To address current shortcomings of regulatory control, participants debated the question of what needs oversight and who should have this responsibility. There was much agreement on what should be regulated but a fair amount of discord on who.
For direct-to-consumer (DTC) products, David Mongillo, vp of policy for the American Clinical Laboratory Association, advocated stringent administration in this growing sector that occasionally embraces the frivolous. CMS, the Federal Trade Commission, and Congress, through the passage of the Genetics Information Nondiscrimination Act (GINA), were deemed sufficient in this regard.
For the remaining testing modalities, Mongillo asserted that regulation is already robust and that CLIA had the ability to function as an effective oversight body. Janet Woodcock, M.D., CMO at the FDA, maintained that the agency has made appropriate regulatory forays in this area. She added, though, that risks are rising especially related to consumers and to emerging fields like pharmacogenomics.
The primary question is the FDA’s authority in regulating genetic testing. The legal representatives generally viewed FDA as having true legal authority over manufacturer-produced testing kits and analytes but not laboratory-developed tests. Responses varied widely from a legal point of view, but there was general agreement that areas in which the FDA and CLIA overlap must be closely examined to avoid further confusion.
In addition, the panelists agreed that changes should come through a formal Notice and Rule-Making process to allow public input and participation on what should then be a predictable regulatory pathway for all test development.
Dr. Woodcock asserted the FDA’s authority in this area and described the agency’s policy of enforcement discretion as a means of dealing with the current testing situation. Future directions depend on outcomes and continuous improvements in testing, which is the reason FDA issues guidance, especially in controversial areas. Because formal outcome assessment is extremely expensive, Dr. Woodcock echoed earlier suggestions to consider alternative ways to measure results.
Closing the perceived disconnect between regulatory bodies and federal agencies will be a significant challenge. Other obstacles for policy makers are numerous: balancing appropriate oversight to not impede innovation, resolving the division between private and public R&D, funding for validation and outcome studies, and integrating the genomics paradigm into health care economics.