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Food and Drug Administration Safety and Innovation Act--Motion to Proceed--Continued

Floor Speech

Location: Washington, DC


Mr. ISAKSON. Madam President, as a member of the Health, Education, Labor and Pension Committee, I rise for a brief speech. But I want to begin that speech by thanking Chairman Harkin, Ranking Member Enzi, and the entire staff of the HELP Committee, and my staff--Francie Pastor--who have helped so much on this legislation which is so important to the American people. There is a chance where we have a bipartisan effort in the Senate to do something constructive and meaningful, and I commend both Senators on their work.

There are component parts of this legislation I want to illuminate for a few seconds because I had a lot to do with them, and they are very important. One deals with third-party logistics providers. As the Chair is aware, and as the Senate is aware, we have a placeholder in the managers' amendment for a third-party provider and logistical providers with track and trace.

Track and trace is the mechanism of tracking the drug from its origin and tracing it all through the system to the individual using the drug to ensure we have safety and security. But there are third-party logistics carriers who deliver an awful lot of content in the United States, such as FedEx and UPS, that operate in all 50 States, and we ought to have a 50-State seamless standard in terms of third-party delivery rather than 50 individual States all having regulatory authority.

So my first message today is to the conferees, that when the conference committee is ultimately reporting, it should take this placeholder on these third-party logistics providers and make sure in the track-and-trace legislation we provide a seamless national policy for the delivery of pharmaceuticals. That is very important to our country and very important to the pharmaceutical industry, but mostly it is very important to those who consume those pharmaceuticals.

Secondly, there is another provision called the Medical Gas Safety Act, which was included in this legislation, and I am very grateful the managers of the legislation agreed to put it in the bill because it is equally important for the people of this country. I want to make sure one thing is underlined. Medical gases are critically important to sustain life, gases such as oxygen. A gas such as nitrous oxide, which is sometimes called laughing gas by some, is sometimes used to sedate individuals. I want to make sure as we go through this process we have a system under which medical gases--that have stood the test of time--remain available through medical use and that brandnew medical products that have never been through the testing of time go through an appropriate FDA review, which is what the original act--the Medical Gas Safety Act--included and which we want to be included in this legislation.

Madam President, I also wish to further speak for a moment about an important section of this legislation--the Medical Gas Safety Act. I want to thank the Chairman and the Ranking Member, and Senator Blumenthal, for working with me to include this in the bill. The Medical Gas Safety Act has a number of important benefits for patients, health care providers, FDA and medical gas providers, it will ensure a continued supply of quality medical gases that patients can depend on, and it will provide regulatory certainty for FDA and providers.

The intent of the Medical Gas Safety Act is to create a process for those medical gases and medical gas mixtures that have a history of safe and effective use to become approved drugs. This will ensure that medical gases that have a long history of use, like oxygen, become approved drugs. The legislation provides FDA with the authority to ensure that any mixture of medical gases be ``medically appropriate.'' Congress urges FDA to work with industry to develop a guidance over the next year to better define the term ``medically appropriate'' so that those mixtures that have been on the market for a long period of time can continue to be available to the patients that need them.

I think we have a finished product that everyone can support--it is a matter of fine tuning at this point, which can be accomplished through FDA guidance. We need to have a system under which medical gases that have stood the test of time remain available for medical use; and brand new medical gas products that have never been tested go through an appropriate FDA review--which is what the original bill envisioned.

I once again thank the chairman and ranking member for all of the hard work they have done to move this entire bill forward in such a bipartisan manner. The way the Committee has approached this important legislation has resulted in a good bill that deserves everyone's support. I also want to express my appreciation for the inclusion of the Medical Gas Safety Act in this bill. Senator Blumenthal deserves credit for the work he has done in this area.

Madam President, I applaud my colleagues, Senators BENNET and BURR, for their efforts to enhance the safety of America's pharmaceutical supply chain. While we are fortunate in America not to have a widespread problem with counterfeit drugs, the potential that they could pose a serious health risk to consumers is significant.

Supply chain compliance and safety is currently a patchwork of inconsistent State requirements and licensing which potentially jeopardizes the safety and welfare of millions of Americans. Unless a uniform Federal policy covering all pharmaceutical supply chain stakeholders is enacted, the United States will fail to provide the best tools needed for regulators and law enforcement to do a more effective job. Additionally, the U.S. would be missing an opportunity to leverage technology that will provide superior, cost effective consumer protection.

Third Party Logistics Providers, or 3PLs, are playing a growing and important role in making sure medicines reach their destination safely and securely. The term ``third party logistics provider'' refers to an entity that provides or coordinates warehousing, distribution, or other services on behalf of a manufacturer, wholesaler, or dispenser, but does not buy, sell, or direct the sales of those products.

Currently, Federal law does not recognize the role of a 3PL. Only one State even offers a license for 3PLs. Other States require a 3PL to apply for a wholesale distributor license, even though 3PLs do not buy or sell drugs. The varying patchwork of inconsistent State requirements makes law enforcement more difficult and there is added cost without a safety benefit.

Failure to include and define 3PLs in Federal language is simply wrong. Recognizing the role of 3PLs is a strong first step towards the development of uniform Federal standards for a 3PL license. Ensuring that all entities are properly licensed within the pharmaceutical supply chain not only makes sense, but it is one of the most effective deterrents to dangerous counterfeit drugs entering the supply chain.

I thank my colleagues Senators BENNET and BURR, and their staff, for their leadership to enhance supply chain safety by working with all industry stakeholders. I also express my gratitude to Ranking Member Enzi, Chairman Harkin and Senate leadership for their support.

Through a constructive conference process, I am confident we can enhance supply chain safety in a reasonable and cost effective manner. By properly defining 3PLs, and ensuring that properly licensed entities handle our medicines, we can help to ensure they safely and securely reach patients in need. My constituents in Georgia expect nothing less.

Once again, Madam President, I commend the chairman and ranking member on their service and their fine work on the FDA bill.


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