Author Archives: Kerry Dooley Young

Kerry Dooley Young

About Kerry Dooley Young

Kerry Dooley Young (@kdooleyyoung) is AHCJ's core topic leader on patient safety. She has written extensively about the Food and Drug Administration, medical research, health policy and quality measurements. Her work has appeared in Medscape Medical News, Congressional Quarterly/CQ Roll Call and Bloomberg News.

Covering the reasons why hospitals struggle to retain nurses

Photo by RODNAE Productions via pexels.

The COVID pandemic drew public attention to an issue already well known in health care circles: the challenges hospitals face in retaining their nursing staff, which can affect medical care. Research shows lower nurse-patient ratios mean better patient outcomes, journalist Sarah DiGregorio explained in a Sept. 28 AHCJ webinar. DiGregorio reviewed some of the key research she found in reporting for her forthcoming book, “Taking Care: The Revolutionary Story of Nursing,” due out in May. 

To help reporters dig into this issue, this blog post contains a brief background section and then provides links and summaries of a few studies and then a resources section.

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How and when the FDA seeks outside advice on drug approvals

C. Joseph Ross Daval, J.D, Ameet Sarpatwari, Ph.D., J.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H ( from left to right)

The U.S. Food and Drug Administration could bolster public trust in medicines through greater transparency about its decisions on when to seek expert feedback and its instructions to its advisory committees, argue members of a group that monitors the agency closely. Recent papers from Harvard’s Program On Regulation, Therapeutics And Law (PORTAL) can help journalists who want to dig more deeply into the question of when and how the FDA seeks advice on drug approvals.

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Evaluating concerns about accelerated FDA drug approvals

House Energy and Commerce Chairman Frank Pallone (Photo courtesy of The House Committee on Energy and Commerce website)

Congress has a chance in September to try to speed the pace of studies needed to confirm whether drugs sold in the U.S. under accelerated approvals are helping people live better or longer. Journalists covering this issue may want to take a look at two recent papers on this subject.

In the first section of this two-part blog, we yesterday explained the politics of this issue. U.S. lawmakers are under pressure to reauthorize the Prescription Drug User Fee Act (PDUFA) by the end of this month. Work on the Senate version of the bill stalled during the summer. The House in June passed its version of the bill, 392-28, with strong bipartisan support. 

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Will the FDA get more tools for handling accelerated drug approvals?

Official House Calendar posted by Majority Leader Steny Hoyer with red circle added by AHCJ.

September is a great time for journalists to examine how well U.S. regulators are handling the accelerated approval pathway for medicines. There’s been growing concern about the ability of the Food and Drug Administration (FDA) to compel drugmakers to hold up their end of the bargain on agreements made to speed seemingly promising medicines to market based on little pools of data.

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Rise in naloxone costs for uninsured, a significant access barrier to life-saving drug

Photo courtesy of the FDA website.

The cost of naloxone has risen sharply for people lacking insurance, even as laws have made it easier to prescribe and obtain the treatment for opioid overdoses, a new report found.

A study of claims data showed the mean out-of-pocket cost of naloxone for the uninsured rising to $249.97 in 2018 from $35.39 in 2014, according to a study published in JAMA Health Forum in August.

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