Questions over FDA’s Authority to Regulate Laboratory Developed Tests

Hyman, Phelps & McNamara, P.C. (HPM) submitted a citizen petition to FDA in 1992 asserting that the agency did not have the authority to regulate assays developed by clinical reference laboratories strictly for in-house use (laboratory developed tests). FDA responded to the petition nearly six years later by saying that it can, in fact, regulate as medical devices such laboratory developed tests. However, FDA did not exercise this supposed authority for several years.

By 2006, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) began asserting authority over laboratory developed tests and began imposing limitations on analyte specific reagents (ASRs). In discussions with and communications to individual companies, OIVD claimed that reagents that tested for multiple markers, products that were multiplexed, and products that were affixed to objects such as miroarrays could not be ASRs. On June 27, 2006, HPM sent a letter to Dr. Steven I. Gutman, Director of OIVD, which argued that these products do and should fit within FDA’s definition of ASRs and are not prohibited by FDA’s ASR regulations. This letter also argued that OIVD’s correspondence to individual companies was creating confusion within the ASR industry and that any changes with respect to what products are considered ASRs should be made through notice-and-comment rulemaking, in accordance with the Administrative Procedure Act.

HPM did not receive a response to its June 2006 letter. On September 7, 2006, FDA published two draft guidance documents relating to laboratory tests; one pertaining to ASRs and one pertaining to In Vitro Diagnostic Multivariate Index Assays – a particular subset of laboratory developed tests. These draft guidance documents collectively represent an attempt by FDA to significantly limit the ability of laboratories to develop new tests, and an intrusion by the agency into a realm already regulated by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The draft guidance document pertaining to ASRs addresses some of the issues presented by HPM in its June 2006 letter.

On September 28, 2006, the Washington Legal Foundation (WLF) submitted a citizen petition to FDA requesting that FDA not regulate laboratory developed tests. WLF’s petition states that the substantive legal basis for this request is consistent with HPM’s 1992 petition. WLF’s petition, however, notes that the facts and the law have changed materially and provides new bases for why FDA does not have the authority to regulate laboratory developed tests. HPM filed comments in support of WLF’s petition on March 23, 2007.

Click here to view HPM’s 1992 petition

Click here to view FDA’s response to HPM’s petition

Click here to view HPM’s June 27, 2006 letter to OIVD regarding ASRs

Click here to view FDA’s September 7, 2006 draft guidance document on ASRs

Click here to view FDA’s September 7, 2006 draft guidance document on In Vitro Diagnostic Multivariate Index Assays

Click here to view WLF’s September 28, 2006 petition

Click here to view HPM’s comments in support of WLF’s September 28, 2006 petition

Click here to view Memorandum of Understanding Between FDA and NCI and CMS

Click here to view a 2003 FDA guidance document on ASRs (ingredients in laboratory developed tests)

Click here to view HHS Press Release on New Federal Health Initiative to Improve Cancer Therapy