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HELP Head Kennedy's Bill Suggests FDA Dominion Over Multivariate Index Assays

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A bill that may soon be introduced by Massachusetts Sen. Edward Kennedy appears to support a draft guidance released by the US Food and Drug Administration covering the oversight of multivariate index assays.
 
Kennedy, speaking at a recent Genetics and Public Policy Center conference in Washington, DC, discussed his intent to introduce a bill clarifying the FDA’s authority to validate certain homebrew genetic tests.
 
Kennedy’s legislation, a draft copy of which was obtained by Pharmacogenomics Reporter, aims to “better protect patients by ensuring that tests developed in laboratories are of proven validity,” according to a press release issued by the Senator’s office. Kennedy plans to introduce the bill “in the coming months.”
 
Specifically, the legislation, called the “Laboratory Test Improvement Act,” aims to clarify the FDA’s authority to regulate tests that “some have questioned,” and guide the agency in how to exercise its power in this regard. Additionally, the bill will “clarify [that] when FDA has cleared or approved a diagnostic, similar lab tests must also be cleared or approved by FDA,” the release states.
 
The legislation appears to support a draft guidance the FDA issued in September that seeks to encourage molecular diagnostic companies to file for pre- and post-market review tests that use an algorithm to generate results from multiple data points, rather than following traditional homebrew rules [see 9/13/2006 PGx Reporter].
 
PGx Reporter could not confirm before deadline, from either FDA or Kennedy’s office, to what extent the draft bill and draft guidance are similar in scope. The draft bill from which information for this article was drawn represents an early version of the legislation. The document is still evolving and is in the process of being finalized so it can be introduced in the coming months, according Kennedy’s staff.
 
Kennedy made his comments in September, around the time FDA issued its Draft Guidance for Industry, Clinical Laboratories, and FDA Staff – In Vitro Diagnostic Multivariate Index Assays.
 
The FDA composed the draft following a meeting with Genomic Health after the company launched its homebrew Oncotype Dx breast cancer recurrence test, which the FDA believes should have obtained approval.
 
The FDA’s draft guidance, and now Kennedy’s draft bill, appear to be trying to encourage other diagnostic companies to submit similar multivariate tests with the FDA rather than pursuing the CLIA route.
 
“Doctors and patients are making important medical decisions based on the results of clinical laboratory tests in the field of genetics,” Kennedy said in the statement. “We need to ensure that they understand the clinical significance of the results, and are confident that the tests are accurately performed. My bill will focus the Congress and others on the need for an important role for FDA in this area.”
 
Kennedy Bill Lays Out FDA’s Authority
 
Among other provisions, Kennedy’s draft legislation requires all Class III devices to obtain pre-market approval and says that all similar lab tests must obtain FDA clearance.
 
According to the draft, Class III devices will be subject to pre-market approval under section 515 of the Federal Food, Drug & Cosmetic Act if they meet the requirements for a Class III device; if they are intended to diagnose a fatal contagious disease; if they might mitigate the public health impact of the condition; or if they are intended for donor screening of a disease to safeguard the blood supply or establish the safe use of tissue products.
 

“We need to ensure that they understand the clinical significance of the results, and are confident that the tests are accurately performed. My bill will focus the Congress and others on the need for an important role for FDA in this area.”

Additionally, the draft states that “a laboratory-developed test shall become subject to the requirements of section 510(k) of the FFDCA if an in vitro diagnostic product of the same type has been cleared under section 510(k).”
 
However, all Class II devices “are subject to both general and special controls under FFDCA” and a report under section 510(k) must be submitted to the HHS Secretary through FDA, the legislation states.
 
It is unclear to what extent Kennedy’s draft legislation is similar to FDA’s draft guidance in this regard. Most in vitro diagnostic multivariate index assays will likely be Class II or Class III, the draft guidance states.
 
Class I products are exempt from FDA approval, Kennedy’s proposed legislation says.
 
Sanctions, Additional Data, Labeling Requirements
 
If sponsors fail to submit 510(k) reports or if FDA doesn’t clear a report, then manufacturers must stop marketing their tests, according to the proposed bill.
 
“If the manufacturer does not immediately cease to offer such tests for sale … such test and such manufacturer shall be subject to provisions of Chapter III of FFDCA,” the draft bill warns. Chapter III of the FD&C Act, “Prohibited Acts and Penalties,” outlines sanctions for makers of unapproved or adulterated products.
 
The bill also grants FDA the authority to request, within 90 days of clearing a 510(k), additional data or revised labeling if “new information in peer-reviewed biomedical literature about the clinical validity of such tests” is found.
 
Also, product labeling will need to reflect “prominently and conspicuously” whether a test has been FDA-approved, its intended use, and if necessary, an acknowledgement that new information regarding the test may have appeared in scientific literature since the test’s approval. A statement in this regard will also need to accompany test results sent to healthcare providers and patients.

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