Tag Archives: fda

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

Access – or lack of access – to health information is making news

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

key-in-lock-showing-forbidden-information-graphicstockSeveral stories about access to public information have caught my eye in the past week. Whether it involves public health data from Florida, evidence in a federal criminal case or embargoes and favored access at a federal agency, it’s clear that journalists are facing obstacles in ensuring the public’s access to information.

In Rhode Island, a judge ruled in favor of a journalist seeking evidence presented in the trial of a doctor now “serving four life sentences for his role in operating a pain management clinic like a ‘pill mill.'” The U.S. Drug Enforcement Administration had refused to release the records since journalist Phil Eil requested them after the trial ended in 2011. Continue reading

Reporters learn about wearables, health IT and telehealth

Kimberly Leonard

About Kimberly Leonard

Kimberly Leonard (@leonardkl)is a health care reporter at U.S. News and World Report. She is a co-chair of the Washington, D.C., chapter of AHCJ.

Photo: Tina Reed, Washington Business Journal

More than 20 people came to the July 14, AHCJ chapter event in Washington, D.C., to learn about how technology affects health and what regulatory issues to watch out for.

The conversation was moderated by Politico Pro’s David Pittman (@David_Pittman), who covers health information technology. Pittman, who proposed the event, invited the panelists for their participation, and pitched the idea to the chapter co-chairs. The panelists were: Continue reading

Trade group’s dispute with FDA highlights need to watch for report revisions

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: Lori Greig via Flickr

Photo: Lori Greig via Flickr

The nation’s clinical laboratories have pushed back hard against a proposal by U.S. Food and Drug Administration in October 2014 that would regulate laboratory developed tests. More than a year later, the disagreement became more heated when the Association of Molecular Pathology (AMP) accused the FDA of fabricating examples in a November report on LDTs.

In the report, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies,” the agency cited 20 examples of problematic LDTs, saying, “…these products may have caused or have caused actual harm to patients.” We covered this report in a blog post earlier this month.

But that’s just the beginning of the story, as Allison Proffitt, editorial director of BioITWorld, found. Continue reading

Debate over regulating lab-developed tests about to heat up

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: Lori Greig via Flickr

Photo: Lori Greig via Flickr

Sometime this year, the U.S. Food and Drug Administration is expected to issue guidance to clinical laboratories that produce lab-developed tests (LDTs). Clinical labs that offer LDTs, and associations that represent these labs, have criticized the FDA’s oversight proposal and are challenging the agency’s authority to regulate these tests.

Many of us will be writing about LDTs, their value to patients and the need for a review of how these tests are produced, whether the results are clinically valid, and whether their marketing claims are accurate. Continue reading