January 1996
WASHINGTON—An alphabet soup of federal agencies evaluates, licenses, recommends, and sometimes administers vaccines. The power of these agencies, however, is offset by annual budget clashes, some of which are fatal.
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The federal agencies that regulate vaccine use are vulnerable to political
whims.
The National Vaccine Program (NVP) has sustained several blows over the past 2 years, and it may now be fighting for its last breath. Created in 1986 as part of the Public Health Service Act (P.L. 99-660), it was charged with overseeing the development, procurement, distribution, and use of vaccines; and evaluating the adequacy of the vaccine supply, immunization programs, and governmental and nongovernmental activities. The NVP was also authorized to allocate funds to other federal agencies carrying out the activities outlined in its annual National Vaccine Plan, which was intended to guide vaccine research and policy.
That legislation also created the National Vaccine Advisory Committee (NVAC) to advise the director of the NVP and the Assistant Secretary of Health and Human Services on vaccine-related issues.
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Although the statute suggested an initial budget of $30 million for the NVP, the program's funding never approached that amount. The Reagan administration considered the NVP a duplication of existing agencies and neglected to appoint a director or provide any funding for its first 3 years. This lack of funding started a chain of events in which the NVP may have hurt itself. The legislation specified that the first vaccine plan was due Jan. 1, 1987, with revisions due every January thereafter; however, the first plan was not delivered until March 1994. Without a blueprint designating where and how the money was to be spent, Congress balked at providing funding. The budget for the NVP dropped steadily, from $9.5 million in 1991 to $7.9 million in 1992. By fiscal year 1993, the budget was only $2.8 million.
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is offset by annual budget clashes in Congress.In comparison, the appropriations that other federal agencies earmarked for vaccine-related activities increased during that same period, with some agencies allocating more than double their 1991 amount. "The delay of the vaccine plan was symptomatic of the budget problems," according to NVAC chair Edgar Marcuse, MD. "There still would have been budget problems regardless of whether the plan was on time. It [the NVP] was a controversy from the beginning, between those who thought it was needed and those who did not. The division always existed."
The Institute of Medicine, in its report The Children's Vaccine Initiative: Achieving the Vision, expressed distress at the state of the NVP's funding. Published in 1993, the report stated:
"The committee is disturbed by the lack of support for the NVP because it believes that the concept of planning, organizing, and managing existing immunization resources under an accountable government mandate is vital to the development and use of vaccines. There is no doubt that the NVP's planning function and coordination of public sector activities must be continued into the future. The NVP does not, however, as currently authorized, possess the programmatic nor operational capability to manage the development of new vaccines."
The NVP's financial situation only grew worse. In 1994, control of the NVP's budget shifted to the CDC, and staff support followed a year later. With the program's Washington offices closed, its future is in doubt.
"The office is not operating at the level it did prior to the transfer, but it is still carrying out its primary responsibilities; that is, coordinating the activities of federal agencies involved in vaccine research and development, coverage, and safety," said Robert Breiman, MD, Acting Director of the NVP Office. Funding for the NVP was up for renewal in 1995. Although reauthorization may be included as part of the federal budget package, as of publication, the outcome is uncertain.
Whether the NVP will be dissolved—and NVAC along with it—are questions that remain unanswered although both are supported by the CDC. NVAC, however, may continue on its own. It is the only forum where immunization experts, public and private sector providers, public advocates, and vaccine developers sit at the table to debate and formulate vaccination policy.
"NVAC will survive if the agencies involved [in vaccine research and development] and their leadership think it is important to them and helps them achieve their missions," Marcuse said. "If not, NVAC will not survive.
The committee is not abandoning the ship just yet, however. It is continuing with its mission and is actively exploring major issues, such as the future of vaccines, adult vaccination, vaccine safety, and vaccine delivery.
| Federal Entity | Appropriations (millions) | |||
|---|---|---|---|---|
| FY1991 | FY1992 | FY1993 | FY1994 | |
| USAID | $46.5 | $61.4 | $75.7 | N/A |
| AHCPR | $1.2 | $1.6 | $1.1 | $1.3 |
| CDC | $217.5 | $296.2 | $341.1 | $528.1 |
| DOD | $162.4 | $151.2 | $170.4 | $160.0 |
| FDA | $11.7 | $15.2 | $15.6 | $25.6 |
| HRSA | —— | $0.3 | $5.0 | $5.0 |
| NVP | $9.6 | $7.9 | $2.7 | $2.7 |
| NIH | | | |
|
| $112.3 $59.9 | $152.6 $70.8 | $165.7 $84.9 | $208.2 $108.0 | |
FY=fiscal year
USAID=United
States Agency for International Development
AHCPR=Agency for Health Care
Policy and Research
CDC=Centers for Disease Control and Prevention
DOD=Department
of Defense
FDA=Food and Drug Administration
HRSA=Health Resources and
Services Administration
NVP=National Vaccine Program
NIH=National
Institutes of Health
N/A=Not available
*Estimates for all DOD vaccine
development and vaccination efforts
Source: National Vaccine Program Office. Disease Prevention Through Vaccine Development and Immunization: The U.S. National Vaccine Plan—1994. Washington, D.C.: Department of Health and Human Services/Public Health Service; 1994; p. 54.
The vaccine advisory committee to the U.S. Public Health Service—the Advisory Committee on Immunization Practices (ACIP)—is on more stable financial footing, but it is not insulated from political turmoil.
Funding for the ACIP comes out of the operating budget for the CDC's National Immunization Program and it does not seem endangered, said Dixie Snider, MD, MPH, Secretary for the ACIP. Its involvement with the Vaccines for Children (VFC) program has opened the ACIP to harsh criticisms, however. The VFC is one component of a broad five-part initiative to improve immunization coverage among children, and it has been a political lightning rod since its inception.
The program originally sought to eliminate the barrier of cost by providing government-purchased vaccines to all children. When it emerged from Congress, however, it provided federally purchased vaccines only to children who qualified for Medicare, were Native American, or had no insurance coverage. Children whose private insurance did not pay for vaccinations might receive government-purchased vaccines from designated providers.
Despite the compromise, the VFC continued to draw the ire of some vaccine developers, who contended that any reduction in the private market share would shrink the funds available for reinvestment in research and development. They were soon joined by other critics—including the General Accounting Office—who produced studies showing that although cost is indeed a barrier to immunizations, it is not the most significant.
VFC policy is developed by the ACIP. The ACIP was charged with recommending which vaccines and schedules were to be included in the VFC program, which began in October 1994. These duties were added to the committee's traditional role of issuing vaccine policy guidelines.
Although its involvement with the VFC opened the ACIP to criticisms about some of its decisions, the program has given the ACIP new-found muscle. In its traditional advisory role, the ACIP has no power to implement policies or authorize funding to carry out its recommendations; it can only publish guidelines and wait for them to be used. By setting VFC policy, however, recommendations are put into practice almost overnight.
"If the VFC is not continued, the ACIP would revert to its traditional role," Snider said. "It would have a more indirect impact, however, the advantage [of the VFC] is that instead of issuing recommendations and having to depend on state budgets or private practitioners to adopt them, the VFC allows the recommendations to be implemented rapidly, especially in underserved populations."
Which committees and programs survive the current political battle remains to be seen. What is clear, however, is that none exists in isolation, and the demise of any one will have lasting repercussions on vaccine development and delivery.
For more information, see:
Institute of Medicine. The Children's Vaccine Initiative: Achieving the Vision. Washington, D.C.: National Academy Press; 1993.
National Vaccine Program Office. Disease Prevention Through Vaccine Development and Immunization: The U.S. National Vaccine Plan—1994. Washington, D.C.: Department of Health and Human Services/Public Health Service; 1994.
Vaccines for Children: Barriers to Immunization. Washington, D.C.: General Accounting Office; Testimony before the Committee on Finance, United States Senate; May 4, 1995. GAO/T-PEMD-95-21.
Vaccines for Children: Refocusing the Program's Goal and Implementation. Washington, D.C.: General Accounting Office; Testimony before the Subcommittee on Health and Environment, Committee on Commerce, House of Representatives; June 15, 1995. GAO/T-PEMD-95-23.
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