Food and Drug Administration Safety and Innovation Act

Floor Speech

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Mr. DINGELL. Mr. Speaker, this is a good bill. I urge my colleagues to support it. I rise in strong support of it, and I urge my colleagues to join.

This legislation enjoys broad bipartisan support on both sides of the Capitol and from industry and patient groups. We should also be proud of the work we have done to get it here today.

I would observe that it has been done because the Members worked together in the finest traditions of this body. And I'm also proud of the work that my colleagues on the committee and the staff have done on this matter. I was pleased to work with them to include strong upstream drug supply chain provisions, something that's been a long priority of mine.

I'm also pleased that, for the first time, commercial importers will be required to register, so we'll know who's bringing what in and whether it's safe or not. There will also be parity between inspections of domestic and foreign drug facilities, something which is a major problem because foreign facilities and foreign manufacturers now import much into this country, much of which is unsafe and improperly inspected.

FDA will be able to maintain a practice in which they will detain and destruct counterfeit drugs and those which are unsafe or intentionally or otherwise adulterated, and they will be able to impose increased penalties on those who adulterate these drugs and pharmaceuticals.

These provisions, which mirror safety provisions in my drug safety bill, will equip FDA with the authorities it needs to better oversee our increasingly globalized drug supply chain and will give American families comfort that the pharmaceuticals that they are taking are safe, and help to deter and to respond to any future heparin-like incidents which killed some 80 Americans and hurt thousands more.

While I am disappointed we were unable to come forward with a consensus on a national track-and-trace standard, it's my hope that we will continue to work on this in coming days. And I want to commend my colleagues, Mr. Matheson and Mr. Bilbray, for the fine work they have done on this matter.

I've also been working on this issue for many years, and we've come closer than ever before to finding a consensus. Given additional time, I think we could have resolved this issue; but because of time pressures, we were not able to.

I also want to thank my friends, Mr. Upton, Mr. Harkin, Ranking Members WAXMAN and ENZI, and their staff for the hard work they did to send this critical bill to the President before July 4. I also want to thank Kimberly Trzeciak of my staff for her diligence on the supply chain provisions and other matters.

I urge my colleagues to support this bill. It will be something of which we will be proud. It will confer much safety on the American people in areas of very substantial danger; and it will see to it that, to a modest degree at least, the industry-supported provisions, including those which involved the collection of fees, will begin to work for the benefit of the American people.

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