Public Release:  Quantifying the FDA's rulemaking delays highlights the need for transparency

Researchers quantify how long it takes the FDA to enact a formal rule affecting drugs, medical devices and other health-related products

Brigham and Women's Hospital

In a study published in Health Affairs on February 3, 2014, Aaron Kesselheim, MD, JD, MPH, and co-authors, quantify how long it takes the FDA to enact a formal rule affecting drugs, medical devices and other health-related products.

The FDA frequently uses rulemaking to establish or modify the way it regulates the medical product marketplace. Rulemaking may also be required by Congress or be needed to correct a public health problem. The FDA's rulemaking is controversial because of its perceived complexity, lack of transparency and lengthy duration. To shed light on the FDA's rulemaking process, the authors examined the evolution of the most important rules that the agency published during 2000-12.

The authors write, "We found that the rules' median time to finalization was 7.3 years, with the pre-rule phase and post review deliberation." Rules that involve cost-benefit analysis were associated with additional delays. The authors recommend, "The FDA's rulemaking could be improved by allocating additional resources to improve efficiency and by embarking on initiatives to promote transparency by the FDA and other parts of the executive branch."

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Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 1,000 physician-investigators and renowned biomedical scientists and faculty supported by nearly $650 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH continually pushes the boundaries of medicine, including building on its legacy in transplantation by performing a partial face transplant in 2009 and the nation's first full face transplant in 2011. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information and resources, please visit BWH's online newsroom.

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