Tag Archives: fda

FDA promises crackdown on researchers who fail to properly register and report studies

Tara Haelle

About Tara Haelle

Tara Haelle (@TaraHaelle) is AHCJ's medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

Photo: Ferrous Büller via Flickr

For two decades, researchers have been required to register clinical trials that use any U.S. federal funding at ClinicalTrials.gov before they begin the study. The requirement grew out of a 1997 law aiming to increase transparency with studies that tested drugs, procedures or other treatments on people.

Researchers had to include the planned protocol, including endpoints, when registering their trial. If the endpoints changed during the trial, their registration had to be updated, including the reasons for the change. As of 2007, the law required all trial registrations to be completed within a year after the trial began, regardless of the trial results. Continue reading

Biogen submits BLA for an Alzheimer’s drug with a controversial past

Liz Seegert

About Liz Seegert

Liz Seegert (@lseegert), is AHCJ’s topic editor on aging. Her work has appeared in NextAvenue.com, Journal of Active Aging, Cancer Today, Kaiser Health News, the Connecticut Health I-Team and other outlets. She is a senior fellow at the Center for Health Policy and Media Engagement at George Washington University and co-produces the HealthCetera podcast.

Photo: GollyGforce via Flickr

Could an Alzheimer’s drug finally be on the horizon? Possibly ― if the FDA agrees with data from several Biogen clinical trials ― but approval is still far from a sure bet.

The company, on July 9, submitted its biologics license application (BLA) for aducanumab, an investigational treatment for the disease. The submission includes clinical data from Phase 3 EMERGE and ENGAGE studies, as well as the Phase 1B PRIME study. Biogen has requested an accelerated review, potentially putting the medication on a path for a final decision by March 2021. However, data from these Phase 3 trials are not without controversy in the scientific community.

“Aducanumab, a so-called monoclonal antibody designed to target amyloid plaque in the brain, has been one of the most closely watched drugs in development for several years,” according to Bloomberg News. Continue reading

U.S. vaccine safety system needs greater visibility, webcast panelists say

Bara Vaida

About Bara Vaida

Bara Vaida (@barav) is AHCJ's core topic leader on infectious diseases. An independent journalist, she has written extensively about health policy and infectious diseases. Her work has appeared in outlets that include the National Journal, Agence France-Presse, Bloomberg News, McClatchy News Service, MSNBC, NPR, Politico and The Washington Post.

PHOTO: SELF MAGAZINE VIA FLICKR

As state legislators have grappled with policies to address vaccine hesitancy, public health officials and journalists could do more to emphasize that the United States has a well-established and effective vaccine safety surveillance system, policy experts told AHCJ members during a Nov. 21 webcast.

The U.S. engages several agencies and organizations, including the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Health Resources and Services Administration, and the National Academy of Medicine, plus eight health care systems and seven academic hospitals in monitoring vaccine safety. Continue reading

Deregulation of pork production highlights need to cover food safety

Bara Vaida

About Bara Vaida

Bara Vaida (@barav) is AHCJ's core topic leader on infectious diseases. An independent journalist, she has written extensively about health policy and infectious diseases. Her work has appeared in outlets that include the National Journal, Agence France-Presse, Bloomberg News, McClatchy News Service, MSNBC, NPR, Politico and The Washington Post.

Photo: Anne Akers via Flkr

In late September 2019, the U.S. Department of Agriculture finalized rules to deregulate the safety inspection process in pork production and to increase the slaughter of animals, despite the opposition of consumer advocates and several former agency officials.

The new rules allow company employees, rather than USDA inspectors, to determine which parts of meat with defects can be removed from the slaughter process. Companies, instead of USDA inspectors, also will be allowed to determine slaughter speeds, based on their ability to prevent fecal contamination. Continue reading

FDA warning letter prompts some creative writing

Liz Seegert

About Liz Seegert

Liz Seegert (@lseegert), is AHCJ’s topic editor on aging. Her work has appeared in NextAvenue.com, Journal of Active Aging, Cancer Today, Kaiser Health News, the Connecticut Health I-Team and other outlets. She is a senior fellow at the Center for Health Policy and Media Engagement at George Washington University and co-produces the HealthCetera podcast.

It seems we just can’t shake our obsession with youth or the idea or living forever. While the field of geoscience is legitimately working on ways to age longer and healthier, some companies are marketing unproven, potentially risky transfusions of “young blood” to those able to afford it or willing to ignore questionable and unproven claims behind the process.

Last week, the FDA said “enough.” Commissioner Scott Gottlieb, M.D., and the director of FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., issued a strong warning for consumers to avoid this unapproved and potentially dangerous therapy. Continue reading

Reporter uses FDA, USDA documents to find year’s biggest food recall

Bara Vaida

About Bara Vaida

Bara Vaida (@barav) is AHCJ's core topic leader on infectious diseases. An independent journalist, she has written extensively about health policy and infectious diseases. Her work has appeared in outlets that include the National Journal, Agence France-Presse, Bloomberg News, McClatchy News Service, MSNBC, NPR, Politico and The Washington Post.

Photo: Victor Wong via Flickr

In 2018, salmonella, e. coli and listeria bacteria were the cause of a number of big food recalls – from romaine lettuce to Duncan Hines cake mix to ground beef.

These recalls got a lot of media attention, but the biggest recall of all in 2018 got little, according to Sam Bloch, a reporter for The New Food Economy, who wrote “The biggest food recall of 2018 is one you still haven’t heard about.” Continue reading