- Strengthening the science that supports the FDA’s medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management. Related FDA initiatives include developing new scientific approaches to detecting,understanding, predicting, and preventing adverse events, developing and incorporating new quantitative tools in the assessment of benefit and risk, and conducting a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis.
- Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products. Related FDA initiatives include the establishment of an advisory committee to provide input to improve the agency’s risk communication policies and practices, conducting a comprehensive review of current public communication tools and developing a comprehensive risk communication strategic plan.
- Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system. Related FDA initiatives include engaging external management consultants to help the Center for Drug Evaluation and Research (CDER) develop a comprehensive strategy for improving CDER’s organizational culture, and making specific organizational and management changes to increase communications among review and safety staff.
I am no expert on drug safety but I expect that follow-up studies on recently approved drugs would prove valuable, particularly in view of the Vioxx fiasco.
On February 1, 2007, Sen. Ted Kennedy (D Mass.) and Michael Enzi (R. Wyo.), the chair and ranking member of the Senate’s Health, Education, Labor, and Pensions Committee re-introduced a drug safety bill (S. 484). According to a press release, Senator Kennedy and Senator Enzi hope to report out a bill addressing the drug user fee reauthorization, drug safety, and three other FDA reauthorizations shortly after Easter, for consideration on the Senate floor by late spring, and a conference with the House with final passage before the August recess. The FDA drug approval user fee program must be renewed this year which provides a further impetus for this bill.