October 26, 2005

Vaccine bill to protect drug companies

Vaccine bill to protect drug companies
Sunday, October 23, 2005

Gary Facer of Orem summed up how most Americans, governmental entities and health professionals feel about a public health emergency.

"I hope it doesn't happen," he said.

But if at some point in the future it does, and Congress has passed the Bioshield II bill, and people are injured because of a government-mandated vaccine that is supposed to protect the American public from the outbreak, those people will not be able to sue the vaccine manufacturer.

The purpose of the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, said bill author Sen. Richard Burr, R-N.C., is to encourage pharmaceutical companies to be developing such vaccines. According to Burr's news release, the bill is a step
toward creating a partnership between the government and private corporations to "rapidly develop effective medical drugs and vaccines to protect the United States from deliberate, accidental and natural incidents involving biological pathogens."

The bill in a large part focuses on bioterrorism and biological, chemical and nuclear warfare, but Burr said in the release it also provides the resources necessary to deal with a naturally occurring epidemic. It absolves pharmaceutical companies from any liability from injured parties if the federal government declares a public health emergency and mandates the vaccine.

The bill's language and its precepts make Barbara Loe Fisher, president of the National Vaccine Information Center, uncomfortable. She said it takes away pharmaceutical companies' responsibility to consumers and gives too much power to the Secretary of Health and Human Services, who declares public health emergencies.

"Now this legislation is going to remove liability from the companies who produce these drugs and vaccines at government request and nobody is held accountable when a state of emergency is declared," she said.

Pharmaceutical companies already are protected from most lawsuits. In 1986 Congress created the National Vaccine Injury Compensation Program, which is a no-fault alternative to litigation, according to information from the U.S. Department of Health and Human Services. It was created after the number of lawsuits filed against vaccine producers spiked, and many companies opted to get out of vaccine production because of skyrocketing legal costs.

The measure could be a good thing, said Lance Madigan, spokesman for the Utah County Health Department. Protecting pharmaceutical companies from prohibitively expensive litigation is positive because it allows the companies to produce vaccines that in the large majority of cases protect the public. In many instances, diseases that could have caused a national crisis are controlled because of vaccines.

"There is always the possibility of adverse reactions" because of allergies or other factors, he said, adding those instances are rare and almost everyone benefits from getting immunized.

Under the bill, injured parties could still sue the vaccine company if they can prove criminal fraud or negligence, unless the vaccine is mandated by the government during a public health crisis, Fisher said. She is afraid that in the event of a national crisis, pharmaceutical companies will push an experimental drug through the
Food and Drug Administration, and it will be approved and distributed without going through the same rigorous process drugs should.

"We just feel that enough is enough," she said. "There has got to be some accountability somewhere for these vaccines and drugs."

Facer agreed someone should be accountable. But he questioned if it should be the pharmaceutical companies.

"If the government mandates it, they should also bear the burden of liability," he said.

Madigan said the FDA's process for approving a drug is thorough and a drug will not hit the market until it is considered safe for general consumption. Should there be a national health crisis, the approval process may be reduced, but it would be determined on a case-by-case basis, he said, with many factors taken into account.

"Obviously, if the disease is that infectious or that deadly, then they're probably going to be willing to have more risk," he said.

The Senate Committee on Health, Education, Labor and Pensions passed the bill Tuesday and now will go to the full Senate for a vote.

This story appeared in The Daily Herald on page A1.

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