Friday, February 21, 2014

February 21, 2014.

FDA to Revamp Approval Path for OTC Drugs

"Yes, I knew the last line. And now, I am afraid, it is time for you to go. But wait. You had better let me give you one of these tablets."

WASHINGTON----The Food and Drug Administration plans to overhaul the way it approves over-the-counter medical products, a move that will change how tens of thousands of medicines and personal care items reach U.S. store shelves.

As Winston stood up O'Brien held out a hand. His powerful grip crushed the bones of Winston's palm. At the door Winston looked back, but O'Brien seemed already to be in process of putting him out of mind. He was waiting with his hand on the switch that controlled the telescreen. Beyond him Winston could see the writing-table with its green-shaded lamp and the speakwrite and the wire baskets deep-laden with papers. The incident was closed. Within thirty seconds, it occurred to him, O'Brien would be back at his interrupted and important work on behalf of the Party.

The products----from pain relievers to sunscreens to antifungal medicines—have for decades been approved through a time-consuming process that hampers manufacturers' abilities to later modify their ingredients.

IV

Winston was gelatinous with fatigue. Gelatinous was the right word. It had come into his head spontaneously. His body seemed to have not only the weakness of a jelly, but its translucency. He felt that if he held up his hand he would be able to see the light through it. All the blood and lymph had been drained out of him by an enormous debauch of work, leaving only a frail structure of nerves, bones, and skin. All sensations seemed to be magnified. His overalls fretted his shoulders, the pavement tickled his feet, even the opening and closing of a hand was an effort that made his joints creak. 

Revamping the approval path would have big implications for the over-the-counter medical products industry, which in 2012 recorded $29.3 billion in annual U.S. sales, according to the Consumer Healthcare Products Association. The industry could introduce new forms of products more quickly as researchers discover better ingredients.

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