KENNEDY: REPUBLICAN 'MIDNIGHT RIDER' LETS DRUG COMPANIES IGNORE SAFETY

AMENDMENT GIVES ONLY AN EMPTY PROMISE TO INJURED PATIENTS

Washington, DC: Last night, in a midnight deal done in a back room of the Capitol, the Republican Congressional leadership attached to the DoD appropriations bill a massive give-away to the drug industry, at the expense of nurses, firefighters, and ordinary Americans injured by dangerous drugs and vaccines. Senator Kennedy has been leading the fight against this sweetheart deal, which its proponents claim provides compensation for injured patients, but the reality is that they get only an IOU. The result of this plan will be that drug companies get a free pass when their products injure innocent Americans, but the injured have no meaningful recourse to help them cope with the costs of their injuries.

The Republican leadership in Congress cut a back room deal to give a massive Christmas bonus to the drug companies. They get everything on their wish list, but nurses, firefighters, and ordinary Americans who will have to take untested vaccines and drugs get no money for compensation if they get injured,” Senator Kennedy said. America can do better than a special interest vaccine plan that will fail to protect us from the flu."

The Republican leadership contend that this sweetheart deal ensures that "bad actors" will have to bear responsibility for their actions, but the reality is that bad actors get a free pass. They claim that this provision is about the response to avian flu, but the reality is that it could cover drugs for diseases from diabetes to drug addiction to everything in between. A summary of what is in the bill is below.

Senator Kennedy supports and has proposed indemnifying drug companies that make pandemic flu and countermeasures for responding to terrorist attacks and a compensation program modeled after the Vaccine Injury Compensation Program for routine childhood vaccines. Under Kennedy’s plan, injured patients could either seek redress from the administrative compensation fund or, if they think they could prove negligence or worse, sue the government in Federal Court. If the Federal government believes the company was grossly negligent or reckless in producing a vaccine or drug, the government could sue the company directly in Federal Court. Kennedy’s proposal offers compensation to injured patients and it protects companies from suits by patients. Drug company liability to the government deters reckless manufacture of vaccines and countermeasures that would cause patients to be injured.

Specific features of the Republican legislation

Drug companies are given complete immunity from civil liability for all aspects of the development and production of drugs, vaccines or devices specified by the Bush Administration.

There is no limitation in scope to pandemic flu or even to major public health hazards. Instead, the immunity can apply to any product directed at an "epidemic". Previously, Republican Senators have declared that conditions ranging from childhood obesity to methamphetamine addiction constitute an epidemic.

In case the scope of the provisions were not already broad enough, it is further expanded to include any product that mitigates the side effects of a drug used to counteract an epidemic. So, if a medicine produces high blood pressure or pain, then any blood pressure or pain medication (such as Vioxx), could also be covered.

The provision gives only a hollow IOU to those injured by faulty or dangerous drugs. They are denied access to courts, and then denied access to an assured compensation program. The legislation cynically sets up the hollow shell of a compensation program but then denies the funding that would make the program a reality.

This immunity applies even when the company has acted with gross negligence or has recklessly disregarded safety standards.

The immunity applies even to criminal violations of FDA standards, if the Bush Administration has not taken action to enforce those violations.

The provision sets up what are likely to be impossible barriers to holding companies responsible by establishing procedural hurdles that injured patients must surmount before their case is even heard in court.

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STATEMENT OF SENATOR EDWARD M. KENNEDY

PANDEMIC FLU FUNDING/LIABILITY ON DOD APPROPS

DECEMBER 17, 2005

Congress has few higher priorities than protecting the American people from the deadly strain of influenza that is threatening the world and could take the lives of millions of Americans and damage the health of millions more.

The threat from this deadly new disease has been compounded by our inattention and failure to prepare. For years, public health experts sounded warning after warning about the devastation that a flu pandemic would bring, but year after year, we failed to respond to this deadly threat in its earliest stages.

Canada, Australia, Britain, Japan, and other nations released plans long ago. They’re implementing their plans now, but the Bush Administration has put out a plan for only one federal agency. A response plan for the Department of Health and Human Services is a critical first step, but even that plan is incomplete. It’s missing the actual operational plans for responding to a pandemic.

The President has called, however, for a significant investment in preparedness. I attended his speech at NIH, where he urged that $7 billion be appropriated immediately for preparedness.

We still have time to avert the serious consequences that a pandemic would bring, but only if we act now to begin improving our readiness. The Senate heeded the call to action by unanimously approving an amendment for $8 billion in preparedness funding offered by Senator Harkin.

But the Republican leadership in the House isn’t on board. They reduced the funding by nearly three and a half billion dollars. These irresponsible cuts will mean that critical programs will have to be delayed. Which parts of our response do our Republican colleagues think we should delay? Production of new vaccines? Stockpiling of flu medicine? Support for hospitals and health agencies preparing for the pandemic? I’d like to hear them explain to the American people which of these activities they think are unimportant, which of these priorities can wait, and which are not needed if disaster strikes.

Not only does the bill fail to fund the President’s request for pandemic flu preparedness, it also contains a provision so offensive that the Republican leadership didn’t even allow it to come before the Senate for debate. The conference report contains a sweeping and dangerous provision to give a free pass to drug makers – even when they cavalierly ignore basic safety precautions and make pills and vaccines that injure or even kill those who receive them.

This giveaway to the drug industry goes far beyond flu. It covers a range of drugs, vaccines, and medical devices that might fall within the broad definitions of the bill. The Administration has never met an industry it doesn’t want to help evade responsibility for its actions – from gun makers, to predatory credit card lenders to pharmaceutical manufacturers.

The provision is such a shameless handout to the drug industry that it was slipped into the bill in a back room in the Capitol, away from the eyes of the public and shielded from Senate debate. It’s an end run around normal Congressional debate that piles one bad idea on top of another.

Attempts to add controversial provisions to major spending bills in the waning hours of Congress have a long and sorry history. These so-called “midnight riders” are often withdrawn or rescinded if they are exposed before they become law. Last year, the Republican leadership inserted a provision into a massive spending bill to give Congressional staff the right to pry into any American's tax returns. Three years ago, Republicans slipped a special favor to Eli Lilly, one of America's largest drug companies, into a massive bill at year's end. Both of these scandalous provisions were rescinded once the bright light of public scrutiny shined on them.

This is another midnight rider that should never be given the chance to ride. This outrageous provision has nothing to do with protecting our troops, and it should be struck from the bill.

In our debate, Congress would reject any proposal that protects irresponsible or reckless companies and fails to assure compensation to health care providers, children, and others harmed by drugs that the government suggested or even required them to take.

The provision now includes a fig leaf of a compensation program – but it’s a compensation fund with no funding. There is no guarantee that any victim of a faulty or negligently made drug or vaccine will receive any compensation whatsoever. We’re asked to believe that the Republican leadership in Congress will act swiftly to appropriate funding for a compensation fund when it’s needed. They say they’ll keep their promises.

Tell that to the survivors of Hurricane Katrina still waiting for the Congress and the White House to make good on promise after promise to rebuild the Gulf Coast, and help meet basic needs on health care, education and job training.

Tell it to the people exposed to deadly doses of radiation because they lived downwind from the atomic test sites in Nevada. The compensation fund set up by the Radiation Exposure Compensation Act runs short of funds. As a result, victims of radiation exposure in Utah, Nevada and other states get IOU’s instead of payments to ease the cost of their injuries. In an article in the Deseret News last year, our colleague Senator Hatch describes this tragedy as “one of the most important issues facing my home state of Utah.” I commend our colleague from Utah for leading the fight to see that the downwinders receive what they deserve, and are not left high and dry.

We shouldn’t repeat the mistakes of the past. We shouldn’t rely on a program that could generate IOU’s – not compensation – for nurses, firefighters and other Americans who receive a pandemic flu vaccine or another product for which a drug maker bears no responsibility because of this provision. That was the wrong approach to take for downwinders, and it’s the wrong approach now.

It’s astonishing that the response of our Republican colleagues to the danger of pandemic flu is to reduce the funds to prepare for it, and use this danger as an excuse for yet another giveaway to their friends in the drug industry.

This provision is particularly objectionable because there is such broad agreement that Congress should act to see that liability concerns do not delay the release of a pandemic flu vaccine to Americans who need it. There’s a tried and true way to achieve that goal – by granting responsible limitations on liability for companies and creating an effective alternate compensation program for those who may be injured by faulty vaccines. The Vaccine Injury Compensation Program has an impressive record of success. It provides incentives for manufacturers of childhood vaccines, encourages families to have their children vaccinated, and compensated those who are injured. When thousands of Americans developed neurological illnesses after being vaccinated against swine flu in the 1970's, Congress protected the manufacturers of the vaccine from lawsuits, but established procedures for injured patients to receive compensation from the federal government. Neither of those programs relied on annual appropriations.

Three years ago, the Bush Administration bungled the program to inoculate first responders against smallpox because it ignored the advice of its own public health experts and refused to provide compensation for those injured by the vaccine. Doctors, nurses, firefighters and other first responders were bravely willing to put themselves on the front lines in the event of a smallpox attack by terrorists. But they were not willing to risk the future of their families without compensation for their injuries if they were injured, disabled, or even killed by the side effects of a risky vaccine. Because the Administration failed to provide a compensation program, thousands of first responders refused to be vaccinated, and a critical biodefense program turned into a fiasco.

At the urging of the White House, Republican leaders in Congress blocked legislation to provide a compensation program until it was too late to undo the damage that the Administration’s action had caused. It is true that the smallpox compensation program relied on discretionary appropriations, but the funding for that program had been approved by both the House and the Senate before the authorizing legislation was considered on the Senate floor. For the smallpox compensation program, we knew that the funding was assured before the program was established. For the hollow shell of a compensation program in the current legislation, there is no such guarantee.

Any proposal to limit liability must meet two basic tests. It must encourage companies to develop and make effective vaccines to counteract a disease outbreak, and it must encourage patients to take those medicines. Unfortunately, the current provision fails on both counts. It protects companies that make ineffective or harmful medicines, and it discourages patients from taking the vaccines needed to protect themselves from a disease outbreak.

The liability provision in this bill offers essentially complete immunity to manufacturers, distributors, and others, including health care providers, involved in the administering of the vaccines. Supporters of this provisions claim that immunity can be broken if a person is a “bad actor,” but the standard and procedures used are obviously designed to block that from ever happening. Under this provision, a drug company can completely ignore all basic safety precautions and be immune from responsibility. Only under the most extreme and convoluted test is there any hint of responsibility for a company.

Our Senate health committee debated how best to ensure that such liability issues could not deter manufacturers from developing needed vaccines and medicines for pandemic flu and other major health threats, while also providing compensation to injured patients. Those discussions should have been allowed to continue, so that the Senate can openly debate a comprehensive proposal on biodefense. We need to work together to find a bipartisan solution that protects all Americans, not just the pharmaceutical industry. That’s the right way to address the serious health threats we face – not by back room deals that protect powerful special interests and leave the public unprotected.