(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.
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
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:
iRECODE: A new computational method that brings clarity to single-cell analysis
New NUS-MOH study: Singapore’s healthcare sector carbon emissions 18% lower than expected, a milestone in the city-state’s net zero journey
QUT scientists create material to turn waste heat into clean power
Major new report sets out how to tackle the ‘profound and lasting impact’ of COVID-19 on cardiovascular health
Cosmic crime scene: White dwarf found devouring Pluto-like icy world
Major report tackles Covid’s cardiovascular crisis head-on
A third of licensed GPs in England not working in NHS general practice
ChatGPT “thought on the fly” when put through Ancient Greek maths puzzle
Engineers uncover why tiny particles form clusters in turbulent air
GLP-1RA drugs dramatically reduce death and cardiovascular risk in psoriasis patients
Psoriasis linked to increased risk of vision-threatening eye disease, study finds
Reprogramming obesity: New drug from Italian biotech aims to treat the underlying causes of obesity
Type 2 diabetes may accelerate development of multiple chronic diseases, particularly in the early stages, UK Biobank study suggests
Resistance training may improve nerve health, slow aging process, study shows
Common and inexpensive medicine halves the risk of recurrence in patients with colorectal cancer
SwRI-built instruments to monitor, provide advanced warning of space weather events
Breakthrough advances sodium-based battery design
New targeted radiation therapy shows near-complete response in rare sarcoma patients
Does physical frailty contribute to dementia?
Soccer headers and brain health: Study finds changes within folds of the brain
Decoding plants’ language of light
UNC Greensboro study finds ticks carrying Lyme disease moving into western NC
New implant restores blood pressure balance after spinal cord injury
New York City's medical specialist advantage may be an illusion, new NYU Tandon research shows
Could a local anesthetic that doesn’t impair motor function be within reach?
1 in 8 Italian cetacean strandings show evidence of fishery interactions, with bottlenose and striped dolphins most commonly affected, according to analysis across four decades of data and more than 5
In the wild, chimpanzees likely ingest the equivalent of several alcoholic drinks every day
Warming of 2°C intensifies Arctic carbon sink but weakens Alpine sink, study finds
Bronze and Iron Age cultures in the Middle East were committed to wine production
Indian adolescents are mostly starting their periods at an earlier age than 25 years ago
[Press-News.org] Quantifying the FDA's rulemaking delays highlights the need for transparencyResearchers quantify how long it takes the FDA to enact a formal rule affecting drugs, medical devices and other health-related products