Monday, July 16, 2007

FDA questions maraviroc.

FDA approval of Pfizer's HIV drug maraviroc was delayed for unknown reasons. The delay came after Question Authority published allegations about illegal premarketing, made by an internal Pfizer whistleblower.

A person inside Pfizer has now added some new information about what is going on.

This source claims that part of the problem with maraviroc is the test developed by Monogram Biosciences (MGRM). The FDA has allegedly requested for Pfizer and MGRM to explain the relationship of the test, which is not labeled, and a product that will be labeled - maraviroc.

Questions being asked are the following:

1. Who is liable if the test is not accurate and someone takes maraviroc and dies - Pfizer or Monogram Biosciences?
2. Does the test need more verification and does the FDA need to label it for safety, etc?
3. Does Pfizer need to include this in their label?
4. Does MGRM have the resources to handle the testing exclusively?
5. Does Pfizer have the right to limit the testing to one company?
6. Is the test sensitive enough?
7. How often will someone need to be tested?
8. Has Pfizer's investment in MGRM become a conflict of interest, affecting the clinical outcomes?
9. Is MGRM solvent and will they be around in a few years?

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