Drugs

Lax GLP-1 Compounding Regulation Hurts Patients: Report

A Center for Medicine in the Public Interest (CMPI) report says FDA regulatory failures in enforcing limits on GLP-1 compounding put patients at risk. The report was written by former FDA associate commissioner Peter Pitts, CMPI president.

Pitts says a temporary shortage of the GLP-1 drugs that have become popular as treatments for diabetes and obesity “opened the door to a flood of unapproved knock-offs from compounding pharmacies looking to cash in. The shortage has ended, but some compounders continue to mass produce compounded knock-offs, which ignores longstanding limits on compounding and puts patients at risk.”

The report calls for these actions to protect patients:

FDA should put a stop to phony “personalization,” in which compounders mass produce manipulated GLP-1 drugs;
FDA must require compounding pharmacies that act like drug manufacturers to register as drug manufacturers;
FDA and Customs and Border Protection must enforce restrictions on illicit foreign active pharmaceutical ingredients;
Congress must require FDA to enforce the rule that prohibits interstate distribution of more than 5% of a compounder’s products unless and until the state enters into a memorandum of understanding with FDA; and
Congress must increase FDA resources to enforce the law as it stands.

“The GLP-1 shortage is over, but the illegal, unsafe, and venal exploitation of the American public by mass-scale ‘corporate’ compounders masquerading as pharmaceutical companies continues,” Pitts concludes…. “Corporate compounding of GLP-1 medicines is a growing part of the misinformation crisis facing FDA. Attention must be paid.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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