FDA aims to encourage drug development; von Eschenbach nominated as permanent head

Last month FDA unveiled a long-awaited list of collaborative projects to streamline and accelerate the development of new medical treatments. Then Health and Human Services (HHS) Secretary Mike Leavitt joined Andrew von Eschenbach, MD, and Deputy Commissioner Janet Woodcock, MD, in urging implementation of the Critical Path initiative. Dr von Eschenbach, who hopes to oversee this effort as permanent FDA head following his official nomination to the position, says he is committed to fully implementing the initiative in order to "dramatically increase the success rate in moving products from the lab to the patient."

FDA launched the Critical Path initiative 2 years ago to reverse a downward trend in new drug approvals. A prime focus of this blueprint for modernizing drug research is to encourage the development of a new generation of predictive biomarkers, or measures of physiological characteristics, that can streamline clinical research and better ensure the safety and efficacy of new treatments while also promoting new research and development strategies.

SEEKING EVIDENCE

The ultimate goal is to pave the way to personalized medicine. "Instead of taking a pill and hoping it works effectively and safely," said Dr von Eschenbach, "results will be more certain and more affordable."

ASSESSING SAFETY

Many of the biomarker research projects described in the Critical Path initiative aim to enhance drug safety by identifying patients at high risk for serious drug side effects, such as cardiac arrhythmia. FDA officials have stated that research could identify biomarkers able to predict adverse reactions to vaccines, whether a cellular or tissue product will trigger an unwelcome human immune response, or whether a new compound will raise liver or kidney toxicity.

Additional proposals for biomarker identification aim to:

ADDRESSING PUBLIC HEALTH NEEDS

By modernizing clinical research processes, making better use of information technology, and encouraging innovation in drug formulation and production, FDA hopes to bring a range of needed treatments to patients more quickly.

Programs established under the Critical Path initiative will facilitate the development of:

CALL FOR COLLABORATION

FDA recognizes that government agencies and individual drug companies alone cannot address this broad range of research projects. By publishing this list of promising activities, the agency hopes it will encourage pharmaceutical companies to collaborate with each other and link up with research organizations to tackle these challenges. FDA expects to play an advisory role in such efforts, defining how partnerships may work and offering to evaluate results and develop policy guidances that can recommend new approaches that the researchers find to be effective.

One example of such a joint effort is the Predictive Safety Testing Consortium formed by the Critical Path (C-Path) Institute of Arizona with several major pharmaceutical companies. Participants will share information about internally developed pre-clinical laboratory test methods to determine if 1 company's approach is valid for others' products.

An initial project is to test a number of proprietary approaches for detecting kidney toxicity in a range of compounds in order to cross-validate which tests can identify drugs that do or do not cause nephrotoxicity. C-Path will submit the resulting data on effective test procedures to FDA, which will weigh whether the information supports agency guidance on new biomarkers and methods to detect kidney safety problems more accurately during drug development.

NOMINATION ON HOLD

Dr von Eschenbach's support for the Critical Path initiative and his success in tackling complex issues may not lead to speedy confirmation as FDA's permanent leader. He has been the acting head of FDA since former commissioner Lester Crawford, DVM, PhD, resigned in September 2005, and he has won praise for gaining needed resources for the agency. However, his decision to remain head of the National Cancer Institute while assuming the top job at FDA has drawn criticism. In addition, concerns about drug safety and the delay in approving an OTC version of the "morning-after pill," or Plan B, have contributed to his nomination being placed on hold in the Senate. Many pharmaceutical companies and other industries regulated by FDA strongly support this appointment, but Dr von Eschenbach will face a tough confirmation.

The Plan B controversy has plagued FDA for several years. Agency delays in approving an application to make the OTC pill available have undermined FDA's credibility and were a main reason Dr von Eschenbach's predecessor, Dr Crawford, had his nomination initially blocked by the Senate. Meanwhile, OTC versions have been approved by some states.

Jill Wechsler is a Washington-based reporter specializing in federal and state healthcare issues.