New law will help stop litigation abuse against vaccines

Oct 21 2004

U.S. Senator Larry Craig announced that legislation will be signed into law in a few days by President Bush which will help avert future flu vaccine shortages.

“President Bush pushed Congress to pass the Jumpstart Our Business Strength (JOBS) bill, and he should sign it very soon. That legislation contains provisions protecting people financially from harm that might result from a bad reaction to a flu shot, and at the same time protecting flu vaccine manufacturers from excessive lawsuits. This is an important move for America’s seniors and for the nation as a whole,” said Craig, who serves as chairman of the U.S. Senate Special Committee on Aging.

The bill President Bush is expected to sign expands coverage under the Vaccine Injury Compensation Program to include vaccinated adults. Since 1986 people hurt by childhood vaccines have been compensated under that federal fund. The U.S. Justice Department reports that since the creation of that law, the compensation fund has paid out in excess of $1.4 billion to nearly 1,800 people. Funding for the program comes from a tax collected on vaccines.

“It’s an insurance policy if you will,” said Craig. “This bill isn’t the final step, though. It’s part of many efforts that are being made to ensure an abundant supply of vaccine in the future.”

Craig noted that the Bush administration has made serious strides on the flu vaccine issue already. “This is the first administration to begin developing a pandemic response plan and to create a stockpile of vaccines and antiviral medications. The Bush administration has also increased the payment rates under Medicare for vaccines to make them more cost effective for doctors and others to provide,” Craig said.

Three weeks ago Craig’s committee held a hearing on flu vaccine at which a company official from Chiron, a flu vaccine maker, as well as public health officials expressed their belief that the nation would have a record supply of flu vaccine this year. But a week later British regulators ruled that the Chiron vaccine was unfit to be shipped.

“We now have all of our eggs in only a couple of baskets,” Craig said. “We need to decrease that risk and get more companies into the vaccine manufacturing business within the United States.”

The Idaho Republican noted that the fear of litigation is a factor in the process.

“Critics contend that lawsuits are a minor story when it comes to vaccines. But the untold story is that the other firm which makes flu vaccines for senior citizens declined to appear at our hearing because of concerns about lawsuits. We need to curb our culture of excessive litigation,” Craig said.

In 1967 there were 26 companies making a variety of vaccines in the United States. Today there are only four that make any type of vaccine, and just three that make flu vaccines. Of the three, only two make flu vaccines that can be used by older Americans, and one can’t ship its product – leaving the U.S. with just one flu vaccine supplier for the nation’s seniors.

“Sen. Evan Bayh and I introduced the Flu Protection Act earlier this year and I have asked my staff to review it and explore the possibilities of getting it passed when Congress reconvenes in November. While it doesn’t address the issue of litigation, under that bill vaccine makers would receive a guarantee of reimbursement by the federal government for a certain number of the vaccines if they go unused. I believe it will be an important incentive to bring more manufacturers into the vaccine making business, and that is step one,” Craig said.

During the 2002-2003 flu season manufacturers lost approximately $120 million through unused vaccines. As a result,12 million fewer vaccines were produced for last year’s flu season.

“Step two in our bill is the inclusion of tax incentives for vaccine makers to build production facilities in the United States. Right now the only flu vaccine made in this nation is produced at one plant in Pennsylvania,” Craig said.

In closing out his comments, he commended his home state of Idaho for the way in which officials there have handled the flu vaccine situation.

“In some areas of the country, the police are being brought in to control crowds. But in Idaho, the state’s Department of Health, local health districts, and private providers are working in a coordinated way, setting up specific appointments for seniors and others at risk to get their shots. The people in Idaho have really set an example on how business should be conducted,” Craig said.

http://aging.senate.gov/