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:

KAIST Develops Retinal Therapy to Restore Lost Vision​

Adipocyte-hepatocyte signaling mechanism uncovered in endoplasmic reticulum stress response

Mammals were adapting from life in the trees to living on the ground before dinosaur-killing asteroid

Low LDL cholesterol levels linked to reduced risk of dementia

Thickening of the eye’s retina associated with greater risk and severity of postoperative delirium in older patients

Almost one in ten people surveyed report having been harmed by the NHS in the last three years

Enhancing light control with complex frequency excitations

New research finds novel drug target for acute myeloid leukemia, bringing hope for cancer patients

New insight into factors associated with a common disease among dogs and humans

Illuminating single atoms for sustainable propylene production

New study finds Rocky Mountain snow contamination

Study examines lactation in critically ill patients

UVA Engineering Dean Jennifer West earns AIMBE’s 2025 Pierre Galletti Award

Doubling down on metasurfaces

New Cedars-Sinai study shows how specialized diet can improve gut disorders

Making moves and hitting the breaks: Owl journeys surprise researchers in western Montana

PKU Scientists simulate the origin and evolution of the North Atlantic Oscillation

ICRAFT breakthrough: Unlocking A20’s dual role in cancer immunotherapy

How VR technology is changing the game for Alzheimer’s disease

A borrowed bacterial gene allowed some marine diatoms to live on a seaweed diet

Balance between two competing nerve proteins deters symptoms of autism in mice

Use of antifungals in agriculture may increase resistance in an infectious yeast

Awareness grows of cancer risk from alcohol consumption, survey finds

The experts that can outsmart optical illusions

Pregnancy may reduce long COVID risk

Scientists uncover novel immune mechanism in wheat tandem kinase

Three University of Virginia Engineering faculty elected as AAAS Fellows

Unintentional drug overdoses take a toll across the U.S. unequally, study finds

A step toward plant-based gelatin

ECMWF unveils groundbreaking ML tool for enhanced fire prediction

[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