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Mr. LATTA. Mr. Speaker, I yield myself such time as I may consume.
I rise today in support of H.R. 1919, the Safeguarding America's Pharmaceuticals Act of 2013. This legislation is the culmination of many years of hard work by legislators and stakeholders alike, and I'm honored to have introduced this legislation, along with Congressman Matheson.
This is an issue that was brought to my attention when I was first elected to Congress 5 1/2 years ago by concerned stakeholders in Ohio, and I am pleased that the legislation is being considered on the House floor today. Securing our Nation's pharmaceutical supply chain is an extremely important issue, and passage of this bill will be an important step forward to protecting America's families.
The pharmaceutical supply chain touches every part of the health care system, and it is imperative that we get the structure and segments of it connected in a safe, secure, and effective manner that provides the best protection for patients.
H.R. 1919 will make improvements to the current supply chain while providing a clear path for industry stakeholders towards enhanced supply chain protections.
Pharmaceutical distribution occurs nationwide, and it is estimated that within the United States there are more than 4 billion prescriptions filled each year. By replacing the current patchwork of multiple State laws with a uniform national standard, we improve safety, eliminate duplicative regulations, and create certainty for all members of the pharmaceutical supply chain.
When anyone takes a prescribed medication, he or she should have full confidence that the medication is as prescribed and will do no harm. It is of utmost importance that we implement commonsense solutions to safeguard our distribution supply chain against counterfeit and adulterated drugs, as well as improve security and integrity throughout the supply chain. This legislation is an important step forward to ensure greater patient safety for all Americans.
I was pleased to receive a support letter for H.R. 1919 from the United States Deputy Sheriffs' Association, which also recognizes that a national system will help curb criminal activity surrounding prescription drug diversion and criminal counterfeiting.
In the letter, it discusses how a national system could deter opportunists' ability to focus their efforts on differing State laws, or those States that have no laws or regulations, thereby allowing for criminal infiltration.
Specifically, the letter states that ``tracking packages destined for patients is a good defense against criminals who would profit from contaminating or stealing those medicines, and put patients at risk.''
To protect patient safety, this bill would replace multiple State laws and create a uniform national standard for securing the pharmaceutical distribution supply chain, thereby preventing duplicative State and Federal requirements.
It would increase security of the supply chain by establishing tracing requirements for manufacturers, wholesale distributors, pharmacies, and repackagers based on changes in ownership.
The bill also establishes a collaborative, transparent process between the Food and Drug Administration and stakeholders to study ways to even further secure the pharmaceutical supply chain.
Finally, the bill puts in place a requirement for the FDA to issue proposed regulations on unit-level traceability. The timeline put forth in this bill for all those steps is reasonable and will allow enough time for stakeholders to comply with these new national standards and ensure that, through feedback from these same stakeholders, phase two is done efficiently and correctly.
As I stated earlier, this issue has been worked on for many years, and setting up a track and trace process is complicated.
Chairman Upton, I appreciate your leadership in moving the Safeguarding America's Pharmaceuticals Act to the floor today. We made a number of changes in the Energy and Commerce Committee to improve the language of the bill as we work to create a safer pharmaceutical distribution system to protect against the threat of counterfeit drugs.
This is a highly complex area, and I understand that additional changes were made to the language in the version we are considering today. Further changes are necessary to ensure that the wholesale distribution system meets the highest standards of safety and consumer protection. In order to achieve those high standards, I am committed to ensuring that language is included in the conference report brought back to the House that establishes a direct purchase pedigree for those wholesalers who only purchase pharmaceuticals directly from the manufacturers.
I know you share my goal of creating the strongest supply chain system, and I look forward to working with you as we move forward.
There has been much work done on this issue over the many years, and I am appreciative of all the input I have received on this bill from stakeholders and interested parties. And I again want to specifically thank Chairman Upton and Subcommittee Chairman Pitts for all their assistance in advancing this legislation. I urge full support of my colleagues for H.R. 1919.
I reserve the balance of my time.
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