Professional Relations Committee Report
By Elaine Lyon, PhD
Chair, Professional Relations Committee
We would like to formally welcome Professional Relations Committee’s (PRC) newest junior member, Robert Klees, from the New York Department of Health. He has joined our calls through the Summer and is a great addition to the Committee. Thank you to all the exceptional candidates who applied.
The FDA has been busy this Summer - and, therefore, so has the PRC. In June, the FDA hosted a public meeting on “Ultra High Throughput Sequencing for Clinical Diagnostics Applications - Approaches to Assess Analytical Validity”. AMP gave both written and oral comments. AMP’s main points were: (1) The FDA needs to partner with professional associations; (2) Different standards are needed for different types of applications; (3) Some aspects of analytical validity fall within the practice of medicine; (5) The FDA needs to review the analytical validity and bioinformatics together and separately.
We also responded to the FDA’s draft guidance document “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions”. To avoid the disruption of patient care, AMP asked the FDA to carefully consider enforcement discretion or alternative regulatory pathways to address circumstances where no FDA cleared/approved products are available, particularly for those products with limited sales volume. AMP gave several recommendations: (1) Direct enforcement requirements for 510(k) or PMA submissions toward test kits and test systems; (2) Create a consistent and clear pathway to encourage and facilitate ASR, 510(k) or PMA applications for RUO and IUO products, with a reasonable compliance timeline; (3) Accommodations should be made to enable certain reagents such as primer or probe mixes to be sold as ASRs; (4) Clearly state the scope of the guidance. The entire response is available on the AMP website (www.amp.org).
Our most recent focus is towards companion diagnostics. AMP has approved a position statement entitled “Reference to Diagnostic Tests in Drug Labels’ that is available on the website. We also sent a letter to Janet Woodcock, MD, Director for the Center for Drug Evaluation and Research re-stating our position. Our main point follows and is worth repeating here: To promote patient safety and high quality care, AMP respectfully asks FDA to specify that diagnostics be described by the biological description of the gene or mutation on drug labels and that identification of recommended diagnostic testing not be by brand name. We were pleased that our recommendation was included in the FDA’s draft guidance for “In Vitro Companion Diagnostic Devices,” however there were additional issues that the PRC wanted to address. While we were beginning discussion within the PRC, the FDA approved Roche’s drug Zelboraf (vemurafenib) for the treatment of patients with melanoma that expresses BRAF V600E. Again, we were successful in that it did not use a brand name test, but the labeling demonstrated the concerns we had. Comments from AMP members who participated in the CHAMP lively discussion were particularly useful as the PRC prepared the comments. We are incorporating many of the points that were raised through the e-mail string. We are finalizing AMP’s response and will submit it shortly to the FDA.
On Capitol Hill this Summer, we worked with Congresswoman Debbie Wasserman Shultz’s staff on her amendment to H.R 1249, the America Invents Act, that reforms the US patent system. The intent of the amendment was to allow testing of patented genes the purpose of obtaining second opinions; however, the language included so many exceptions and loopholes that it failed to reach this goal and actually reinforced the patents. Fortunately, this language was removed, thanks to the great efforts of Mary Williams and Jennifer Leib, and replaced with a study to investigate the effects of gene patents on access to testing. The bill has passed both the Senate and the House and will be signed into law. During the debate on the Senate floor Senator Patrick Leahy stated that this legislation does not imply Congressional support for or against the gene patent case, and in doing so, mentioned AMP. AMP’s name is now officially part of the Congressional Record for this vote.
We look forward to meeting face-to-face in November, so until then, best wishes from the PRC.