Comments on the poll question "Funding FDA Inspections"

May 15, 2008
By Pharmaceutical Technology Editors

Your comments

"Regarding inspection fees, one approach for establishing fees would be to assess the actual cost or the average cost for doing the inspections after let’s say 100 inspections at various size manufacturing plants. The FDA could then establish, based on the size of the manufacturing facility, a fixed fee. The larger manufacturing facilities might have a larger fee. Many local governments set their fees based upon a historical average of what it costs to perform the task. The goal is that the local municipality is able to recover their out-of-pocket costs and not make any profit from the fees."

The question

The proposed Food and Drug Administration Globalization Act of 2008 recommends imposing a fee for inspections to fund the cost of FDA inspections (both domestic and foreign inspections). If such a measure is adopted, how should the fee be assessed?

1. On a facility basis, based on the size of the manufacturing facility.
2. On a company basis, based on company revenues.
3. On a company basis, based on the number of manufacturing facilities operated by the company.
4. A flat fee for all companies with pharmaceutical manufacturing facilities.

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