Drugs

FDA Changing Drug Manufacturing Rules

FDA is proposing new rules as part of a multi-year effort to change the way drugs are manufactured in an attempt to improve the safety of the nation’s drug supply. Bloomberg News reports that currently FDA mostly relies on the drug industry to police itself. “That approach has been strained by the increasing proportion of generic drugs and drug ingredients made for the U.S. market in countries like China and India, where the regulator has few boots on the ground,” the report says.

The proposed rules change will focus on the active pharmaceutical ingredients.

The story quotes FDA commissioner Scott Gottlieb that “We’ve seen a lot of instances of adulterated products—contamination, impurities—recently. The underlying causes have been traced back to manufacturing, inadequate quality controls, and generally poor management oversight.”

Blomberg gives several examples of issues with drug active ingredients from different manufacturers.

In addition to enhancing the self-regulation process through the revised regulations, Gottlieb said, FDA also plans tougher water purification requirements.

The commissioner said the manufacturing standards were last updated in 2008. “It’s a significant modernization for the requirements that haven’t been changed in years,” he said.

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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