On July 2, 2014, five U.S. Senators sent a letter to the head of the Office of Management and Budget (“OMB”) urging OMB to release a draft guidance proposed by the U.S. Food and Drug Administration (“FDA”) relating to the regulation of laboratory developed tests (“LDTs”).
LDTs are diagnostic tests developed and performed by a laboratory. They are widely used; among other tests, this category includes genetic tests, tests for rare conditions, and companion diagnostics. Thousands of different LDTs are currently available, many of which are the standard of care. Starting in 1992, FDA stated that LDTs were medical devices but that it generally was exercising enforcement discretion. FDA announced in June 2010 that it was revisiting this years-long policy of exercising enforcement discretion over LDTs and was holding a public workshop to discuss the issue in July 2010. FDA officials subsequently indicated that it was developing a plan to more actively regulate LDTs under a risk-based framework, to be issued for comment as guidance. The recently enacted Food and Drug Administration Safety and Innovation Act (“FDASIA”), requires FDA to notify Congress at least 60 days prior to issuing a draft or final guidance on the regulation of LDTs. The notice must include anticipated details of the action. We have previously blogged on this here, here, here, and here.
According to the letter, the draft guidance has been in front of OMB for several years. As the five Senators stated that they are in favor of additional regulation of LDTs, they urged OMB to release the draft guidance.