In October 2014, the US Food and Drug Administration (FDA)2 released a long-promised draft regulatory guidance document outlining the FDA's plan to regulate one of the most innovative areas of laboratory medicine—laboratory-developed tests (LDTs) (1). While the document and public discussion was extremely broad, the draft guidance and subsequent official public interactions often highlighted LDTs by using molecular biology techniques, next-generation sequencing, and mass spectrometry. The majority of the released comments from laboratory and public health professionals involved in patient care and public health activities opposed the draft guidance as potentially limiting patient access, increasing costs, limiting innovation, and interfering in the practice of medicine (https://www.regulations.gov, Docket ID: FDA-2011-D-0360). These concerns have been repeatedly stated in public forums, but the guidance process, unlike the comment-and-rule-making process, does not require that these specific concerns and comments be addressed or considered before release of the final regulatory guidance. Educated estimates by thoughtful and knowledgeable professionals suggest that all but the largest and well-funded commercial and academic medical centers will not be able to bear the financial and/or administrative burden that is likely required by the FDA (2). Additionally, the specific requirements lurking in the final guidance are currently unknown, and the ability of the FDA to effectively implement the proposed regulations is uncertain (3), which makes the true impact of the regulations on patient care activities even more difficult to estimate.
Pathology and laboratory medicine is a relatively small specialty in the scope of healthcare in the United States, but professionals in this field have a wide breadth of professional interests, which has led to the formation of dozens of professional societies, serving almost every conceivable niche interest in specialty. Since the release of the draft guidance, nearly every one of these professional organizations has released position statements outlining shortcomings and incorrect assumptions of the draft guidance, offering constructive suggestions or even proposing regulatory alternatives. These statements and proposals have many key ideas in common; however, rather than attempting to reach a consensus on what needs to be done to provide the best care to our patients, there has often been tenacious adherence to internally generated language and concepts. This scenario has led to a cacophony of similar, yet differing voices from our profession, which has detracted from our ability to have our perspectives heard and our expertise seriously considered by regulatory and legislative bodies. The lack of a consistent message on key regulatory principles and concepts on which we agree has undermined our ability to substantially influence the marketplace of ideas that could have generated a patient-centered update to the existing extensive regulatory framework.
The release of the final guidance is likely imminent, with the FDA stating in multiple public forums their goal of revealing the final guidance in 2016. In the absence of legislation, laboratories will be required to abide by the final guidance. A legislative update to the CLIA regulations, with input from the full spectrum of laboratories, diagnostic companies, patients, and medical-content experts, is in the best interests of patients and practitioners, but the lack of a unified and coherent message from our profession is a major impediment to our viewpoints being considered by our legislative bodies. It is past time that our professional societies come together to formally identify our common concerns, which will allow us to make a reasoned argument why professionals on the frontlines of patient care should have a say in how updated regulation of our practice can address the perceived deficiencies in current regulations (4). This may be an uncomfortable proposition for our professional societies, because some will be asked to put aside positions that represent an investment of time and energy, and others will be asked to participate in a more active way in promoting common ideas. While the impulse for some professional societies is to maintain the status quo, the membership in these organizations—the reason for their existence—can pressure their leaders to work collaboratively in the spirit of benefiting our patients through the innovative and high-quality results that are provided using LDTs. Based on public comments delivered in response to the draft guidance, the FDA is working to finalize their guidance on the regulation of LDTs, with an incomplete understanding of the varied roles laboratory and pathology professionals play in personal and public health. If we are going to fulfill our professional obligations to our patients, it is past time to unify our message to promote a more reasonable regulatory approach.
↵2 Nonstandard abbreviations:
- Food and Drug Administration
- laboratory-developed test.
Authors' Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form.
Employment or Leadership: E.Q. Konnick, University of Washington.
Consultant or Advisory Role: None declared.
Stock Ownership: None declared.
Honoraria: None declared.
Research Funding: None declared.
Expert Testimony: None declared.
Patents: None declared.
- Received June 20, 2016.
- Accepted June 29, 2016.
- © 2016 American Association for Clinical Chemistry