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Regulatory Enforcement And Compliance



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Blood Banking and Regulation: Procedures, Problems, and Alternatives II Regulatory Enforcement And Compliance

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Blood Banking and Regulation: Procedures, Problems, and Alternatives This page in the original is blank.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives CBER Compliance Activity James Simmons COORDINATION BETWEEN THE CENTERS AND THE FIELD A question that blood bankers sometimes raise is that of inspectional consistency. To better understand that issue, we should begin with the basics of the interaction between Food and Drug Administration (FDA) headquarters and its operations in the field. FDA has five product-specific centers—he centers for foods, drugs, devices, veterinary medicine and biologics—and one process-oriented unit, namely, the Office of the Associate Commissioner for Regulatory Affairs, all of which report to the Commissioner through the Deputy Commissioner for Operations. The Center for Biologics Evaluation Research (CBER) has the principal responsibility for the regulation of blood; the Associate Commissioner for Regulatory Affairs has the principal responsibility for establishing regulatory inspectional policies and procedures. The product-related centers and the process-oriented Office of Regulatory Affairs interact at various levels. It is difficult to separate all of these functions clearly, but to a large extent, it can be said that the product-related centers have responsibility for scientific review of new product applications and the establishment of product standards, specifications, and regulations such as current good manufacturing practices (GMPs). The Associate Commissioner for Regulatory Affairs and his or her staff are responsible for enforcement policies and procedures and for inspectional activities for all five product-related centers. Each of these organizations has subdivisions. Reporting to the Director of CBER are three product-related offices—blood, vaccines, and therapeutics—and some function-related offices such as the Office of Management, the Office of Establishment Licenses, and the Office of Compliance. These units within CBER service all three product-related CBER offices. The Office of Compliance is responsible for providing compliance enforcement inspectional activities for the product-related offices. It bears the

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Blood Banking and Regulation: Procedures, Problems, and Alternatives primary responsibility for establishing policies and guidance that go to the field inspection staff. OFFICE OF REGULATORY AFFAIRS The Office of Regulatory Affairs (ORA) also has various components with specialized functions. It includes all of the field personnel, who report directly to the Associate Commissioner for Regulatory Affairs through the six regional directors and other field structures. Also in that office are support offices to the field, one of which is the Office of Regional Operations, which is responsible for providing direction, guidance, and support to the field, and in providing such services, it ensures inspectional uniformity. There is a good deal of coordination between the Office of Compliance at CBER and the Office of Regional Operations at ORA, including a number of shared responsibilities; for example, the offices jointly develop good manufacturing practices (GMP) regulations, inspectional guides, procedural manuals, and training programs. In the development of these programs, each office takes the responsibility for soliciting input from its respective organizations and for disseminating output to the same organizations. The inspections are coordinated in accordance with guides developed by this process. The reports of violations that may proceed from these inspections come back from the field offices to the Office of Compliance and to CBER for review. After receipt, they are evaluated and decisions are made concerning the appropriate regulatory or enforcement action, if such action is indicated. That is a rather highly condensed review of the nature of the headquarters-field interaction, but it leads to a few observations about the question of inspectional consistency. INSPECTION CONSISTENCY It is important that we clearly define the issues and understand the magnitude of the problem. Although there is much debate about uniformity of inspections, there may be some confusion regarding the relationship between inspectional uniformity and enforcement uniformity. Yet another term, "regulatory uniformity," has an even broader connotation. The term "inspections" is more focused; it describes a site visit at a regulated establishment for the purpose of determining compliance with laws and regulations. Inspections may be comprehensive, covering all phases of the operation, or they may be limited to one or a few regulated activities. For example, limited inspections are frequently conducted as part of a follow-up to

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Blood Banking and Regulation: Procedures, Problems, and Alternatives complaints, product recalls, or adverse experience reports. They would concentrate on the specific area of concern and not on all activities of the establishment. Some critics who point to inconsistencies of inspections fail to take into consideration the impacts of the different types of inspections. It would be inappropriate to expect a limited inspection to reveal the same findings as a comprehensive inspection. That is one of the factors that is not always taken into consideration when one suggests that there is a high degree of nonuniformity or a lack of consistency in the inspection process. INSPECTIONS AND ENFORCEMENT The word ''enforcement'' refers not to an inspection but rather to the administrative or legal sanctions taken in response to documented longstanding or serious violations. Although an inspection usually precedes an enforcement action, not all inspections result in enforcement actions. In fact, only 5 to 10 percent of all inspections lead to enforcement of any sort, and the enforcements themselves range from serious penalties like injunctions or license suspensions down to the simple and much more common issuance of a letter of warning. The statute provides for a range of enforcement actions, with each one having a clearly defined objective. Some are meant to stop the further distribution of violative products already in distribution channels; others are meant to remedy the conditions that may cause violations before additional products are produced. The choice of one enforcement action over another requires a consideration of the nature and severity of the problem, its frequency of occurrence and its duration, past efforts to remedy the problem, the distribution status of products, the establishment's compliance history, and a number of other factors. It is clearly appropriate to take different enforcement actions in response to different inspections even if the inspectional findings themselves are nearly identical. The decisions to take different enforcement actions in the presence of similar inspectional findings may lead to the appearance of inconsistency. Neither a uniform process for conducting inspections nor a uniform process for enforcement decision-making, however, will produce uniform results unless there is uniformity of operations that are subject to the inspection. Those of us who see uniformity do so on the basis of uniformity of the process. Those who see nonuniformity do so on the basis of the results of the process. As we examine this issue of inspectional consistency, we need to make sure that we are distinguishing between the process and the results of the process.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives FDA Practice in the Field Richard Swanson TRAINING FOR THE FIELD FDA has about 1,040 investigators spread throughout the United States in six regions, 21 district offices, and 135 resident posts. About 350 of FDA's 1,040 investigators have had national training in the inspectional activities of blood and blood products. Two national experts and three regional experts are involved in the inspectional activities of blood and blood products. Because industry has not remained stagnant over the years, training is not a one-time effort. Therefore, continuous training is required. Training contributes to consistency, as do FDA's guides and regulations. Industry has access to those guides and to the training manuals and inspectors' operational manuals. These can be used to see how we are going to do an inspection and whether we have quality assurance within those situations to ensure consistency with inspectional observations. SOURCES OF CONSISTENCY The basis of consistency begins with the Code of Federal Regulations. FDA has, in addition, a regulatory procedures manual that describes how it establishes the regulatory posture on a particular item, such as blood and blood products. The compliance policy guides on biologics are spelled out in another manual. The words in the manuals mean the same to each of those 350 investigators. The investigators, however, are not robots who see everything in exactly the same way. Investigators see the same set of facts in various ways, leading to various interpretations. To expect that every one of 350 people is going to have exactly the same observation is unrealistic, yet we do have enough supervisory review to pick out any outliers. This would be a quality assurance process in itself.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives An additional guidance is the investigations operational manual, which spells out the specific parameters that the inspector should to look for and examine further in an inspection. FDA has gone further, by publishing a guide to the inspection of blood banks, conducting training sessions with industry, having grassroots seminars with industry, and producing materials for industry and health professionals. On this basis FDA is attempting to ensure uniformity and consistency. FDA has expanded our dialogues with the industry. FDA's Field Biologic Committee has had numerous opportunities to talk with segments of the industry through trade associations. As we start seeing a dynamic change in the government in the next 5 years with the downsizing and with the flattening of government, with the restriction of resources, it is going to behoove us all to make sure that consistency remains. In the past few years we have had annual inspections of blood banks. That has now been reduced to looking at the compliance of various firms. The firms that are in compliance are inspected every other year. We are still inspecting 100 percent of plasma facilities yearly, however, things do change, and these things have improved.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Challenges and Questions About Compliance William Sherwood Current compliance procedures are subject to a number of challenges. Although they are most frequently questions without obvious answers, it will nonetheless be important to answer some of these questions in the coming months and years. IMPROVEMENTS IN SAFETY During the past 12 to 15 years there has been an enormous improvement in the safety of the blood supply and this is an accepted fact. Blood transfusions are not 100 percent safe, but we are almost at a position of de minimis risk. Many studies and examples demonstrate that improvement in safety. One particular example, however, does provide an interesting additional feature of the safety of the blood supply. The data are from case reports of clinical transfusion-associated hepatitis reported to the American Red Cross blood service region in Philadelphia over a 10-year period beginning in 1981. There had been an active reporting mechanism during that period to seek out such cases at the hospital level and to report them to the Blood Center to identify donors that should be deferred. These cases of clinical transfusion-associated hepatitis are only the tip of the hepatitis iceberg, but we can assume that, like an iceberg, what is found at the tip is proportional to what is found at the bottom. The data provided the number of cases of transfusion-associated hepatitis over 6-month intervals. Consider just two points: in 1981 there were 75 reports. In 1991, there were two. During the 10-year period from 1981 to 1991, the Blood Center increased it collections from 290,000 to 360,000 units, or about 100,000 additional components at risk. Through 1995, with the same system still in place, we are still experiencing only one, two, or three reports of hepatitis a year. I believe that these data illustrate another phenomenon. Surrogate testing for non-A, non-B hepatitis (alanine aminotransferase and hepatitis B core

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Blood Banking and Regulation: Procedures, Problems, and Alternatives antibody testing) was initiated in 1985 and 1986; anti-hepatitis C virus (anti-HCV) testing was initiated in 1991; and although there could be a debate about the effectiveness of the deferral of high-risk groups, the introduction of surrogate and anti-HCV testing had a profound effect on clinical transfusion-associated hepatitis. The correlations with the data intervals seem apparent; this point should be kept in mind as we proceed. QUESTIONS ABOUT ENFORCEMENT Four basic questions need to be raised. The first question is quite direct: Are the current regulatory compliance methods, techniques, and institutions the best approach to ensuring the safest and most effective blood supply possible for the American people? This question may seem irreverent at best, considering the acts of Congress that established Food and Drug Administration (FDA) and that conveyed authority to it, the success that FDA has experienced over the years, and the reverence that the agency enjoys throughout the world. As we look for ways to improve, however, the very basis of our institutions sometimes needs to change in order to make progress. Some areas clearly seem to need fixing, yet there have been few regulatory changes in recent years. This may be the result of a cumbersome regulatory process. The agency has resorted to publishing guidelines that have the effect of regulation to keep up with our dynamic environment. The licensing process is interminably slow. I suspect that is a resource problem for the agency, but the question is still a broad one, and one that needs to be proposed. Evidence That Compliance Works The second of the four questions is as follows: Is there evidence that the current approach, of law, regulation, inspection, observation and sanction is effective? The key word in this question is "evidence." There is clearly good evidence that the general policies intended to improve blood safety such as the introduction of donor deferral policies and serologic testing have been very successful. Much of the credit for those tests has a basis in FDA and its

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Blood Banking and Regulation: Procedures, Problems, and Alternatives regulation. This question, however, is intended to deal with the compliance process as well. What is the incremental contribution to blood safety that the compliance process adds? Can we point to evidence of results from the compliance process that benefit the public? Perhaps it is unfair to separate the rule-making and the licensing processes from the compliance process and to give each the burden of providing proof of its effectiveness. The current paradigm of law and regulation must include a process for enforcement. That much is accepted. A technical and scientific world however, requires data to demonstrate effectiveness, which in this case is not the gross weight of Form 483 (post inspection reports of noncompliance) and the number of observations, but more the prevention of disease and the improved quality of products and services. That is what we would be looking for. Maybe the relevance of the question is itself an issue: regardless of the data, FDA could rightly argue that it has the responsibility to uphold the law, whether there is an effectiveness to its methods that can be demonstrated or not. This point leads to the third question: Is there such evidence of effectiveness for the compliance process? If there is, are the outcomes that benefit the American people proportionate and consistent with the effort expended by both government and industry? Useful data on effectiveness about an isolated compliance process would be difficult to obtain. There are many variables, and there are likely both direct and indirect effects. The direct effects follow from the inspections themselves, along with the observations on Form 483 and the corrective actions that are taken as a result of those observations. However, there are also indirect effects. Indirect Effects: "Bulletproofing" The behaviors that blood establishments undertake in attempts to "bulletproof" themselves against future FDA inspections, may well be the behavior that has the greatest practical impact, so deserves some additional scrutiny. In my experience, FDA inspections have been variable and uneven. It is not unusual for an establishment to receive a number of annual inspections, receive no Form 483s or receive little in the way of observations, and then suddenly to be totally surprised and receive a devastating inspection, with multiple pages of Form 483 and perhaps worse. Changes in the performance of blood establishments, occur over time, but those changes do not have the

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Blood Banking and Regulation: Procedures, Problems, and Alternatives same degree of variability seen with FDA inspections. This circumstance creates a behavior in blood centers by which systems and procedures may be put in place to provide some armor for the blood center against the worst case scenario: the most aggressive FDA inspection and, in particular, the widest possible interpretation of the regulations. The establishments thus find themselves invoking systems and procedures that they believe do not contribute to the safety, purity, or efficacy of the blood supply. These actions may not be required by a narrow interpretation of the regulations, but they are put in place in anticipation of the worst-case possibility. This behavior carried to an extreme has many consequences. Blood centers lose sight of what is important. It is a drain on resources, people, and money, that otherwise could be directed to research and development, to new products and services, and to meaningful improvements in quality. Today, blood establishments cannot afford to do anything that is not important. Most blood centers are not-for-profit, have little or no reserves, and are in a poor position to increase their revenues through the health care system. Unlike some firms in the for-profit pharmaceutical industry, they cannot afford to have a legion of quality assurance staff. Blood establishments rely heavily on operational staff to perform double duty in procedure development, training, and quality control. In other words, government spends an enormous sum to ensure compliance, and industry spends multiples of that to carry it out. The public pays for it at both ends. Is the public getting its money's worth in the process? Is Compliance Improving? The fourth question is as follows: Is our industry improving in its compliance behavior and if not, why? Here is a troubling observation: In the early 1980s, at about the time that it became clear that the human immunodeficiency virus (HIV) could be transmitted by blood, FDA focused attention on the blood industry, as well it should have. The industry has now enjoyed at least 12 years of this attention. The safety of the blood supply today is enormously improved over what it was 12 years ago, but what is the regulatory record of the industry now at the end of these 12 years? The largest blood collection organization is under a consent decree. The next largest one has received an intent-to-close notice. At least one of the largest independent centers has received a serious warning letter. It is

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Blood Banking and Regulation: Procedures, Problems, and Alternatives a simple fact that a large proportion of the blood collected in the United States is under significant regulatory sanction. Is it true that although the safety of the blood supply has improved, the regulatory performance of the industry has worsened? As the earlier question posed, are blood safety and regulatory performance unlinked, or are we dealing with a timing issue—a frameshift problem in terms of blocks of time and improvements in safety and regulatory matters? If we are not improving and if after 12 years of trying we continue to worsen, why is that so? Is it an industry problem? Haven't we "gotten it" yet? Is it an agency problem? Or is it both? If we continue on the same course, should we be looking forward to a time when the blood supply will have reached an ultimate degree of safety, yet our regulatory performance will have worsened to the degree that there will not be any qualified blood centers to distribute it? That is, of course, hyperbole to make the point. Clearly, we hope that our safety improves, and we hope that our compliance performance improves as well. REGULATION AND OTHER FORCES There is a much that moves us to try to do the right thing, only one factor of which is the regulatory apparatus. Beyond that are our own concerns with quality assurance. The mission statements of many blood banking organizations are such that we are not carrying out our job if we are not doing it in a way that meets the needs of and benefits the people. Our people intend to be honest in that way. There is in also the specter of tort litigation. In the United States that is a profound aspect, and we do a great deal because of it. If we are in violation of the law, whether we receive a Form 483 on it or not, if we are inspected or not, if it causes harm to a patient we are in trouble. Thus, although there is a role for regulation, compliance, and enforcement, that is not the only thing that moves us to do the right thing.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Discussion Question from the Audience: Language conveys meaning. Why are Food and Drug Administration (FDA) enforcement people called "investigators" rather than "inspectors"? These titles have very different meanings. The fire inspector comes around to look at your place and see if everything is all right, but the fire investigator comes to examine whether a fire should be called arson. The feeling of these things is important. They set a stage of cooperation and noncooperation. Richard Swanson: It might be confusing to you, but we also have a group of people called inspectors. There are about 150 people who have the title inspector. This question points out the need for us to have a dialogue with each other so that we understand our nomenclature, understand how we can talk, and, understand the difference between an inspector and an investigator and a compliance officer. Question from the Audience: Are the contents of the various manuals and booklets that you described regulations or guidelines or both, and how are changes distributed and explained? James Simmons: In the last several months, if not longer, there has been a debate about the difference between regulations and guidelines. The charge has been made that FDA in particular is issuing guidelines but is trying to enforce them as regulations, and that the investigators have been trying to take the guidelines and act as if they were law. There is a debate even among legal scholars about some of these distinctions, but for our purposes these manuals are meant to provide guidance to the inspectors, telling them how to do their job. Since all of this information is available to the public, some people choose to call them guidelines. Certainly, that sort of document does not rise to the level of being a formal regulation. Most of them are intended to be procedural guides and instructions—not that different, perhaps, from the industry's own use of standard operating procedures. They tell the inspectors how to present their credentials and how to issue a notice of inspection, how to write a Form 483, who to talk with at the conclusion of the inspection, and other things of that sort. All of

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Blood Banking and Regulation: Procedures, Problems, and Alternatives these internal documents are updated periodically, sometimes as much as annually and possibly even more often. Richard Swanson: The Code of Federal Regulations (CFR) contains the regulations that we are asked to enforce. All of the other documents are procedures designed to provide consistency, to guide inspectors, and to have the industry be able to be prepared for what we expect. James Simmons: It is interesting to speculate about what would happen if these documents were not out there. If you just handed the basic statute that was passed by Congress to 500 different individuals and let them make their own interpretations of what it meant, we would have far more non-uniformity than is perceived to be there now. All of these other documents are designed to assure greater uniformity, though it sometimes seems from the dialogue that it is perceived to be quite the opposite. Richard Swanson: The regulatory procedures manual and the investigator's operational manual go through a clearance process and a review by our General Counsel, so that the legal interpretation is also subjected to review. Question from the Audience: How would you answer the question of whether there is any evidence that the system of law, regulation, inspection, compliance, and sanction is effective? Has the Office of Compliance done any cost-effectiveness studies of its own regulatory activities? Is there, on the other hand, evidence of reactions similar to the wasteful practice of "defensive medicine"? James Simmons: The rate of compliance in 1993 was about 93 percent. That means that 7 percent of the inspections concluded that a firm was out of compliance to the point that enforcement action would be appropriate. In 1994 that dropped to about 5 percent. At present, data for 10 months of 1995 are available and that figure is about 3 percent. I believe that the total degree of compliance in the blood industry is higher than most people expect it to be. Dramatic improvements have been made in the state of compliance. It takes some time to turn around big organizations that have widespread noncompliance, but once these things start falling in place, they make tremendous improvements, and I have personally observed many improvements in the area of compliance. Therefore, improvements in compliance are occurring. There is a presumption that the regulations lead to safety. As to the cost-effectiveness, the only studies done at FDA are those examining the costs of our own operations. We have almost no method of doing industry costs. In proposing new regulations, there is an economic

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Blood Banking and Regulation: Procedures, Problems, and Alternatives impact statement, but we do not have the capabilities for doing the kind of cost-effectiveness study that you described. The tendency to build a ''fire wall'' to prevent future Form 483 observations is a critical point that needs to be made. I suspect that some people in all of the industries that FDA regulates go beyond what would be necessary to correct the problem, and if anybody is involved in that process, I would firmly recommend that you consult with the agency in terms of correcting your remedies. Question from the Audience: FDA published its last inspection checklists book in 1991. The checklists were used by the blood banks and donor centers to identify which parts of the CFR or which memorandum or guidance was being applied in a 483. That check-off list has been eliminated, allowing the inspectors—who are mostly not blood bankers—to apply anything they are comfortable with. Now when one asks the inspector, "Can you please identify which CFR or memoranda that 483 is against?" they reply that legal counsel has told them they cannot identify it. James Simmons: We should start with the culture of FDA and its inspection staff. As you know, blood establishments were not subject to FDA inspections until 1972, yet this agency had a history of almost 70 years of inspectional procedures prior to the time it started inspecting blood establishments. The traditional FDA units have never used a checklist. In 1972, when we started inspecting blood establishments, because it was such a new area the management of the agency thought it would be helpful to have such a checklist. Blood establishment inspections were not the only ones for which a list was used. Responsibility for regulating blood and blood products came to FDA from existing U.S. Public Health Service agencies in the 1960s and early 1970s, along with the Radiological Health Program, the Interstate Milk Shippers' Program, and a program that dealt with sanitation of interstate carriers like buses, trains, and airplanes. All of those programs, and several others, which were traditional Public Health Service programs when they were brought into FDA, brought checklist type forms, and for the most part, employees who were formerly with the Public Health Service units that did that work came to FDA. They were familiar with the form. They transferred with the transfer of functions and they continued using the form, even though the traditional FDA inspectors had never used checklists, and quite frankly, we had difficulties getting them to accept a checklist. Traditional thought in FDA is that checklists put blinders on the inspectors, in that they look at certain things and are not able to look at the broader spectrum. As a result of these kinds of discussions the agency did away with the checklist but left it as an option for inspectors to use if they chose to do so.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Inspectors should probably not have to list CFR citations. One of the reasons why the Office of General Counsel does not like the concept is that investigators are not attorneys; they do not want them to give an incorrect citation. We have even eliminated the requirement of putting CFR citations in our warning letters. The concept is simply to tell the establishment in lay terms what is perceived to be wrong and to let them make the corrections. If you look at the statutory intent of the Form 483, it is to be a communication device from the inspector to the establishment. It is not meant for third parties. It merely says, on the part of the inspector, that "during the course of my inspection I observed the following conditions which may lead to adulterated products." It does not say that the product is adulterated. It is intended to identify things that may cause adulteration if they are not corrected. Some of those things may not necessarily be that applicable to a CFR citations, as opposed to being a helpful tool. Unfortunately, we have gotten to the point in our relationships between inspectors and establishments that sometimes it does not look like a helpful tool. Question from the Audience: How are the guidelines that come from the agency and that are intended for the inspectors developed, and how can the blood banking establishments provide feedback to that process? James Simmons: If it is a technical or a scientific matter, the policy largely comes from work done within the Office of Blood, and the Office of Compliance and the Center for Biologics Evaluation and Research (CBER). We then incorporate the feedback from the Office of Regional Operations. If the issue relates to procedures, it usually emanates from the Office of Regional Operations. We have a system that is not dissimilar from that of the Blood Products Advisory Committee, which the agency uses to elicit feedback from the regulated industries and scientific experts within FDA. Twice a year we have an advisory committee meeting between CBER and some of the field managers who have identified problem areas and who have asked for guidance. Once the guidance is requested, we start the process of obtaining input from the Office of Blood and from the Office of Compliance. In consultation with the Office of Regional Operations, we try to develop the process. Unfortunately, we get many more requests than we can fulfill because we simply do not have enough time to answer all of the procedural requests. What is ironic is that the more of these requests that we receive and the more specific the guidance that we give out, the more they become seen as regulations. We are then told that we are overregulating, yet if we try not to answer one of the questions, whether it is a request from industry or from one of our field staff, we are on the other side of the dilemma. Either we provide the guidance or we do not, and we get criticized on both points. I do not have

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Blood Banking and Regulation: Procedures, Problems, and Alternatives an answer to that dilemma. Question from the Audience: At present what may be found to provoke an enforcement action in New York may not be an enforcement action in Cincinnati, or vice versa. Do you perceive this change? James Simmons: Because there is great criticism throughout the country about our inspections, there has been an effort to bring about some kind of change. The management of FDA and some of the people who advocate change have not clearly defined what that change should be. Although everybody recognizes that we could make some improvements in some areas, there is a role for an inspector in the changing environment. I am not sure that the role is going to change. I think that the methods and procedures for doing business will change, but I think that the role is pretty well fixed. Question from the Audience: Just as the data show improvements in blood safety, there has also been an improvements in the quality of automobiles. The methodology that got us there have not been the same, however. There are approaches to safety other than the one now used at FDA. Total quality management, for example, is a very different approach. It is not a punitive regulatory approach nearly as much as it is achieving the highest possible quality through positive incentives. James Simmons: We are looking at the regulatory procedures used by other agencies and these show some things might be done differently. There is, for example, much interest in third-party certification. We have operated with the same regulatory process for almost 100 years and although I cannot see that we are ever going to do away with regulations, the methods of approaching them could be different, and your suggestions would be helpful. Perhaps the culture that we are talking about has some relationship to past and present organizational changes and responsibilities. The former Center for Biologics was a very strong science-based organization. Most of the people there did a little bit of everything, including research, investigational new drug applications, review, inspection, standard writing, and just about the whole potpourri of what goes on in the current CBER. The inspectors in the field were in constant touch with the science-based policy that was developing from day to day. My sense is that starting in 1972, when FDA took over that responsibility, the field inspections drifted away from CBER. The FDA field offices are now more in charge of inspections. The interface between the field offices with CBER may be less than what it has been. If that interface were closer, perhaps we would see less of the difficulty of inspectors operating in a vacuum, more so than they did years ago. They would have more of a science-based tradition behind them. Compliance and science would be joining

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Blood Banking and Regulation: Procedures, Problems, and Alternatives science-based tradition behind them. Compliance and science would be joining hands better, and the regulated industry would find it more palatable. We are not all the way to the point that you have described, because in fact, the only part of CBER inspections done in the field environment is blood and blood product inspections; and now that is limited primarily to the annual inspections, not the preapproval inspections. Interestingly, however, the primary motivation for doing that was itself uniformity. This shows how we sometimes chase ourselves around in a circle. Richard Swanson: The organizational chart presents only a part of the picture. Communications occur not only through solid and dotted lines. The Field Biological Committee has an interface across many avenues. Enforcement and inspection must be a team effort, and so the formal lines are interconnected with additional communications.