Drug Quality and Security Act

Floor Speech

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Mr. GRIFFITH of Virginia. Mr. Speaker, I thank Subcommittee Chairman Pitts for giving me the freedom to work on this. I appreciate it very much.

It has been a year since last fall's fungal meningitis outbreak associated with the tainted sterile compounded drugs from the New England Compounding Center. In my district and in our area in Virginia, we had several deaths, we had 50 confirmed cases, and we had approximately 1,400 patients who were notified that they could have been exposed to fungal meningitis because they received tainted steroid injections.

In working on this bill, I appreciated the bipartisan manner that we used to address this and to work on this matter, particularly with my colleagues across the aisle, Representatives Gene Green and Diana DeGette, for whom I am very grateful for all of their time and effort by both them and their staffs. I should also thank my staff member who worked on this most, which was Adam Harbison.

Having said that, I agree with Mr. Dingell that it is a good bill and not a perfect bill, but I am glad to see that language from the Griffith-Green-DeGette effort was adopted and the FDA will be required to engage in meaningful communication with all of the States when potential problems are identified, as this has always been my priority.

In my opinion, this was the biggest failure of the FDA in handling the NECC case, as they were warned about problems by at least two States prior to this problem coming to the forefront with all of these deaths and with this horrible situation. Two States had sent out a warning signal. The State of Colorado had said, Wait a minute, we're not going to let these folks operate here. The State of Ohio had notified the FDA that they had concerns about NECC being a manufacturer, yet there was not any swift action taken on NECC or even an attempt to alert other States, including the State of Massachusetts, to the problems that were happening.

I know there's a lot of concern out there by some in the medical community, particularly the doctors and some others, but this does not change the existing law on office use, and it does not change the existing law on repackaging.

There were legal questions that evolved with this situation surrounding the advertising requirements of the original bill. I was a little surprised that the FDA had waited 10 years to bring that up, but this bill fixes that problem and takes away that cloud of uncertainty as to whether or not the whole bill was not constitutional because the advertising sections were not constitutional.

This is a good bill. I'm just talking about the compounding sections, but also the track-and-trace sections are very good. I think we are drawing a clear line defining so that the FDA can better determine who are the traditional compounding pharmacies and who are really outsourcers or manufacturers. I think that is great that this bill has that in here.

I would be remiss if I didn't tell a story that struck me last week as we are on that 1-year anniversary.

The SPEAKER pro tempore. The time of the gentleman has expired.

Mr. UPTON. I yield the gentleman an additional 1 minute.

Mr. GRIFFITH of Virginia. Last week, I went to have lunch with my sons at their elementary school. As I was going in, the elementary school secretary said to me, ``I know I probably shouldn't say anything, but I want to thank you for working on this compounding bill.''

Doug Wingate, who died a year ago, was my family's best friend, and he and his wife were supposed to be on a cruise for their 25th anniversary and instead we were attending his funeral. His wife last week was on that cruise with her son, but we can never bring her husband back. This bill will make sure that we don't have that problem again, and the other Doug Wingates of the world will not have to die in order for us to change the law to make a better protected system for the American people.

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