Feature Articles

What Will CMS Do With Avastin In Breast Cancer? / With FDA’s decision to pull the indication for Avastin in breast cancer, CMS is now waiting and watching for residual use patterns. / The RPM Report February 2012

Biosimilars: Inverting the Innovator Development Model / When it comes to the new biosimilar pathway, it’s the IND—not the BLA—that matters. / The RPM Report February 2012

Secondary Uses of Sentinel / FDA’s new drug safety surveillance system is up and running, though the implications for safety oversight are only just beginning to be felt. But the conversation is already under way about what else Sentinel can do—and the answers may be very important to the future of drug regulation. / The RPM Report February 2012

FDA Beat

Primatene Mist – Adventures in Tangents at User Fee Hearings / It’s hard to anticipate what will come up in the user fee hearing process. / The RPM Report February 2012

CMS Beat

Coverage With Evidence Development and Expedited Approvals: Policy Proposals For FDA and CMS / Based on stakeholder consultations, former FDA and CMS head Mark McClellan and former CMS official Sean Tunis present a potential upside for biopharma in broader use of Medicare coverage with evidence development. Pfizer executives participate in workshop on coordinating expedited drug approval, CED policies. / The RPM Report February 2012

Street Smarts

Biotech Stocks and Advisory Committees: No News Is Good News? / Consider these two datapoints: In the first six weeks of 2012, the US Food & Drug Administration approved six novel molecules, and five were approved without going before an advisory committee. Meanwhile, FDA’s drug center held four meetings to review pending NDAs, and all four ended in overwhelming votes against approval. / The RPM Report February 2012

Pointed View

Re-Earning the Public Trust / Pharma has made big changes in marketing and promotion practices and the systems to assure compliance, but the industry’s ethical image is lagging the efforts at reform. Pfizer Specialty Care/Oncology President Geno Germano says a shared commitment among companies to convince the public of the impact of the industry’s compliance reforms is the key to a healthy environment for the industry. / The RPM Report February 2012