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Be True To Your Republican Roots - A Call for All Republican Legislators to Put Individual Rights Above Industry Protection


By Beth Clay

Beth Clay is a health policy consultant and a former Senior Professional Staff Member to the Committee on Government Reform of the US House of Representatives. She can be reached at beth@bethclay.com (www.bethclay.com)

Growing up in South Carolina in the town noted as the birthplace and deathbed of the Confederacy with a father who was and remains a staunch Democrat, deciding to register as Republican was not a decision I took lightly. I take the basic tenets of Republican philosophy very seriously and the older I am the more I realize the wisdom in the importance in keeping our eye on protecting the Constitution and staying true to the core tenets of what brought me to the Republican Party. Five years leading a health care oversight team on Capitol Hill further underscored their importance. I am increasingly disturbed that so many of our Republican legislators seem to have been swayed away from these tenets. I am not alone in this concern and it is on behalf of my fellow Republicans around the country that I speak out.

Our History Promoting Individual Liberty

Republicans have a long and rich history promoting the basic principles that individuals, not government, can make the best decisions; all people are entitled to equal rights; and decisions are best made close to home.

Individual liberty is the hallmark of the American success story. Preserving the freedom of Americans to make their own decisions, and to live their own lives, relatively free from governmental or other interference has always been the foundation of our Party. Protecting individual liberty and preserving the integrity of the three branches of government assures us that we remain a free people and can protect the Constitution.

The United States is at a place in our history when the Executive and Legislative Branches of government are working actively to restrict the power of the Judicial Branch by restricting American’s access to the legal system. And sadly, it is Republicans leading us down this liberty-destroying path.

Liability Protection of the Pharmaceutical Industry – Bad for Liberty and Bad for Safety

Putting liability protection of industry before the rights of individuals to seek legal recourse has never been and should never become a Republican ideal, and yet, this is what Republican legislators in Washington are repeatedly attempting. Every Republican who believes in individual liberty and in preserving the integrity of the three branches of government is obligated to speak out and demand the madness to stop.

There are at least ten bills (S3, S975, S1437, S1828, S1873, S1880, HR650, HR3154, HR3970, and HR4245) that have language to restrict American’s ability to seek legal recourse when injured by a pharmaceutical product. Talk about town is that every possible legislative vehicle will be utilized this week to protect industry and restrict liberty. I urge Republican legislators to stop the madness and stand up for their constituents and the ideals of our Republican party and take every action available to stop this from occurring.

Our Republican elected leaders have been tag-teamed by left leaning bureaucrats whose long-term liberal agendas have infiltrated conservative policies unabated, and by industry representatives whose highest priority is protecting their bottom line. Congress has already recognized the dangerous symbiotic relationship between industry and health agency officials. It has been recognized but not resolved. So much of what is bantered about, maximizing fear about terrorism and avian flu, is not based in fact, but driven by ulterior motives.

If the Congress moves to provide liability protection to the industry, the Food and Drug Administration (FDA) approval process will have absolutely no value. Americans will loose trust in the process if they do not retain the safety net of legal recourse when serious injury or death occurs. The FDA approval and regulatory process is not perfect. It is effective because Americans know they have the right to legal recourse if the system has broken down and an unsafe product enters the market-place or when a product has more risks than originally made known to the public. One has only to look over the last decade at drugs that have been removed from the market (Rezulin, Vioxx, Bayacol, etc.) or that now have black-box warnings (Accutane, Ritalin, etc) to realize that protecting the FDA regulatory process by protecting American’s access to legal recourse is essential to the public health. To take away the right to legal recourse is reminiscent of Soviet-era Communism, not that of a democratic Republic.

What About Vaccines?

Much has been said in the media and on Capitol Hill over the last five years about vaccine safety and rights of Americans to be compensated for vaccine injury. Congress, led by California Congressman Henry Waxman created the Vaccine Injury Compensation Program in the late 1980s to protect vaccine manufacturers and doctors from lawsuits when an individual is injured from a vaccine included in the Childhood Immunization Schedule. Vaccines are the only drugs in the United States that are required to be given as a condition of school and day care attendance (and for certain jobs), except when there is a medical or religious exemption in place. Congress has rebuked the Departments of Health and Human Services and Justice for making the program more litigious and cumbersome than intended. A key provision that protects the integrity of the process is the ‘Opt Out’ clause giving the injured or their parents the opportunity to leave the program after a certain amount of time or if the award is not satisfactory so they may seek legal recourse in state courts. Few actually opt out, but that clause is essential to the integrity of the program.

This ‘Opt Out’ has been targeted for elimination by industry so that they will have no liability at all. Few realize that vaccine manufacturers pay nothing into the Vaccine Compensation Fund. Instead, the Fund is paid for through an excise tax off the sale of each vaccine. The reality is that the taxpayer pays for this fund as the Centers for Disease Control and Prevention (CDC) is the largest purchaser of vaccines in the country. The CDC acts as distributor to the state governments.

The Myth of Fewer Manufacturers

We repeatedly hear from legislators and the media that there are only one or two vaccine manufacturers in the United States, that we must provide liability protection to these companies so they will stay in the business of making vaccines. The truth is that there are at least ten companies with vaccines licensed by the FDA. Yes there were many more companies in the 1980s, they all merged. Most current vaccine manufacturers are the product of 3 or more mergers. Vaccine capacity has not been lost. The only big pharmaceutical company that got of out of the vaccine businesses was Eli Lilly.

Vaccine manufacturing is big business; one has only to look at the size of contracts from HHS and the annual reports to stockholders to realize this.

While we as a Party have pushed for higher standards and stronger accountability in education, we are weakening the accountability in FDA quality control by taking away legal recourse. If product liability is passed into law, will Congress in five years be holding hearings about rampant bribe taking or extortion at the FDA from an industry that has nothing to loose by manipulating the product approval system? I hope not, but know that even FDA officials are individuals with human failings and vulnerabilities.

Our Party platform states, “Republicans have always been the Party of fresh ideas and new thinking. We encourage debate on the major issues of our day, and we will consistently act in accord with the greatest values of our country – freedom and opportunity for all.”

It is time to turn away from this path we started down in 2000, and focus on the promotion of freedom and opportunity, not constriction. In 2000, during the passage of legislation that created the Department of Homeland Security an unnamed staffer in the middle of the night slipped a provision taking away the rights of families to seek legal recourse for vaccine injury and injury from the mercury-laced vaccine preservative thimerosal into the Bill without the knowledge or approval of the Chairman of the Originating Committee. A controversy ensued and the language was repealed. Since that time, this language and language like it has been repeatedly inserted and rejected.

I urge Republican legislators to reject language on any bill that takes away Americans’ right to legal recourse for product injury. I urge you get the facts and to speak out, take a stand for your constituents. When a loved one is seriously injured or dies, a law suit is not frivolous. When a child’s life is shortened or devastated by a vaccine-injury, a lawsuit is not frivolous. Whether you believe thimerosal, the mercury-containing preservative given to babies in increasing amounts in the late 1980s and through 2003 contributed to the epidemic rise of rates of autism spectrum disorders and ADHD or not, protecting the integrity of the vaccine program by preserving the rights of the thousands of families who seek to have their day in court is essential to the tenets of democracy and liberty.

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