On Tuesday, November 17, 2015, the House of Representatives’ Energy & Commerce Committee will hold a hearing entitled, “Examining the Regulation of Diagnostic Tests and Laboratory Operations.” The goal of the hearing is to build upon the dialogue received in response to the committee’s white paper (A Modernized Framework for Innovative Diagnostic Tests) released during the 21st Century Cures process. The hearing will provide the committee with the opportunity to hear from FDA and CMS officials regarding each agency’s respective “responsibilities and areas of expertise in the regulation of diagnostic tests, as well as what their roles should entail going forward.”
On October 22, 2015, the committee released a draft discussion bill aimed at establishing a framework for the regulation of in vitro clinical tests. In this 185 page document, the committee states that the goal of the bill is to:
“Establish a regulatory framework for in vitro clinical tests that advances innovation for patient benefit, protects patients, provides a predictable and timely path to market, ensures reasonable risk-based regulation, avoids duplicative regulation, advances precision medicine, and applies the same regulatory principles to the same activity regardless of entity type, and for other purposes.”
The bill states that a new division, the Center for In Vitro Clinical Tests, will be formed within FDA. This Center will establish procedures and process for the regulation of in vitro clinical tests and accompanying development activities. This division will also be responsible for executing and ensuring that all applicable companies are compliant with these regulations.
According to the document, an in vitro clinical test is defined as “a laboratory test protocol or finished product intended by its developer to be used in the collection, preparation, analysis, or in vitro clinical examination of specimens taken or derived from the human body, solely or principally for the purpose of identifying, measuring, predicting, monitoring, or assisting in selecting treatment for, a disease or other condition.” However, tests for products meeting the definition of a “biological product” are not included in the above mentioned definition, and thus are not subject to the regulations established by the bill.
In vitro diagnostic (IVD) products are defined as “those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.” The House committee’s recent draft bill defines and refers to “in vitro clinical tests,” but it does not explain how they will be regulated differently than IVDs, which are considered to be medical devices under section 210(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act and are regulated as such by FDA. IVDs are subject to FDA’s relevant premarket and postmarket controls, as well as the Clinical Laboratory Improvement Amendments (CLIA '88) of 1988.
In 2014, FDA announced its plans to change the way Lab-developed Tests (LTDs) are regulated, making the process align more closely with the Agency’s policy for regulating IVDs. In October 2014, the Agency published a draft guidance on the issue which, if finalized, will change the policy that has been in place for decades. However, if the recent draft bill is signed into law, it is thought that it will work alongside this guidance to establish a regulatory policy for these tests.
In addition to the establishment of the “Center for In Vitro Clinical Tests”, the bill also contains information on FDA fees associated with the proposed regulation, required certification for laboratories conducting in vitro clinical tests, and various transitional provisions. For more details, view the draft bill here.
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