FDA’s expertise — not courts should determine drug safety

March 23, 2009
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Even as the Van Andel Institute is completing its expansion and beginning recruitment for 500 new positions, one wonders whether it will be sufficient. In the last week, the VAI hosted National Cancer Institute Director John Niederhuber, who told the Business Journal the federal economic recovery act offers "tremendous opportunity" for biomedical research. The National Institutes of Health is earmarking more than $8 billion of the $10.4 billion federal funding for research grants to institutions as well as colleges and universities like Michigan State University and University of Michigan. In other business news, Sequenom Center for Molecular Medicine announced it would open a second office to accommodate its corporate and employment growth in Grand Rapids, currently headquartered at the Cook-DeVos Center for Health Sciences.

Against this backdrop of gains in the life sciences industries, the Michigan House Judiciary Committee last week began debate on three bills that would repeal Michigan's 1996 law granting legal immunity to pharmaceutical companies if a drug claimed to be injurious was approved by the Federal Drug Administration. Further, the bills make the repeal retroactive, allowing patients who claim injuries from medications to hold drug companies liable back to 1996. The bills also include pharmaceutical companies in the Consumer Protection Act, though they are currently exempt.

MichBio, an advocacy group for the Michigan biosciences industries, is at the front of debate rightly arguing that the FDA is the only agency with enough expertise to regulate drug makers and that its decisions should not be second guessed by courts. MichBio also notes in its most recent newsletter that "a proliferation of lawsuits could lead to an overlapping patchwork of rules and would burden companies in their research and development efforts, and discourage patients from taking useful medicines."

That position also is supported by the Small Business Administration and the Michigan Chamber of Commerce as well as health-related agencies across the state.

The Business Journal supports that position and reminds legislators that they do Michigan citizens no favor in economic recovery or in asking juries to decipher scientific evidence already given oversight by the FDA. The House bills are purely intended to provide financial gain for those trial attorneys who look for such loopholes of "protection" for consumers. The worst aspect of the legislation is not only the tremendous economic disadvantage it would cause in Michigan's life sciences industries and supporting businesses but also the absolute certainty of increasing health care costs. It is schizophrenic to suggest health care "reform" aimed at costs and then add additional regulatory burdens and costs to the system already the supposed target for reform.

The NCI grants now possible are the lifeblood of research, increasing the number of new scientific investigators. Universities are currently negotiating a path through dwindling endowments. NCI research shows that a single research grant supports seven jobs and every $1 spent on research in a community generates $2.25 in local economic activity.

Sequenom, internationally recognized over a 20-year period as the leader in successfully translating innovative technology into commercial opportunities, provides genetic analysis products sold nationally, and its acquisition of the VAI's Center for Molecular Medicine provides cutting-edge diagnostics, translational research and clinical trials. Its work in Grand Rapids has the potential for personalized medicine.

Michigan has much, much to lose in this nocuous proposal, especially now.

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