addressing lack of sponsor compliance (US House of Representatives Committee on Government Reform Minority Staff, 2006). The industry’s once sterling reputation has been blemished by reported compliance problems, delays in responding to safety concerns and complying with postmarketing commitments, highly publicized concerns about the effects of direct-to-consumer advertising, and the preponderance of “me-too” products, rather than truly pioneering therapies (PricewaterhouseCoopers Health Research Institute, 2005; Wall Street Journal and Harris Interactive, 2005). The integrity of the academic research enterprise has also been questioned, as universities and scientists are increasingly dependent on industry funding for their work. The behavior of prescribers, the gatekeepers for patient access to prescription drugs, are also under public and congressional scrutiny, as health care providers receive intense and targeted promotional (“detailing”) efforts of pharmaceutical companies.

Of particular concern are the common but inaccurate perceptions that FDA approval represents a guarantee of safety, that approval is based on a high degree of clarity and certainty about a drug’s risks and benefits, and that such safety actions as boxed warnings on drug labels and withdrawals reflect sponsor or agency failures.

Addressing weaknesses and missed opportunities in the drug safety system requires some fundamental changes in the organizational culture of CDER to support effective action on drug safety (Chapter 3), in the scientific approaches to drug safety (Chapter 4), in the regulations pertinent to drug safety (Chapter 5), in communication about drug safety (Chapter 6), and in the agency’s funding structure (which currently leaves critical regulatory and public health functions inadequately resourced) (Chapter 7).

Some of the recommendations offered in this report echo proposals made over the last two decades by various groups convened by the agency or by the Department of Health and Human Services (DHHS) (DHEW Review Panel on New Drug Regulation, 1977; Joint Commission on Prescription Drug Use, 1980; DHHS/FDA, 1999). It is puzzling and troubling that despite this series of reviews and recommendations, some have not been fully implemented and some issues have resurfaced repeatedly. A primary obstacle, the committee suspects, may be the chronic underfunding of core FDA activities owing to inadequate attention to resource needs by Congress and by the Office of Management and Budget. The committee asserts that the piecemeal organizational modifications and short-lived programmatic initiatives of the past and the current, seemingly fragmented and reactive initiatives to improve CDER are not sufficient to meet the need to improve postmarket drug safety activities and protect the public health better. The present report endeavors to provide an integrative approach to transforming drug safety in FDA and in the agency’s interactions with other stakeholders

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