pleasure to serve CDER in that capacity and in other ways during my career here. Warren Rumble has agreed to take over the ombuds duties, at least until the position is advertised and filled permanently. His background as a NIH researcher and nuclear pharmacist, a program manager in CDER and a senior reviewer in the Division of Drug Marketing and Advertising gives him a good foundation for success. Most importantly, he has a warm and calm personality, an invaluable asset to an ombudsman. I know you will give Warren the same generous cooperation you have given me, and I wish him and CDER all the best in the future.

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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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