Tag Archives: fda

How often do drugs obtaining accelerated approval fulfill their potential?

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.

Image: Seattle Genetics

If a new drug appears to show remarkable success in curing patients with a specific, aggressive cancer type that has few or no other effective treatments, there can be a compelling reason to get it on the market as soon as possible.

However, evidence requirements for drugs to receive accelerated FDA approval often rely on surrogate endpoints. That’s particularly true for conditions such as cancer where the ideal primary endpoint — survival — isn’t possible to assess in a short period. Continue reading

Study suggests FDA medical device approvals ripe for investigative dives

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: A.M.D. via Flickr

Medical devices — and the unrecognized or undisclosed risks some of them have — have been in the news quite a bit over the past few years, especially in the area of women’s health. The death of physician and activist Amy Reed last spring (and the push back she experienced from her advocacy) again drew attention to the dangers of power morcellation during gynecologic laparoscopies. Power morcellation during surgery has been used for two decades, but the research showing that they risk spreading an undetected cancer took much longer to appear, and controversy continues over the technique. Continue reading

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. Follow her on Facebook.

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 vice president 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