Tag Archives: fda

FDA moves on digital health innovation

Rebecca Vesely

About Rebecca Vesely

Rebecca Vesely is AHCJ's topic leader on health information technology and a freelance writer. She has written about health IT since the late 1990s for a variety of publications.

Photo by Tim Gee via Flickr

Photo by Tim Gee via Flickr

Last week’s blog post by Food and Drug Administration Commissioner Scott Gottlieb, M.D., is providing digital health innovators with a new roadmap to navigate pre- and post-market federal oversight of their products.

The topline for journalists is that in the coming months, the FDA will publish new guidance on digital health products and launch programs to monitor the industry, according to the blog post.  Key timeframes and details, culled from Gottlieb’s post: Continue reading

What’s next for drug costs? #AHCJ17 hears from the experts – including a patient

Joanne Kenen

About Joanne Kenen

Joanne Kenen, (@JoanneKenen) the health editor at Politico, is AHCJ’s topic leader on health reform and curates related material at healthjournalism.org. She welcomes questions and suggestions on health reform resources and tip sheets at joanne@healthjournalism.org.

President Donald Trump has spoken about the cost of drugs frequently. Though not always clearly and consistently, he has called for government negotiation of prices. Drug prices also have caught Congress’s eye, although we’re not quite sure what (if anything) legislators are willing to do about it.

But patients are fed up, as David Mitchell, founder of Patients for Affordable Drugs reminded us last week during a Health Journalism 2017 session in Orlando. Continue reading

FDA bans ‘close-hold embargoes’ in response to AHCJ protest

Felice J. Freyer

About Felice J. Freyer

Felice J. Freyer is AHCJ's treasurer and chair of the organization's Right to Know Committee. She is a health care reporter for The Boston Globe.

usfda-logoThe Food and Drug Administration has banned a communications practice that troubled journalists and sparked protests from AHCJ and others.

The agency has forbidden its media staff from using “close-hold embargoes,” in which reporters receive early access to information provided they promise not to seek comments from others until the embargo lifts, according to a letter sent Thursday to Karl Stark, president of the Association of Health Care Journalists. Continue reading

While genetic tests proliferate, journalists cite the lack of scientific evidence

Joseph Burns

About Joseph Burns

Joseph Burns (@jburns18), a Massachusetts-based independent journalist, is AHCJ’s topic leader on health insurance. He welcomes questions and suggestions on insurance resources and tip sheets at joseph@healthjournalism.org.

Photo: Caroline Davis2010 via Flickr

Photo: Caroline Davis2010 via Flickr

The potential benefits of genetic testing are widely touted and drive greater interest in these tests – even though the validity of the science behind such testing remains unclear.

Charles Piller, the West Coast editor for Boston-based online news site Stat, recently reported on the lack of a firm scientific basis for a test that Proove Biosciences in Irvine, Calif., has been marketing as an “opioid risk” detector. Continue reading

AHCJ objects to FDA’s ‘close-hold embargoes,’ requests explanation

Felice J. Freyer

About Felice J. Freyer

Felice J. Freyer is AHCJ's treasurer and chair of the organization's Right to Know Committee. She is a health care reporter for The Boston Globe.

Image by Logan Campbell via flickr.

Image by Logan Campbell via flickr.

AHCJ is protesting the Food and Drug Administration’s recent restrictive practices in handling news embargoes and has asked the agency for clarification of its policies.

In an Oct. 11 letter to Jason Young, the FDA’s acting assistant commissioner for media affairs, AHCJ President Karl Stark raised strong objections to the practice of providing embargoed information on the condition that reporters refrain from seeking outside comment until the embargo lifts. Continue reading