It is ironic that while various regulatory agencies in many nations have been struggling to make technique-based regulatory schemes plausible, risk-based alternatives have been widely available—and working. Field trials of organisms that pose significant risk warrant biosafety oversight and appropriate precautions. In , several colleagues and I refined an earlier biosafety algorithm that was mentioned in chapter 3. Like its predecessor, the more recent version of the algorithm 8 is scientifically defensible and risk-based.
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The basis of the algorithm is the tabulation of organisms into risk categories. The algorithm accommodates any organism, whether naturally occurring or genetically modified by old or new methods. It can provide the foundation for a cost-effective oversight system. It is adaptable to the resources and needs of different forms of oversight and regulatory mechanisms, whether they are implemented by governments or by other institutions. This tabulation would be based on scientific knowledge and experience as compiled by experts.
Thus, the lists would provide an indication of the intrinsic level of risk of the organism, ranging from, say, Level1 lowest safety concern to Level5 greatest safety concern. An important factor in stratifying plants according to potential risk, for example, would be the presence in a geographic area of cross-hybridizing relatives of the plant to be tested. For example, there is limited gene flow from maize to nearby teosinte and vice versa. Even when such gene flow occurs, it appears neither to be detrimental to the teosintes nor to change their basic nature as distinctive wild races and species.
By contrast, distinct varieties of oilseed rape Brassica napus, or canola with widely differing concentrations of erucic acid and intended for different applications should be kept segregated to avoid outcrossing between varieties. For example, high-erucic acid canola might be classified as category 1 in regions where that variety of the plant is grown but perhaps category 4 where low-erucic acid canola is grown.
This approach is analogous to that used for categorizing microorganisms by the U. As a practical matter, it would be difficult for experts to stratify every organism in every geographic region according to risk. However, categorizing, say, a hundred of the major crop plants that are the likeliest candidates for field trials would be a feasible and useful beginning.
Additional panels of experts could then address subsets of fish, terrestrial animals, microorganisms, insects and other groups. Next , the preliminary categorization would be subject to reconsideration and adjustment in light of any new traits introduced, independent of the technique used for modification. The biosafety level could be adjusted up or down—on the basis of a major change in evolutionary fitness, pathogenicity, toxigenicity or invasiveness. Adjustments to higher categories might include, for example, field trials with pathogens manifesting new multiple antibiotic resistance or increased host range.
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Adjustments to lower categories could include a plant with decreased pollen production or a toxigenic microorganism after the complete deletion of its major toxin gene s. Given the kinds of changes currently being made with molecular genetic techniques, 14 reclassification to higher biosafety levels would rarely be indicated. This is important because, arguably, field trials in these lowest risk categories can be exempt from case by case review and managed using standard research practices appropriate to the test organism.
By contrast, field trials with organisms in the highest risk categories should automatically require biosafety evaluation. It is worth noting that this graduated approach to regulated and nonregulated field trials is both more scientific and more risk-based than either the pre- or post-rDNA regulatory regimes of EPA 15 or USDA; 16 see chapter 3. In theory, the degree of oversight of proposed field trials can vary widely between exempt that is, subject to only the usual standard of practice for an agricultural experiment with that organism and prior approval required that is, by a national, regional or international agency , with various levels in between.
However, we proposed only three levels of oversight: exempt, notification to a local or international agency , or prior approval required. In our scheme, the degree of required oversight can take into consideration not only the perceived level of risk but also other factors such as the available regulatory resources and the financial and manpower burden that regulation exacts from researchers and the government.
Within the algorithm, a national or other policymaking authority could choose to apply regulatory strictures more stringently tending toward more prior approval or less stringently tending toward more risk categories being exempt or requiring only notification. Of paramount importance, however, is that the algorithm ensures that the overall approach is always within a scientifically sound context and that the degree of oversight is commensurate with risk. Many regulatory authorities would likely require case-by-case review for organisms in categories4 and 5, exempt experiments in categories 1 and 2, and require a simple notification describing the organism to be tested, the site, the risk management measures and so forth for category 3.
Within this internally-consistent scheme, other permutations are possible that would be chosen to meet regional preferences and needs. This algorithm is very flexible and applicable to any organism. It meets the basic requirements of a biosafety regime—it is risk-based, scientifically defensible and focused on the characteristics of the test organisms and the environment of the field trial.
The algorithm is highly adaptable; it can be incorporated into existing regulatory regimes in industrialized countries or be used by nations that currently lack such mechanisms. Moreover, it can offer adequate safety precautions to protect the public health and the environment from significant risk, coupled with the cost-effectiveness demanded by limited government resources. As discussed in chapter 3, EPA's biotechnology policies make neither scientific nor economic sense. It is both dismaying and ironic that the EPA's expenditure of hundreds of thousands of staff-hours in order to craft and implement new policies, over more than a decade, was unnecessary.
Had agency officials simply applied the prevailing scientific consensus to their FIFRA and TSCA proposals, they would have concluded that no changes were needed from policies and requirements that were in effect before the advent of new biotechnology just as FDA did. Products of the new rDNA technology would have been held to the same standards for testing and marketing as similar products used for similar purposes.
Had regulators, the application of the new biotechnology to fields such as bioremediation, mining, oil recovery and pest control, that path now would be more advanced. Little magic is needed to improve EPA's sorry state. This could be easily accomplished. It is unlikely that there is either interest or willingness to do so at EPA, however.
The agency's regulatory infrastructure and personnel need a thorough, unbiased, nonpartisan, extramural review—and the recommendations should, for once, be implemented. The agency needs to incorporate avoidance of Type2 errors into employees' performance plans and reviews, and would benefit from the kind of ombudsman panel described below that has the power to discipline agency officials for flawed policies or decisions.
EPA needs to introduce accountability for regulators. We need a knowledgeable, tough and competent EPA Administrator who will clean house and work with the Inspector General to deal severely with the kind of chicanery described above and in chapter 3. None of this is likely to happen during the Clinton-Gore administration. We can expect only more of the same. For the regulation of biotechnology, the FDA adopted a scientific paradigm early on that avoided discriminating against biotechnology products. That Clinton administration officials are not serious about FDA reform, however, is clear from what was not included in the announced changes.
The minimal benefits will accrue principally to larger, established companies that already have products on the market. Entrepreneurial companies, whose products are primarily in early developmental stages, are left out. The most serious flaw in the administration's proposals—one likely to vitiate much of their impact—is that the reforms are to be implemented by the FDA itself.
Experience should have taught the futility of an agency being directed to reform itself. They included such changes as outside organizations performing reviews under contract to FDA ; expanded use of extramural advisory committees; an expanded role for Institutional Review Boards; a more flexible interpretation of the efficacy standard; U. An important element of many of these reforms was structural change—which would actually diminish the scope of FDA's discretion or jurisdiction—rather than mere managerial tinkering.
To no one's surprise, the agency studied them, literally, to death.
As an FDA official at the time, I recall agency officials' amusement at the prospect of their reforming themselves. And that was during a presidential administration that really did care about streamlining regulation. This can be accomplished by exempting entirely certain regulated activities or products, or by transferring regulatory functions to nongovernmental entities where the professional culture and the incentives and disincentives that shape behavior are more propitious.
Applying these principles, the Congress could, at a stroke, achieve real reform. A few narrow but critical amendments to the FDA's enabling statutes would remove certain functions from the governmental monopoly and reduce the agency's opportunities for mischief:. These genuine reforms would offer no less safety to consumers but would confer several benefits. They would lessen the regulatory load—and the costs—of pharmaceutical development, permit the FDA to focus on essential functions and provide physicians and patients more and less expensive therapeutic alternatives.
While these reforms would improve the efficiency of drug regulation and do no harm to consumers in the process, none of them addresses the fundamental problem of the distorted incentives, disincentives, rewards and punishments that influence federal regulators' behavior. Avoidance of Type1 errors implicitly is already built into reviewers' and managers' performance plans.
An employee whose actions compel his superiors to defend his mistaken approval of a hazardous product will suffer during his annual performance review. The system should similarly foster aversion to Type2 errors. For all FDA and EPA employees involved in product evaluation or compliance, therefore, performance plans and employee annual reviews should be required to give equivalent weight to Type1 and Type2 errors. Similar performance plan elements, such as meeting affirmative action goals, are currently applied at least as widely at federal agencies.
Another remedy is an ombudsman panel that evaluates agency actions and disciplines misbehavior. Cases could be submitted to the panel by drug companies, associations, patient groups or others. My own experience as an FDA reviewer and manager suggests a number of cases appropriate for the ombudsman. During the s, despite a demonstration that a certain proven anticancer agent could shrink the malignant Kaposi's sarcoma lesions found in AIDS, the FDA would not consider approval for that use.
Even though that decision was eventually reversed, the officials who were responsible for it should be held accountable. An ombudsman panel must have several characteristics: 1 an organizational location outside the agency, to provide arm's length from FDA officials, including the Commissioner the Department of Health and Human Services' Office of Inspector General might be an appropriate location ; 2 access to a wide spectrum of scientific, medical and regulatory expertise, either via a large membership or ad hoc experts as necessary; and 3 authority to recommend disciplinary sanctions, ranging from censure to forfeited pay and bonuses or demotion, depending on the egregiousness and impact of the decision.
This innovative mechanism could help to balance regulators' incentives and disincentives. More fundamentally, it could be applied to other regulatory agencies. It is a conservative governmental mechanism for correcting the entrenched bias toward eliminating product risk regardless of the cost of lost benefits.
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In February , the Washington D. Their solution to the systemic problems is to turn over much of the evaluation of drugs to nongovernmental entities—a recommendation that has been made repeatedly by blue-ribbon expert groups convened to evaluate the drug-approval system. The PFF proposal would retain the basic requirements that a drug be proved safe and effective before marketing.
The DCBs can be private- or public-sector organizations universities, for example , profit-making or nonprofit. In the event that the FDA denied approval, an appeal mechanism would be available to the drug sponsor. The PFF proposal is derived both from first principles and careful study of three decades' experience with the FDA's drug regulation. As discussed in this essay and in chapter 3, a fundamental problem at the FDA is the agency's tendency to slow the approval process to avoid even the remotest possibility of approving a product that might be harmful.
The PFF plan redresses this problem ingeniously by introducing the element of competition into the drug review process. DCBs would compete for clients, and thus, the system would favor those that offer the greatest expertise, the best service and a reputation for integrity. This balance is not unlike that confronted by Underwriters' Laboratories, which certifies that electrical equipment meets certain safety standards. It also closely resembles the system of medical device regulation in the European Union.
It is remarkable that within two months of its publication major elements of the PFF proposal found their way into proposed legislation, HR, the House of Representatives' Drugs and Biological Products Reform Act of The bill addresses in several ways the ponderousness and length of drug testing and evaluation. It clarifies that the voluminous raw data from clinical trials—often running to hundreds of thousands, sometimes millions of pages—will not always be required by the FDA. Condensed, tabulated or summarized data often will be adequate.
Agency reviewers would have access to additional material if it were requested by supervisory FDA officials. This change removes ambiguity in the language of the existing statute. It is also humane: it would permit other patients the same treatment currently reserved for those with AIDS.
The bill would change in important ways FDA's censorship of scientific and medical information chapter 3. Equally important because it goes to the basic issue of how new uses are sanctioned for an already-approved drug, HR would permit retrospective evidence from clinical research instead of expensive and time-consuming prospective studies as an alternate basis for approving additional uses. The bill includes some modest incentives for the FDA to improve its performance, such as mandatory annual reports to the Congress that summarize the agency's success in meeting goals and statutory deadlines and that compare the FDA's performance with its foreign counterparts.
To ensure that the FDA's attempts at international harmonization are sensible, the bill would require congressional notification before the FDA enters into international agreements. The most significant changes wrought by the legislation—similar to but less sweeping than the PFF proposal—address the FDA's monopoly over the drug approval process.
These provisions would provide a partial answer to systemic problems in the regulation of drug development, by turning over part of the evaluation of drugs to nongovernmental entities. There is, however, nothing sacrosanct about a government regulatory monopoly that offers manufacturers no alternative route to the review and certification of products. Moreover, regulation that assures public safety is not a binary choice—that is, either government or private-sector. That is illustrated by the bill's establishment of nongovernmental alternatives to some FDA oversight.
Drug sponsors could opt to have their products reviewed by nongovernmental organizations that could be private- or public-sector universities, for example , profit-making or nonprofit. These organizations would be subject to FDA accreditation and auditing. Strict requirements backed by civil and criminal sanctions would assure the confidentiality of data and the management of potential conflicts of interest.
This new approach closely resembles regulatory apparatuses already operating elsewhere, except that the sponsor could choose to have the FDA perform the review and in all cases the agency would retain the responsibility for final sign-off. HR omits any concrete provisions for reciprocity, which would hasten the approval of a drug in the United States after its sanction by a major foreign regulatory authority. Reciprocity could be achieved, for example, simply by giving the FDA a finite period of time say, 60days from the date of a UK or EU approval to show cause why a product should not be approved.
In the absence of such evidence from the FDA which carries the burden of proof , the drug would be approved automatically. They are logical, carefully targeted, and bipartisan and—most important—favor the public interest. They would get drugs to patients who need them, faster and cheaper. Legislation should balance momentous social and economic issues, legal precedents and the public interest. HR, which strongly reflects the influence of House Commerce Committee majority counsel John Cohrssen and is a kind of reprise of his earlier attempts to reform FDA while at the Bush administration's Council on Competitiveness , is a stunning example.
Habituation, the gradual adaptation to a specific stimulus or to the environment, is a biological phenomenon that may also be said to apply to responses to political influences. Irrational and burdensome public policies can become so much a part of the landscape that their victims—consumers, businesses and research institutions—no longer experience the appropriate rush of self-righteous anger and push for reform.
The worst becomes the norm. Habituation can be observed in the unresponsive attitudes of academic and industrial scientists towards the excessive regulation of agricultural and environmental biotechnology. Scientists should actively question the flawed paradigms underlying the regulations. Few do. Putting this another way, the members of the research community need to pursue their self-interest aggressively, as other groups do.
We have seen the behavior of industry trade associations toward ill-conceived or excessive biotechnology regulation above and chapter 3. The expected chorus of indignation from individual agricultural biotechnology researchers and companies has been absent. Surprisingly, most have settled for clarity instead of reasonableness.
They have settled for predictability, even though it is the predictability of delay and frustration. Often, rather than working to make regulation more reasonable investigators have changed the direction of their research to avoid regulatory strictures. Exceptions include a handful of individual scientists, the University of California's Systemwide Biotechnology Program, and a few professional societies that have called for the rationalization of regulation in editorials and letters to government agencies. If those who are interested in the vitality of science, technology and innovation sit on their hands, nothing will change—except, perhaps, for the worse.
The agencies seem unwilling and unable to reform themselves. The Clinton administration certainly is not serious about reforms. Earlier in this chapter, I suggested ways that government regulation could be improved by structural and management changes, along with a risk-based algorithm for the oversight of field trials.
But government left to its devices won't adopt these changes.
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It is past time that those outside government began to hold policy makers accountable and to exert pressure. But whence is this pressure to come? First, scientists, as individuals, must do more of what physicist and writer Freeman Dyson, paleontologist Stephen Jay Gould and the late microbiologist Bernard Davis have done in their articles and books: they have participated in the dialogue on public policy issues.
As scientists, they have made unique contributions, especially when exposing nonscientific arguments. Whether one agrees or disagrees with their arguments, their contributions are invaluable. This strategy is not, however, without its risks. No matter how brilliant a scientist may be in his specialty, acuity in public policy requires a different perspective. I was reminded of this by a Science editorial by yeast geneticist Gerry Fink. Their experiments accelerated research leading ultimately to the development of a much improved, second-generation hepatitisB vaccine of which I was one of the FDA reviewers; see discussion above.
But in his editorial Fink neglected the critical point—that other U. Because Lewis was such a notable exception to the rule, the story should have been about bad science making bad policy, and the real-world impacts of bad policy. But Fink lacked a perspective on the wider dimensions of the NIH policy. The second strategy pertains to science in its institutional forms—the professional associations, faculties, academies and journals.
These institutions should explore and elucidate the controversies over public policy and seek to elevate the level of discourse on them. Scientific societies can, for example, help to create and promote a broader policy perspective by building public policy symposia into national and international conferences. And to return to the example of the Fink editorial, the editors at Science could have steered the piece to the more didactic and broader theme.
Reporters—and by extension, their bosses, the editors—have tremendous power to illuminate public policy issues that have a scientific component. The Flat Earth Society should not receive the same attention and credence as the geography department at Berkeley, when the former eschews empirical evidence. Third, companies and trade associations should consistently take the long view of regulation, one dictated by scientific and free-market economic principles, and resist the temptation of flawed short-term fixes.
There is no sound reason for the U. In the long-run, commercial interests will benefit from the predictability and logic of science-based policies—and from a robust academic research enterprise. Productivity is squandered by strategies that are anticompetitive, that make experiments more expensive and difficult, and that force researchers to do mountains of unnecessary paperwork instead of experiments.
Fifth, government officials need dramatic behavioral modification. Consider the old story about the city slicker who sees a farmer whacking his mule with a two-by-four. The city slicker asks the farmer what he wants the animal to do. Negative reinforcement, appropriately applied, can redress some of the existing asymmetry between Type1 and Type2 errors.
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For example, independent ombudsman panels that have the authority to discipline individuals at regulatory agencies for egregious errors would introduce accountability into regulators' policy-making and decision-making. There is nothing sacrosanct about a government monopoly over regulation.
There are a variety of alternative institutional arrangements that could serve to oversee the premarket approval and monitoring of products like drugs, medical devices, food additives and pesticides. As economist Robert Tollison has said of pharmaceutical regulation:. There are a variety of alternative institutional arrangements which could be called upon to regulate and monitor the safety and effectiveness of the nation's supply of new drugs and medical devices.
These range from the present system, which can be classified as a government monopoly on drug and device certification, to a free market system in which government would have no regulatory role at all. In between these two extremes are a number of institutional alternatives which combine more or less government oversight with more or less private involvement. There are costs and benefits of each system, and it is through a careful consideration of these costs and benefits that one can proceed to choose a system that provides the most net benefits to medical consumers.
As I have argued throughout this book, the costs of the present system often outweigh its benefits; I have identified several examples where the balance is overwhelmingly negative. It is past time for the regulatory pendulum to swing away from government monopoly to a part of the arc that emphasizes the innovation and efficiency favored by nongovernmental mechanisms. Turn recording back on. National Center for Biotechnology Information , U. Madame Curie Bioscience Database [Internet]. Austin TX : Landes Bioscience; Search term.
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Blame industry! Biotechnology trade groups' checkered past A few examples will illustrate how the biotechnology trade associations served the interests of a few big and influential companies in an anticompetitive campaign inimical to the public interest. An official of the Institute of Food Technologists, a nationwide professional association that supported the amendment, described their experience with BIO and Monsanto: I just had a meeting this morning with a delegation from BIO and Monsanto who trooped into town to educate me.
BIO and the convention on biological diversity While the primary goals of the CBD are laudable but of little conceivable advantage to U. Follow the self-interest Congressional committees with jurisdiction over these agencies and issues have been nonplussed by the goings-on.
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In an August 4, , letter to BIO's members, President Carl Feldbaum explained: As our industry progresses, bioethics issues grow increasingly important and they are frequently raised by the media in response to new biotechnology discoveries and developments. Bureaucratic versus societal risk Government regulators, like the rest of society, generally act in their own self-interest, even when those actions are inimical to the best interests of others.
Essay 2 Strategies for Reform The conundrum of what to do about government regulation of technology and its products requires a multifaceted solution. A risk-based algorithm for field trials As discussed extensively above, rDNA-manipulated organisms can be regulated in the same manner as other organisms. The FDA For the regulation of biotechnology, the FDA adopted a scientific paradigm early on that avoided discriminating against biotechnology products.
A few narrow but critical amendments to the FDA's enabling statutes would remove certain functions from the governmental monopoly and reduce the agency's opportunities for mischief: Exempt from FDA jurisdiction early small-scale clinical trials, which are overseen already by research institutions' Institutional Review Boards;.
Require the FDA to recognize drug approvals by comparable regulatory apparatuses abroad e. Essay 3 Building a Constituency for Science-Based Policies Habituation, the gradual adaptation to a specific stimulus or to the environment, is a biological phenomenon that may also be said to apply to responses to political influences. As economist Robert Tollison has said of pharmaceutical regulation: There are a variety of alternative institutional arrangements which could be called upon to regulate and monitor the safety and effectiveness of the nation's supply of new drugs and medical devices.
Bovard J. Miller H I. Crooke S T. Experience I was a consultant on this report but not one of its authors. Anon Statement of policy: foods derived from new plant varieties. Federal Register. Feldbaum C F. Anon Unified regulatory agenda. Hoyle R. Biosafety protocol draft spooks U. Helms R B. Essay 2: Reform Strategies 1. R——01, Ratner M. BSCC addresses scope of oversight Biotechnology —8.
See also UW researchers stymied by genetic test limits. Naj A K. Clouds Gather Over the Biotechnology Industry. The Wall Street Journal. Governmental regulation of the products of the new biotechnology: A U. Anon Coordinated framework for regulation of biotechnology. Government Printing Office, Anon Proposed guidelines for research involving the planned introduction into the environment of organisms with deliberately modified traits.
Safe biotechnology: III. Safety precautions for handling microorganisms of different risk classes. Appl Microbiol Biotech. In public policy making, numerous individuals, corporations, non-profit organizations and interest groups compete and collaborate to influence policymakers to act in a particular way. The large set of actors in the public policy process, such as politicians, civil servants, lobbyists, domain experts, and industry or sector representatives, use a variety of tactics and tools to advance their aims, including advocating their positions publicly, attempting to educate supporters and opponents, and mobilizing allies on a particular issue.
Many actors can be important in the public policy process, but government officials ultimately choose public policy in response to the public issue or problem at hand. In doing so, government officials are expected to meet public sector ethics and take the needs of all project stakeholders into account. Since societies have changed in the past decades, the public policy making system changed too. In the s, public policy making is increasingly goal-oriented, aiming for measurable results and goals, and decision-centric, focusing on decisions that must be taken immediately.
Furthermore, mass communications and technological changes such as the widespread availability of the Internet have caused the public policy system to become more complex and interconnected. As an academic discipline, public policy brings in elements of many social science fields and concepts, including economics , sociology , political economy , social policy , program evaluation , policy analysis , and public management , all as applied to problems of governmental administration, management, and operations.
While the majority of public policy degrees are master's and doctoral degrees, there are several universities that offer undergraduate education in public policy. Traditionally, the academic field of public policy focused on domestic policy. However, the wave of economic globalization that occurred in the late 20th and early 21st centuries created a need for a subset of public policy that focused on global governance , especially as it relates to issues that transcend national borders such as climate change , terrorism , nuclear proliferation , and economic development.
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