FDA “Flexibility” Presages Good Climate in 2012 for Approval Decisions, Shortage Situations
This article was originally published in RPM Report
Executive Summary
As FDA girds for the Capitol Hill phase of the user fee reauthorization push in 2012, the agency is projecting an image as a flexible problem-solver. FDA’s underlying message: the agency has sufficient authority and does not need tinkering with the legislative mandate. From the drug industry’s perspective, a continued stress on flexibility through the first nine months of the year could create a favorable climate for application reviews and for resolving lingering manufacturing issues.
You may also be interested in...
Genentech’s Cancer Product Line Expands, As Do Its Post-Market Manufacturing Obligations
Genentech appears to be having significant manufacturing problems for some of its new cancer therapies. FDA hasn’t taken enforcement action yet, but the agency has delayed two approvals and tied them to post-market requirements to address QC issues.
Lone Wolfe: Drug Industry Critic Ends Tenure As Advisory Committee Member With Rare Decisive Vote
Sidney Wolfe’s stint as permanent member of the Drug Safety and Risk Management Advisory Committee ended May 31; his final meeting was the May 23 review of Xarelto for ACS. That gave him a second chance to vote against the product. A look back at Wolfe’s tenure shows he was a sure “no” vote when he sat on a panel—but that his service can hardly be construed as having damaged the industry.
Prometheus Rebound: Where Weak Patents Can Benefit Pharma
Biotech and pharma companies were disappointed when the Supreme Court limited patent rights surrounding personalized medicine. But the ruling may end up simplifying the path to adoption of targeted therapies by reaffirming a much more critical point: the therapeutic—not the diagnostic—is the dominant partner.