DEPARTMENT OF DEFENSE APPROPRIATIONS ACT, 2006--CONFERENCE REPORT
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Mr. BIDEN. Mr. President, I rise to express my surprise and deep-seated opposition to the so-called Public Readiness and Emergency Preparedness Act, which is included in the Defense Department Appropriations bill.
This provision would give the Secretary of Health and Human Services authority to provide almost total immunity from liability to the makers of almost any drug, and to those who administer it.
While the measure's proponents portray it as a simple tool to make sure we have sufficient vaccine available in the case of an avian flu pandemic, the actual language of the provision is far broader than that, and it therefore poses a danger to all Americans.
The actual provision permits immunity for the makers of virtually any drug or medical treatment. All the secretary need do is declare that it is a ``countermeasure'' used to fight an epidemic. One solitary person gets to decide what is a countermeasure and what is an epidemic. There is nothing to prevent the declaration of immunity for, say, Tylenol. There is nothing to prevent a declaration that, say, arthritis is an epidemic.
What's more, this is no typical grant of immunity. No, the breadth of this provision is staggering. A drug maker can be grossly negligent in making or distributing a drug, and still escape liability. It can even make that drug with wanton recklessness and escape scott-free after harming thousands of people.
In fact, under this provision, the only way a victim could still recover compensation from a drug maker for a dangerous drug or vaccine would be to prove ``willful misconduct,'' and then only by ``clear and convincing evidence.'' What this means is that, for a victim to be able to be compensated by the company that harmed him, he must prove that they committed a crime. And even if he can do that, the company can still avoid liability simply by notifying the authorities within 7 days that someone was harmed by their product. In other words, so as long as you ``confess'' to your bad behavior, you can get away with it!
Is this the sort of justice system that Americans desire?
The answer to this question seems clear from the way this provision was inserted in the larger bill. No hearings were held on this language; no Committee vote was taken; no bill passed the House or the Senate. Not even the House and Senate conferees had a chance to give input on this provision. Indeed, I'm told it was inserted in the dead of night, after conferees had already signed the conference report!
Perhaps the folks who secretly inserted this provision in the dead of night knew that it was overly broad, as I've discussed; perhaps they knew that it was constitutionally suspect, as has been noted by at least one prominent law professor; or perhaps they just knew that, if this provision ever saw the light of day, the American people would not stand for such secrecy and injustice.
This should not be how we conduct the business of the American people, and we will all suffer if this provision is permitted to go forward.