Biotech Values

[AlpineBV_Miller]

The FDA is being very careful about this as Congressional intent specifically denied them the ability to do comparative reviews. Where you are seeing it is in non-public meetings with sponsors and from advisory panel members who, while temp FDA employees, are not seen as representing the FDA in the eyes of Congress.

I'm surprised pharma didn't make a bigger push to deal with this (again) in PDUFA IV. Perhaps they were hoping the drug safety items they agreed to would lessen this trend.