Medical Device Daily Washington Editor

WASHINGTON – The FDA's Center for Devices and Radiological Health (CDRH) recently released figures for the first quarter of fiscal year 2005 concerning funding generated by the Medical Device User Fee and Modernization Act (MDUFMA).

With launch of the fiscal year last October, CDRH has collected $7.6 million in fees. The target for the year is $32,429,908, which is slightly higher than originally budgeted due to an inflation adjustment of more than $2.6 million. Part of the adjustment was the result of a pay raise for employees in the Washington area.

In 2004, the revenue target was $31.7 million. The fees collected totaled $26.9 million. For FY05, just as with FY04, the compensating adjustor was deferred. The compensating adjustor is used so that industry can make up its fee shortfalls in subsequent years. This part of user fee accounting has generated much industry controversy.

The FDA has toyed with the idea of forgiving the government its appropriated shortfalls for the device user fee program.

However, industry organizations such as the Advanced Medical Technology Association and the Medical Device Manufacturers Association (both Washington) have argued that the same forgiveness should be offered to the industry and that device manufacturers should not be held accountable for shortfalls in the FDA's target budget.

As part of its report, CDRH also reports ongoing increases in its workload.

In FY04, CDRH received a record high of 14 expedited premarket approval applications (PMAs), compared to three in FY03. For this fiscal year, CDRH has reviewed three so far. The agency reported that expedited PMAs and combination products require more resources.

Real-time PMA supplement receipts increased from 139 in FY02 to 193 in FY03 and 198 in FY04. FY05 so far has seen roughly 50 real-time PMAs, with 42 meeting MDUFMA performance goals, two not meeting goals, and six awaiting a decision.

In FY03, CDRH received 73 PMA modules, compared to 32 in FY01. In FY05 CDRH said it will be extending modular review for panel track supplements. Modular reviews require reassembling the review team many times and use more resources than traditional PMAs.

Also adding to a drain on the agency's resources, the number of 510(k)s with clinical data has increased, according to the report.

A full accounting of fees and types of applications submitted and processed is available at

NIH expands genome sequencing targets

The National Human Genome Research Institute (NHGRI), part of the of the National Institutes of Health (NIH; Bethesda, Maryland), recently reported that it will begin sequencing 12 more organisms as part of its ongoing work to expand understanding of the human genome.

The National Advisory Council for Human Genome Research, a federally chartered committee that advises NHGRI on program priorities and goals, recently approved a comprehensive plan that identified two groups of new sequencing targets.

"Our sequencing strategy continues to focus on identifying the sets of organisms with the greatest potential to fill crucial gaps in biomedical knowledge," said Mark Guyer, PhD, director of NHGRI's Division of Extramural Research. "The most effective approach we currently have to identify [is] the essential functional and structural components of the human genome is to compare it with the genomes of other organisms."

NIH hopes two of the sequencing projects will provide insight into model organisms used in research on drug development and disease susceptibility. The marmoset, for example, is a key model organism used in neurobiological studies of multiple sclerosis, Parkinson's disease and Huntington's disease. The marmoset is also an important model for research into infectious disease and pharmacology.

The second project chosen for its medical relevance to humans will identify 280,000 single nucleotide polymorphisms (SNPs) in the genomes of eight different strains of laboratory rats. SNPs can be used as markers to zero in on genetic variations that may affect an individual's risk of developing common, complex illnesses such as heart diseases, diabetes and cancer.

Building a catalog of rat SNPs will assist researchers trying to find genetic variations associated with common, complex diseases in rats, which can then be used to help identify similar genetic variations that may be involved in human disease, NIH said.

Another set of 11 non-mammalian organisms was chosen, each representing a position on the evolutionary timeline marked by important innovations in animal anatomy, physiology, development or behavior.

Most sequences of the human genome originated long before humans themselves. Scientists will use the genome sequences of the 11 non-mammalian animals to learn more about how, when and why the human genome came to be composed of certain DNA sequences, as well as to gain new insights into organization of genomes, according to NIH.

In addition, NIH hopes many of the organisms can shed light on human disease. For instance, the skate – related to many species of shark – was chosen because it belongs to the first group of primitive vertebrates that developed jaws, an important step in vertebrate evolution. Other innovations in this group of animals include an adaptive immune system similar to that of humans, a closed and pressurized circulatory system, and myelination of the nervous system.

Understanding the systems of the skate, at a genetic level, will help scientists identify the minimum set of genes that create a nervous system or develop a jaw, possibly illustrating how these systems have evolved in humans and how they sometimes go wrong, NHGRI said.

Sequencing efforts will be carried out by five centers: Agencourt Bioscience (Beverly, Massachusetts); Baylor College of Medicine (Houston); The Broad Institute of MIT and Harvard University (Cambridge, Massachusetts); The J. Craig Venter Science Institute (Rockville, Maryland); and Washington University School of Medicine (St. Louis).