Rosen Comments on Report That Found Flaws in FDA Drug Approval Process

Partner David Rosen was quoted in a Modern Healthcare article, “Federal investigation finds holes in orphan drug approval process,” about an investigation by federal regulators that found fault with the U.S. Food and Drug Administration’s process for approving so-called orphan drugs.

While the report suggests there may be holes in the agency’s documentation process, Rosen said, that doesn’t mean that FDA reviewers aren’t weighing the impact of a drug’s regulatory or marketing history. “The fact that maybe all the i’s aren’t dotted or t’s aren’t crossed is a technical claim, but whether it has a true material bearing is another story,” he said.