On June 2, 2013, U.S. Food and Drug Administration (“FDA”) Commissioner Margaret Hamburg delivered a speech at the American Society of Clinical Oncology’s annual meeting, in which she explained that the FDA is in the process of changing the regulations governing laboratory-developed tests (“LDTs”). (To read the full text of Commissioner Hamburg’s speech, please click here.) In her speech, Commissioner Hamburg stated that the FDA is developing a risk-based framework that is intended to “make sure that the accuracy and clinical validity of high-risk tests are established before they come to the market” and “provide for safe and effective diagnostics while promoting innovation and patient access.” Although the FDA has not formally announced any changes to the regulation of LDTs, Commissioner Hamburg’s comments suggest that the FDA is closer to finalizing the modified regulatory framework for LDTs. (To read our previous coverage of the FDA’s regulation of LDTs, please click here.)
The FDA defines LDTs as “a class of in vitro diagnostics that are manufactured, including being developed and validated, and offered, within a single laboratory.” (To read the full text of the Federal Register notice requesting comments for the Oversight of Laboratory Developed Tests published on June 17, 2010, please click here.) Common examples of LDTs are genetic tests, emerging diagnostic tests, and tests for rare conditions. The FDA claims authority to regulate LDTs under the federal Food, Drug, and Cosmetics Act but has not drafted applicable regulations with respect to LDTs. Therefore, the primary federal regulation of laboratories and LDTs has been under the Clinical Laboratory Amendments of 1988 (“CLIA”).
Since 1992, the FDA has consistently maintained its position that it will not enforce regulations regarding LDTs. The most notable departure came on June 10, 2010, when the FDA issued five Untitled Letters to companies stating that their tests did not qualify as LDTs because they were “not developed by and used in a single laboratory.” (To read the FDA’s Untitled Letters to Industry, please click here, here, here, here, and here.) In those instances, the FDA determined that it would regulate those tests as medical devices and require premarket approval. In June 2010, the FDA stated that increased regulation of LDTs may be necessary due to the changing nature of LDTs from “generally relatively simple, well-understood pathology tests” to tests that “are often used to assess high-risk but relatively common diseases and conditions and to inform critical treatment decisions.” (To read the full text of the Federal Register notice regarding federal oversight of LDTs, please click here.)
One week after the FDA issued the Untitled Letters described above, the FDA announced that it would hold a public meeting because the “agency believe[d] it [was] time to reconsider its policy of enforcement discretion over LDTs.” (To read the full text of the Federal Register notice requesting comments for the Oversight of Laboratory Developed Tests published on June 17, 2010, please click here.) In the Federal Register notice announcing that public meeting, the FDA stated that LDTs were originally intended to be used by doctors and pathologists within a single facility or institution where both the doctor and pathologist were actively involved in the patient’s care. According to the FDA, the nature of LDTs had changed significantly over the last two decades. The FDA indicated in the Federal Register notice that modern LDTs are often used to diagnose “high-risk” diseases and conditions and to guide “critical treatment decisions.” Furthermore, the FDA explained that modern LDTs have departed from traditional LDTs because modern tests are “often performed in geographically distant commercial laboratories instead of within the patient’s health care setting under the supervision of the patient’s pathologist and treating physician.”
On July 19-20, 2010, the FDA held the public meeting to discuss the state of regulations governing LDTs. In that meeting, the FDA reiterated that laws for regulating LDTs were already in effect and that the agency had merely exercised enforcement discretion with respect to LDTs. The FDA also claimed that it could implement a new regulatory framework at any time through the issuance of guidance. With the exception of the FDA’s issuance of Untitled Letters in June 2010, the FDA has not taken any formal steps to exercise its enforcement authority. (For more information about the FDA’s public meeting, please click here.)
Roughly two years after the FDA’s public meeting, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (“FDASIA”), which requires the FDA to notify Congress at least 60 days prior to issuing a draft or final guidance on the regulation of LDTs. (For the full text of FDASIA, please click here.) The legislative history is silent as to Congress’s rationale for requiring the FDA to provide notice prior to issuing new guidance; however, some have interpreted this provision to suggest that Congress views LDTs as an important issue that warrants close monitoring. At a minimum, the notification requirement contained in FDASIA effectively acts as a warning to industry to prepare for new changes to the regulation of LDTs before they take effect.
Resistance to FDA’s Regulation of LDTs
The FDA’s push for increased regulation over LDTs has been met with resistance by the laboratory industry. On June 6, 2013, the American Clinical Laboratory Association (“ACLA”) submitted a Citizen Petition requesting the FDA to confirm that LDTs are not devices under the FDCA. (For more information about ACLA’s Citizen Petition, please click here. To read the full text of ACLA’s Citizen Petition, click here.) In its Citizen Petition, the ACLA argued that the Center for Medicare and Medicaid Services (“CMS”) has authority to regulate LDTs under the CLIA and, therefore, LDTs are beyond FDA’s jurisdiction. This Citizen Petition is not the first of its kind to suggest that the FDA does not have authority to regulate LDTs. In fact, the FDA has addressed and denied similar Citizen Petitions in the past. (For example, Genentech submitted a Citizen Petition regarding LDTs in 2008, which is available here.)
Commissioner Hamburg’s speech at the American Society of Clinical Oncology meeting is the most recent public FDA activity in the area of LDT regulation since it issued Untitled Letters to industry in 2010. However, it is important to recognize that the FDA could move forward at any time and issue new guidance modifying how LDTs are regulated. Members of the laboratory industry should be prepared to comment on any proposed guidance or regulation that the FDA may announce in the Federal Register. Additionally, it would be prudent for physicians and laboratories using or creating such tests to take notice of whether their tests satisfy the criteria for LDTs or whether the tests could otherwise qualify for regulation as medical devices.