Docket Management
Docket: 02N-0534 - Medical Device User Fee and Modernization Act of 2002
Comment Number: EC -4

Accepted - Volume 1

Comment Record
Commentor Mr. Fred Adler Date/Time 2003-02-07 16:25:33
Organization Innominata dba GenBio
Category Company

Comments for FDA General
1. General Comments We are happy that if a fee speeds the process, that the fee is implemented. I would like you, however, to consider the field of in-vitro diagnostics. We are planning this year to submit several standard microtiter kits for various infectious disease serologies. The markets are quite small but in the area of in-vitro diagnostics it is not uncommon that annual sales for a kit are $25,000 to $50,000 worldwide. The industry is misunderstood as evidenced by the sale of most diagnostic companies by their pharmaceutical owners. The industry is a cottage industry for the most part with only a handful of individual product which surpass a few million dollars in sales per year. As an example, our company has over 25 510(k)'s and sells a few million dollars worldwide per year. Even with a fee of approximately $2500 per submission, it is difficult to recover say $25,000 (a relative high percentage of annual profits) if we submit 10 menu extending products to the FDA. Would it be possible to set fees based on potential market sizes and/or total annual sales volume for the company? Royalty schedules are often set up that way allowing small companies to be competitive and preventing additional trade barriers. Our regulatory costs have risen constantly in the decade that we have been in the business but our ability to increase our prices has been greatly limited by decreasing reimbursements. I applaud your regulation of in-vitro diagnostics since it has greatly improved the quality of the tests in the market in the 30 years that I have been in this area, but please consider that many diagnostics companies by your own statistics are small and below 50 employees with revenues below $5 million dollars per year and pre-tax profits in the 5-7% range. Respectfully, Fred E. Adler, President, Innominata dba GenBio

EC -4