Drugs

New PMI Form Explained

FDA’s new Patient Medication Information (PMI), proposed in 5/2023, will eventually replace Medication Guides and Patient Package Inserts, according to CDER Office of Medical Policy regulatory counsel Christopher Diamant. Interviewed for a CDER Conversation, Diamant says PMI was developed after research showed that the existing Consumer Medication Information does not consistently provide patients with clear, easily understood information about their prescription medications.

The researchers found that Patient Package Inserts, Medication Guides, and Consumer Medication Information contain information that can be difficult to understand, repetitive, incomplete, or conflicting, which could cause some patients to take their medications incorrectly.

The new PMI was developed based on research, Diamant says, involving input from interested parties including consumers and consumer groups, industry, healthcare professional groups, physicians, pharmacists, and pharmacy organizations. Prototypes were developed and then tested, focusing on the key elements that a patient would find relevant and useful.

“CDER ultimately decided the PMI format would be a one-page document, highlighting the most important information for patients,” he says. “PMI would be organized by the following sections: drug name, important safety information, common side effects, and directions for use.”

PMI would be distributed to patients who receive prescription drugs in an outpatient setting such as retail pharmacies and hospital outpatient care pharmacies. Patients will be able to choose whether to receive PMI in paper or an electronic format, he says.

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