**Letter and Fact Sheet Included** FOR IMMEDIATE RELEASE CONTACT: Laura Capps/Melissa Wagoner (202) 224-2633

Washington, DC: Today Senator Kennedy and twenty of his colleagues in the House and Senate sent a letter to Speaker Hastert and Majority Leader Frist to express their disapproval of the tactic that was used to slip in a damaging provision on vaccine liability. Senators Kennedy, Dodd, and Harkin introduced a bill that would repeal the deeply flawed provision, and enact in its place a measure to give pharmaceutical companies and medical professionals appropriate liability on a targeted set of vaccines and other countermeasures -- while ensuring that injured patients are properly compensated. Today's letter urges the Republican leadership to repeal their measure, for the sake of the health and well-being of all Americans. To prevent this kind of stealth action, Democrats have included a provision in the Honest Leadership Act that would require that all conference committee meetings be open to the public and that members of the conference committee have a public opportunity to vote on all amendments. It would also make copies of conference reports available to Members, and post them publicly on the Internet, 24 hours before consideration, unless waived by a supermajority vote. Below is the text of the letter and a fact sheet on the Kennedy-Dodd-Harkin bill. A PDF of the letter with signatures and the bill is available upon request. February 15, 2006

The Honorable Bill Frist, M.D. The Honorable J. Dennis Hastert Majority Leader Speaker U.S. Senate U.S. House of Representatives 509 Hart Senate Office Building 235 Cannon House Office Building Washington, DC 20510 Washington DC 20515

Dear Speaker Hastert and Majority Leader Frist,

All of us share the goal of seeing that the nation is properly prepared for an influenza pandemic or a biological attack. Effective planning and adequate funding are both indispensable elements of preparedness.

We must also see that concerns about possible litigation do not deter responsible manufacturers from supplying vaccines and other drugs to our national stockpile, or dissuade medical practitioners from administering them to patients. An essential element of any program to limit the legal liability of manufacturers and medical professionals must be an effective and properly funded compensation program for patients injured by these products.

Many of us worked closely with our colleagues in the majority to develop a bipartisan proposal to meet this national need. We are deeply concerned that a stealth provision to shield manufacturers from responsibility for making faulty drugs and vaccines was included in the Defense Appropriations Act without Congressional debate or public scrutiny.

Legislation of such significance should have been debated in the open, not sneaked into a larger bill behind closed doors as a favor to special interests. Doing so without the approval of the members of a House-Senate conference committee was, in the words of Thomas Mann of the Brooking Institution " a travesty of the legislative process."

The provision included in the bill is not limited to vaccines for pandemic flu or other major threats to the nation's health, but could instead be used to allow manufacturers of virtually any drug or vaccine to escape responsibility for gross negligence or even criminal acts. The provision fails the basic test of fairness by including only an empty shell of a compensation program for injured patients with none of the funding needed to make compensation a reality.

To correct this serious violation of Congressional procedures, we urge you to schedule immediate action on legislation to repeal this deeply flawed provision, and enact in its place a measure to give pharmaceutical companies and medical professionals appropriate liability protection while ensuring that injured patients are properly compensated. Signed by: Senator Edward M. Kennedy Senator Christopher J. Dodd Senator Patrick J. Leahy Senator Carl Levin Senator Jack Reed Senator Barbara A. Mikulski Senatory Patty Murray Senator Hillary Rodham Clinton Senator Daniel K. Akaka Senator Dianne Feinstein Senator Ron Wyden Senator Mark Dayton Senator Barbara Boxer Senator Tom Harkin Senator Russell D. Feingold Senator Debbie Stabenow Representative John D. Dingell Representative David R. Obey Representative Lois Capps Representative Henry Waxman

The Responsible Public Readiness and Emergency Preparedness Act of 2006

Background When faced with the threat of smallpox, the nation's health experts recommended that health care workers be vaccinated. Congress provided indemnification for those who manufactured and administered the vaccine, which had not undergone FDA clearance using modern procedures. The limited circumstances that made this policy advisable in the case of smallpox may recur if, for example, a pandemic strain of flu hits the United States and the only available vaccine has not been cleared for use under full FDA review procedures, yet HHS recommends that people receive the vaccine. Under these circumstances, it is advisable to provide a targeted indemnification for those who make and administer the vaccine, provided that patients who suffer injury are compensated.

The Republican Approach: Blanket Immunity with a Fig Leaf of Compensation

Instead, in the conference report on the Defense Appropriations bill passed in December 2005, Republicans inserted at the last minute the Public Readiness and Emergency Preparedness Act. This Act provides a broad immunity for pandemic flu vaccines, other countermeasures, and a broad class of other products, including products that have received full FDA approvals and are used everyday by patients. The compensation program provided is one in name only, because the established fund has absolutely no money appropriated into it. As a result, the Republican plan will fail to protect the American people. It provides protection to a manufacturer even if its product is ineffective or unsafe, and offers no help to patients injured by a countermeasure.

Broad immunity.—Republicans gave drug companies and those who administer a countermeasure effectively complete immunity from suit for injuries caused by the countermeasure when it is named in a "declaration" by the Secretary of Health and Human Services. A countermeasure can include any medical product to prevent, treat, mitigate, or diagnose an epidemic. Diabetes, obesity, methamphetamine addiction, and arthritis are considered "epidemics," so products such as Vioxx could get complete immunity protection under the bill, and a court could not review the decision.

"Limit" on immunity ("bad actors").—An injured person can break the immunity only by providing clear and convincing evidence that the drug company or the person who administered the medical product (the "bad actor") acted with "willful misconduct." This standard will be essentially impossible to meet.

Willful misconduct includes only acts or omissions taken— • intentionally to achieve a wrongful purpose, • knowingly without legal or factual justification, and • in disregard of known or obvious risks that are so great as to make it highly probable that the harm will outweigh the benefit. Gross negligence and recklessness are excluded. The Secretary of Health and Human Services must amend the definition of willful misconduct by regulation, but only to make it narrower.

An administrator, such as doctor, can act with willful misconduct and may still be immune if it reports the injury within 7 days. A drug manufacturer can act with willful misconduct and is still immune unless FDA initiates and wins an enforcement action against it. Injured persons must meet extraordinary hurdles to bring a lawsuit, including bringing the suit in Washington, DC, heightened pleading requirements, very limited discovery, and special appeal rights for drug companies.

Compensation.—The compensation program includes no funding, and drug companies receive immunity even when the drug is administered to the wrong person, but that person is denied compensation. Past experience has demonstrated that, in the absence of a compensation program, first responders will refuse to be vaccinated.

The Democratic Alternative: Real Compensation and Targeted Indemnification

The Democratic alternative, the Responsible Public Readiness and Emergency Preparedness Act of 2006, repeals the Republican approach and replaces it with a responsible alternative. It will protect the American people by offering an incentive to manufacturers to make safe and effective countermeasures, while encouraging first responders, health care workers, and ordinary citizens to take these medicines in the event of a pandemic flu or infectious disease outbreak or a bioterror attack.

The bill provides a limited liability protection for a limited set of countermeasures, and a fully funded compensation program modeled on the successful Vaccine Injury Compensation Program.

Indemnification, not immunity.—Manufacturers of, and those who administer, certain countermeasures, including pandemic flu vaccine, are indemnified by the Federal government. In other words, injured patients may sue the Federal government in Federal court to pursue claims of negligence, strict liability, failure to warn, or malpractice. Patients will not be able to sue companies or doctors who administer these indemnified countermeasures.

A targeted set of products.—Indemnification is available only where (1) the product has not undergone full FDA testing and (2) the product is recommended for use by the Secretary of Health and Human Services in a declaration. Products for epidemics like diabetes, obesity, and arthritis cannot be given the liability protection.

Real compensation.—Any injured patient for an indemnified countermeasure will also be able to seek compensation through a program modeled after the Vaccine Injury Compensation Program, whether or not there is negligence involved. Claims against the government under both the indemnification program and the compensation program are paid for the same way claims under the Federal Tort Claims Act are paid—no additional appropriations are required.

Accountability.—The government can sue a manufacturer or doctor who was grossly negligent or reckless to recover payments made to injured patients under the indemnification or compensation programs.