FDA should have some level of oversight for all laboratory tests, including the more than 1100 genetic tests now offered by hundreds of laboratories across the nation, according to an HHS advisory committee report.
The committee voted recently that the gap in oversight of the clinical validity of these tests should be closed as quickly as possible. The final report from the Secretary’s Advisory Committee on Genetics, Health, and Society was written in response to a charge from HHS secretary Michael Leavitt to examine the need for genetic testing oversight. It calls for a number of actions in various HHS agencies to beef up information-gathering and regulation of the tests.
The recommended FDA oversight is a huge undertaking, committee members recognized, and it will require “commitment of significant resources†to avoid harming patients and to avoid stifling technological innovations. According to the committee’s draft report, FDA has cleared or approved fewer than 100 genetic tests so far.
A key issue in committee discussions was whether there should be a difference in regulatory oversight for in vitro diagnostics (IVDs), which are developed by manufacturers for distribution to numerous labs after FDA clearance or approval, and oversight for laboratory-developed tests (LDTs), which are developed for use solely in the developer’s laboratory. The report notes that only recently has FDA exercised regulatory authority over LDTs.
For the most part, LDT regulation has been left to regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the report says. Overseen by the Centers for Medicare and Medicaid Services (CMS), CLIA requires all clinical laboratories to be inspected for standards compliance. The secretary’s committee says that is not enough, although some committee members did voice concern that it would slow innovation if laboratories were to go through the same level of FDA regulation as IVDs. The committee decided that from a patient’s viewpoint, the question of whether a test is an LDT or IVD is not a priority.
Steven Gutman, CDRH’s director of IVD device evaluation and safety and also an ex officio committee member, said that patients simply want a test to work. They also want someone other than the sponsor to be responsible for saying that it works.
The committee discussed how to prioritize tests for oversight according to the risks they pose to patients—especially in light of the huge number of LDTs, many of which may be exotic and rare, according to Gutman. The panel finally recommended that HHS convene a multistakeholder group from the public and private sectors to determine the criteria for risk certification of tests. The group would also be tasked with developing a process for systematically applying such criteria.
In another major recommendation, the committee indicated that a yet-to-be-determined federal agency should create a mandatory, Web-based database of all tests. The committee discussed whether such a database should be at the Centers for Disease Control and Prevention, CMS, or FDA. However, in light of the practical and legal questions, the committee said HHS should appoint and fund a lead agency to develop the database, maintain it, and to work closely with its sister agencies on it.
FDA should engage other agencies and prepare a guidance document on its authority to regulate clinical support systems, the committee said. The guidance should “explain in particular which features of the system constitute a device†as the term is used under FDA authority.
The recommendations also said that FDA, among other federal agencies, should strengthen its monitoring and enforcement efforts against labs and companies that make false and misleading claims about genetic tests.
In addition, the committee stated its concern about certain types of genetic tests that are marketed directly to consumers, especially about the insufficient oversight of the labs offering them. The committee said that CLIA’s authority, along with FDA’s risk-based regulatory authority and processes, should be expanded to encompass the full range of health-related genetic tests.
It also noted that although “FDA has asserted its authority over clinical decisions support systems, the extent to which the agency intends to regulate such systems is not clear. Given that [such] systems will be necessary to communicate information appropriately in the pre- and postanalytic period, and because these systems contain elements that involve the practice of medicine, clarification of the nature and scope of FDA oversight of such support systems is critical.â€
– James G. Dickinson
