Drug safety and public health: Legislative changes to reform the FDA

The public health community has been actively engaged in the debate on how to improve the safety of pharmaceuticals in the US, and the APHA formally adopted a policy statement recommending FDA and system reform in 2006. This session sponsored by the Drug Policy and Pharmacy Services committee of the Medical Care Session addresses recent reform proposals from the Institute of Medicine (IOM) by engaging represenatives from Congress, the FDA, the industry, in a dialogue on the public health implications of these proposals. The IOM committee's report, The Future of Drug Safety – Promoting and Protecting the Health of the Public made a number of recommendations to improve drug review, safety surveillance, and related activities of the FDA Center for Drug Evaluation and Research (CDER). Since the release of the report, the FDA and the Pharmaceutical Industry have urged that drug review fees under the Prescription Drug User Fee Act (PDUFA) be increased to pay for the improved capacity of the FDA to monitor drug safety during a drug's lifecycle. However, many critics have called this an inadequate response to the problem of drug safety and have made a number of additional proposals. Some of these proposals have been the subject of legislation that is being debated in Congress. One of the most controversial issues is whether a new drug safety center should be created, and whether this center should be inside the FDA or fully independent of CDER's drug review and approval process. Other reform recommendations have included mandating more disclosure of clinical trial data, giving the FDA the authority to order rather than negotiating new labeling changes, requiring drug companies to carry out post-market safety studies, and prohibiting direct to consumer drug advertisements for a period of time after a new drug enters the market. The implications of these proposals will be discussed in detail by the various stakeholders, and more the recent legislative efforts at drug safety reform will also be described by a congressional representative.