Magazine article Drug Topics

FDA Makes First Regulatory Reforms, More Coming

Magazine article Drug Topics

FDA Makes First Regulatory Reforms, More Coming

Article excerpt

The Food & Drug Administration is moving on its own to cut government red tape, making one change that will eliminate more than 700 pages of regulations, In hopes of staving off tougher actions by Congress. Under the revisions announced at the White House last month, many special rules instituted decades ago when antibiotics and insulin were first introduced are being dropped. If new products are treated like other pharmaceuticals, the FDA said, these products may come to market sooner. Other administrative changes would:

* Allow drugmakers to modernize their plants and make minor changes in their manufacturing practices for approved drugs without FDA clearance, if the changes won't affect a drug's quality and performance.

* Add about 140 low-risk medical device categories to the 441 already exempt from premarket review. Examples of new exempt categories include piston syringe, immunoglobulin G-test system, oxygen mask, and scented menstrual pad.

* Exempt drug applications from including environmental risk assessments.

"These FDA reforms, and others we'll announce in the next few weeks, will keep quality at world-class levels and save industry and consumers nearly half a billion dollars a year," President Clinton said. …

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