By Turna Ray
The American Clinical Laboratory Association, a group representing laboratories regulated under the Centers for Medicare & Medicaid Services' CLIA, met with the head of the US Food and Drug Administration this week to discuss a proposal that would keep oversight of laboratory-developed tests under CMS with FDA taking on an advisory role.
The FDA drew the ire of laboratory test developers when the agency issued draft guidelines for regulating a more complex subset of LDTs, called in vitro diagnostic multivariate index assays. Historically, CMS has had oversight over the majority of LDTs, with the FDA practicing enforcement discretion over LDTs and regulating test kits.
Many LDT developers feel that FDA regulation of IVDMIAs will impose costly and time-consuming regulatory hurdles that would hobble innovation and make reimbursement even more difficult, particularly for diagnostics in niche markets [see PGx Reporter 02-14-07].
During a webinar hosted this week by Genetic Alliance, Paul Radensky, a partner in the law firm McDermott Will & Emery, discussed FDA's regulation of diagnostic tests and noted that ACLA had met with FDA Commissioner Margaret Hamburg to discuss a proposal for an inter-agency approach to regulating LDTs.
Radensky represents the Coalition for 21st Century Medicine – an alliance formed in the wake of FDA’s first IVDMIA draft guidance that represents many LDT developers and supports a "least burdensome" approach to regulating LDTs.
The ACLA has already submitted to CMS and FDA its inter-agency proposal for the regulatory oversight of IVDMIAs. "The key elements are that it maintains CMS as the agency with direct regulatory oversight and enforcement over laboratory test services and provides a clearly defined consultative role for FDA in clinical validity review," the ACLA states on its website.
ACLA's meeting with Hamburg is strategically timed during a period of regulatory fluctuation at the FDA.
Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, recently said that currently there is a lot of "uncertainty" at the agency since the current administration of President Barack Obama wants to make many changes. Specifically, he revealed that after holding a public meeting and issuing two draft guidances on regulatory guidelines for IVDMIAs, the agency may need to go back to the drawing board on this pending regulatory issue, as well as others [see PGx Reporter 08-12-2009].
Also recognizing the opportunity with the new administration, more than 100 stakeholders, including Genetic Alliance, the Johns Hopkins' Genetic and Public Policy Center, and the Coalition for 21st Century Medicine, sent a letter in May to HHS Secretary Kathleen Sebelius proposing three principles for regulating advanced diagnostics.
The three principles urge HHS to advance regulations that ensure that the oversight of all advanced diagnostics is risk-based; to develop a mandatory genetic testing registry; and to strengthen CLIA regulations and harmonize them with the FDA.
During the Genetic Alliance webinar, there was some discussion of how the FDA should regulate consumer genomics services.
The agency has not publicly expressed any intent to regulate this nascent field, but has said it is watching the industry with interest.
However, Jeffrey Gibbs, director at law firm Hyman, Phelps & McNamara, noted that not only has the FDA been watching the industry, it has expressed concern that companies like 23andMe are selling genetic risk information directly to consumers, using risk markers with questionable clinical validity and utility.
Gibbs added that the Obama administration has also expressed concern over the business practices of DTC consumer genomics firms.