Michael Mccaughan

Nothing gets biopharma policy watchers more worked up than the possibility that the Centers for Medicare & Medicaid Services (CMS) will second-guess FDA approval decisions. In reality, though, CMS often has no choice but to apply its own interpretation to issues that also fall under the FDA’s jurisdiction-and implementation of the health care reform is bringing more of those cases to the fore.

Second-Guessing FDA: CMS’ Expanding Regulatory Role