Blood Banking and Regulation Procedures, Problems, and Alternatives (1996) / Chapter Skim
Currently Skimming:
III Innovations and Alternatives in Regulation
III Innovations and Alternatives in Regulation
Pages 47-90
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 47... ...
III Innovations and Alternatives in Regulation 47
|
From page 49... ...
A partial mismatch occurs when government relies on a regulatory tool that is less effective or more expensive than another option would have been. REGULATORY DIAGNOSIS AND MISMATCH Critics of regulation argue that the failure to balance the costs and benefits of health and safety regulation has burdened economic development and wasted scarce resources.
|
From page 50... ...
As Justice Breyer has indicated, a partial mismatch occurs when the government relies on a regulatory tool that is less effective and more expensive than an alternative. According to many critics, a significant source of regulatory failure is the use of rigid, highly bureaucratic command-and-control regulations.
|
From page 51... ...
Finally, some research has indicated that regulatory entities tend to oppose less stringent regulatory initiatives with the same vigor as they oppose stricter proposals. The reason is simple: delay typically saves regulated entities money, and given enough time, the political environment could change in favor of the regulatory entity.
|
From page 52... ...
This approach requires regulated entities to report certain kinds of information to the public, which in turn can create political and legal pressure via liability provisions to reduce risks. OSHA, for example, requires employers to distribute a Material Safety Data Sheet concerning each chemical or toxic substance to which a worker is exposed.
|
From page 53... ...
The correct public policy question, therefore, remains "Which method of regulation produces the fewest problems in reaching the intended regulatory goal? " As Neal Komisar has aptly concluded, "In a society of millions of persons with ever-changing technology, selecting the best means of preventing injury means carefully considering and comparing highly imperfect alternatives."
|
From page 55... ...
The model was, in appropriate circumstances, to bring together a committee of representatives who could speak not necessarily by authority of particular 'Subsequent to this presentation Congress provided no FY96 funding for ACUS, which halted all operations 30 September 1995. David Pritzker is now with the Regulatory Information Service Center, and continues to provide information on regulatory alternatives for federal agencies.
|
From page 56... ...
. The Administrative Procedure Act requires the agencies, when they are considering the adoption of a rule, to let the public know through an announcement in the Federal Register that the agency has identified the problem, to give some indication (which might be quite brief or it might be quite extensive and detailed)
|
From page 57... ...
RECENT DEVELOPMENTS AND THE FEDERAL ADVISORY COMMITTEE ACT (FACA) A number of agencies have tried the regulatory negotiation process, with some success.
|
From page 58... ...
58 ~ to :.
|
From page 59... ...
These regulatory schemes have generally been fairly successful. They have also been applied in a number of other settings, including standards of medical care under government insurance programs, agricultural marketing agreements, certification of medical testing laboratories, and others.
|
From page 60... ...
ACUS is now examining a further step: What safeguards are needed when there is no such self-regulatory private organization? There are different terms forthis self-implementation and sometimes self-enforcement-although the essence is the government's reliance on agents or employees of the regulated entities themselves to interpret and enforce the applicable laws and regulations, with the agency again being limited to monitoring the effort.
|
From page 61... ...
Recently, the reformulation of gasoline to reduce toxic emissions was a negotiated rule. The Clean Air Act required a dramatic reduction.
|
From page 62... ...
All the accidents are either above 30 feet, where people are already violating the existing rule, or below 10 feet, which is where the safety precautions really kick in, or doing something else." Getting the people together at the table to talk about how to build a building, what the needs are, and where the real risk is changed the perspective of the regulatory agency fundamentally something that can occur only through this kind of direct dialogue. THE PUBLIC AT THE NEGOTIATION TABLE The beginning of negotiated rule-making is a sophisticated analysis of the kinds of interests at stake (who is substantially affected by the rule)
|
From page 63... ...
For the purposes of a negotiated rule, "consensus" means that each interest represented at the table concurs basically, unanimity. Each interest that participates has a veto.
|
From page 64... ...
Again, the reformulated gasoline process offers an example. The Clean Air Act prescribed one number for the evaporation limits.
|
From page 65... ...
POLITICAL CONSENSUS There is a further benefit to the negotiated rule-making process. Representatives of the parties sit at the table, haggling it out, and at the end they find an agreement.
|
From page 66... ...
There are conditions for likely success, and some degree of analysis is necessary to determine if the issues are of the sort for which a negotiated rule would be appropriate. This is the next question.
|
From page 67... ...
The essence of a negotiation is trading off one issue against another. For example, in the reformulated gasoline rule-making the petroleum companies agreed to a very stringent rule in return for an averaging process.
|
From page 68... ...
People can see what is happening; people in the audience can present issues to be considered. REG-NEG PROCESS The following outline of the steps in a negotiated rule-making process was provided by David Pritzker: 1.
|
From page 69... ...
Agency publishes consensus on draft rule. · If consensus is reached only on issues or outline: Agency drafts proposed rule.
|
From page 70... ...
It has usually worked better if, in such consultations, the agency decides what organizations or what interest groups should be represented and then leaves it to the groups or the organization to determine exactly who will come to the table. As to how appropriate issues are determined, like so many other things, it depends.
|
From page 71... ...
The standard traditionally used in court is whether the agency acted arbitrarily and capriciously. It is likely to be difficult to show that the agency was arbitrary when it has been through this negotiation process and has only one or two holdouts.
|
From page 73... ...
REGULATORY INITIATIVES AT FDA I would like to share with you some of the initiatives currently being taken by CBER, and how they integrate with broader initiatives such as government streamlining/government reinvention, including the National Performance Review activities. CBER has begun a strategic planning process.
|
From page 74... ...
That is a job that for all of us people in the blood banking industry, and people in the government. If we need to take steps to do that, then that is part of our job.
|
From page 75... ...
Under the National Performance Review, some of our initial negotiations with industry in developing the user fee program for new prescription drugs provide an example of not quite negotiated rule-making for the agency, but this is probably as close as we have come to collaborative discussion of what we thought would help improve processes as well as performance. It has had a lot of benefit to the public, the industry, and the agency.
|
From page 76... ...
This was started under the pharmaceutical drug user fee negotiation, but it is clearly on the agency's agenda to extend it to the area of blood regulation. The idea is to determine the minimum necessary change requiring reporting and determine what requires prior approval versus what can be implemented with a subsequent report to the agency.
|
From page 77... ...
We have done this now for irradiated red cells, and we have the intention to do it with leuko-f~ltered blood components. Another change that has been made concerns the way that we are using the Blood Products Advisory Committee.
|
From page 78... ...
That is not seen by the agency as a wonderful thing, because it tends to result in a proliferation of the number of meetings, and, some discussion of the subject matter tends to be repetitive. That aside, however, we have a regular liaison on the Transfusion-Transmitted Diseases Committee, regular liaison meetings with American Association of Blood Banks, and liaison meetings together and separately with the Council of Community Blood Centers and the American Blood Resources Association.
|
From page 79... ...
That is a bit of an experiment because it is an alternative to device regulation. Second, there is the issue of the extent to which CBER will elect to review more of the in vitro diagnostic devices under premarket approval versus product licensing application.
|
From page 80... ...
THE ROLE OF THE RULE-MAKING PROCESS Question-from the Audience: Two questions were put to Jay Epstein concerning the fact that FDA has not often used the "Code of Federal Regulations CFR process"-the formal notice-and-comment procedure for rule-making under the Administrative Procedure Act, but has, rather, relied more on issuing guidelines and recommendations than on promulgating rules. Thus, the following questions were asked.
|
From page 81... ...
In addition to the new regulatory tools already discussed, another one worth mentioning is "error management," looked at from the point of view of both the transfusion service and the blood center. The Federal Aviation Administration (FAA)
|
From page 82... ...
COMMENTS AND QUESTIONS Question from the Audience: As a practical matter, there is an increased risk of civil liability when FDA issues a recommendation and a blood bank does not abide by it. Thus, in effect, the blood industry complies as fully with recommendations as with regulations.
|
From page 83... ...
It has so far been FDA creating policy entirely internally and then seeking comment. We should now be talking about a true partnership, not a partnership between FDA and the field office or between CBER and the field office, but a true partnership with an of the parties involved and in which there is no risk to anyone.
|
From page 84... ...
It is the enforcement function of FDA, however, that we also need to work with, specifically, the inspection process, which does have a role to play in improving blood safety. Part of where we should be headed, in terms of trying to work together, is to build not only an FDA that has credibility with the public at large and with the congressional constituency, but also an FDA that has the same credibility with the industry that is being regulated.
|
From page 85... ...
Department of Health and Human Services, and ultimately to the Congress, and that should never be forgotten. As an example, increased role of the field offices in decision-making and policy generation is a direct result of congressional oversight, which faulted the agency for not responding enough to the role of the field in that process.
|
From page 87... ...
CRITERIA FOR SELECTING ISSUES affected. David Pritzker: The following is an amalgam of several of the published checklists describing the features of problems for which Reg-Neg seems most .
|
From page 88... ...
At the Blood Products Advisory Committee in December 1994, we presented a model by which certain decisions could be made. The idea was that each blood center would report those diseases to a central place, for example, to the Food and Drug Administration, which would file them and once a year convene a panel of experts, including patients and others, and ask the questions, "Would notification of recipients of these products be beneficial to them?
|
From page 89... ...
· Organizational alternatives to current U.S. blood banking system: federation (e.g., Scotland)
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.