Compliance, Legal, and Malpractice

FDA Takes a Second Crack at Draft Guidance on IVD-MIAs

Last Thursday, the FDA issued a second Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.  The first version, released in September 2006, attracted many critical comments from laboratories producing IVDMIAs free from FDA oversight.  Due to proposed legislation from Senator Edward M Kennedy (D-MA), increased regulation of laboratory-developed tests and IVDMIAs has previously been predicted by both The Dark Report  and Dark Daily.

The FDA Law Blog from Hyman Phelps & McNamara, P.C., provided some great analysis of the second draft version of IVDMIA guidance.  An excerpt from the blog states: 

"One of the major criticisms of the first draft was that the definition of an IVDMIA was not clear.  The proposed definition has been modified.  An IVDMIA is now defined as a device that:

1)  Combines the values of multiple variables using an interpretation function to yield a single, patient-specific result (e.g., a "classification," "score," "index," etc.), that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, and

2)  Provides a result whose derivation is non-transparent and cannot be independently derived or verified by the end user."

The draft guidance gives examples of tests that are and are not IVDMIAs to further clarify its definition.  Regardless, there is still likely to be controversy from many of the laboratories producing IVDMIAs over whether or not their tests fall in the category of IVDMIAs.

Dark Daily asked Kim Popovits, President and COO of Genomic Health  to comment on the second IVDMIA draft guidance.  Genomic Health is affected by the guidance because of its role as a company that conducts sophisticated genomic research to develop clinically validated molecular diagnostics, which provide individualized information on the likelihood of disease recurrence and response to certain types of therapy.  "We are pleased to see that FDA has addressed some of the concerns raised by commenters who responded to the September draft guidance," said Popovits.  "In particular, we are encouraged they recognized the importance of providing a transition period before enforcing any new regulatory requirements that a final policy would impose on clinical laboratories."  The period, however, is shorter than most laboratories would have hoped - 12 months from the date of the final guidance document for currently marketing IVDMIAs, 6 additional months if a 510(k) or premarket approval application is submitted.

Although the new draft guidance is intended to prevent slick operators from selling useless tests to unwitting consumers, it is likely to have an overall negative effect on the efforts of legitimate laboratories and biotech companies to develop clinically-useful assays. That is often what happens after a law is passed to control abusive behavior by those willing to push ethical boundaries. The resulting law ends up constraining honest citizens and damping technological innovation-while not stamping out the abuses that the law was designed to stop.

The comment period for the second draft guidance is a brief 30 days.  Electronic comments can be submitted to http://www.fda.gov/dockets/ecomments.  All comments should be identified with the docket number 2006D-0347.  Many people are concerned with the short 30 day comment period during the month of August and some organizations are requesting an extension to the comment period. All such requests should also be submitted to the comment docket process.

Laboratories interested in learning more about the second draft guidance may want to attend the American Clinical Laboratory Association's 90-minute audio conference entitled "In Vitro Diagnostic Multivariate Index Assays - FDA Releases Revised Guidance Document"   on August 14th at 2pm.  The conference will focus on what is and is not an IVDMIA, perspective on the regulatory status of an IVDMIA, response to concern that regulatory compliance for IVDMIAs will discourage tests for rare disease, and more.

Related Articles and Resources:

• Draft Guidance for Industry, Clinical Laboratories, and FDA Staff In Vitro Diagnostic Multivariate Index Assays 

• FDA Issues Second Draft Version of IVDMIA Guidance 
• American Clinical Laboratory Association's 90-minute audio conference entitled "In Vitro Diagnostic Multivariate Index Assays - FDA Releases Revised Guidance Document"