Blood Banking and Regulation Procedures, Problems, and Alternatives (1996) / Chapter Skim
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II Regulatory Enforcement and Compliance
II Regulatory Enforcement and Compliance
Pages 27-46
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II Re~ula10ry Enforcement and Comphnuce 27
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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.
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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)
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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.
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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.
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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.
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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.
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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.
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From page 37... ...
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.
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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.
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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.
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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.
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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.
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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.
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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.
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My sense is that starting in 1972, when FDA took over that responsibility, the field inspections drifted away from CBER. The FDA field offices ares now more in charge of inspections.
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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 proapproval inspections. Interestingly, however, the primary motivation for doing that was itself uniformity.
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