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Science at the FDA: Improving the scientific basis of regulation through collaboration with "stakeholders"

April 5, 1999

Bernard A. Schwetz, Susan A. Homire, and James T. MacGregor, U.S. Food and Drug Administration, Rockville, MD (1)

Science and technology are advancing at an extraordinary pace, and industry and government alike face the challenge of maintaining the scientific expertise and resources, necessary to remain current with new technologies. Indeed, FDA's effectiveness in assuring the safety and efficacy of regulated products depends on meeting this challenge. Yet, it is becoming increasingly difficult to maintain, and even harder to enhance, the necessary resources within the FDA to bring new scientific knowledge and technology to bear on the issues that will arise from the diverse array of new products introduced in the next decade. As industry faces increased pressure to reduce development times, regulatory agencies such as FDA are being asked to increase the efficiency of their review and approval processes. The increased pressure for rapid review has made it more difficult for FDA to maintain its science base and for the scientific developments. In many areas, review staff lack the time and/or the opportunity to stay fully up-to-date on the technologies they are being asked to evaluate.

Dr. Jane Henney, FDA's new Commissioner, recognizes the need to maintain a strong science base and sees this as a critical time for review of our science resources as she begins to prepare the agency for its responsibilities into the next century. Dr. Henney has made the restoration and enhancement of FDA's science base one of her top priorities. To meet these challenges, FDA must find novel approaches to maintaining and acquiring needed expertise and resources. These approaches are likely to include an increased reliance on knowledge and resources from outside the agency. Many factors have created a need for increased cooperation and communication between the FDA and its constituencies. The Food and Drug Administration Modernization Act (FDAMA) of 1997 providesa strong impetus for interaction with "stakeholders," the "appropriate scientific and academic experts, health care professionals, representatives of patient and advocacy groups, and the regulated industry." This emphasis is a result of the increased recognition that there are synergistic benefits when government, industry, universities, and the public work together toward common goals. This recognition has been supported by recent legislation and has resulted in an increasing number of successful collaborations. In this environment, scientific societies such as ASPET will have the opportunity to play an increasingly important role in facilitating the collaborative interactions to advance science and regulation.

One example of leadership that may be taken by a scientific society is the formation of the Product Quality Research Institute (PQRI) under the umbrella of the American Association of Pharmaceutical Scientists (AAPS). PQRI will be a nonprofit foundation that serves as a vehicle for FDA, industry, and university collaboration to address key issues in pharmaceutical product quality through research and expert group analysis. This collaborative effort is expected to benefit the industry, FDA, and consumers by providing publicly available data to support regulatory policy in the area of product quality.

The series of ICH (2) conference is an example of highly successful collaboration between regulatory bodies and industry organizations from the three major pharmaceutical-producing sectors of the world (North America, Europe, and Japan) to harmonize recommendations for information to support the approval of new pharmaceuticals. These conferences were extraordinary successful, and achieved a worldwide set of uniform recommendations in the areas of efficacy, safety, and quality that had previously been disparate.

Other examples of successful stakeholders collaborations include both ad hoc and legislatively mandated activities. The Federal Technology Transfer Act of 1986 (Public Law 99-502) encourages government/industry collaborations on technology development and authorizes Cooperative Research and Development Agreements (CRADA's) between government and private industry. Although regulatory agencies must avoid conflicts of interest when collaborating with regulated companies, there are many areas of common interest where collaboration is possible.

There are a number of successful CRADAs currently in place, including (1) a CRADA between the Center for Drug Evaluation and Research (CDER) and MULTICASE, Inc., to develop structure-based predictive software for prediction of drug toxicities based on CDER's database of known drug-related toxicities; the resulting databases and software strategies provide important tools for use in regulatory decision-making, (2) a CRADA between CDER and Boehringer-Ingelheim Pharmaceuticals that supports the development of a mouse model of skin carcinogenesis exhibiting accelerated tumor development, allowing for earlier and more economical identification of the carcinogenic potential of chemicals, and (3) a CRADA between the National Center for Toxicological Research (NCTR) and industry to determine the binding affinity of chemicals to the estrogen receptor, together with a proposed Interagency Agreement between the FDA and the EPA, to develop an endocrine disruptor knowledge base. These examples of collaboration between FDA, industry, and EPA illustrate the benefits that can be derived from cooperation between regulatory agencies and external constituencies.

FDA has recently implemented a major collaborative undertaking with the University of Maryland, the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), to support a joint research program between university and FDA scientists in the area of food safety. A similar agreement between the FDA and the Illinois Institute of Technology Research Institute (National Center for Food Safety and Technology) provides a setting for researchers from FDA, academia, and industry to work collaboratively and/or independently on product development and food safety issues. These initiatives serve as models for interactions between scientists of the FDA, industry and academia.

A new collaborative effort, still in its formative stages, is the Collaboration for Drug Development Improvement, involving FDA' Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization(BIO), and universities. This effort seeks to improve the scientific basis of the drug development process through collaborative research and the use of joint technical committees for recommendations on drug development information to support regulatory approvals.

We are pleased that the American Society for Pharmacology and Experimental Therapeutics (ASPET) has begun discussions with the FDA about ways of working together to facilitate collaborative interactions. Dr. Henney strongly endorses the kinds of collaborative efforts described in this article to improve the scientific infrastructure of the FDA and thereby improve the process for making high quality regulatory decisions. We hope that periodic contributions to The Pharmacologist by FDA staff and ASPET members on issues of mutual interest will stimulate these types of productive scientific exchanges and lead to further collaborative efforts.

For further information about FDA's science programs and collaborations, see Science@FDA on this Website or contact the FDA Office of Science at 301-827-3340.

1. Dr. Schwetz is Interim Chief Scientist of the Food and Drug Administration and Director of the National Center for Toxicological Research. Dr. Homire is a Senior Science Policy Analyst in the FDA Office of Science. Dr. MacGregor is Director of the Office of Testing and Research, Office of Pharmaceutical Science, in the FDA Center for Drug Evaluation and Research.

2. International Conferences on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use

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