Federal Agency Interactions

The traditional roles and responsibilities of the National Institute of Allergy and Infectious Diseases (NIAID), the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the Department of the Army are described in Chapter 2. Despite the existence of the Interagency Group to Monitor Vaccine Development, Production, and Usage, these agencies still act largely independently, without the benefit of an overall policy framework or set of objectives.

One consequence of this lack of coordination is that infectious disease problems are often approached in a compartmentalized or sequential fashion. For example, problems with potential under-utilization of a vaccine (arising from public or provider misperceptions) often are ignored until laboratory studies have been completed. Addressing these problems earlier could save valuable time and improve the public health returns on vaccine investments.

Lack of an overall immunization and vaccine development policy does not appear to have greatly affected vaccine regulation. Concern has been expressed, however, that no specific mechanism or forum exists for the systematic review or revision of FDA regulations on vaccines. ⁶

Molecular biology and immunology offer many powerful new research tools and production techniques for biologics. The committee found that no mechanisms exist for the systematic dissemination of knowledge about these advances and their applicability to vaccine development.

Also, no procedures are available to encourage their use in cases in which commercial incentives might be inadequate, e.g., for vaccines of interest to developing countries.

Public-Private Sector Interactions

In the background papers prepared for this committee, and at the conference sponsored by the committee in November 1983, a variety of concerns were raised about interactions between federal agencies and the vaccine industry. Some of these concerns related to reluctance on the part of industry scientists to discuss current activities, Presumably for fear of losing a commercial competitive advantage. ⁷ This fear may be grounded partly on a belief that it is difficult for the federal government to ensure confidentiality in its dealings with industry. Industry also may refrain from interactions with federal agencies in the research and development phases because of the complexity of federal contracting and reporting procedures. These factors may have played a role in the lack of a commercial response to a NIAID request for proposals to develop an improved pertussis vaccine.⁷

Concerns about the effectiveness of public-private sector communications also were raised during recent congressional hearings on the events preceding and following recommendations made by the Interagency Group to Monitor Vaccine Development, Supply, and Usage in response to the anticipated DTP vaccine shortage.^8,9

Provider and Recipient Perceptions

Chapter 3 describes the tendency in the current health care system to emphasize the use of diagnostic and therapeutic technologies rather than preventive technologies, even when the latter have been documented to be highly beneficial and cost effective. This tendency serves as a commercial disincentive for vaccine innovation and production, and also deprives the public of appropriate health protection measures. Health care providers, with the exception of pediatricians, often are not adequately informed about the benefits of prevention generally, and of immunizations in particular. Also, their perceptions of the risks of certain diseases and of the relative risks and benefits of vaccines may be inaccurate. These problems have been recognized by various groups concerned with the public's health. Numerous efforts have been made to promote increased awareness, including the development of guidelines on adult immunization by the American College of Physicians. ¹⁰

These efforts also could lead to more accurate perceptions among the general public of the benefits and risks of immunizations. The committee believes that all potential vaccine recipients (or their parents) should receive (from a health care provider or another appropriate source) accurate information about the risks of vaccine preventable diseases and the benefits and risks of specific immunizations, including contraindications to vaccination. Accomplishing this task will require concerted and coordinated efforts by public health agencies and those individuals and organizations involved in the dissemination of information to health professionals and the public.

The role of responsible and well-informed media coverage should not be overlooked. In the past, news reports concerning vaccines have focused extensively on risks, perhaps leading to confusion about relative risks and benefits.¹¹ The media should be encouraged to provide complete, accurate information about all aspects of vaccine development, production, and use in this country.

Rationale for Establishment

A successful immunization program must be based on a consensus among research scientists, developers, producers, program administrators, and recipients that the program is needed, that benefits exceed the risks, and that it is practical and feasible. Currently, no formal mechanism exists to bring the interested parties together or to provide a forum for debate.

Mechanisms for gaining public and professional acceptance of immunization recommendations, especially for adults, also need improvement. One way to accomplish this would be to provide more opportunities for those who administer and receive vaccines to participate in the decision-making process. The commission, as envisioned by the committee, would provide these opportunities.

The Secretary of the Department of Health and Human Services, as the individual responsible for policy and legislative initiatives in the health field, also would benefit from such a commission. No existing advisory body has a membership that allows it to present the viewpoints of all participants in the vaccine enterprise.

The commission would work to conserve the effective components of the present system; thus, society would continue to benefit from the expertise concentrated in the relevant government agencies, the pharmaceutical industry, and the advisory bodies described in Chapter 2. These groups would be encouraged to assist in the development of new approaches to sustaining and stimulating commercial interest in production and innovation, ensuring improvement of vaccines, designing clinical and epidemiological research, restructuring liability and compensation, and increasing public and professional awareness. A commission or similar body also would provide an appropriate forum in which to explore applications of new scientific technologies to vaccine development.

Purpose and Functions

The objectives of the proposed commission would be (1) to advance the control of infectious diseases by promoting the continued innovation, production, and use of vaccines and (2) to ensure that this goal is achieved in a socially responsible and just manner.

The commission would monitor all aspects of immunization efforts in the United States, acting in a consultative and advisory capacity; one of its primary responsibilities would be early identification of problems. It also would help to educate and inform the public, physicians, and government decision makers about appropriate immunization actions and policies. As necessary, the commission would become an impartial broker to promote production and supply of needed vaccines and to coordinate collaborative activities.

Reporting

The commission would report at least annually to the Congress and the President, and on other occasions if immediate action is required to avert threats to the public health.

Location, Establishment, Membership

The base from which the commission operates could have a significant effect on its ability to fulfill its purpose, which is to identify national needs for vaccine development, production, and utilization and to promote programs to meet the needs. Furthermore, optimal functioning of the commission will require certain attributes that would be achieved more readily under some auspices than others. These attributes include:

• Stature and credibility sufficient to command acceptance of commission recommendations. Important factors in this will include:
  • —participation of all relevant parties—government, industry, health professionals, and the public;
  • —the capacity to pursue public health goals in a responsible and just manner, independent of political considerations and commercial interests;
  • —members with outstanding knowledge and experience, appointed without regard to political views;
  • —the capacity to identify solutions to immunization problems independent of the activities and responsibilities of a parent organization.
• The capacity to ensure that necessary programs are instituted. This will probably require:
  • —the ability to sustain commission efforts irrespective of fluctuations in the level of political interest in its mission;
  • —the ability to make direct representation to the federal legislature on budgetary matters related to its mission;
  • —the ability to call upon existing federal agencies in the collaborative pursuit of objectives;
  • —the ability to elicit greater industry interest in collaborative efforts than is presently forthcoming, possibly through the use of direct contracts;
  • —the ability to receive funds from any source (e.g., private foundations, industry) and direct them to achieving the commission's objectives.

A variety of possible modes of operation for the commission were identified, some of which have been the subject of previous proposals. It could be established within either the executive or legislative branches, be affiliated with an independent entity such as the National Academy of Sciences, or be created as a federally chartered, nonprofit corporation.

Options identified by the committee, and their advantages and disadvantages are listed below:

• Creation as a presidential commission.
  Although such a location would confer high visibility on the enterprise, presidential commissions are often short-lived and can become overly influenced by partisan concerns. This option therefore fails to confer many of the attributes described above.
• Establishment within the Department of Health and Human Services (DHHS).
  This location would give the commission the most immediate influence on existing agencies in the implementation of its recommendations. However, interactions between federal agencies and the private sector generally have not exhibited the level of coordination and collaboration that would be required for successful operation of the commission, perhaps because of the complexity of federal administrative rules. Additionally, location within DHHS might result in pressure on the commission to modify evolving recommendations in light of other departmental priorities (see the discussion in Chapter 3 of funding requests for a vaccine stockpile).
  The analysis conducted by the National Immunization Work Groups for the Assistant Secretary of the then Department of Health, Education, and Welfare (DHEW) led to the suggestion that a vaccine commission be appointed by the Secretary (National Immunization Work Groups, 1977). To date, however, the executive branch has not acted to establish such a commission. Nor has action been taken to create within DHEW/DHHS the broad-based interagency body envisaged by the Office of Technology Assessment (Office of Technology Assessment, 1979).
  If a broad-based body were established within DHSS with the appropriate safeguards for its independence and with mechanisms to facilitate interaction with the private sector, it could perform many of the functions the committee envisages for the commission. Its independence from political influence might be still subject to question or misperception because of its location within the executive branch.
• Affiliation with the Congressional Office of Technology Assessment (OTA).
  Such a location would confer the benefits of close association with national policy makers. However, the policy recommending and operational activities of the commission would depart significantly from OTA's traditional role, namely, the identification of policy options.
• Affiliation with the National Academy of Sciences, e.g., association with the Institute of Medicine.
  Such a location or association would confer the advantages of good access to expertise in pertinent scientific and health related areas, established structure and procedures resulting in recognized independence of judgment, and an existing federal advisory responsibility/ role on matters of science and health. However, the envisaged policy formulation and promotion, and possible operational activities of the commission are not roles taken up by an advisory organization such as the National Academy of Sciences or the Institute of Medicine.
• Establishment as a congressionally chartered, nonprofit corporation.
  This option would enable the commission to establish an intermediary role between federal agencies, industry, and health professionals without the perception of control by any of these groups. The commission would be in a position to accept funds from federal and other sources and disperse them in an efficient manner. It could maintain an impartial, independent focus on vaccine development and immunization problems and, through reports submitted directly to Congress and the President, draw their attention to issues of concern. It is recognized, however, that some existing quasi-independent corporations serving general public needs have not operated in financially successful fashion due to difficulty in raising funds from private sector sources or revenues. Funding of the commission is discussed further below; but these types of problem, if encountered, could result in overreliance on public appropriations.

If created as a nonprofit corporation, the commission's influence on the activities of existing federal agencies and others would derive solely from the persuasiveness of the arguments behind its recommendations. Such a situation could be helpful in ensuring broad and thorough discussion of the issues that the commission identified as needing attention.

Public accountability of such a body would be ensured by its creation under congressional charter and the manner of appointment of its members.

Based on its analysis of the potential options and its knowledge of the fate of previous recommendations, the committee favors establishment of the commission as a congressionally chartered, nonprofit corporation. However, certain other loci for its operations are not altogether incompatible with the purposes of the commission. (It is understood that public and elected officials must consider recommendations in light of the pros and cons of the alternatives as seen from the perspectives derived from their responsibilities.)

As envisioned by the committee, the commission would have a relatively small board of directors with members drawn from the fields of biotechnology, immunology, infectious diseases, public health, public representation, health care policy, health care economics, health care delivery, bioethics, behavioral science, law, or medicine.

The manner of appointment should be designed to ensure that the commission attains the attributes of authority and credibility discussed above. In developing a slate of candidates for possible membership on the commission's board of directors, recommendations should be sought from all relevant groups (see Appendix J).

Representatives of the National Institute of Allergy and Infectious Diseases, the Centers for Disease Control, the Office of Biologics of the Food and Drug Administration, the Department of Defense, the Health Care Financing Administration, the Veterans Administration, and the Agency for International Development should be appointed as liaison members.

Funding

Preliminary projections indicate that a budget of about $1 million per year would be required for a minimum level of effective activity by the commission. A federal appropriation would be the simplest mechanism for ensuring rapid establishment of the commission. In the long term, it would be desirable for funding to be obtained from a variety of public and private sources to ensure the body's independence and credibility.

Possible Areas of Activity

The mode of operation of the commission and its initial activities should be determined by the commission itself. Efforts that might be initiated include (not in order of priority):

• monitoring the availability of existing vaccines to anticipate problems resulting from production difficulties or commercial decisions affecting supply
• monitoring the need for improvement of existing vaccines and setting priorities in this area
• monitoring vaccine innovation activities in the public and private sectors to determine whether they accurately reflect U.S. public health needs and the special needs of the military
• monitoring the vaccine needs of developing countries and promoting efforts to meet those needs
• evaluating the potential applications of advances in basic biotechnology to vaccine development
• evaluating the application of knowledge from the behavioral sciences in the design of campaigns to promote vaccines
• reviewing the effectiveness of promotional campaigns
• monitoring and evaluating patterns of infectious disease as an aid to determining priorities
• monitoring the training of personnel needed to ensure continued vaccine innovation
• monitoring and evaluating legal issues related to vaccine development and use