The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]
CMS to Congress: “We Do Not Plan to Finalize” Certain Controversial Medicare Part D Proposals – All “Protected Classes” Will Remain Protected. For Now.
Yesterday, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Marilyn Tavenner responded to several Congressional concerns regarding CMS’ recent proposed rule on the Medicare Part D outpatient prescription drug benefit. We previously reported on that proposed rule here. In a Letter to Representative Sander Levin, Ranking Member of the House […]