By Michael McCaughan
The idea of FDA/CMS collaboration makes plenty of folks in the biopharmaceutical industry nervous. Their fear is understandable: the specter of a direct pipeline between government reimbursement authorities and regulatory...
Second-Guessing FDA: CMS' Expanding Regulatory Role
Nothing gets biopharma policy watchers more worked up than the potential that the Centers for Medicare & Medicaid Services 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 FDA's jurisdiction-and the health care reform implementation is bringing more of those cases to the fore.
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