Regulatory Innovation: A Dialogue
This article was originally published in RPM Report
Center for Drug Evaluation & Research Deputy Director Douglas Throckmorton and AstraZeneca R&D President Martin Mackay took part in a moderated discussion of new initiatives and ideas for drug regulation during The RPM Report’s FDA/CMS Summit in Washington DC in December 2011. Here is a portion of that conversation, transcribed by The RPM Report and lightly edited for clarity.
You may also be interested in...
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.
FDA is entering a big legislative year with a good story to tell based on 30 new molecular entity approvals. But the level of submissions remains constant—suggesting it may be time to shift the focus from what comes out of FDA to what makes it in.
The Future of Drug Regulation: An Interview With Center for Drug Evaluation & Research Director Janet Woodcock
FDA’s top drug regulator sat down for us for an interview about the agency’s efforts to build a higher quality regulatory system in the US—one that focuses on the “content” of regulatory standards rather than just the process. The discussion touched on the need for new and improved standards in classes like weight loss and rheumatology (albeit for very different reasons); the characteristics that make for good drug reviewers (and their managers); and on the drug center’s responsibility for preserving private sector drug development.