Science and Safety - Pharmaceutical Executive


Science and Safety

Pharmaceutical Executive

Stress on Science

More consultation with outside experts fits the stated goal of commissioner Hamburg to position FDA as a science-based organization where politics doesn't override medical and technical judgment in making regulatory decisions. Hamburg hopes that these and other organizational and policy changes will deal effectively with internal disputes over product safety and approval decisions and avoid public controversies, such as that which delayed approval of an over-the-counter version of the Plan B emergency contraception pill.

One sign of the times is Hamburg's decision to bring new leadership to the Center for Devices and Radiological Health (CDRH). Veteran FDA official Dan Schultz resigned in August as CDRH director in the wake of several high-profile device safety cases, plus internal whistle blower complaints about management ignoring staff concerns regarding safety and efficacy testing of new products seeking market approval. FDA chief scientist Jesse Goodman has the task of ensuring scientific integrity in agency deliberations through a new office to resolve scientific disputes within the agency and to oversee advisory committees.

At the August meeting of FDA's Science Advisory Board, Hamburg highlighted the importance of strengthening regulatory science as an academic field, noting that it has atrophied compared to the surge in biomedical research investment by the National Institutes of Health and other research organizations. She acknowledged concerns about the slim pipeline for new drugs and medical products and emphasized the need to "revitalize and re-energize" support for the Critical Path Initiative. Another assignment for Goodman is to make the case for FDA support of high-quality scientific projects under Critical Path, along with personalized medicine and comparative effectiveness research.

Concerns about the "black box" aspects of FDA operations were raised by biotech companies and venture capitalists at a recent meeting with FDA officials and the White House Office of Science and Technology Policy. Hamburg agreed that a lack of transparency about the FDA review process and regulations can be "very stifling to innovation," while an increased focus on regulatory science can support development of new pharmaceutical products.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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