CDER Director Dr. Janet Woodcock discusses resource constraints and generic backlog at FDA, outlines proposals to streamline clinical trials – March 10, 2015

Dr. Janet Woodcock (Director, Center for Drug Evaluation and Research, FDA, Silver Spring, MD) sat down with Ms. Anne Rowzee of the Director’s Corner podcast to discuss the successes of 2014 – biosimilars, the Office of Pharmaceutical Quality, and generics – and the challenges and opportunities of 2015. Dr. Woodcock listed a number of challenges on her plate: limited resources coupled with the demands of congressional legislation (21^st Century Cures), a sizable backlog of generic drug reviews, and continued efforts to ensure better quality management. Still, she also named some promising developments expected at the center in 2015, including the development of a new IT platform to better manage and document decisions and the study of new protocols to cut down on waste and inefficiency in clinical trials and allow for more rapid testing and evaluation of new therapies. The conversation was quite forthright about the challenges ahead: CDER (like most government agencies) is clearly resource constrained and the backlog of generic reviews still consumes excess resources and time. However, if the years ahead bring significant progress toward improved clinical trial protocols, the field could eventually see a more streamlined evaluation process for new drugs with lower trial costs – something that is sorely needed in diabetes, where we worry about skyrocketing development costs driving many more companies away from the area (in addition to BMS and Genentech leaving the field, Novartis de-emphasizing it, and others). We also believe that despite the challenges of implementation, the 21^st Century Cures legislation could lead to some very meaningful reforms, including accelerated approvals, changes to CMS coverage, and updated social media regulation.

• Dr. Woodcock listed biosimilars, the Office of Pharmaceutical Quality, and generics as her top three successes of 2014. She cited the FDA’s first review of a biosimilar application as a major step forward – while insulin formulations like Lilly’s Basaglar (insulin glargine) are not technically considered biosimilars by the FDA, their arrival will certainly be one aspect of the trend toward increased competition for biologic drugs. Dr. Woodcock also hailed the launch of the new Office of Pharmaceutical Quality (OQP) as a major reorganization of quality functions that will hold all drugs to equal, high quality standards. Finally, she cited new steps to bring more generics to the market, including the formation of a new Office of Generic Drugs and a new IT platform to more efficiently manage the hundreds of generic applications the FDA receives each year.
• Dr. Woodcock expressed the need for a better IT platform to handle the timing, documentation, recording and workflow of the thousands of decisions her center makes each week. She recognized the time, sweat, and energy that is needed to make such a transformation but noted “if it had been done 10 years ago, we’d be in so much better a place now.” There is little room to argue with this. We applaud the FDA for its recent efforts, though it is somewhat depressing to think of where the Agency could be by now if it had had adequate structure and financial resources to implement these changes a decade ago.
• According to Dr. Woodcock, reforming the clinical trial system is a major goal for CDER in the coming years. We were thrilled to hear her acknowledge the enormous wastefulness of the current system, particularly the need to set up entirely new infrastructure for each individual trial. She mentioned that the FDA is currently designing “master protocols” in which dedicated groups of investigators would run trials continuously and evaluate multiple products at once; while such groups would receive broad industry funding, the paradigm would shift away from individual companies funding trials for their specific products, hopefully alleviating public concerns about trial independence. Such reforms would certainly represent an improvement over the current expensive and unwieldy system; other potential solutions in our view include (i) the use of large patient registries to replace randomized clinical trials in some cases; and (ii) conditional approval pathways, in which drugs could be approved for a specific subset of patients without needing to demonstrate a favorable risk/benefit profile in the general population.

--  by Maxwell Votey, Emily Regier, and Kelly Close