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:

Corday Selden selected for the Oceanography Society Early Career Award

MIT chemists determine the structure of the fuzzy coat that surrounds Tau proteins

Same moves, different terrain: How bacteria navigate complex environments without changing their playbook

Severe weather is deadly for vulnerable older adults long after the storm ends, study finds

Expert panel highlights opportunities for improving cancer studies

Hearing aid prescriptions not associated with changes in memory and thinking

Seth Zippel selected for The Oceanography Society Early Career Award

Jeremy Horowitz selected for The Oceanography Society Early Career Award

Kennesaw State University’s Jerry Mack named Paul “Bear” Bryant Newcomer Coach of the Year

Ancient teeth are treasure troves of data on Iron Age lifestyles

Avocados may become easier to grow in India—but not if global emissions remain high

Pregnant women with IBD show heightened inflammation in vaginal mucosa

Underwater photos show seabirds, seals and fish interacting with a tidal turbine in Washington State

1 in 5 surveyed UK adults who have experienced the death of a pet report it as more distressing than experienced human deaths, with significant rates of prolonged grief disorder symptoms also being re

Polyester microfibers in soil negatively impact the development of cherry tomato plants in experiments, raising concerns over the potential effect of high levels of such contaminants

LGBTQ+ adults may be around twice as likely to be unemployed or to report workforce non-participation compared to heterosexual adults, per large representative Australian survey

Horses can smell fear: In experiments where horses smelled sweat from scared humans, they reacted to scary and sudden events with increased fear and reduced human interaction

New synaptic formation in adolescence challenges conventional views of brain development

Scientists identify target to treat devastating brain disease

Oliver Zielinski selected as Fellow of The Oceanography Society

Has progress stalled on gender equality at work?

Quantum simulator sheds light on how nature moves energy in systems like photosynthesis and solar conversion

Can a hashtag help prevent atrocities? Study shows social media can be a powerful tool

The American Ornithological Society (AOS) announces the winner of the 2025 Wesley Lanyon Award

Woolly rhino genome recovered from Ice Age wolf stomach

An earthquake on a chip: New tech could make smartphones smaller, faster

New research shows how AI tools are expanding individual capabilities while contracting scientific attention

A nanomaterial flex — MXene electrodes help OLED display technology shine, while bending and stretching

Global research team uncovers mechanism by which metabolites guide cellular decisions

Work hours, stress, and burnout among resident physicians

[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