Tag Archives: fda

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

Health writer discusses story on experimental dental treatment

Mary Otto

About Mary Otto

Mary Otto, a Washington, D.C.-based freelancer, is AHCJ's topic leader on oral health, curating related material at healthjournalism.org. She welcomes questions and suggestions on oral health resources at mary@healthjournalism.org.

Andrea McDaniels

Andrea McDaniels

Baltimore Sun reporter Andrea McDaniels was surprised to learn about an off-label treatment for tooth decay that some dentists are using.

In the fight against decay-causing bacteria, some researchers call the agent, silver diamine fluoride, a “silver-fluoride bullet.”

They point to evidence suggesting that SDF is not only effective in halting the decay process but in preventing the development of new caries. The material is cheap and can be easily painted onto the affected tooth.

In this Q&A, McDaniels tells us more about her work on the story, and offers some insights into how she manages her busy health and medical beat at the Sun.

Stat details failure of research institutions to submit required study reports

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 social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

Photo: Lydia Polimeni, National Institutes of Health via Flickr

Photo: Lydia Polimeni, National Institutes of Health via Flickr

A Stat investigation has found that “prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments.”

The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer.

Continue reading

Communicating drug risks in pharma marketing: A new FDA challenge

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.

pill bottle label

Photo: Joel Rorabaugh via FreeImages.com

Many American consumers may not realize this, but only New Zealand and the United States are the only countries with strong pharmaceutical regulations in which direct-to-consumer advertising from pharma companies is allowed.

All those TV commercials and double-spread ads for prescription drugs – whether it’s for erectile dysfunction drugs or mental disorders or high blood pressure or some chronic condition – are missing from the media in most of the world.

The way such ads look and sound (including the usual mind-numbing text block tucked into a print ad detailing risks and potential side effects, or a hastily spoken voice-over toward the end of a commercial), may soon change. The U.S. Food and Drug Administration is revising regulations governing how companies communicate risk to consumers. Continue reading