The proposed rule undermines the 'sameness' requirement in Hatch-Waxman and will result in situations where multiple FDA-approved, therapeutically equivalent products will have different safety-related labeling.

Without objection, so ordered.

The chair thanks the gentleman and now recognizes the gentleman from Florida, Mr. Bilirakis, 5 minutes for questions.

One of the great successes in healthcare in the past 30 years has been the introduction and widespread use of generic drugs, saving patients and taxpayers trillions of dollars.

The chair thanks the gentleman.

The only outcome I see if the rule is enacted is mass confusion.

FDA has admitted that the proposed changes will open generic manufacturers up to greater liability under state tort lawsuits.

Would you commit to working with the Committee to provide any other communications between agency officials?

Would you please provide the Committee with the minutes from this February 2013 meeting?

I sorely wish I were here getting ready to vote on a bill that would permanently repeal and replace the sustainable growth rate. In this Chamber, we passed a bill that would do that and that would have fully offset the cost of the repeal…

At this time, I am pleased to yield 2 minutes to the gentleman from Florida (Mr. Bilirakis), an important member of the Health Subcommittee.

We have groups who have expressed support for this bill: the American Clinical Laboratory Association; the American College of Radiology; Easter Seals; the Family Research Council; the Juvenile Diabetes Research Foundation; the Medical…