Center for Drug Evaluation and Research

Index for 2000

• CDER's Pet Peeves—Part II
• Happy Anniversary to the Pike
• What's What
• 'FDA Made Me Do It'
• Now, If Only We Could Float an IPO
• St. Sebastian Kept a Stiff Upper Lip
• Pride and Prejudice
• Ignorance Is Not Bliss
• Annual Report: Complaints About Processes Move to Top
• A Map to the Road Ahead

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CDER's Pet Peeves—Part II

This month's column concludes my report of an informal, Centerwide poll seeking feedback on what behaviors by the regulated industry bug our staff the most. Remember, industry folks suggested this topic, so I hope it proves useful in improving our interactions.

In my last column, I covered complaints regarding overly aggressive communications and quality problems with submissions. This month we'll look at unrealistic expectations and what may appear to Center staff to be industry attempts at "gaming the system."

Several complaints involved firms' requests for exceptions from stated policies and procedures or for special treatment, such as expedited review or moving up in the queue. Naturally, each such request is justified by appeals to the staff member's sense of fairness and equity. Appeals usually cite hardships, sometimes, but not always, created by CDER's past actions. It's just not realistic to expect Center staff to bend or break established rules of procedure or change priorities to accommodate everyone's specific circumstances.

Were CDER to honor these requests, charges of favoritism and misfeasance would soon follow. If you really feel you've suffered a grave injustice that needs to be addressed, I would recommend that you talk with the director of the appropriate division or contact me.

Another common complaint was that newcomers to the pharmaceutical industry sometimes expect CDER to function as a consulting service. Many of us in the Center have been approached by someone who claims to have discovered a great treatment for a disease and wants us to tell him or her how to get the product on the market. I always recommend that neophytes seek the services of a consultant.

The Center makes a lot of information about the drug review process available through the Internet and elsewhere, and it offers guidance to the industry in meetings. However, it is unrealistic to expect that the limited time CDER staff members have would be sufficient to guide a company through the entire drug product development process. One shouldn't expect extensive training in drug development from CDER anymore than one would expect training on how to build a space station from NASA.

Other examples of unrealistic expectations include:

• Asking for a determination when there is clearly insufficient information on which to base a decision.
• Seeking immediate answers to complex regulatory issues at meetings or on the phone.

The term "gaming the system" implies an intentional effort to subvert or misuse procedures and systems. I know that not all examples of the behaviors discussed below are intentional gaming strategies; however, they are often perceived by Center staff as such.

From my experience, the vast majority of people who work in the regulated industry are honest and try to do the right thing. When their motives are questioned, they are understandably affronted. Industry representatives do try to further their company's position but do not see themselves as gaming the system.

However, CDER staff must occasionally deal with those who seek to test legal and ethical limits. When they see behavior that can be construed as devious, they may well assume the worst—that the person is gaming the system. Avoiding the following behaviors can materially increase trust and improve interactions:

• Deviating from an agreed-upon protocol design to achieve a more favorable result. Examples include changing inclusion and exclusion criteria or using different statistical methods.
• Burying protocol changes or other key information in general correspondence and not discussing them with the reviewing division.
• Exaggerating the consequences of failing to get whatever is being sought. Staff hear so frequently that the company will fold if the requested accommodation is not made, that they routinely ignore such claims.
• Aiming to come as close to the regulatory line as possible or to do the absolute minimum work needed to fulfill regulatory requirements.
• Complaining about a competitor's behavior and then asking to do the same thing if immediate regulatory action is not forthcoming.
• Being less than forthright about safety issues with investigational or marketed drugs.
• Asking CDER to delay an action to avoid adverse publicity or postpone bad news until after a shareholders' meeting or a critical financing decision. The last two are particularly troubling to Center staff. Nothing destroys working relationships and trust so much as appearing to be willing to trade public safety or corporate reputation for financial advantage. In the long run, strategies that attempt to hide information, even for a short time, cause much more damage than they can ever avoid.

One of the messages I took away from this survey of pet peeves is the wide range of behaviors and ethics to which CDER staff are exposed. It is well for industry people to keep in mind that Center staff are exposed to enough examples of untrustworthy behavior that it may color other interactions. That thought may help those interacting with the Center to forgive staff members who have become generally suspicious.

The most difficult aspects of any type of law enforcement or regulatory work are how to recognize who is trustworthy and who is not—and to deal with each accordingly. It is a credit both to the regulated industry and to CDER staff that the vast majority of interactions between the Center and the regulated industry are positive, straightforward and mutually respectful.

Whether you are a member of the regulated industry or a Center employee, you should be able to expect high standards of professionalism, courtesy and respect in your interactions. I appreciate hearing about interactions that fail to meet those standards. You can contact me by phone or e-mail (301-594-5298, morrisonj @cder.fda.gov).

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Happy Anniversary to the Pike

At times, it seems my memory of FDA predates recorded history. My tenure here really began with the Bureau of Drugs in the early 1970s. From that perspective, the changes have been spectacular. But since this is the fifth anniversary of the Pike, in this column my reflections go back only as far as 1995, which is also the year the CDER Ombudsman position was created. The major focus of activity in CDER then was the 1992 Prescription Drug User Fee Act. The Center was getting into the tough part of the goal dates for NDAs.

Judging by complaints from the industry, it was still too early to tell if PDUFA was going to be a success or if it would be another failed attempt to revolutionize new drug reviews. There was a dwindling backlog of pre-PDUFA applications, but some review divisions were struggling to get their work done on time. Inside CDER, however, there was a clear mandate to make PDUFA work, and there was a sense of urgency that meant reviewers were working harder, smarter and longer hours. However, just doing more of the same was not the long-term solution.

In February of 1996, Center Director Janet Woodcock, M.D., led about 30 senior managers in a go-away. CDER had management go-aways before, and some in attendance were skeptical that anything more would come from this one. But instead of focusing on planning or budgets, this one focused on taking a step back, on breaking down the barriers to communication among CDER's diverse offices and on figuring out what CDER was about and what it needed to do to adapt to a changing world. The participants in that go-away became the CDER Change Team.

The result was a palpable change in the climate in CDER. There was a growing cohesiveness, collegiality and a renewed sense of direction. To illustrate the extent of the change in CDER, I'll cite one example. In the fall of 1996, during one of many sessions to acquaint first- and second-line supervisors with the change process and to get their input, we had an exercise to write a headline for the Washington Post for a date in the year 2000. Several of the working groups produced a headline that read something like: "CDER Wins Prestigious Award for Outstanding Achievement." Although that mock headline was viewed as an improbable stretch at the time, just two years later, CDER and the Agency won the Ford Foundation's prestigious Innovations in Government award.

Awards are fine, but are there more lasting indicators that CDER has changed in five years? From my perspective, while the number of complaints has stayed fairly constant, the attitude of complainants has changed. Five years ago, complainants from the industry and members of the public were angrier and were very willing to buy into the image of CDER as a group of hide-bound bureaucrats who delighted in putting roadblocks in the path of progress.

While there is still a small minority of people out there who cling to that image, those who contact me and who know CDER have a greater respect for us and an expectation that whatever problem they have encountered is an aberration that can be fixed. The edge in people's voices is generally gone, as is most of the anti-FDA sentiment. No award or public relations campaign can bring about that change in attitude. People believe their own experiences over PR. The surest way to win people over is one person at a time, and CDER has been doing just that.

No five-year retrospective would be complete without some mention of where we are headed in the next five years. The Internet is changing the way people think about information. It is also raising expectations about how much information should be instantly at everyone's fingertips. One of CDER's most important challenges over the next five years will be to fill the demand for better information about health care and medicines.

This demand is coming, not only from the public, but also from health care professionals and other stakeholders. With the number of Internet sites numbering in the tens of millions and increasing daily, there will be more misinformation about drugs and dietary supplements out there spreading confusion. As people realize the need to get information from reliable sources, they will grow to depend on sites such as FDA's.

CDER needs to be there with accurate information, displayed in an easy to use format that is updated constantly. To do that, we will need to completely rethink the way we handle information within CDER.

CDER has come a long way in the past five years in transparency and openness. The Pike has been part of that progress. It has become a popular and trusted source of information about CDER, not only for staff here but perhaps more so for people outside the organization. That underscores the need for even more openness and transparency by CDER. The challenges in the next five years will be tough, but if the past five years are any indication, CDER will successfully meet those challenges.

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What's What

It's been about two years since I made an appeal for CDER staff to be alert to whether the product they were reviewing was really a drug (Pike, April 1998).

I haven't been flooded with questions, so I assume that either everything coming into the Center belongs here, which is mostly true, or that folks don't spend a lot of time worrying about intercenter jurisdiction, which is also mostly true.

Since I am an exception to the latter assumption—it's part of my job to worry about intercenter jurisdiction—I have been thinking about ways to simplify how we distinguish between drugs, devices and biologics.

The boundaries between the different product classes, each of which has its own regulatory system, are interesting. Some fascinating products straddle normal boundaries.

Liquids and powders can be devices—for example, liquid bandage preparations and bone cements. Monoclonal antibodies coupled with oncologic agents are drugs. Cultured skin is a device; although, tissue implants are biologics.

In this counterintuitive world, where products may not be what they seem, it helps to have a general, simplified algorithm to follow. I have devised one, but I stress that it is only intended for internal use by CDER staff. It is oversimplified, informal and cannot replace, annotate or amplify the formal intercenter agreements. Any inconsistency with the intercenter agreements is unintended.

The algorithm is designed to be an easy way to decide if it is appropriate to ask the CDER intercenter jurisdiction contact—that would be me—to take a closer look. Ultimately, the determination of intercenter product jurisdiction rests with the FDA Ombudsman's office.

This algorithm may generate more questions for me, but the extra effort is worthwhile if we can avoid learning at a pre-NDA meeting that a product is in the wrong center and regulatory system. This happened recently.

Even if a product doesn't fit anywhere in the algorithm, the prudent rule is: when in doubt, ask!

If you want to take a look at the intercenter agreements, they can be found on the FDA Web site at http://www.fda.gov/oc/ombudsman/pj.htm.

Informal Product Jurisdiction Guide

In general, a product is virtually always a drug if it is:

• Synthetically produced.
• Similar to other products that are drugs and easily characterized.
• An antibiotic to treat humans.

However, the product may be a biologic—and you should consult the intercenter jurisdiction officer—if it or any of its parts is:

• A vaccine.
• An in vivo diagnostic.
• An allergen for therapeutic or diagnostic use.
• Derived from human blood.
• Used in blood transfusion or blood banking.
• A blood-cell substitute.
• An immunoglobulin.
• Composed in any part of intact cells or microorganisms.
• A protein, peptide or carbohydrate produced by recombinant cells or transgenic animals, except for antibiotics, hormones and products very similar to approved drugs.
• An animal venom.

Finally, the product may be a device—and you should consult the intercenter jurisdiction officer—if it or any of its parts uses:

• An implanted drug delivery system.
• Computer software or hardware, for example, programs or devices that calculate dosage or activate the drug.
• Device components, such as: inhalers, catheters, probes or bandages.

A product is also likely to be a device if it:

• Is used to irrigate, moisten, lubricate or flush skin or indwelling devices.
• Protects the body from injury, irritation or infection by physically shielding it.
• Does not achieve its primary function by chemical or metabolic action on or in the body.

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'FDA Made Me Do It'

In December and January, I focused on pet peeves about the industry from CDER reviewers. This time, I'd like to add one of my own. It seems that some people in drug company customer service departments and some pharmaceutical sales representatives have developed a new strategy. Whenever they get a complaint about their product, they just say that FDA made them do it. Over the years, I have received occasional questions from people who were told that FDA made a company do whatever was the subject of the complaint, but lately it has become a much more frequent occurrence.

For example, just recently I received several complaints alleging that drug company representatives said they couldn't change the size of the packaging, because FDA made them put the drug in that container size. Alternatively, one person was told that the company would have to redo all of its studies in order for FDA to allow a change in packaging. The implication was that they would have to retest the drug for safety and effectiveness, not just stability.

Another person was allegedly told that the same product was given two different names because FDA required it. Now, in rare instances FDA has asked companies to give a different name to a drug with a new indication, but only when safety issues were involved, such as special warnings, dosages and routes of administration. The complaint I'm concerned about involved a drug product that is sold under two different names purely for marketing reasons, a practice that FDA usually tries to discourage.

This shifting of blame doesn't involve just one or two companies. It is such a common element in complaints about drugs made by different companies, that it appears to be a growing industry practice. I don't think it's a conspiracy. It's more likely the result of misinformed employees.

My appeal is to the folks at pharmaceutical companies who have opted to take this easy approach to dealing with complaints from consumers and health professionals. Every organization makes mistakes and unwise decisions. FDA certainly makes them, and when we do, it is difficult to explain to the public why they occurred. I certainly can empathize with customer service personnel, since a significant part of my job is handling complaints. But passing the buck eventually hurts the credibility of those who try to shift responsibility.

I am grateful to people who seek me out to confirm that FDA really did require that companies do these things. It gives me a chance to set the record straight. But I know that for every one of these questions I get, there are perhaps hundreds of people who don't bother to ask or who are all too willing to believe in the inherent stupidity of government agencies.

I also ask CDER staff to please let me know when they get a complaint from someone who was told by a drug company: "FDA made me do it." It will help me track this trend and try to find ways to address it.

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Now, If Only We Could Float an IPO

An ancient Chinese blessing says: "May you live in interesting times." Well, we are blessed. We are privileged to witness the beginning of a new age, the Information Age, which is fast replacing the Industrial Age.

The Information Revolution is being fueled by computer, Internet and wireless technologies, just as the Industrial Revolution was fueled by steam and electric power, the assembly line, the telegraph, the telephone and better transportation technology.

When the telegraph was invented, people said: "It will change our world, and it will transform the way we live." In my view, the Internet has a greater potential to change our world than the telegraph ever had. Who can say if the new economy can sustain the multibillion-dollar capitalization of IPOs (initial public offerings) that have made a lot of people rich? But the hype has provided an unprecedented bankroll for venture capitalists to play with and to feed progress.

When venture capitalists decide to fund infotech startups, they ask several questions:

• Does the company have unique information that businesses or the public want or need?
• Does the company have a catchy dot-com name or can it develop name recognition?
• Can the startup sustain a buzz that will keep its name in the public consciousness?
• Can the firm manage and sustain growth?
• Does it have the technological savvy to stay at the cutting edge?

Since all organizations, not just startups, need to assess how they will meet the challenges of the Information Revolution, lets look at how CDER would fare in a venture capitalist driven world. First, we certainly have unique information that people want and need. Secondly, we have an Internet identity that attracts Web traffic, and FDA is a household name that is kept in public view daily by news media reports of our activities. Our growth is limited by the budget, but we have shown we can manage growth to improve performance dramatically. Do we have cutting edge information technology? Well, four out of five isn't bad. In fact, if we were a private enterprise, venture capitalists would be beating down our door. Now, if only we could float an IPO . . .

About now, you are probably asking yourself: "Any moron knows CDER can't sell stock, so what is his point?"

Good question. My point is that regulatory agencies, like the rest of society, are greatly affected by paradigm shifts. The FDA was created in the Industrial Age, when the focus of enterprise was on producing goods. The FDA was created to act like a funnel with a filter. All drugs would pass through the funnel before reaching the consumer. In the Information Age, when people in Peoria are hard-wired to Paris, Potsdam and Beijing, the funnel is developing leaks.

Rather than being dismayed that we cannot create a funnel large enough to encompass the whole world, we should recognize that we are in an excellent position to thrive in the new Information Age. Although we don't have cutting edge information technology, that's OK. The Information Revolution is propelled by technology, but it is really about content, about developing relationships among far-flung strangers with common interests and about communicating information instantaneously and globally.

Hardly a day passes that I don't get e-mail from consumers and health professionals complaining about being spammed or about seeing Internet sites for fraudulent products or for prescription drugs obtainable without actually seeing a physician. With over a million Web sites being created annually and a 150,000 new Internet users added daily, the world is drowning in information about diseases and treatments, much of which is of dubious veracity.

When people are bewildered by the glut of contradictory information about drugs and health, they look to the Websites of organizations they trust. That is why venture capitalists put so much value on name recognition and ongoing publicity about startups. The FDA has that already, and we can do a lot of good if we understand how to communicate what we know about drugs.

That isn't to say we should abandon our traditional role of filtering and regulating. There will always be pharmaceutical development and production, just as agriculture is still an important enterprise long after society stopped being predominately agrarian. All of us need to keep doing what we are doing now while devoting thought and resources to adapting CDER to the Information Age. We have vital information to communicate. We need to do it more effectively.

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St. Sebastian Kept a Stiff Upper Lip

Well, it seems like slings-and-arrows season again. The Center has certainly received more than its share of bad press in the past few months, and it takes its toll in staff morale. From the mail I've been getting, mainly from consumers, it is apparent that there is a lot of misinformation and false perceptions about the benefits and risks of drugs and how CDER decides to approve a drug or ask its sponsor to withdraw it from the market.

It's painful to get flaming e-mails, but it's equally painful to hear colleagues express a stoic acceptance of these barbs as the fate of regulatory agencies. The Agency's traditional approach has been to quietly accept the public's wrath, born of misperceptions and incomplete information, while waiting for the complete, scientific truth to emerge some time in the future and prove the wisdom of Agency actions. But information delayed is an educational opportunity lost—or worse—a tacit endorsement of the misinformation.

The situation reminds me of paintings by Giovanni Bellini (1426-1516) and others depicting the martyrdom of St. Sebastian. He is usually shown with his body pierced by arrows and a woeful expression on his face. But Sebastian kept a stiff upper lip. Sporting numerous arrows protruding from your body may look good if you are applying for sainthood, but it is less becoming to a regulatory agency. One of our important obligations to society is to educate the public about drugs, how to use them safely and about what the Agency is doing to assure that only appropriate drugs are on the market.

To quietly endure the slings and arrows of a misinformed press and public is not noble—it is a failure to communicate. The public needs to have a basic understanding of drugs and how to decide whether to take a drug in a particular circumstance.

The public does not learn from reading transcripts of advisory committee meetings or scientific articles. The public needs to get this information in short, comprehensible messages that are not unlike the sound bites they get from the media.

We have no one but ourselves to blame for the public's lack of understanding that "safe drug" is an oxymoron and that benefits must be weighed against risks, with different people usually getting the benefits and suffering the risks.

Thanks to the science fiction genre, the public has a better comprehension of Einstein's special theory of relativity (E=mc²) than it does of drug regulation and benefit-risk evaluation. It's doubtful that the average person will ever need to use Einstein's equation, but ignorance of the risks of drugs can be fatal.

If the public is being educated by the media in sound bites, we need to educate the public and to explain our actions in a collection of sound bites that add up to a cohesive picture. If these bites are repeated in interviews, posted on the CDER Web site and disseminated to the public at every opportunity, the messages will sink in. Stating the reasons for actions is always preferable to remaining silent in the face of criticism.

We simply can't afford to allow misinformation to prevail. Educating the public and the media is an important function of government. In the Information Age, it is becoming even more important. Fortunately, this vital function is becoming easier to fulfill. With the Web, the Agency has the opportunity to interact with the public individually in numbers never before possible.

Each of us can contribute to the process. We can begin by trying our communication skills on our family and friends. If we can't explain to our spouses and kids about benefit-risk in drugs, it's not likely we can get the message across to people who call and write letters. We also need to carry on a dialogue among ourselves and to share consensus views with the public.

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Pride and Prejudice

Political comedian Mort Sahl said of President Eisenhower that once he had made his mind up, he was thoroughly confused. Historians have made similar comments about George Washington's alleged indecisiveness. These were meant as criticisms, but I sometimes wonder. Are the pundits and historians identifying true indecision or are they mistaking a willingness to revisit decisions for weakness or indecision? Being always willing to review a decision and to change it in light of new information is a rare virtue. Sadly, it is rare because of the tendency in most of us to exhibit pride and prejudice.

We take pride in making the right decision. Pride in itself is fine. All of us should take pride in our work and in our lives. But pride sends us astray when it prejudices us so that we are reluctant to revisit a decision in the light of new information or a reanalysis of old information.

Almost every significant decision in life must be made with less data than one would like. This is certainly true of governmental decisions, whether made by the president or by regulatory staff at the FDA. We should recognize that such decisions are inherently susceptible to challenge later. However, having pride coupled with prejudice about a decision leads to a reluctance to reexamine it when new data become available. And that unwillingness may lead to flawed decisions subsequently. Such reluctance can also create a delay in acting on new information.

Specifically, if the new information were adverse to a newly approved drug, the consequences to the public of a delay in action caused by a reluctance to reexamine the decision could be grave. On the other hand, this pride and prejudice can lead to an unwillingness to accept supervisors' and managers' reviewing a decision and overruling it. It can also bias a reviewer whose negative recommendation regarding a drug's effectiveness was overruled, causing him or her to unnecessarily restrict labeling or to suggest new studies in a supplemental application that would not otherwise be needed.

Fortunately, decisions made in CDER are generally institutional rather than individual, so it is unlikely that one person's pride and prejudice will have a major effect. The true danger of such bias is when a group of individuals adopts a bias about a collective decision.

The institutional nature of our decisions should be a basis for curbing our pride and prejudices. None of us is fully responsible for Agency decisions, whether we think they are good or bad. That should allow us to distance ourselves from our decisions and to be willing to revisit them when new data or analyses come to light.

August 31, 2000.

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Ignorance Is Not Bliss

The composer Gian Carlo Menotti once wrote: "A man only becomes wise when he begins to calculate the approximate depth of his ignorance." One benefit from working in CDER is a never-ending depth gauge for ignorance. It isn't that we are dumb, it is just that the science, policies and issues are so extensive and change so frequently that it is not possible for us to ever feel that we have mastered them. Whenever we think we are on top of them, it's time to wake up.

There are both internal and external opportunities for displaying our ignorance. But knowing that we don't know everything is a safety net most of us acquire sometime after adolescence. It is always possible to learn by asking someone or to defer to someone who does know. When we don't know what we don't know, as Yogi Berra might say, we get into trouble.

Each of us has areas of expertise, and collectively CDER has a wealth of knowledge about drug development and regulation. But there are blind spots. For example, too many of us tend to make assumptions about marketing and economic factors that motivate drug companies. And, yes, it does work the other way. Sometimes companies make assumptions about what motivates the FDA rather than asking the Agency.

Just recently I saw such a case of mutual ignorance. Reviewing staff were encouraging a company to pursue studies that might have led to an expansion of the labeling and use of a drug. The company viewed the encouragement as an unwanted requirement. The reviewers could not understand why the company was resisting such sound scientific advice. The situation developed into something of an impasse.

Had the reviewers asked the company about its plans for the drug, they would have learned that the firm viewed the product as very marginal and were unwilling to spend additional resources to develop it further.

Had the company asked the reviewers about their proposals, it would have learned that the reviewers thought they were being helpful and that the suggestions were not intended as requirements. Five minutes of discussion would have prevented weeks of perplexed correspondence.

Even CDER staff who have worked in the pharmaceutical industry are unlikely to know the particular reasons behind the actions or inaction of applicants. Motivations may not be knowable by even the most astute observers. Confidential business deals or commercial strategies may be involved that even the company's regulatory affairs contacts are not aware of. Just know that we can't know enough to predict regularly what people or companies will do, so don't try.

Too often regulated companies assume that FDA is making a request or acting out of bureaucratic ignorance. From my observations, most often FDA staff have legitimate motives and intelligent reasoning behind their requests and actions.

It is never inappropriate for companies to discuss with the Agency the reasons behind their actions. Likewise, it is appropriate for CDER staff to engage applicants in a discussion of their aims and plans for a proposed product. Of course, it is not legitimate for CDER staff to press companies for financial information.

Not only is it difficult for companies to discern what motivates the Agency, but CDER staff should not assume they always know what other parts of the Center or the Agency are doing. In our ignorance we sometimes unknowingly create a Catch 22. But believe me, regulated companies are very good at knowing when they are presented with a Catch 22.

I don't know how the notion that "ignorance is bliss" ever got started (perhaps a misquote from a poem), but from where I sit, ignorance is anything but blissful.

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Annual Report: Complaints About Processes Move to Top

Two things you can count on at the end of a fiscal year are continuing resolutions to keep the Agency funded and my Ombudsman's annual report. The continuing resolutions are over, and here is my report. Complaints to the CDER Ombudsman are on a plateau, but there are a few worrisome trends that point to problems that need addressing.

As with last year, the number of cases stayed a little below 100, virtually all externally generated. I tabulated the complaints into the same classes that I did last year to make trends easy to spot. While unfairness of policies or decisions led the list last year, it dropped to second place, behind problems with processes or inadequate information about them. Specifically, there was a 20 percent decrease in unfairness complaints and a similar percentage rise in process problems.

The Center has spent a considerable effort to reduce inconsistencies among reviewing divisions, and I believe those efforts account for at least some of the drop in the unfairness complaints. I don't know why reported process problems rose, except that if one category drops others must rise, because reporting is on a percentage basis. However, many of the process-related complaints could have been avoided with additional clarity in our communications.

Untimeliness complaints continued to drop, a constant trend throughout the five years I have been ombudsman. The predictability of actions through user fee goals has made grumbling about new drug reviews virtually disappear.

Two trends are troubling, in that complaints about both difficulty in gaining access (mostly a lack of returned phone calls) and rude or unhelpful interactions rose, with the latter doubling from last year. It is difficult to pinpoint why this should be, but I would encourage CDER staff to reread my column in the June 1999 News Along the Pike (http://www.fda.gov/cder/pike/june99.pdf).

In December and January I devoted two columns to the results of a survey I did among CDER staff about their pet peeves regarding industry behavior. Those articles gained a lot of attention, demonstrating the wide readership of News Along the Pike outside the Agency. They resulted in a chapter in a Food and Drug Law Institute book about working with the FDA, and I heard from several companies that they were required reading in their regulatory affairs departments. The interest in the articles also shows that people are hungry for insights into the workings of the Center.

As I have said many times, most of the problems I see relate to miscommunications, a lack of communications and inappropriate communications. Despite the numerous guidances and procedures published by the Center, there is still a lot of mystery surrounding how CDER works and why we do what we do. The publication of standards and criteria is a good thing. But publishing why the Center is setting those particular standards and criteria is important as well.

People outside CDER will never fully understand what makes the Center tick unless they understand why we take the actions we do. Adding a few sentences in not approvable and clinical hold letters, for example, to explain why the actions are being taken, not just what needs to be done, will aid those receiving the letters immensely. We too often assume that the reasons for our actions are self-evident. But that assumption doesn't hold if you are addressing the letter to the person who put the application together and thought everything was fine.

Overall, the actions CDER takes are well-reasoned and valid. We can reduce the complaints about processes if we take the time to explain the actions we take to those we regulate and to those we serve.

If you have a complaint or suggested solution to a problem, please give me a call (301-594-5443) or send me an e-mail (morrisonj@cder.fda.gov).

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A Map to the Road Ahead

An important event has been lost in all the finger-pointing at FDA in the press lately. It is a quality assurance report on the processes involved with troglitazone (Rezulin). The report is available on CDER's Web site at http://www.fda.gov/cder/about/qualityassurance/default.htm.

There are two remarkable things about this report. The first is that it was done at all, because, until recently, there was no organizational process in the Center by which lessons could be learned from outcomes that didn't meet either the public's or our expectations. And the second is that it was published for all to see.

From comments in the press, it seems, sadly, that the prevailing concept of quality assurance is still to find someone to blame, execute him or her and then get on with business as usual. The problem with that approach is that we execute the one person who probably knew most about how the problem occurred and how to prevent it from happening again. Beyond that, it instills in people within an organization a fear of being wrong or of making a mistake. Put another way, it encourages people to do nothing.

As all quality assurance experts and ombudsmen know, the way to solve problems in any organization is to recognize that all humans make mistakes, to analyze the system as a whole, to identify what went wrong and to publish consensus recommendations. Then people, freed from the need to defend their actions, can learn from their own and others' mistakes.

Those of us who have been in FDA for a long time are conditioned to working in a fish bowl. It is the price we pay for doing work that is important to people. In the private sector, quality assurance reports are virtually never made public. That CDER's reports are and will continue to be posted on our Web site shows a strong commitment to our stated values, one of which is transparency.

However, publishing quality assurance reports and recommendations is but one step in a journey. The report highlights important issues. There are procedural and organizational recommendations that may be easier to implement than the scientific ones. The most difficult by far to implement will be developing a prospective plan for assessing new safety information about marketed drugs and taking action. But, as recent events have shown, such a plan is critically needed, and it can be invaluable to us in explaining to the public the reasoning behind CDER's actions.

There is not much doubt that the trend toward FDA operating in full public view will continue. The public's demand for a carefully thought out and generally understandable explanation for every action CDER takes will also intensify. I see it in the content and volume of the e-mail I get. We are rapidly moving into the information age, and there is no turning back. The road will have many curves and we will need to learn new ways of thinking and new approaches to old problems. CDER will flourish in that new age, so long as we all keep in mind the saying, "A bend in the road is not the end of the road . . . unless you fail to make the turn."

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News Along the Pike
CDER Office of Training and Communications (HFD-210)
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Editor: Norman "Joe" Oliver

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