July 2009 Clinical Laboratory News: News from the FDA

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July 2009: Volume 35, Number 7

Hamburg Sworn In as Head of FDA

Health and Human Services Secretary Kathleen Sebelius swore in Margaret Hamburg, MD, as the new FDA commissioner on May 22. Hamburg is a Harvard-trained physician and former New York City health commissioner considered to be an expert on bioterrorism and other public health issues. After her confirmation hearing, Hamburg said her priorities would be to improve the safety of medical products and foods, as well as make more flu-related medical products and lab tests available in the wake of the H1N1 swine flu epidemic. Hamburg was unanimously confirmed by the Senate to head the agency, replacing Andrew C. von Eschenbach, MD, who ran the agency from 2005 until the end of the Bush administration, and Frank Torti, MD, MPH, who served as the interim commissioner.

Bio-Rad Receives FDA Clearance for HSV Tests

Bio-Rad received 510(k) clearance for two new multiplex infectious disease serology panels for use on the BioPlex 2200 system. The BioPlex ToRC IgG panel simultaneously detects IgG class antibodies to Toxoplasma gondii, ruebella, and cytomegalovirus. The HSV-1 and HSV-2 IgG kit uses type-specific proteins to detect and differentiate IgG-class antibodies to the two most common herpes subtypes, HSV-1 and HSV-2. The ToRC kit is currently available for sale and the HSV kit is pending launch. The BioPlex 2200 system is a fully automated, random access platform that employs multiplexing technology to analyze multiple disease markers from a single patient sample.

Osmetech Submits Request to FDA for Swine Flu Test

Osmetech submitted a request to FDA for Emergency Use Authorization for its Respiratory Pathogen Test Panel to be used to screen for the H1N1 swine flu virus. The Respiratory Pathogen Test Panel, which is expected to be launched as a research-use-only product next quarter, detects and differentiates between 18 common bacterial and viral infections, including Influenza A and its H1N1 subtype. Osmetech is currently developing an extension to the panel that will differentiate the H1N1 subtype between the human and swine forms of the virus. The Respiratory Pathogen Test Panel has been adapted from QIAGEN’s QIAplex-based respiratory viral test for use on Osmetech’s eSensor XT-8 diagnostics system.

Luminex, Prodesse, and BD Receive Warning Letters for H1N1 Flu Test

The three diagnostic manufacturers Luminex, Prodesse, and BD were cited by FDA for illegally marketing unapproved, uncleared, or unauthorized products related to the 2009 H1N1 swine flu outbreak. The tests cited as suspected fraudulent products are Luminex’s xTAG Respiratory Viral Panel, Prodesse’s ProFlu+ Assay, and BD’s Directigen EZ Flu Test. Each company was added to the published list on FDA’s website of firms and websites that have received warning letters concerning marketing unapproved, uncleared, or unauthorized products in violation of the Federal Food, Drug, and Cosmetic Act. In early June, all three firms reported that they have complied with FDA’s instructions outlined in the warning letters.

FDA Releases Draft Guidance on Drug, Medical Device Promotion

A new draft guidance issued by FDA on May 27, “Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion,” outlines the agency’s criteria for determining whether drug and medical device ads “adequately present risk information.” The draft guidance advises that FDA will review the “net impression” of promotional advertisements to ensure that ads are “accurate and not misleading” and up to a “reasonable consumer standard.” The document follows a series of warning letters sent to pharmaceutical companies earlier this year instructing them to include risk data in internet advertising. FDA is accepting comments on the draft through August 25. A copy of the guidance is available online.

IVD Research Cited for GMP Violations

FDA sent a warning letter to IVD Research stating that the company did not require its employees to conduct risk analyses or document design validations for several of its devices. The agency cited the company for failure to establish and maintain written procedures to control the design of its devices, specifically citing its Microwell Serum ELISAs—including the Dengue IgG, Chagas Serology, and Leptospira IgM—as adulterated because they did not conform to good manufacturing practice requirements. According to the letter, the company failed to conduct stability studies to support expiration dates for reagents, controls, strips, solutions, and finished in vitro diagnostic devices. FDA requires that these studies include production testing under actual or simulated conditions to ensure that devices conform to their intended use. At CLN presstime no response had been posted by IVD Research.

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