Comments on the poll question "Funding FDA Inspections" - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Comments on the poll question "Funding FDA Inspections"


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.

Click here to submit a comment. Go to the poll archive to see past questions and results.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy

Click here