Finding allies in Congress
It took 13 years for the Genetic Information Nondiscrimination Act (GINA) to be officially signed into law. While the passage of this law should benefit the IVD industry, it raises the question of why it took so long to get signed. This experience with GINA shows that any bills addressing IVD industry issues will continue to encounter difficulties and long waits before they can even come close to getting passed.
Legislating is a complex process that involves a lot of backroom dealmaking, compromises, and, most importantly, politics. GINA appeared to have finally gotten over the hump after Senators Edward M. Kennedy (D-MA) and Olympia Snowe (D-ME) gave their blessings. These two senior, high profile Senators probably used their political muscle to push the bill through Congress.
During the past few years, a couple of bills that would have a significant impact on the IVD industry have been introduced in Congress. Unfortunately, all of these bills have stalled and have not gone anywhere since their introduction. Based on GINA’s experiences, such IVD-related bills could languish in Congress for many years; worse yet, they could get lost in the shuffle and eventually be forgotten.
The reality of the matter is that Congress spends most of its time working on legislation dealing with issues that are of greater concern to its constituencies and the general public: the economy, the wars in Iraq and Afghanistan, healthcare. Against such odds, if IVD-related bills ever want to have any hope of getting the proper attention needed to reach eventual passage, they need to find those members of Congress and other powerful political allies who will champion their cause.
In August 2006, Senator Barack Obama (D-IL) introduced the Genomics and Personalized Medicine Act. The bill proposed to increase funding for research on genomics, expand the genomics workforce, and provide a tax credit for the development of diagnostic tests that can improve the safety or effectiveness of drugs. The bill also provided a 100% tax credit for private research to develop companion diagnostic tests that can improve the effectiveness or safety of certain drugs. In addition, this bill would modernize FDA’s outdated process for reviewing genomic tests.
As the bill’s primary sponsor, Senator Obama has obviously not been able to work on pushing this bill through Congress these past couple of years. However, if Obama were elected president and if he were to continue to have deep convictions for this issue, there would be no greater champion for this bill than the President.
Finding such allies in Congress to champion IVD-related legislation is no easy task. At the very least, IVD manufacturers can be involved in legislative affairs by maintaining close, regular contact with their representatives in Congress. In addition, manufacturers can work on coordinating their legislative priorities through various industry trade groups such as AdvaMed (Washington, DC).
In addition, in a letter to SACGHS, AdvaMed stated that its proposed risk-based approach focuses on the following factors for determining risk: risk associated with the clinical use of the test; degree of novelty of the analyte; degree of novelty of the technology; and the level of professional training of the operator.
While AdvaMed’s proposal may not offer the most perfect solution, it is at least a way to start addressing this ongoing problem of regulating molecular diagnostics. While the decentralization of molecular testing may not happen next year, the IVD industry should try to make it happen sooner than later.