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Public Statements

Food and Drug Administration Reform Act of 2012

Floor Speech

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Date:
Location: Washington, DC

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Mr. LaTOURETTE. I thank the gentleman very much for yielding.

I commend the Energy and Commerce Committee for producing a good piece of legislation. I also want to applaud the efforts to enhance the safety of America's pharmaceutical supply chain. While we are fortunate in America to not yet have a widespread problem, counterfeit drugs pose a serious health risk to all consumers.

The current patchwork of State requirements and licensing, however, makes supply chain compliance and safety inconsistent and challenging, 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 U.S. will fail to provide the visibility and leverage technology that will provide a superior cost-effective consumer protection.

Third party logistic providers, or 3PLs, are playing a growing and important role in making sure that safe medicines reach their destinations. The term ``third party logistics provider'' refers to an entity that provides or coordinates warehousing, distribution, or other services on behalf of a manufacturer.

Currently, Federal law does not recognize the role of a 3PL. Only one State today offers a license for 3PLs. Other States require a 3PL to apply for a wholesale distributor license, even though 3PLs don't buy or sell drugs.

The varying patchwork of inconsistent State requirements does not provide for optimum law enforcement, and there is an added cost without a safety benefit. 3PLs need to be defined in Federal legislation and properly licensed. Including a 3PL definition in Federal language is a strong first step towards the development of uniform Federal standards and 3PL licenses.

I want to thank my colleagues on the Energy and Commerce Committee in advance for a successful and constructive conference process, and I am confident that we can enhance the supply chain safety in a reasonable and cost-effective manner.

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