CDC VACCINE STOCKPILE FISCAL AND MANAGEMENT ISSUES A Presentation At The National Vaccine Advisory Committee Meeting February 4, 2003 Kimberly S. Lane Associate Director for Management and Operations National Immunization Program

Overview Legal Authority Budget Purchase Timetable Accountability

Legal Authority OBRA 1993 legislation authorized DHHS to procure an adequate supply of vaccine. GAO recommendation - “specifically address whether vaccines stockpiled under this program may be made available to children not otherwise eligible”. HHS’s Office of General Counsel reviewed this issue and confirmed the Secretary’s authority under current law to establish a VFC stockpile of vaccines equal to the amount needed for the U.S. pediatric population for 6 months.

VFC Stockpile Fiscal Update FY 2001 and $29M FY 2004 President’s Budget - $124M FY 2003 President’s Budget (approved January 2002) - $29M December 2002 Budget Negotiations with HHS and OMB secured additional FY 2003 funding - $+143M for a total of $172M January 2003 OMB approved a 4-year stockpile purchase plan in the amount of $707M

VFC Stockpile Fiscal Update Estimated 4-year stockpile purchase plan* FY $172M FY $124M FY $206M FY $206M *Assumption: 6 month national supply of recommended childhood vaccine based on estimated quantities of vaccine that the manufacturers can produce by Manufacturer estimates provided in September 2002.

VFC Stockpile Fiscal Update Contract award for the development of stockpile strategic plan in February Strategic Plan may alter current stockpile cost estimates New vaccines recommended by ACIP may alter current stockpile cost estimates

CDC’s Estimated Purchase Timetable (Sept. 2002) VaccinePurchase Price Number of Doses Purchase Amount Obligation Date Outlay Date Varicella$40.691,300, ,020 $52.90 M $17.42 M 01/ / / /2004 Hib$8.32 $ ,000 7,500,000 $4.16 M $50.10 M 01/2003 unknown 09/2003 unknown Hep A$11.153,000,000 1,000,000 $33.45 M $11.15 M 01/ / / /2004 Hep B$ ,000,000 $24.75 M $27.30 M 01/ / /2003 PCV$45.248,000,000$ MUnknown DTaP$9.5010,000,000$95.0 M01/200409/2005 OPV$7.254,000,000$29.0 M01/200309/2003

Accountability Stockpile purchase and storage/rotation contract modifications based on: New CDC Strategic Plan Office of General Counsel Expertise Financial Management/Accounting Expertise Stockpile Access Manufacturer “borrowing” Official withdrawals 317 and VFC orders authorized Resale to manufacturer for private sector purchases

Accountability Financial Transactions Automation via NIP’s new Vaccine Management Enterprise System Transaction process included in new HHS Unified Financial Management System Account transaction Standard Operating Procedures (SOPs) due to multiple funding sources (317, VFC and manufacturer resale)

Conclusions Expansion of the CDC stockpile is imminent Strong support from HHS and OMB Legal Authority exists under current law 4-year $707M estimated cost Enhanced program accountability