Trends & Perspectives

Published: January 4, 2012
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Examining IVD-related election year issues

The editors of IVD Technology asked industry analysts to share their thoughts and opinions on next year’s elections, the IVD-related issues that could be raised during the election year, and their potential impact on the IVD industry and IVD manufacturers.


The primary election issue for IVD companies is the evolution of the clearance and approval system. My belief is that the rules and regulations are fine, and OIVD management needs to make improvements to clarify, standardize, and speed up the clearance and approval processes. Compliance issues need to be dealt with outside of the clearance/approval system, and the IVD industry needs to lobby on that. However, since legislators like to legislate, there is a threat of new laws that will require changes at FDA. In fact, there are already a series of bills that have been introduced by House Republicans. What the IVD industry needs to decide is whether to evaluate, support (or not), and comment on such draft bills, or assume that they are just campaign material.
—Glen P. Freiberg, president, RCQ Consulting (San Diego)

There are many important regulatory issues facing the IVD industry, such as regulatory consistency, predictability, ensuring that the level of regulation is congruent with the level of risk, and promoting innovation. These areas will have an important effect on the delivery of healthcare, costs, and the ability to stimulate new jobs in corporations and academic research. Unfortunately, it appears that no candidate is prepared to talk about these issues at all, let alone discuss them in a meaningful way.—Jeffrey N. Gibbs, JD, director, Hyman, Phelps & McNamara (Washington, DC)

OIVD specifically, and FDA in general, appear currently to be struggling between supporting the development of novel technologies, like companion diagnostics and personalized treatments, and protecting the public from untried and unproven technologies, like direct-to-consumer genetic testing for as of yet non-established diagnostic and prognostic markers. Developing the knowledge, expertise, and reasonable regulatory pathways to manage these new technologies, without stifling innovation or unnecessarily delaying diagnostic test availability (or novel therapies that they may accompany), will be a balancing act that the agency will face irrespective of candidates or parties. IVD-specific issues and policies that likely will be in the forefront will be FDA’s ever-increasing requests for more data and longer follow-up in establishing the clinical truth of any diagnostic marker and ensuring that physicians and patients understand the true implications of any IVD test result, especially for genetic/genomic markers and directed drug therapies.—Jonathan S. Kahan, JD, partner, Hogan Lovells (Washington, DC)

I will be closely following any legislation related to FDA’s reauthorization of the user fee act, including any provisions that may be related to the reform of the premarket review program-PMA or 510(k)-for IVDs, as well as legislation related to the potential for increased FDA oversight over diagnostic tests developed by a clinical laboratory. So far, around ten bills have been introduced in the House of Representatives. I’m sure many more are to come as the user fee statute is scheduled to sunset next year if it is not reauthorized.
—Michele Schoonmaker, PhD, vice president, government affairs, Cepheid (Sunnyvale, CA)

I will personally be following the Congressional focus on changes to the FDA regulatory approach for diagnostics, as well as Medicare payment changes that might impact those products. Right now, there are a lot of good ideas being batted around on Capital Hill and in the IVD industry. They each take a somewhat different approach to the same basic problem: delays associated with introducing important new diagnostics into the marketplace, and the irrational differences in the regulatory schemes that apply to diagnostics developed by IVD manufacturers and laboratories. Some of these seek fundamental changes in the whole regulatory paradigm to bring us, for example, closer to the European model, while others are more of simple refinements to the existing FDA process. Some of these proposals seek to harmonize the regulatory scheme between IVD manufacturers and laboratories by up-regulating laboratories, while others seek to achieve that harmonization by moderating the regulatory requirements on IVD manufacturers.—Bradley M. Thompson, JD, attorney, Epstein Becker Green (Washington, DC)

IVD Technology's sister publications, MDDI and MX, have launched a microsite called "Medtech Issues in the 2012 Election Year," which will cover and provide the latest news and information on policy issues that affect the medical device and IVD industries.


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