identify adverse events and made a series of substantive recommendations to strengthen risk management. Some of the recommendations of the task force have been implemented, including the convening of public meetings to solicit input on drug safety and risk management from various constituencies.
Drug safety concerns have continued to emerge, as have the proposals to address them. Alosetron was withdrawn and then returned to market with restrictions and a label warning. Troglitazone, propulsid, cerivastatin, rofecoxib, and valdecoxib have been withdrawn. Celecoxib and other non-selective non-steroidal anti-inflammatory drugs had boxed warnings added to their labels. Warnings have been added to all antidepressant labels. FDA’s performance in approving drugs or monitoring their safety after approval has been questioned and criticized. Several major factors converged to create at the least the appearance of a crisis in drug safety, among them, CDER’s limited resources, organizational and management challenges, seemingly long reaction times, poor external communication, questions about external influences on CDER’s decision making, an ever more diverse information environment (news media, the Internet and the blogosphere, and advertising) coupled with increasing consumer awareness and engagement, and growing congressional concern.
The Committee on the Assessment of the US Drug Safety System believes that as more drugs are being approved faster with less time to intensively investigate premarketing safety data, FDA does not have adequate resources or procedures for translating preapproval safety signals into effective postmarketing studies, for monitoring and ascertaining the safety of new marketed drugs, for responding promptly to the safety problems that are discovered after marketing approval, and for quickly and effectively communicating appropriate risk information to the public. The committee is aware of promising components of the current drug safety efforts at CDER and of agency improvement initiatives (see Appendix A), but it believes that neither the agency’s newly enhanced postmarketing safety initiatives nor the necessary contributions of other actors in the US drug safety system are equal to the task. Major obstacles remain. They include inadequate resources, the complexity of the science and technology involved in drug development and regulation (e.g., assessing risk and benefit), a dysfunctional organizational culture, problems with credibility and public trust, and the lack of adequate communication about and limited public awareness of drug risks and benefits.
The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years (Kaiser Family Foundation, 2005; Wall Street Journal and Harris Interactive, 2005). FDA’s reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in