December 7, 2021

Volume XI, Number 341

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December 06, 2021

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FDA's 'Conversation Starter' Paper Suggests Altered Approach for Laboratories

While a new U.S. Food & Drug Administration discussion paper neither serves as legal guidance nor effects any immediate policy changes, its issuance does suggest that the FDA may take a less stringent approach to regulating Laboratory Developed Tests (LDTs) in the future than previously understood by laboratories and other stakeholders.

The paper, published on January 13, provides a review of LDT guidance previously proposed by the agency and an analysis of public comments and feedback received from stakeholders.  The FDA's consideration of appropriate LDT oversight has been ongoing for a number of years.  In 2014, the agency proposed a new oversight scheme for LDTs, drawing the criticism of many industry participants that the FDA would be over-regulating this type of testing.  In November of 2016, the FDA announced that it would not finalize its 2014 proposed guidance, signaling that opposing arguments that LDT oversight should be incorporated within Clinical Laboratory Improvements Act (CLIA) oversight and other mechanisms may have carried weight.

The new LDT Discussion Paper indicates that only a certain subset of new or significantly modified tests would require premarket approval under the LDT oversight framework proposed by FDA; the vast majority of existing tests would be grandfathered in and even some new LTDs, such as testing for rare or low-risk diseases or those used for forensic purposes, would be exempt from premarket review by FDA. The FDA suggests that even those LTDs requiring approval, which would mainly be for moderate and high risk diseases, may not find the process challenging, indicating that medical and scientific literature and databases may be enough to support the necessary validity of a test. Existing tests would only be subject to such a review if malfunctions or associated patient harm were reported. The paper further emphasized the importance of transparency in the approval process of a new LTD, proposing publication of validity testing.

The Discussion Paper also outlined a more rapid implementation of any new LDT oversight framework than originally proposed, with a full rollout expected to occur within four years, as opposed to the 2014 guidance, which suggested a 9-year timeline. In part, this appears to be based on the FDA's new focus on a collaborative approach to the oversight, by suggesting different roles other stakeholders may take in the oversight process to "best streamline effective oversight by taking advantage of each federal agency's existing structure and strengths." Food and Drug Admin., Discussion Paper on Laboratory Developed Testes (LDTs), at 2 (2017). The paper indicates the FDA's willingness to coordinate and share regulatory responsibility with the Centers for Medicare & Medicaid Services (CMS), which promulgates CLIA; in fact, the FDA suggested that its aim for any potential LDT oversight framework would be to complement existing CLIA requirements, not duplicate them. Furthermore, the FDA plans to share some of the reviewing burden with a variety of third-party programs, leveraging its existing relationship with New York State's Clinical Laboratory Evaluation Program and organizations that are CLIA-approved to offer laboratory accreditation.

The FDA indicated that the paper serves as a "conversation starter," while the agency continues to receive public feedback for an undisclosed period of time on the matter and best determines how to balance patient safety concerns with burdensome and costly regulations and undue hardship on innovation.  Although the FDA released its last LDT-related publication backpedaling on its stricter 2014 guidance almost immediately after the 2016 election, it is nonetheless unclear how the Trump administration will impact the final regulations or their implementation.

© Polsinelli PC, Polsinelli LLP in CaliforniaNational Law Review, Volume VII, Number 26
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About this Author

Barry Alexander, Polsinelli Law Firm, Healthcare Attorney
Shareholder

Barry Alexander provides strategic legal advice to a wide range of health care providers, specialty pharmaceutical and medical device companies, and private equity investors on the complex legal and regulatory environment surrounding the health care industry and the implications to business operations and success in a dynamically changing health care market.

Whether an acquisition or sale, establishing clinically integrated networks, negotiating complex agreements and joint ventures with health care systems and strategic partners, addressing...

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Carey Nuttall, Polsinelli Law Firm, Life Sciences Attorney
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Carey Nuttall is committed to providing clients with an understanding of FDA laws and regulations along with the policies and objectives those laws are intended to address. Carey strives to present clients with practical advice that takes into account their business goals as he provides insight into FDA’s priorities and perspectives. Carey’s understanding of the complex FDA-regulatory framework was shaped by early experience in FDA’s Office of the Chief Counsel and continues with the representation of a broad variety of clients engaged in the manufacture, marketing, and...

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Cybil G. Roehrenbeck, Polsinelli PC, Precision Medicine Lawyer, Genomics Attorney
Counsel

Focusing on emerging health care sectors, Cybil Roehrenbeck is dedicated to helping clients achieve their objectives by employing a comprehensive, interdisciplinary approach to their legal and business challenges. She counsels clients on federal legislative and regulatory opportunities in the following areas:

  • Health information technology  

  • mHealth and telehealth

  • Precision medicine and genomics

  • Innovative health care delivery...

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Jessica Schmit, Polsinelli Law Firm, Healthcare Attorney
Associate

Jessica Schmit's strength derives from her ability to navigate both operational health care matters and complex corporate cases for clients. As an associate in the Health Care Services practice group, her role focuses on transactional and regulatory health care law. 

Jessica has a background in complex corporate litigation, financial regulation, and toxic tort involving federal cases. Prior to law school, Jessica worked as a medical laboratory scientist for one of the nation’s largest hospital systems, which allows her to bring a unique...

314-622-6640
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