TRENDS & PERSPECTIVES
With the Democrats retaking control of the U.S. House of Representatives and the Senate in last November’s midterm elections,
IVD Technology asked some industry analysts to share their thoughts on how this shift in power in Congress may affect the IVD industry and IVD manufacturers.
I expect the Democrats will continue the efforts that have begun to increase data mining of computerized hospital records, and put pressure on physicians and hospitals to better standardize the utility of the most effective and cost-efficient tests. In the short run, this will increase utility because the Democrats will spend more time expanding healthcare to the uninsured than the Republicans have. However, in the long term, this utility may decrease.
There will also be continued pressure on pricing and appropriate utilization of tests. Concurrently, qualified lab technicians will remain in short supply. Increased automation with test menus will drive IVD sales. Where new tests require new equipment and there is a limited menu on the new equipment, few labs will adopt such tests and, when necessary, will send samples to specialty labs.
—Glen P. Freiberg, president, RCQ Consulting (San Diego)
The issue that I foresee as being one of the most important is new legislation involving FDA regulation of laboratories. Both bills introduced by Senators Edward Kennedy and Barack Obama would have a powerful impact on laboratories if enacted. Such legislation would affect not only the laboratories themselves, but also the tests used by the laboratories, including both analyte specific reagents (ASRs) and kits. Any legislation that
reshapes the laboratory business and significantly increases regulatory costs will necessarily affect the IVD industry. In addition, a significant increase in regulatory workload by the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) is going to have an effect on the timelines for OIVD review of submissions.
—Jeffrey N. Gibbs, JD, director, Hyman, Phelps & McNamara (Washington, DC)
There will likely be legislation introduced under the Democratic regime that will be overly broad and burdensome to the IVD industry. For example, Senator Kennedy’s recently drafted bill is such an overly broad and unworkable piece of legislation. The IVD industry can also expect a continuation of and likely increased reliance on device user fees. In the minds of many in the industry, such fees have not produced the results expected and have been counterproductive to efficiency within CDRH.
The challenge to the IVD industry will be to keep one step ahead of draconian Democratic legislation. There will also likely be investigations and hearings that will try to shine a negative light on FDA and the industry.
It will be important for the IVD industry to prepare for and properly address the topics of such hearings.
—Jonathan S. Kahan, JD, partner, Hogan & Hartson (Washington, DC)
I don’t believe that the change in leadership in Congress from the Republicans to the Democrats will necessarily affect the IVD industry and manufacturers one way or the other. However, the Democratic Party is perceived as the party of big spending and opening up access to drugs and medical devices. This could potentially allow broader access to devices and diagnostics by the public.
However, if Congress passes legislation directed at lowering the cost of drugs, and it appears to be moving in that direction, such legislation could potentially spill over to include medical devices and diagnostics. Therefore, it could have a negative impact on IVD companies.
—Leif E. Olsen, regulatory affairs specialist, Hogan & Hartson (Washington, DC)
There is a good chance that the House committees will hold hearings on FDA’s proposed regulation of clinical laboratories vis-à-vis the ASR and IVDMIA draft guidances issued last September. I think such hearings will be motivated in large part by clinical lab organizations that fear FDA will intrude on other types of home-brew testing as the IVD organizational profile within FDA continues to grow and reach out.
In general, Democratic politicians, led by Senators Kennedy and Obama, have favored increased FDA scrutiny in the genetic testing area. However, there very well may be concerns about layered regulation of clinical labs, such as what may occur between CMS and FDA. This is of course a major concern among clinical labs and traditional IVD companies.
—Thomas M. Tsakeris, president, Devices and Diagnostics Consulting Group Inc. (Rockville, MD)
