Medicare Part D Sponsors Will Need Their Own Survey Data For Bidding, CMS Advises
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency is beginning to make certain data on drug use and spending by Medicare beneficiaries available to potential bidders, but CMS Chief Actuary Foster warns plans that the information will not be sufficient for plans to craft their bids.
You may also be interested in...
Endo’s Lidoderm Mailings Draw FDA Warning Letter For Unsubstantiated Claims
FDA asks Endo to disseminate “corrective messages” to doctors who received the violative promotional materials, which the agency says omit risk information and contain unsubstantiated effectiveness claims.
Efficacy Differences Within Drug Classes Unsupported By Data, FDA's Temple Says
Studies that look for differences in efficacy among members of the same drug class are only performed when necessary for approval, CDER Office of Medical Policy Director Temple tells DIA. While questioning the introduction of "follow-on" compounds, Temple also highlights AstraZeneca's success in achieving a more optimal dose for Nexium.
GSK Resumes Shipment Of Paxil CR, Plans 30-Day Free Trial Program To Relaunch
Paxil CR is back on pharmacy shelves after compliance concerns kept the antidepressant out of production for four months. The company expects to return Avandamet to the market within two weeks. FDA seized all lots of the products in March.