Accelerating Drug Discovery And Development By Creating A More Effective, Efficient FDA

By Creating A More Effective, Efficient FDA Author: Karl A. DeSante Without question, one of the most important endeavors facing the United States pharmaceutical industry is reforming the drug-review process at the Food and Drug Administration (FDA). Changes to help streamline the regulatory process can help ensure financial underpinning for ongoing research and innovation, and decrease the cost of medications while increasing the speed with which effective new drugs reach physicians and patients. These benefits of accelerating drug discovery and development are significant, and my colleagues at the American Association of Pharmaceutical Scientists (AAPS) and I feel it is time for scientists to come together to lay the groundwork for reform in order to help the FDA help itself. With all of the changes that need to be made, however, the agency's paramount objective should always remain to protect the public health. Reform should speed up the regulatory process without compromising the confidence that the American public, and indeed the world, feel toward FDA decisions on drug safety and efficacy. I believe this is achievable by focusing on the following: Establishing risk assessment as a guiding principle for the disposition of new products in terms of the process for development and eventual approval. Creating international cooperation and harmonization in drug development and approval, and providing incentives for new innovations and technology. Separating regulatory elements (approval for marketing) from pre-market evaluation and review and from post-market review. Delegating some or all of the technical and scientific functions of the review process to non-governmental bodies. Establishing an open, interactive and -- most important -- flexible process for review and approval; a system that can incorporate change based on sound scientific principles and judgment. These recommendations were discussed in detail at the recent AAPS annual meeting and exposition in Miami Beach. The focus of the event was "Accelerating Drug Discovery and Development," and visiting scientists heard W. Leigh Thompson, recently retired as chief financial officer of Eli Lilly and Co. in Indianapolis, explain how the pharmaceutical industry is changing to meet the demands for cost containment and faster drug development while facing several significant obstacles. Specifically, Thompson raised his concerns about "regulatory creep," which refers to the pattern of adding (well-intentioned) incremental steps and regulations to the review process year after year while never taking anything off. To fully understand what these incremental burdens mean in terms of time, energy, and money, you only have to look at the new drug application for Prozac: 2.5 million pages, the equivalent of 240 copies of all of Shakespeare's work. Scientists were also able to share their opinions and feedback with all of the participants during a session entitled "Drug Regulatory Reform." Specific calls to action included the need for uniformity in inspections and to initiate a frank discussion about privatizing components of the review process. Many scientists called for FDA to implement quality management -- to identify who its customers are and serve them better. Certainly, FDA's overriding mission is to protect and serve Americans, but many scientists feel the agency should also recognize that in order to fulfill this mission FDA needs to work more effectively and efficiently with drug companies and researchers. During several discussions, I heard scientists commenting on the importance of revising FDA's charter to acknowledge the intimate relationship between the regulatory process and economic competitiveness. After careful consideration, I, too, feel that this is a critically important step toward an effective and efficient agency. In the coming months, AAPS will issue specific recommendations for reforming new drug research, approval for drugs and biologics for marketing, and FDA harmonization and performance accountability. In order to obtain the assistance and support of the administration and Congress, we will require industry- wide cooperation. I urge all of the members of the scientific community to express their sentiments regarding the importance of this issue to your colleagues and peers. By organizing efforts that reach policymakers, the entire industry can speak in unison in its call for change. If we combine our efforts, I am confident we will succeed in establishing positive reform that will fortify FDA's position as the most scientifically sound and efficient drug regulatory agency in the world. I encourage members of the scientific community to contact AAPS to learn more about its initiatives for reform. The association can be reached at (703) 548-3000 or by visiting its Internet site: http://www/cpb.uokhsc.edu/aaps/aaps.html. Researchers are also invited to contact me by E-mail at: theprez@aaps.org. Karl A. DeSante is senior research scientist at Lilly Laboratories in Indianapolis and president of the American Association of Pharmaceutical Scientists.

Accelerating Drug Discovery And Development By Creating A More Effective, Efficient FDA

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