FDA’s ROLE IN CLINTON VACCINE INITIATIVE FUNDED AT $35 MIL. IN FY 1994; PRESIDENT’s FY 1994 BUDGET SEEKS $60 MIL. FOR CDC EFFORT TO CONTAIN TUBERCULOSIS

FDA activities related to the Clinton Administration's comprehensive childhood immunization initiative would be funded at $35 mil. for FY 1994, under the president's budget request issued April 8. The vaccine funding will be used by FDA for "enhancing pre-licensure activities (laboratory standards, animal models and procedures for measuring immune responses), expanding post- marketing activities (monitoring unknown or unanticipated events of new vaccines) and accelerating research to understand more precisely vaccine risks," HHS budget summary documents explain. The FDA figure is part of the $840 mil. allotted to the HHS Public Health Service for the intensified immunization efforts. The $840 mil. represents a 91% increase over PHS's enacted immunization funding of $440 mil. in FY 1993. However, the president already has requested the addition of $300 mil. in supplemental FY 1993 funding for immunizations. The bulk of the PHS immunization funds will go to the Centers for Disease Control and Prevention, which is slated to receive $668 mil. for these activities under the FY 1994 request. About 75% of the CDC's share will be used "to finance state immunization action plans, develop immunization tracking systems and purchase vaccines," the budget documents explain. "Remaining funds will support a broad range of activities from vaccine safety, research and development, to global polio eradication." Elsewhere in PHS, the National Vaccine Program Office would receive $9 mil. under the president's FY 1994 request. About $3 mil. was provided for the office in FY 1993, although the Clinton Administration has requested supplemental funding to bring that figure to $9 mil. The 1994 allotment would allow the office "to maintain the impetus" of the proposed 1993 increase. Housed within the Office of the HHS Assistant Secretary for Health, the office's role is to "coordinate the establishment and attainment of a unified national immunization program." While the childhood immunization initiative has garnered much public attention, HHS Secretary Shalala is stressing that the department is bolstering a variety of its public health and prevention programs. At an HHS budget briefing April 8, Shalala declared: "I am happy to say this is a disease prevention budget, with a total of $10.7 bil. for prevention activities -- an increase of $1.2 bil. over the amount enacted last year." For example, the budget proposal also includes $60 mil. to fight the resurgence of tuberculosis, Shalala noted. CDC's total 1994 budget request for tuberculosis elimination activities is $129 mil., up by $50 mil. from FY 1993. Those funds would go "to support states in providing directly observed TB therapy and screening in high-risk populations, and to improve TB diagnosis, surveillance and prevention education," HHS said. The Public Health Service would receive a total of $21.3 bil. in FY 1994 in the first budget developed by the Clinton Administration. AHCPR's budget includes $85 mil. allocated for the continued development of guidelines for medical practice. By the end of FY 1993, the agency expects to issue guidelines on early HIV infection; cancer pain management; sickle cell disease; benign prostatic hyperplasia; and depression (to be released April 14). The PHS and other "discretionary" programs account for only 6% of the $641 bil. budget calculated for HHS. About half of the budget goes to Social Security and a quarter to Medicare.