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CDER 2007 Update
Director’s Message
I am happy to present the CDER 2007 Update, which documents the Center for Drug Evaluation and Research’s activities and performance across program areas. CDER’s continued ability to carry out its mission of protecting and advancing America’s health rests squarely on the commitment of our talented and dedicated staff.
CDER continues to work to assure that medicines are safe, effective and available to the public, and to provide clear and easily understandable drug information to health professionals, patients and consumers. Our ability to carry out this mission has been bolstered by recent legislation.
On September 27, President George W. Bush signed into law the Food and Drug Administration Amendments Act (FDAAA) of 2007. This new law is a significant addition to FDA authority.
FDAAA reauthorized and expanded the Prescription Drug User Fee Act (PDUFA) to ensure that CDER has the resources needed to conduct complex and comprehensive drug reviews and to provide more resources for drug safety activities. Two other important laws were reauthorized; the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Both laws encourage more research into developing treatments for children.
A number of our 2007 initiatives were in response to a comprehensive report on the nation’s drug safety system that we asked the Institute of Medicine (IOM) to conduct. We have taken steps to put many of IOM’s recommendations in place, including establishing a new advisory committee to address how we communicate information about the efficacy, safety and use of drugs and other FDA-regulated medical products.
On June 4, 2007, FDA established a Risk Communication Advisory Committee, as suggested by IOM and endorsed in the FDAAA. The committee is comprised of practitioners and experts in risk communications. These highly-qualified individuals will play a vital role in helping us improve our practices, procedures and programs. As a result of these efforts, consumers and health-care professionals can make better-informed decisions about the risks and benefits of all regulated products.
Safety First/Safe Use
When I assumed the role of Acting Director of CDER in October 2007, I announced an initiative called Safety First/Safe Use. This initiative builds on authorities and opportunities provided by the FDAAA. These authorities further establish our critical role in assuring the safe and appropriate use of drugs after they are marketed and gives us substantial resources and regulatory tools. Essentially, FDAAA supports our ability to manage safety throughout the entire life cycle of pharmaceutical products.
We have been tremendously successful in developing a world-class pre-market review process. This process enables us to approve safe and effective drugs effectively and efficiently without sacrificing the quality of our reviews. Over the past 15 years, additional resources and commitments resulting from PDUFA brought unprecedented accountability to the new drug review and institutionalized project management, prioritization and tracking for pre-market drug review. Now we are going to apply the same high standards to managing the post-marketing safety process.
Safety First refers to steps that strengthen and modernize our internal policies and processes to manage significant drug safety issues. Safe Use describes CDER’s mission to expand partnerships with other components of the health care system to ensure that medicines are used safely and appropriately.
The specific objectives of Safety First are to:
- Create and maintain a collaborative, multidisciplinary, team-based approach to the review of drug safety.
- Apply our world class project management skills to make sure we have the same focus on and attention to post-market safety issues as we do to drug development.
- Align our policies and processes to ensure that the most appropriate and best-qualified experts lead or have an equal voice in regulatory decisions.
- Build the scientific, administrative and technological capacity to carry out the provisions of FDAAA and PDUFA IV.
- Ensure that significant post-market safety issues are our highest priority.
As we put these changes in place, we will also begin focusing on the longer-term goal of influencing the safe and appropriate use of drugs by the healthcare system. The preliminary objectives of the Safe Use initiative are to:
- Develop a cutting-edge pharmacovigilance system for evaluating drug performance using electronic health data.
- Collaborate with stakeholders in the healthcare system to devise effective, efficient steps to ensure drugs are used as appropriately as possible, in ways that minimize medical errors and manage risks aggressively.
Critical Path Initiative
Several years ago, we launched the Critical Path Initiative. This initiative was designed to bridge the gap between basic scientific research and the medical product development process. It called for a collaborative cross-sector effort to modernize the drug development process.
The Critical Path Initiative has rapidly matured and is now poised to yield benefits. Today, we are building on our unique position to work with outside stakeholders to identify areas ripe for improvement, and to coordinate, develop and/or disseminate solutions to scientific hurdles that are impairing the efficiency of developing and evaluating regulated products.
Many critical path tools, such as new biomarkers and more informative clinical trial designs produce enhanced information about the safety and efficacy of the product. This is information that health-care providers can use to tailor therapies to the individual needs of patients.
For example, better methods for selecting patients and assessing their responses during a clinical trial can translate directly to better methods of diagnosing and monitoring patients in the clinic, and better methods for targeting treatments to the patients who are most likely to benefit. Such tools will help bring individualized medicine into the physician’s office and help to shape the medical practice of the future.
Posted descriptions of some of our Critical Path activities are on our Web site. We will be adding new activities as they begin to take shape.
CDER’s initiatives hold the potential to usher in a new era of certainty and predictability in the development and performance of products that we regulate. We are extremely proud of the work outlined in this CDER 2007 Update. The ultimate beneficiaries of our efforts will be the public whom we serve.
Janet Woodcock, M.D.
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Date created: July 31, 2008 |
