FDA Responds to IOM Recommendations
Last week, the FDA responded to the Institute of Medicine's 2006 report entitled "The Future of Drug Safety: Promoting and Protecting the Health of the Public." In the FDA's press release, the FDA noted plans to increase drug safety by taking actions in support of the following (as taken directly from the press release):
- 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;
- 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; and
- 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.
- 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.
This blog allows for the reader to understand some of the background on the FDA safety requirements for the production of pharmaceuticals. The careful observations are made, highlighting special bills in congress that amend FDA standards for pharmaceuticals entering the market. Additionally, I would like to respond to a quote made by William K. Hubbard regarding the safety of pharmaceuticals that I believe is relevant to this discussion "If you're going to be serious about drug safety, you've got to spend the money. You can't do this on the cheap." To this quote I would like to say that safety reform is indeed expensive, but we must understand the propelling forces that drive pharmaceuticals corporations, along with all corporations; profit. What the government must address is the underlying dichotomy between profit and quality. Although this issue is potentially complicated, a government program that subsidizes the profits lost by a manufacturing corporation while conducting research at above usual standards may help alleviate the problems faced by corporations today.