American Association for Clinical Chemistry
Better health through laboratory medicine
May 2009 Clinical Laboratory News: Regulatory Profiles

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May 2009: Volume 35, Number 5

GAO Tests IRBs with Fake Study Proposal

Institutional review boards (IRB) are supposed to protect the health and safety of people that participate in medical experiments, but a recent GAO investigation found serious and embarrassing flaws in the system. As part of its inquiry, GAO successfully registered a fake IRB with HHS. The department registers IRBs to ensure they follow ethical standards.

GAO was also able to gain approval for a fake draft study proposal from Colorado-based Coast IRB using a fictitious company, counterfeit documents, and an imaginary medical device. GAO’s covertly proposed study called for a liter of the fake product to be poured into a woman’s abdominal cavity after surgery to supposedly help with healing. The fake protocol was based on an actual high-risk study for a product FDA had to withdraw from the market because of deaths and infections of patients.

The House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing about GAO’s report on March 26. “GAO’s findings raise serious questions not only about the specific IRB involved in this investigation, but with the entire system for approving experimental testing on human beings,” said Rep. Bart Stupak (D-Mich.), the chair of the subcommittee. “As a society, we have a moral obligation to ensure that human testing is done in the most responsible and ethical manner.” The committee vowed to push for reform of IRBs.

According to the company’s website, Coastal IRB is conducting an internal audit with an outside consulting firm, and has suspended all new study submissions for 30 days of review. Testimony from the hearing is on the subcommittee’s website.

AdvaMed Proposes New Approach for IVD Regulation

In a new chapter of the contentious debate surrounding FDA oversight of lab-developed tests (LDT), AdvaMed submitted a proposal to the FDA that recommends regulating all IVDs, including LDTs, through a new risk-based decision system that would determine the intensity of review for each test, as well as exempt low-risk tests from burdensome premarket submissions. AdvaMed’s proposal comes on the heels of Genentech’s citizen petition to FDA last December that the agency regulate all lab-developed tests the same way it reviews those marketed to other labs.

AdvaMed’s risk-based model would have FDA determine the necessary level of regulatory oversight based on: risk associated with clinical use of the test; degree of novelty of the test’s analyte; degree of novelty of the technology involved; and the site of service or training of the test operator. The proposal also asks FDA to consider certain risk-mitigating factors: scientific evidence; general and special controls for medical devices; lab process controls; and user experience.

AdvaMed said it designed this new approach based upon contemporary principles of risk management, including ISO standards. AdvaMed has been in talks with FDA about the plan and suggested in the proposal that it expects to continue discussions with both HHS and FDA. The proposal is available on the association’s website.

Bill Would Revise Lab Fee Schedule

Recently introduced legislation would create a special committee to revise the clinical lab fee schedule and require the committee to consider key problems before drafting a proposal, including: patient access to tests; creating a single, national fee schedule; updating the schedule for inflation; adequately reimbursing new tests; revising for changes in cost, value, and utilization of tests; updating the system at least every 5 years; barring a beneficiary copayment; and accepting input from stakeholders. Introduced by Representative Bart Stupak (D-Mich.), the bill would have the HHS secretary appoint members of the new negotiated rulemaking committee (NRC), and if this group cannot reach consensus, MedPAC (Medicare Payment Advisory Commission) will take up the issue in its next report to Congress. Separately, the bill also would update the specimen collection fee to $6.04 in 2010 with annual inflation adjustments thereafter.

The legislation (H.R. 1452) is available online.