PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

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

2014-02-04
(Press-News.org) Contact information: Jessica Maki
jmaki3@partners.org
617-525-6373
Brigham and Women's Hospital
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 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."

### 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.


ELSE PRESS RELEASES FROM THIS DATE:

Scientists call for screening mammography every 2 years for most women

2014-02-04
Adoption of new guidelines recommending screening ...

Mood-stabilizing drug could treat inherited liver disease, says Pitt/Children's team

2014-02-04
PITTSBURGH, Feb. 3, 2014 – Opening up a can of worms is a good way to start hunting for new drugs, recommend researchers from Children's Hospital ...

New technique makes 'biogasoline' from plant waste

2014-02-04
Gasoline-like fuels can be made from cellulosic materials such as farm and forestry waste using a new process invented by chemists at the University of California, Davis. The process could open up new markets ...

Perceived control reduces mortality risk at low, not high, education levels

2014-02-04
The less education you have, the more your attitude counts when it comes to staying alive and well. That's the finding of a new study conducted by personality ...

Smithsonian reports fiery-red coral species discovered in the Peruvian Pacific

2014-02-04
A new coral species, Psammogorgia hookeri, has been collected by scuba divers from rocky ledges at depths to 25 meters in Peru's Paracas National Reserve. The corals' hand-sized ...

Diamond film possible without the pressure

2014-02-04
Perfect sheets of diamond a few atoms thick appear to be possible even without the big squeeze that makes natural gems. Scientists have speculated about it and ...

New maps highlight habitat corridors in the tropics

2014-02-04
Falmouth, Mass. – A team of Woods Hole Research Center (WHRC) scientists created maps of habitat corridors connecting protected areas in the ...

Local foods offer tangible economic benefits in some regions

2014-02-04
Despite their typically small size and sparse distribution, farms that sell their products locally may boost economic growth in their communities in some regions of the U.S., according to a team of economists. "There ...

Solving a physics mystery: Those 'solitons' are really vortex rings

2014-02-04
The same physics that gives tornadoes their ferocious stability lies at the heart of new University of Washington research, and could lead to a better understanding of nuclear dynamics in studying fission, ...

US should revisit media policy on China in light of growing Chinese digital media industry

2014-02-04
HOUSTON – (Feb. 3, 2014) – Chinese protectionism in the digital media sphere has created a major underdiscussed trade gap between China and the United States, and the U.S. government must ...

LAST 30 PRESS RELEASES:

AI can spot which patients need treatment to prevent vision loss in young adults

Half of people stop taking popular weight-loss drug within a year, national study finds

Links between diabetes and depression are similar across Europe, study of over-50s in 18 countries finds

Smoking increases the risk of type 2 diabetes, regardless of its characteristics

Scientists trace origins of now extinct plant population from volcanically active Nishinoshima

AI algorithm based on routine mammogram + age can predict women’s major cardiovascular disease risk

New hurdle seen to prostate screening: primary-care docs

MSU researchers explore how virtual sports aid mental health

Working together, cells extend their senses

Cheese fungi help unlock secrets of evolution

Researchers find brain region that fuels compulsive drinking

Mental health effects of exposure to firearm violence persist long after direct exposure

Research identifies immune response that controls Oropouche infection and prevents neurological damage

University of Cincinnati, Kent State University awarded $3M by NSF to share research resources

Ancient DNA reveals deeply complex Mastodon family and repeated migrations driven by climate change

Measuring the quantum W state

Researchers find a way to use antibodies to direct T cells to kill Cytomegalovirus-infected cells

Engineers create mini microscope for real-time brain imaging

Funding for training and research in biological complexity

The Journal of Nuclear Medicine Ahead-of-Print Tip Sheet: September 12, 2025

ISSCR statement on the scientific and therapeutic value of human fetal tissue research

Novel PET tracer detects synaptic changes in spinal cord and brain after spinal cord injury

Wiley advances Knowitall Solutions with new trendfinder application for user-friendly chemometric analysis and additional enhancements to analytical workflows

Benchmark study tracks trends in dog behavior

OpenAI, DeepSeek, and Google vary widely in identifying hate speech

Research spotlight: Study identifies a surprising new treatment target for chronic limb threatening ischemia

Childhood loneliness and cognitive decline and dementia risk in middle-aged and older adults

Parental diseases of despair and suicidal events in their children

Acupuncture for chronic low back pain in older adults

Acupuncture treatment improves disabling effects of chronic low back pain in older adults

[Press-News.org] 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