(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:
New study reveals gendered language patterns in children’s television across 60 years
Ancient fault line poses future earthquake hazard in Canada’s North
Scientists uncover DNA secrets to bolster corn crop traits
Hidden bacterial redundancy could be antibiotic game-changer
New study reveals how corals teach their offspring to beat the heat
Understanding relationship development: Towards a more rigorous approach
Surgical stroke initiative targets deadliest brain bleeds
Understanding how the superfungus Candida auris withstands antifungal treatment
Call for papers: CPA special issue on polypharmacology in cancer therapy—overcoming resistance and enhancing efficacy
An alternative adhesive for wearable medical devices
Pavlov’s dogs were conditioned to go to their treat. Why do some animals learn to interact with the bell instead?
Call for Young Editorial Board members at Current Molecular Pharmacology
MSU team develops scalable climate solutions for agricultural carbon markets
Playing an instrument may protect against cognitive aging
UNM study finds link between Grand Canyon landslide and Meteor Crater impact
Ultra-hot Jupiter’s death spiral could reveal stellar secrets
You only get one brain! The best helmet material for protecting your noggin
Neurodegeneration and stroke after GLP-1RAs in diabetes and obesity
Pediatric COVID-19 hospitalization trends by race and ethnicity, 2020-2023
Research spotlight: New genetic roadmap offers insights into obesity and diabetes
Fred Hutch leads new Vanguard Study for Cancer Screening Research Network
‘Mismatched’ transplants now safe, effective for blood cancer patients, study finds
New research helps narrow down uncertainties in near-term precipitation projections for the Asian Water Tower
AI tool accurately detects tumor location on breast MRI
Researchers use OCT imaging to uncover how the fallopian tube transports embryos
PolyU secures RGC theme-based research scheme funding to develop cost-effective and sustainable Co-GenAI model
Van Andel Institute scientists develop technique for high-resolution single cell epigenetic analysis
The Lundquist Institute wins multi-year NIH grant exceeding $11 million to transform diagnosis and treatment of deadly mucormycosis
Review suggests ending adult boosters for tetanus, diphtheria
ESMT Berlin welcomes Rebecca Schaumberg to faculty
[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