Professional Relations Committee Report
By Elaine Lyon, PhD
Chair, Professional Relations Committee
The FDA was very busy this summer calling for public workshops. Therefore, the Professional Relations Committee (PRC) was very busy too. So busy, that we had to split into small ad-hoc working groups to accomplish the jobs by the deadlines. On June 24th, the FDA held their public workshop on "Indentifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development." Our PRC industry members formed an ad-hoc group to prepare comments, requesting that the FDA be "clear and consistent" with their regulation of IVDs (in vitro diagnostics). Mark Sobel presented verbal comments that day and written comments were submitted. We also called on our members with background in cytogenomic microarrays to respond to the FDA public meeting "Array-Based Cytogenetic Tests: Questions on Performance Evaluation, Result Reporting and Interpretation," held on June 30th. We stressed the higher resolution of the array-based methods than traditional methods and emphasized that testing is performed in the context of patient phenotype and interpreted in collaboration with the clinical scientist and treating physician. The working group also addressed specific questions that were posted by the FDA. The third FDA meeting, held July 19-20, focused on the "Oversight of Laboratory Developed Tests." This two-day forum began by the FDA's introducing their concerns and stating that all options were on the table. I had the opportunity to read AMP's position, and AMP President, Karen Mann, was part of a panel discussion reinforcing our position. Press coverage by GenomeWeb was very favorable to AMP (for those interested, it can be found at http://www.genomeweb.com/blog/fda-has-three-ldt-cards-play-how-will-it-play-them).
NIH wanted to be in on the action, too. They called for comments regarding a Genetic Test Registry. We thank all the AMP members that responded to our CHAMP survey that formed the basis of our comments, which was submitted July 29. We were able to provide an overview of elements our members deemed important to incorporate in a registry, including concerns that members had expressed. We (Mary Williams, Jennifer Leib and I) had the opportunity to meet with Kathy Hudson and Jim Ostell at the NIH to discuss our points in person.
We are progressing with "Hill Days" with our liaison Jennifer Leib. We have made significant progress lobbying for a programmatic budget increase for NIST to develop standard reference materials for molecular diagnostics. The language was introduced and accepted into the House appropriations bill by Rep. Patrick Kennedy. We are working hard to make sure our language remains intact as both the House and Senate consider the legislation. We will soon begin to form and work with a coalition of other lab groups to get legislation passed that permits PhDs to bill for interpretive services using the Physician/Professional Fee Schedule. We are also continuing to talk with House and Senate offices about health care reform, gene patents, and various other bills that affect molecular pathology.
Thanks goes to all of the PRC members and those on the ad hoc working groups who helped accomplish all that we did in a short period of time. For those interested in details of these documents, please access the AMP website and click on Professional Relations Committee and then AMP Position Statements and Letters.