Mr. President, I rise to make a few remarks concerning the Public Health and Emergency Preparedness Act of 2006 which was inserted in a year-end appropriations vehicle, the Department of Defense…
Mr. President, I rise to make a few remarks concerning the Public Health and Emergency Preparedness Act of 2006 which was inserted in a year-end appropriations vehicle, the Department of Defense Appropriations Act.
Protecting the American public against acts of bioterrorism like the 2001 anthrax attacks and natural disease outbreaks such as the risk posed by the avian flu is an important national security priority.
For 4 years, I have worked in a bipartisan manner with my friend from Connecticut, Senator Lieberman, on comprehensive legislation to address this concern.
We have vetted our proposal with literally hundreds of experts over the last 4 years.
We understand full well that our proposal contains a number of bold proposals that challenge our colleagues to make fundamental changes in our biomedical research, public health management, regulatory, antitrust, intellectual property, tax and civil liability systems toward the end of materially increasing our Nation's public/private sector capacity to design, develop and distribute hopefully hundreds of new products to counter the effects for the dozens of known biological, chemical or nuclear threat agents for which we today literally have no diagnostics, vaccines or therapeutic responses.
This is a tall order.
It will likely take 20 or more years to build this capacity to the level we will need to discourage our enemies from attacking us in this manner or, if they do so, to be able to respond in the way that the public will expect to ensure the strength of American society.
We have made some progress in recent years but we have to do much more in this area.
This is the type of issue that takes time, money, creative energy and patience.
We need a Manhattan Project type of effort, and we needed it 4 years ago.
Throughout my years in the Senate, I have worked on dozens of important public health bills.
In my experience, public health bills go better if they are done on a bipartisan basis.
I have also observed over time that, generally speaking, good public health policy turns out to be good politics. I know of no disease or condition that chooses its victims along party lines.
I am pleased that a key concept of the legislation that we introduced in 2002, the ``guaranteed market'' for those firms that successfully develop certain bioterrorism countermeasures was finally adopted in the Bioshield I legislation passed in the 108th Congress.
In the first session of the current 109th Congress, there has been a great deal of interest in bioterrorism and pandemic diseases. This is good for the American public.
In the Senate, the HELP Committee was infused with new leadership on this issue in the persons of our new chairman, Senator Enzi, and the chairman of the new Bioterrorism and Public Health Preparedness Subcommittee, Senator Burr. Majority Leader Frist and former Chairman Gregg have continued their longstanding involvement on these issues.
Across the aisle, led by a veteran leader in public health issues who has been on the HELP Committee or its predecessors for 43 years, Senator Kennedy and others including Senators Harkin, Dodd and Clinton have been interested in these issues.
Throughout the Spring of this year the Bioterrorism Subcommittee held a series of bipartisan hearings and discussion roundtables that were attended by leading experts. Throughout the August recess the staffs of the committee members worked on various drafts of bioterrorism legislation that culminated in a markup in September.
Unfortunately, from my perspective, the bill that resulted from the HELP markup did not contain the intellectual property and tax provisions that Senator Lieberman and I have long advocated. Such is the reality of the dance of legislation. But, as has developed in the provisions related to the guaranteed market, liability, and compensation, we believe that the day will come when these ideas from our original legislation are also seen as meritorious.
Subsequent to that markup, the Bush administration unveiled its comprehensive plan to prevent and respond to the potential catastrophic outbreak of human-to-human avian flu transmission.
Throughout the Fall, many Members of Congress, the administration, industry, the public health community and other interested parties worked on various pieces of legislation to respond to these threats. Unfortunately, as sometimes happens at the end of very busy congressional sessions, not everyone was able to work together at the same time.
For a variety of factors, we have now arrived at a point where a potentially integral piece of an effective legislative response to bioterrorism and pandemic threats has been inserted into the Department of Defense appropriations bill. Using year-end appropriations bills as vehicles can be an opportunity to solve important problems but, sometimes, can pose a risk that an inadequately vetted measure becomes law.
As many who are not members of the esteemed Appropriations Committee, I have a preference for the regular order of the authorization process. In all candor, from time to time in my career, I have availed myself of appropriations vehicles to move authorization bills that I desired to see passed. Sometimes, as shocking as it sounds, there is gambling in Casablanca.
Comes now the newly drafted, and redrafted and redrafted, Public Readiness and Emergency Preparedness Act.
Both Senators Frist and Gregg must be singled out in the Senate for their efforts to develop and move this new bill. In the House, I understand that Speaker Hastert and Chairman Barton, even as he was hospitalized, are largely responsible for this effort.
All of these good and earnest members should be recognized for attempting to tackle two of the most vexatious policy and legal issues confronting us in this critical area: liability; and compensation reform.
We need to encourage the private sector to work vigorously on scores of new, potentially dangerous drugs and biological products designed to counter both natural and bioterroist threat agents. That is what liability reform is all about.
At the same time, if some of these products--some of which will never be tested in human clinical trials since it would be unethical to infect a patient with a microbe like the Ebola virus just to see if a potential treatment were safe and effective--turn out to injure and even kill patients, there must be a fair and funded system of compensation.
Some critics are already falsely charging that these new provisions are nothing but a Republican gift to the drug industry during the Christmas season.
Hogwash.
There should be no doubt that the sole intention of the principal drafters of this legislation is to help devise a system that will increase the readiness of our country to respond to bioterrorist or natural public health threats.
I also think it is way past time that Members of this body and others stop unjustifiably vilifying the pharmaceutical industry. Due in large part to the unique partnership between the public and private sector biomedical research enterprise--undergirded by the substantial annual $28 billion taxpayer investment in the National Institutes of Health-- we are on the verge of a revolution in our understanding of human health and disease. Let's just hope that neither the avian flu not the bioterrorists strike before we have developed the means to defeat these threats.
We will not defeat biological enemies with bullets or battleships. It will be accomplished with basic biological knowledge and the applied know-how required to translate ideas from the lab to the patient's bedside.
Integral to this system and to our national security is the too often-maligned pharmaceutical industry.
They are tough, profit seeking companies. They are often their own worst enemies. They are not always right.
But nor are they always wrong. The products they produce are aimed at
preventing and treating diseases and reducing suffering. And that is not the worst business to be in by any means.
The situation is that we are confronting an enormous chicken-and-egg problem in developing new vaccines and countermeasures due to the fact that in the last several decades product liability exposure has drastically reduced our domestic vaccine production capability. I understand that in 1976, 26 companies produced vaccines for the U.S. market. This year, only five companies produce vaccines sold in the U.S. and only three have U.S. production facilities.
This constitutes both a public health and national security challenge that must be addressed.
While I have concerns about many of the precise provisions in this new language, I recognize and commend my colleagues for attempting to solve a problem that needs solving.
I have great respect for the majority leader, especially as he attempts to navigate this year's exceedingly complex package of pending bills which include the budget reconciliation bill--the first such measure in nearly 10 years--the PATRIOT Act, the Labor-HHS appropriations bill, as well as the Department of Defense authorization and appropriations bills. This is a tall order by any standard.
Although I urged the Leader not to include this new bill in the year- end legislation, I told him that I would not vote against this measure if it were part of one of the year end, must pass vehicles.
I did this largely out of deference to our majority leader.
For reasons that I will explain, if it came to a simple up-or-down vote on this measure as currently drafted, I could not yet support it and would vote no.
If this measure does in fact become enacted into law, I will be open to considering further modifications in this language should our study of this new language indicate that changes are advisable.
Many will question whether this bill, in its current form, contains too much indemnification and not enough compensation. This is a fair question.
For example, the funding mechanism in the bill does not appear to be guaranteed.
I have been down the hard road of discretionary funding with respect to the Radiation Exposure Compensation Act, which I authored, and I cannot say that I would recommend such an important program to be subject to the uncertainties of less than stable, certain funding.
Still others will question why the bill provides for no judicial review, apparently even by the United States Supreme Court, for certain actions by the Secretary of Health and Human Services?
There will be concern that the bill does not allow adequate judicial review to assure that the Secretary has not acted either arbitrarily or capriciously in certain circumstances.
Because of the great significance of this measure, I suggest that Chairmen Enzi and Specter hold hearings on this language once the Congress reconvenes after the holidays.
It is, for example, important to learn what the administration thinks about this new bill and whether, upon reflection, it would urge some refinements.
I have not seen a Statement of Administration Policy on this measure.
Nor have I seen a Congressional Budget Office score so it is a little unclear to me how much this new section would cost.
The administration will be called upon to administer a new compensation program and we need to know how they plan to implement this program and whether they have any suggestions to improve the operation of this program.
As well, I would not be surprised if more Members and other interested parties will want to weigh in on the structure of the new compensation program, which is based in large part, on the current smallpox vaccine injury compensation program.
As our experience with the asbestos legislation teaches us, there is always great interest in the level of compensation injured citizens may receive, especially if they give up their possible tort remedies.
I note that there is a higher standard imposed upon the Secretary in constructing an injury table under this new bill than must be met under the current smallpox vaccine injury compensation law. Many will want to know exactly what is intended and what the practical effect of this new standard will be on the health experts who will advise the Secretary in this critical area.
There are also many questions that must be explored with respect to how the liability shield will operate in practice.
Let me state clearly that I favor a strong liability shield so that many pharmaceutical and biotechnology firms will enter this critically important field of research and development. The fact is today that there exists a pervasive climate of apprehension about product liability and litigation exposure and this is chilling the necessary private sector activity.
Clearly something must be done. It is not so clear that the new liability language is yet as good as it needs to be. For example, the way in which the willful misconduct and FDA defense provisions operate together in the context to potential court challenges merit particular attention. As well, the policy and business-behavioral ramifications of drawing a hard line between all forms of negligence and wilful misconduct deserve careful thought and analysis.
In the case of dual use products, such as antibiotics, it appears that, should a bad batch of drugs be made due to ordinary negligence, a patient injured when taking the product for a normal, garden-variety infection will have a much greater range of legal remedies than a person who took a pill from the same adulterated production batch but under a Secretarial declaration of a public health remedy. It is not readily apparent why this should be the case.
There may be ways to further improve and refine these provisions and other parts of the bill as well. For example, consideration is warranted with respect to whether there ought to be a subrogration provision in certain cases when the Federal Government must compensate patients for injuries caused by negligent or grossly-negligent actions of manufacturers, distributors, or others connected with developing the drug or delivering it to patients.
In any event, I think we should keep an open mind to viewing this new language as something as a work in progress.
Rather than embarking down a path of political who-struck-John on how this new section got into the bill and who drafted this provision or that provision, I think the public will be better served if we focus our future efforts on evaluating what the bill does and deciding whether there are ways we can make it better.
One thing is certain. If we do not find a better way to unleash the creative efforts of the private sector in researching and developing a panoply of new products designed to diagnose, prevent and treat bioterrorist and natural threats, the health and welfare of our Nation cannot be secure.
We have a big job ahead of us.
I urge that we move forward in a constructive, bipartisan effort to further improve the Public Readiness and Emergency Preparedness Act that has been placed in the DOD appropriations bill conference report. If others are willing to proceed in this fashion, I am certain that Senator Lieberman and I, and many others, stand ready to discuss and refine this and any other piece of related legislation.