Christopher Dodd

Mr. DODD

Mr. DODD. Madam President, I just wanted to raise an issue to my colleague from Missouri, the manager of the bill, and the distinguished Senator from Maryland. This is just as an issue to raise with you. We may want to take a look at it. I regret I didn't bring this up earlier. Under the present system, as I understand it, nurses at VA hospitals do not receive cost-of-living adjustments. It is based on locality pay. In many areas around the country, nurses in our VA hospitals have not been getting raises. It is a bit more complicated an issue than just a simple amendment to deal with this, but for the last 3 years, in many veterans hospitals there have been no cost-of-living or locality increases during a robust economy. Many of these, mostly women but some men, work very hard on behalf of our veterans. I know all my colleagues know and understand this. I urge, if we could, maybe enter into a colloquy in some way and look at report language in which we might examine that issue in terms of how, for nurses who work in these hospitals, we may be able to work out some better pay increase arrangement for them at these VA hospitals. I really raise that for the consideration of the two managers of the bill. I apologize for interrupting what I know is a decision to just move to final passage on this bill.

Mr. DODD

Mr. DODD. Mr. President, this is a second-degree amendment to my own amendment. I ask for the yeas and nays on this amendment.

Mr. DODD. Mr. President, I send the amendment to the desk.

Mr. DODD. Mr. President, let me return to the amendment to mention several people here who deserve a great deal of credit for bringing this issue to the attention of Congressman Shays and myself. Betty Patterson is the nurse at St. Theresa's School in Trumbull, CT. There are thousands and thousands of school nurses all across America who probably don't get enough credit for the work and job they do every day, caring for our children while they are away at school. It was Betty Patterson who came across the notification that the EPI-PEN had been recalled, and knew that one of the students in the St. Theresa school, Matthew, would need to get a safe and effective replacement. First, I want to congratulate Betty Patterson for the tremendous job she did. Second, I'd like to commend Karen McGarry, Mathew's mother, who, discovering that her pharmacist had not notified his patients, contacted the Connecticut Post, a major newspaper in my home State of Connecticut, to look into the matter. And I'd like to commend Michael Mayko of the Connecticut Post who wrote stories on this incident and did the checking to discover that there was no Federal law or State law that required that consumers be notified. So I want to thank him for doing so much to highlight this important story. Of course, I want to thank Matthew himself, who is one of 1.47 million people in this country who suffer from severe allergies and must rely on products like the Epi-Pen, for telling his story. Mr. President, I'd like to once again restate that this amendment simply says that the Food and Drug Administration, when working with manufacturers to plan a class I recall, should take all appropriate measures to ensure that consumers are directly and promptly notified. I think most would agree this should be a commonsense requirement. For those reasons, Mr. President, I hope my colleagues will feel confident in supporting this amendment. I don't seek any recorded votes on it. If the majority and minority can accept it, I am prepared to conclude the debate and go to other amendments. I don't know what their pleasure is. I see my distinguished floor manager rising. I yield to him.

Mr. DODD. Yes.

Mr. DODD. That is correct. What I intend by the amendment is to make certain that in the case of every Class 1 recall FDA does provide notice to the public. I certainly would not want to do anything to suggest that such authority does not now exist, or that such authority does not exist for Class 2 and Class 3 recalls, or other actions as deemed appropriate for public notice by FDA. I just want to make certain that they use their authority in all Class 1 recalls. Mr. BUMPERS addressed the Chair.

Mr. DODD. Mr. President, this is a very straightforward proposal and is similar to legislation that was offered by my colleague in the other body, Congressman Shays of Connecticut. This amendment deals with the issue of defective pharmaceutical products and medical devices that have been recalled by the manufacturer. We almost had a very tragic case in Connecticut several months ago involving recalls, which provoked this piece of legislation. A child in Connecticut, a young boy by the name of Matthew McGarry, has food allergies to peanuts and needs a device known as an Epi-Pen to counteract the severe reactions--seizures or even death--that could result if he inadvertently eats certain foods. The Epi-Pen that Matthew relies on was recalled by the manufacturer because it was found to have substantial leaks in it, rendering it ineffective. Matthew was fortunate that his school nurse, Betty Patterson, heard of the recall and immediately notified his parents, Karen and William McGarry, that they needed to replace the product. Had she not heard of the recall and had young Matthew had an attack, he very well could have died. The family is very well aware that a tragedy was averted. His family and other Connecticut families brought this to the attention of Congressman Shays and myself and suggested this would be an appropriate area for some thoughtful legislation to require that consumers be notified when dangerous products are taken off the market--a requirement not currently found in law. Consumers have the right to be notified when the cars they drive or the toys their children play with are unsafe. Shouldn't they have the same right when it comes to drugs and devices found in every family's medicine cabinet? The recall process presently relies almost exclusively on the good- faith efforts of manufacturers, wholesalers and retailers. Most of the time it works very well to protect consumers. However, a recent spate of recalls involving these Epi-Pen devices--first in October of 1997 and most recently in May of this year--has highlighted the need to better ensure that consumers, when appropriate, are directly informed that a drug or device may be dangerous. An Epi-Pen is a device, as my colleagues, I am sure, are aware, that injects epinephrine and is used by children with severe food allergies to counteract life-threatening reactions. Due to a defect in the manufacturing process, some lots of the device were found to leak the encapsulated drug, potentially leaving patients with an amount of the drug insufficient to counter an allergic response. A class I recall of the product was issued, indicating a reasonable possibility that the use of the product could cause serious health effects or death. Despite the severity of the defect, the recall notification failed to notify consumers whose children relied on these products, either because the retailers did not pass along the notification in a timely fashion or because the retailers themselves received notification days after the recall was first issued. In an effort to provide the public with better and more timely notice of the most serious recalls, this amendment will, for the first time, explicitly require the Food and Drug Administration to ensure that consumers receive prompt notification of class I recalls. How the directive will be accomplished will be left up to the FDA. We don't mandate a specific approach. The FDA could, for example, encourage distributors and pharmacies to employ more effective and rapid notification technologies, a shift that some in the industry are already advocating. We do not micromanage the notification process. We are just suggesting that better mechanisms be put in place to give consumers who use these products and rely on them a higher degree of confidence. I hope my colleagues can support this straightforward amendment. I hope that my colleagues will recognize that if we do not take up this issue now, we run the risk that some other child won't be as lucky as Matthew and will suffer serious harm. For those reasons, Mr. President, I urge adoption of the amendment.

Mr. DODD. I am happy to yield.

Mr. DODD. I will be happy to take a very brief time agreement. If you have some other agenda you want to move ahead, I say to the floor manager, I will be happy to consider some other program the floor manager may have.

Mr. DODD. Mr. President, I have an amendment which I want to send to the desk to be considered. I talked to the ranking member, but I wasn't able to talk to the floor manager of the bill. I am willing to accept a short time agreement on this amendment.

Mr. DODD. Mr. President, I ask unanimous consent that reading of the amendment be dispensed with.

Mr. DODD. Mr. President, I send an amendment to the desk.

Mr. DODD. Mr. President, what is the pending business before the Senate?

Mr. DODD. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. DODD. If my colleagues want to move to another amendment, I am more than happy to set this aside.

Mr. DODD. Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with.

Mr. DODD. I say to my colleague, I am informed the bill has been introduced by Congressman Shays, whom I know my colleague and friend from Mississippi knows. I don't believe they have moved the bill over there. By the way, we have checked with the FDA and the words they use--we have included and incorporated the comments of the FDA in the legislative proposal.

Mr. DODD. Mr. President, I move to reconsider the vote.

Mr. DODD. Mr. President, there may be some technical questions that we will have to address in conference, and I have agreed, if that is the case, I would certainly strongly support those corrections, but I am deeply grateful for support of this amendment and ask unanimous consent it be adopted.

Mr. DODD. Mr. President, let me say briefly, if I may, for purposes of the Record on this amendment, I want to express my gratitude to the managers of the underlying bill, the agriculture appropriations bill, for their support on this, as well as my colleague from Vermont, Senator Jeffords, and Senator Kennedy of Massachusetts. There may be some technical questions that have to be addressed in conference.

Mr. DODD. Mr. President, the yeas and nays have been vitiated?

Mr. DODD. Mr. President, I ask unanimous consent to send a modification of my amendment to the desk and ask for its immediate consideration.

Mr. DODD. No.

Mr. DODD. Mr. President, I suggest the absence----

Mr. DODD

Mr. DODD. Absolutely not, Mr. President; none whatsoever. To characterize the amendment as such is completely misleading, or as not to have read it at all. It only applies to unilateral economic sanctions. For instance, this amendment does nothing with regard to the multilateral sanctions on Iraq. Those are not unilateral sanctions. Those are multilateral sanctions that apply to that country. So it only applies there. If the President, this President, or any future President, wants to apply sanctions on some basis other than economic, they may utilize this tool. We are merely removing it from the unilateral economic sanctions.