July 2, 2014

Lawmakers ask White House to Review FDA Rule for Generic Label Changes

From: WSJ/Pharmalot

By Ed Silverman

A pair of Republican lawmakers has written the White House to question the authority the FDA has to issue a rule allowing generic drug makers to independently provide updated safety warnings about their medicines.

The proposed rule, which the agency released last fall, has become controversial as generic drug makers argue the FDA is on a misguided mission to close what consumer advocates call a safety loophole in the national medicine chest. The generic industry, however, funded a white paper that maintains the rule would add $4 billion to the nation’s health care bill, mostly due to higher litigation costs that may ensue.

The generic industry has now caught the ear of U.S. Sen. Lamar Alexander of Tennessee and Bob Goodlatte of Virginia, who chairs the House Judiciary Committee. In their June 25 letter, they also caution the rule is troubling and asked the White House Office of Management and Budget to review the legality of the proposed rule and what they call a “flawed” cost-benefit analysis by the FDA.

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