American Association for Clinical Chemistry
Better health through laboratory medicine
January 2008 Clinical Laboratory News: News From the FDA

January 2008: Volume 34, Number 1

FDA Can’t Keep Up with the Science

The scientific knowledge base at the FDA has eroded to a dangerous degree due to lack of resources, an overloaded workforce, and an inadequate IT infrastructure, according to a report released by the FDA Science Board’s Subcommittee On Science And Technology. Titled “FDA Science and Mission at Risk,” the report found, similar to reports from previous committees, “a very dangerous trend: the continual expansion of FDA responsibilities coupled with a dramatic decline in resources, particularly during the past two decades.” The subcommittee named eight emerging technologies that have been most challenging to the FDA: systems biology (including genomics and other ‘omics’), wireless healthcare devices, nanotechnology, medical imaging, robotics, cell- and tissue-based products, regenerative medicine, and combination products. One of the major problems preventing the FDA from keeping pace with new science is that its workforce has hardly increased in two decades. Moreover, the IT system on which FDA staff depend is obsolete, “problematic at best—and at worst it is dangerous.” The report noted that critical FDA data reside in warehouses in piles of paper documents with no backup, including clinical trial data. The report is available online.

FDA Revamps Advisory Committee Program

In response to recommendations from a 2006 Institute of Medicine report (IOM), the FDA announced a series of steps aimed at making conflict of interest waivers for advisory committee members more transparent and accessible to the public. The FDA overhaul features two draft guidance documents — one describing a simultaneous and open voting process for committee members, the second recommending the agency more fully disclose committee members’ financial interests when there is a conflict. In addition, the FDA Web page on advisory committees offers updated access to information on waivers. Both draft guidance documents are available on the FDA advisory committee Web page.

   FDA Recommends Genetic Test in Carbamazepine Labeling 

The FDA announced in December that drugs containing carbamazepine must now carry labeling recommending a genetic test, marking the first time the FDA has so strongly recommended pharmacogenomic testing in the labeling of a drug. Used for treatment of epilepsy, bipolar disorder, and neuropathic pain, carbamazepine can in rare cases cause a serious, even life-threatening skin reaction. Studies found a strong link between the serious skin reactions and an inherited gene found almost exclusively in patients with Asian ancestry. The labeling for carbamazepine already warned of the risk of these adverse reactions, but now both this information and FDA’s recommendation for genetic testing must appear in the boxed warning of the drug.

   FDA Clears Tests for Flu and RSV

Meridian Bioscience (Cincinnati, Ohio) announced it has received FDA clearance to market two new upper respiratory tests. TRU FLU detects both influenza A and influenza B, while TRU RSV detects respiratory syncytial virus. The new rapid tests are based on a technology that offers better safety for labs. The two tests can be run simultaneously on the same patient specimen, and can aid physicians in treating patients promptly with antiviral drugs and avoid prescribing antibiotics.

  Circulating Tumor Cell Kit Cleared

Immunicon Corporation (Huntingdon Valley, Pa.) announced FDA clearance of its CellSearch circulating tumor cell (CTC) kit for use as an aid in monitoring patients with metastatic colorectal cancer. The test was originally cleared in 2004 for IVD use in patients with metastatic breast cancer. Immunicon’s clinical trial looked at CTCs in patients with metastatic colorectal carcinomas and found CTCs predict survival at multiple time points during the course of therapy. Immunicon said it is working on adding claims for prostate cancer to the kit in mid-2008.