TRENDS & PERSPECTIVES
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With President-elect Barack Obama’s victory in last November’s presidential election, IVD Technology asked some industry analysts to share their thoughts on the impact of the new Obama administration on the IVD industry and IVD manufacturers.
IVD manufacturers are faced with a quadruple change that could affect the industry, and not just a new President. In addition to the Obama administration, Tom Daschle has been designated as the new Secretary of Health and Human Services, and there will likely be a new FDA commissioner and certainly a new director at OIVD due to Steve Gutman’s retirement. From the top level, the administration will clearly look for cost cutting in medical programs. The impact of such cost cutting will be an even greater challenge to reimbursement for innovative products that can help prevent illness, because prevention has rarely been regarded in annual funding since the savings are long-term.
—Glen P. Freiberg, president, RCQ Consulting (San Diego)
President-elect Obama is probably the first President who ever introduced as a Senator any legislation relating to diagnostics, and perhaps the first who ever gave a speech on genetics and medicine, and he has a staff that is very knowledgeable about this topic. He will probably know more and maybe care more about diagnostics and diagnostic issues than any previous President.
—Jeffrey N. Gibbs, JD, director, Hyman, Phelps & McNamara (Washington, DC)
With the Democrats controlling Congress and the White House, there is now a greater chance of new legislation regarding laboratory-developed tests (LDT) and genetic testing being passed and signed into law. Senator Edward Kennedy (D-MA) is especially expected to press this issue. Many IVD manufacturers are thinking of opening or have already opened their own CLIA labs to come within the LDT loophole.
—Jonathan Kahan, JD, partner, Hogan & Hartson LLP (Washington, DC)
President-elect Obama has shown a particular interest in the development of genomic tests. While he was in the Senate, he submitted legislation designed to encourage the development of those tests and assure that they are properly regulated. From a broader perspective, Obama will be championing broad health reform legislation, which could have a significant impact on the diagnostic tests market as well as other sectors. The Obama administration will be emphasizing improving healthcare quality, prevention, and better management of chronic disease. Each of these could stimulate the utilization of underutilized tests and provide an important market for new tests.
—David Nexon, senior executive vice president, AdvaMed (Washington, DC)
I anticipate little impact by the Obama administration on the IVD industry, especially in terms of any effect on FDA’s oversight and new regulations. However, the administration could affect healthcare reform legislation that could affect IVD reimbursement issues and make certain IVD products more available to the disadvantaged. The administration will very likely seek feedback from various sources to see how they can reform healthcare, including improving the availability of appropriate diagnostic testing especially to low-income families, the elderly, and children.
—Leif E. Olsen, director of regulatory sciences, Hogan & Hartson LLP (Washington, DC)
The renewed awareness of the need for regulations, which is fueled by concerns about the safety of imported drugs, will spill over into IVDs, and FDA should expect some budget relief. Consequently, IVD manufacturers can expect more FDA scrutiny. The congressional focus on healthcare will include a review of reimbursement and regulations, which could be good or bad for the IVD industry. FDA will experience much less interference from the new administration, which could result in more warning letters and other enforcement actions against IVD manufacturers.
—Donald M. Powers, PhD, president and principal consultant, Powers Consulting Services (Pittsford, NY)
