Originally Published IVD Technology January/February 2005
INDUSTRY NEWS
Assessing the election aftermath
 |
With President George W. Bush’s election to a second term last November, IVD Technology asked some industry analysts to share their thoughts on how President Bush’s reelection may affect the IVD industry and IVD manufacturers.
 |
| Glen Freiberg |
During the next four years, it will be business as usual for IVD manufacturers. There will likely be less pressure on the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) to meet certain metrics since the public focus is on drug safety and vaccine availability. However, it’ll be a true measure of AdvaMed’s effectiveness to see if improvements in the IVD industry can be accomplished. At the same time, the reimbursement process will have to be taken much more seriously and considered earlier during the development process. Pricing pressures could reduce innovation if we cannot improve the timeliness of coding and the amount of reimbursement.—Glen Freiberg, vice president of regulatory, quality, and government affairs at Gen-Probe Inc. (San Diego)
 |
| Carolyn Jones |
The election will not affect IVD manufacturers any differently than other medical device manufacturers. With the conflict in Iraq continuing, the budgets of non-war-related agencies may be cut. Any budget cuts at FDA could have an adverse effect on the IVD industry. However, it is unlikely there would be any policy changes that could directly affect IVDs, unless it is in the area of reimbursement.—Carolyn Jones, JD, associate vice president for technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed; Washington, DC)
 |
| Don Powers |
The administration’s policies will continue to be favorable to business. The U.S. dollar will continue to fall and stimulate international sales. However, in the end, the escalating war, the ballooning deficit, and their negative impacts on the general economy will probably outweigh such benefits. Consequently, reimbursement dollars will probably get tighter. On the regulatory side, there has been a significant reduction in warning letters and enforcement actions during the first Bush administration. However, major swings in the regulatory pendulum tend to be driven by scandals, and there have been Congressional calls for another FDA reform in the wake of the flu vaccine crisis and the Vioxx recall. Any increased enforcement will probably spill over into the IVD industry.—Don Powers, PhD, president and principal consultant of Powers Consulting Services (Pittsford, NY)
 |
| Pat Shrader |
The greatest challenge facing the IVD industry will be continuing to make the case to all relevant stakeholders that early, accurate, and accessible diagnostic testing can reduce long-term healthcare costs. It will be important to look for credible and consistent means to quantify the positive cost impact of new diagnostic technologies. The current administration is on record regarding the importance of reducing the rise in healthcare costs and has identified modern healthcare technologies as one of the ways to do so. This opens the door for positive trends in reimbursement and regulatory approval. The President and his administration have also continued to work on streamlining and improving the approval process for drugs and medical devices. It will be interesting to see the success, or lack thereof, of the Medicare prescription drug plan. If it proves to be successful, it is possible that coverage could extend to IVDs and other, similar technologies. —Pat Shrader, JD, vice president of regulatory, public policy, and communications at Becton, Dickinson & Co. (BD; Franklin Lakes, NJ)
 |
| Tom Tsakeris |
President Bush often mentioned, especially during the campaign, the need to support small businesses as the key to expanding the economy. If the Bush administration follows through, then this will benefit the IVD industry by lessening the demand of acquiring capital to fund R&D and product development. Indeed, during the last few years, significantly more capital has become available through venture capital organizations for IVD startups than was available after 9/11. However, it is difficult to determine if this renewed interest in biotechnology is a function of a growing economy due to the administration’s policy, especially tax policy, or simply a natural turn in the business cycle that is expected following a recession. —Tom Tsakeris, president and founder of Devices and Diagnostics Consulting Group Inc. (Rockville, MD)
Copyright ©2005 IVD Technology
