ANN ARBOR, Mich., Jan. 30 In a letter toGovernor Jennifer Granholm today, MichBio Executive Director, StephenRapundalo, Ph.D., responded to the Governor's State of the State Addresswherein she called for a repeal of current tort laws. MichBio is thestatewide association for Michigan's life sciences industry.
"MichBio lauds your efforts, and those of the legislature, to diversifythe state's economy by focusing on high technology areas like life sciences,"said Rapundalo, writing on behalf of MichBio's more than 230 members."However, a repeal of existing tort laws would be a detriment to the lifesciences industry, would reverse 10 years of steady growth, neuter theeconomic development impact of the 21st Century Jobs Fund, and without a doubtdiminish future investments in this market sector."
Rapundalo indicated that biotechnology and life science companies facemany difficult challenges, a risk-averse investor climate, and lengthy andcostly research and development timelines.
"Reversing current law would send a strong message that Michigan is notopen for business, forcing new and existing biotech companies to lookelsewhere to invest. Companies will not pursue their R&D plans with theknowledge or potential for litigation waiting for them at the end of theircommercialization pathway. Repeal will result in a loss of current Michiganjobs and discourage any future biotech business investments and job creationin Michigan."
Noting that drugs and medical devices are the most regulated productsaround, Rapundalo said, "Less than 1/100 of a percent of potential medicationsinvestigated survives the FDA regulatory review gauntlet and become productlaunches. The contention that lay juries with no medical or science training,or understanding of the new drug application process, are better judges ofrelatively brief testimony, as opposed to the 12-18 month exhaustive review byexperts in the field, is irresponsible. The tort system is simply ill-suitedto reach a better conclusion than the FDA on drug or medical device safety.
"So let's leave product liability to the experts, and leave the tortsystem as is. Current law and process present an appropriate balance wherebythe FDA is allowed to perform its regulatory duties, but allowing forpunishment of companies that willfully withhold information or interfere withthe drug approval process. Let's not unduly raise the risks for the many dueto failures of the few, where current law and tort reform already provides formeaningful recourse to the injured. Michigan residents are already more thanadequately protected."
Rapundalo said the issue of tort reform may be politically expedient, butit is not a benefit in practical terms. "We have made so much progress inMichigan, especially in the face of difficult economic times. I know the statewould like to see the growth in the life sciences community continue, butchanging these laws could do irreparable harm to all of the progress that wehave made. The proposed repeal is simply at odds with our state's economicdevelopment strategy at a time when we can least afford further losses in thelife sciences industry."
MichBio is committed to driving the growth of Michigan's life scienceindustry and to fostering the collective impact of its members by serving astheir unified voice and by providing them with education, information,connections and other services. MichBio members include life sciencescompanies, academic and research institutions, bioscience service providers,and related organizations.