Drugs

People Want More FDA Transparency: Survey

What is believed to be the first reported survey on views of the U.S. public on FDA transparency shows that the public would like to see much more transparency from the agency. Researchers from Johns Hopkins University write in a JAMA open access article that they asked a representative sample of U.S. adults about 10 potential transparency measures:

FDA should share with the public the reasons why medications are not approved;
FDA should share the name of the company and medication when companies seek to conduct studies on human subjects;
FDA should share when studies are suspended, as well as the reasons for suspending a study;
FDA should share the reasons for allowing a suspended study to restart;
FDA should share the company and medication name when applications for generic drugs are filed;
FDA should share when the agency speeds a review and the scientific basis for this action;
FDA should share how special safety measures put in place for certain medications are working;
FDA should make public a list of medications that drug companies have stopped developing;
FDA should share its analysis of medications that drug companies have stopped developing; and
if drug companies provide false or misleading information about the development of medications to the public, FDA should share the correct information with the public.

“Support for all transparency measures was high,” the researchers write. “Specifically, 86.2% of participants supported the disclosure of the reasons medications are not approved, 66.7% supported the release of basic information about medicines in development, 77.6% supported disclosure of the reasons clinical studies are placed on hold, and 77.2% supported disclosure of the reasons studies are permitted to resume. There was strong support for FDA disclosing basic information on pending applications for generic drugs (71.6%), explaining the reasons medications receive expedited review (80.5%), and sharing whether safety programs are working (83.2%). When asked whether FDA should list medications that drug manufacturers have stopped developing, 67.6% of participants said yes, with 65.9% supporting the release of relevant FDA analyses. In addition, 90.7% of participants supported FDA correcting the misleading information spread by drug manufacturers.”

The researchers say that historically, FDA has considered much of the oversight of clinical trials, interactions with companies, and review processes to be confidential. But in recent years it has faced calls for greater transparency, including in its Covid-19 response and the use of expedited review pathways.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome