RFP Clarification Questions.doc

1. Reducing Fear of Companies To Participate On A Project for Their Regulatory Authority: Because of the FDA’s regulatory role over Biopharmaceutical companies, some may be hesitant to participate in a benchmark study of this type? What assurances can the FDA provide to participants that improvement opportunities surfaced at an individual company during a benchmark analysis won’t be brought against it by the FDA in a disciplinary action? Similarly, what safe harbor can the FDA provide for the many large biopharmaceutical companies that may be operating with a Corporate Integrity Agreement in place for promotional practices? (The CIA might seem to discourage or preclude some companies from participating.)

FDA Response: The FDA is not aware that pharmaceutical companies may have a hesitation to participate in a benchmark study. Participating companies will be briefed on the survey purpose and to determine if they meet the criteria for consideration. The FDA will work closely with the contractor to establish criteria for inclusion into the survey.

2. Assuring Confidentiality: Can you confirm that confidentiality and blinding mechanisms can be employed by the consultancy performing the benchmark in order to safeguard the confidential nature of the benchmark data that each participant would be asked to provide?

FDA Response: Confidentiality as relevant and where necessary will be employed.

3. Use of Site Visits: Can you confirm or clarify that site visits will be approved as part of the analysis – for the highest performing participants – in order to perform a benchmark analysis of depth and rigor similar to a Baldrige site assessment.

FDA Response: Site visits, upon concurrence from the COR and technical SMEs may be a part of the benchmark analysis. Incurred costs will need to be approved prior.

4. Benchmark Class Size & Composition: Can you confirm that the biopharma manufacturer sample size (of at least 5 companies) does not have to include all manufacturing technologies and manufacturing approaches for all therapeutic forms and delivery mechanisms (e.g. Bioengineered products, large molecule biologics, small molecule process manufacturing, extended release technologies, dermal patch transfers, etc.) If all manufacturing technologies and approaches are included, this project’s scope becomes dramatically larger.

FDA Response: As stated in the solicitation, the FDA criteria is as follows:

· Studying no fewer than five (5) non-pharmaceutical firms with highly complex manufacturing operations (ex: semiconductor sector, automotive sector, etc) who have achieved six sigma (or better) defect rates.

· Study no fewer than five (5) pharmaceutical manufacturers who are close to a six sigma defect rating. If none can be located, the contractor can substitute firms which appear to have a good compliance history (as Identified by OMPQ) and who possess some of the best practices identified in the non-pharmaceutical sectors Best Practices®, LLC Monday, May 07, 2012

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