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Panel I of a Hearing of the Health Subcommittee of the House Energy and Commerce Committee - Drug Safety Provisions of the Food and Drug Administration Globalization Act Discussion Draft Legislation


Location: Washington, DC

REP. JIM MATHESON (D-UT): Well, thank you, Mr. Chairman.

As my colleagues before have stated, I do want to thank you for allowing consideration of the legislation that Representative Buyer and I have been working on.

I want to thank Representative Buyer for all his efforts on this issue. He's been a real leader and it's been a very good experience to work with him in forming this legislation.

And in the tradition of this committee working in a bipartisan way, when this bill was originally introduced, in addition to Representative Buyer and myself, we also had Representative Green and Representative Rogers from the committee as original cosponsors. And I think that speaks to the broad-based support for this legislation.

I just want to highlight three key points that bear noting with regard to this legislation. I want to be clear with my colleagues regarding the intent of this legislation. It's to protect our nation's pharmaceutical from domestic and international counterfeiting threats. I think this is a carefully thought out approach to achieving this goal.

So specifically, this legislation does the following: It creates a system by which we will be able to track drugs from the time they leave the manufacturing facility to the time they reach patients in the pharmacy, hospital, nursing home or doctor's office.

Counterfeiting of drugs is a public health concern. People need to know that when they take a prescribed pill, it is real, undiluted and not laced with phony ingredients. By implementing these steps now, we can go a long way towards safeguarding the medicine people need to get well and stay healthy.

Second, the legislation provides for one uniformed national pedigree system. By having one federal standard, we can ensure our nation's drug market is efficient and can ensure products flow safely and freely throughout the country. This is a guiding principle that seems to unite a majority of the members of the supply chain.

And third, this legislation raises the standards for drug wholesalers, while maintaining state's rights to regulate drug wholesalers. I believe this is a necessary step to ridding the market of bad actors and ensuring that anyone handling America's pharmaceuticals should be held to high standards.

Counterfeit drugs harm people. Our families, our friends and our constituents need to know that they have secure sources of medication. The victims are often people who need real quality drugs the most -- cancer patients, AIDS patients and people being treated for heart disease.

And the main reason, as Mr. Buyer indicated in his testimony -- the main reason for why we're so concerned about the counterfeit drug issue, not surprisingly, is money. The Center of Medicine in the Public Interest predicts that the worldwide market for counterfeit drugs will go to $75 billion annually by 2010. And some experts say it's more lucrative to sell a counterfeit drug than a narcotic.

Counterfeiters are alarmingly good at their jobs. They can create pills and drug packages that are so close to the real products that they are indistinguishable to consumers. By strengthening current laws and regulations, and by creating a uniformed national standard, our legislation further secures the health care supply chain. This enhances our country's current high standard of patient safety.

I look forward to the witnesses' testimony regarding this important issue.

And Mr. Chairman, I'll yield back.


REP. JIM MATHESON (D-UT): Thank you, Mr. Chairman.

Thank you, Dr. Woodcock, for being here today. As you know, and Representative Buyer just asked you some -- oh --

REP. PALLONE: Your mike may not be on.

REP. MATHESON: I think I'm on. There we go.


REP. MATHESON: As you know, and Mr. Buyer just asked you questions related to the legislation that he has introduced and I've joined him in doing that.

Let me ask you -- and there may be a little repetition -- but first of all, does the FDA support looking at track and trace technology and maintaining or improving from the 1988 pedigree law in doing that?

MS. WOODCOCK: Yes. Again, I'll turn to Dr. Bernstein because she's been spearheading that effort.


MS. BERNSTEIN: The FDA -- we have in 2004, 2005, 2006 -- we've continuously put out reports on ways that the drug supply chain and measures that could be taken to further supply the drug supply chain. Tracking and tracing and electronic technology measures and solutions are one of the cornerstones of that approach. So yes, we do support it. The Food Drug Administration Amendments Act of 2007 had provisions in it that requires FDA to develop standards for tracking and tracing, authentication and identification, and we think these measures as -- will further move the supply chain and provide incentives for them to implement track and trace.

REP. MATHESON: You're probably also familiar that our legislation will create the one uniform national pedigree standard to prevent proliferation of 50 different state requirements in this area. In your opinion, does the FDA support a uniform national pedigree standard as opposed to having the 50 state standards?

MS. BERNSTEIN: We have said that a single national uniform standard would be ideal to help the distribution of drugs in the United States.

REP. MATHESON: This may sound like an obvious question, but I think it's important to have the right -- what is the importance of having chain of custody information for drugs as they flow through the supply chain?

MS. BERNSTEIN: As I said, the measures that -- for tracking, tracing and pedigree in chain of custody is to ensure accountability and transparency. And that chain of custody, where you know where the drug has been, where it's going, who has had it makes that -- allows you to be accountable -- allows everyone to be accountable to ensure that that patient gets a safe, effective drug and genuine drug.

REP. MATHESON: Where do you think the technology is now? We're hearing different opinions from different witnesses about if we're ready to do this.

MS. BERNSTEIN: There has been tremendous progress and movement in the technology and standards. And though in -- as part of the provisions in the Food Drug Amendments Act -- FDAA -- we are in the process right now of a data call. We have put out a federal register notice and asked for comments on the state of technology and the technologies that are available, and in addition where the standards are. So we should know very soon because by May 19th, that docket is closing and we'll have more information.

But in my opinion, the technology has progressed significantly since we first called for the use of technology in 2004.

REP. MATHESON: Excellent.

Thank you, Mr. Chairman. I'll yield back.


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