Rep. Sheen, having reserved the right to explain his protest against the passage of the bill, made the following statement:
"Mr. Speaker and members of the House:
I could not in good conscience vote for House Bills 4044, 4045 and 4046 which would allow more lawsuits and predominantly benefit attorneys, not consumers. These bills will drive up the cost of all prescriptions for Michigan residents. The inane position that states, 'If this legislation helps just one person or even 100 people, we should pass it,' is foolish at best. If Congress or any state legislature passes legislation which benefits one to a hundred people, but potentially hurts and drives up the cost of healthcare for thousands or millions of people, they have in fact passed bad legislation.
It is difficult to control the cost of prescriptions, medical procedures and operations, but limiting the ability to sue issomething we can do. The FDA approval process is by leaps and bounds the most stringent, costly, and time-consuming drug approval process in the world. It is one of the reasons prescription drugs cost more in the United States than anywhere else and why it generally takes 7 to 10 years and millions of dollars to get a new drug approved. Most of the drugs currently being reviewed in the U.S. are already available in other countries. People around the world are already benefiting from these new drugs and in some situations these drugs have saved their lives.
I think we should limit liability more, not less, and divide the FDA approval process into two steps. The first step would allow people to take drugs currently in the approval process at their own risk and choice. They would not be able sue and the risks would be made clear, but people ought to be given that choice. They may not have 7 to 10 years to wait, especially when already approved medications and procedures are not working. The second step is full approval. If the process was in place, it would lower the cost of all medications entering the market in the U.S. Pharmaceutical companies would be able to get their product to the market sooner and still retain their patent, which usually only last ten years, and thus recover their costs over 7 to 10 years rather than 1 to 2 years. This would also reduce the drug importation differentials between the U.S. and other countries.
I do not want to ignore the pain and tragedy which can take place when someone reacts negatively to a medication or procedure, which unfortunately will always be a possibility. FDA-approved drugs have very good effectiveness ratios, especially when you compare ratios of 10 to 100 people reacting negatively, to millions of people reacting positively. The overwhelming majority of people using FDA approved drugs, are living healthier and longer, because of them. The risk should be clear, but the choice should be theirs.
Finally, if we want to truly reduce the cost of health care, give people more choices and options, and control lawsuits that have nothing to do with health care, then we should limit lawsuits-not expand them as this legislation does."