You asked several questions about flu vaccinations. Specifically you wanted to know: (1) the number of doses of and expenditures for H1N1 and seasonal flu vaccines, (2) if the Patriot Act permits the federal government to preempt state law when the President declares a national emergency, and (3) if anyone died from the swine flu vaccine administered in 1976. We answer each question in sequence, below.

2009 FLU DOSES AND COST

The federal government has contracted for about 250 million doses of H1N1 flu vaccine at a cost of $ 1. 5 billion. Unlike H1N1, most seasonal flu influenza vaccine manufacture, distribution, and administration are private sector functions. About 115 million doses of seasonal flu vaccine should be available by the end of November, an increase from the 103 million doses used last year, manufacturers say. But we could not find out how many doses the federal government will purchase or how much it will spend for them.

The federal government buys and distributes relatively small amounts of seasonal flu vaccine. The Food and Drug Administration, Centers for Disease Control (CDC), National Institutes of Health, and the Office of Health and Human Services (HHS) Secretary will spend about $ 300 million this year for their ongoing annual pandemic influenza activities. In its role as an employer, the government pays some of the costs of vaccinations for employees and insureds, and the Veterans' Administration purchases vaccines for its clients. We could not find out how much the government expects to spend on these purchases.

PATRIOT ACT PREEMPTION AND NATIONAL EMERGENCY DECLARATIONS

Patriot Act Preemption

The Patriot Act preempts state laws in just two areas, both dealing with liability. Section 358 preempts state laws concerning credit record privacy. It requires consumer reporting agencies to disclose credit reports to government agencies investigating terrorism and protects the consumer agencies from state liability laws. Section 507 protects educational institutions from state liability laws when, as the Patriot Act requires, they turn over records to the U. S. Attorney General's Office.

National Emergency Declaration

President Obama declared a national emergency concerning H1N1 flu on October 25^th. The declaration was made under section 1135 of the Social Security Act (42 USC § 1320-5).

The emergency declaration permits health care facilities to ask HHS to waive certain patient treatment and privacy requirements of the Medicaid, Medicare, Children's Health Insurance Program, Emergency Medical Treatment and Active Labor, and Health Insurance Portability and Accountability (HIPPA) laws.

● Hospitals can seek waivers to (1) set up alternative treatment locations away from their main campuses, (2) facilitate transfers of patients to other emergency rooms and hospital inpatient units, and (3) exceed bed limits and average patient stay requirements (for critical care hospitals).

● Nursing homes can ask for a waiver permitting them to increase the number of certified beds in a distinct area without prior federal approval.

● The HHS secretary can waive sanctions and penalties against hospitals that fail to comply with HIPPA rules concerning (1) obtaining a patient's agreement to speak to family members, (2) honoring a patient's request to opt out of a facility's directory, (3) distributing notice of privacy rules, and (4) a patient's request for privacy restrictions and confidential communications.

Previous national emergency declarations were made after Hurricane Katrina, flooding in North Dakota, and hurricanes Ike and Gustav.

1976 SWINE FLU VACCINE

More than 40 million people were vaccinated over a 10-week period in 1976. No deaths were linked directly to the vaccine, but some 500 vaccinated people developed Guillain-Barre Syndrome, a disorder in which the body's immune system attacks part of the peripheral nervous system. Of these 500, 25 died.

The Institute of Medicine concluded after an extensive review in 2003 that the “evidence favored acceptance of a causal relationship” between the 1976 vaccine and the syndrome. It stopped short, however, of saying the evidence “established” a causal relationship.

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