Mr. Speaker, I thank the distinguished ranking member for yielding me this time. I rise in opposition to H.R. 2427. Mr. Speaker, I think it is very important for everyone in the House to really understand exactly what this bill will do.…
Mr. Speaker, I thank the distinguished ranking member for yielding me this time.
I rise in opposition to H.R. 2427. Mr. Speaker, I think it is very important for everyone in the House to really understand exactly what this bill will do.
Some think that drug reimportation will dramatically reduce drug costs in the United States. This has never been proven. Secretaries of Health and Human Services for two Presidents have stated that they could not certify that reimportation would actually save Americans money.
Now, minus this guarantee that the bill would ever achieve its primary purpose, I think we are taking huge risks for little or no gain.
Secondly, the bill is dangerously flawed and poses considerable risks to the people that we represent. Current law states that the Secretary of HHS must certify that reimportation will not add risks to the public health. This bill removes that requirement, effectively eliminating our last line of defense against unsafe and illegal pharmaceuticals.
The bill expands reimportation to 25 countries, many of which do not have the regulatory regimes that even remotely, remotely match the FDA.
This is very different from ``Canada only.'' We have the safest drug supply in the world today, and Americans rely on this safety every day. Do we really want to dilute this?
The sponsors of 2427 have said the bill contains numerous provisions that will ensure that drugs reimported into our country are safe. I disagree. The bill purports to only allow reimportation of drugs made in FDA-approved factories, but the bill also eliminates the requirements that reimporters demonstrate who has had custody of a drug since its creation. Now, how can we verify that a drug is made in an FDA-approved facility if we do not even know who had custody of it last?
The bill requires reimporters to test the drugs they are bringing back into the United States to ensure they are legitimate. The results of those tests are to be verified by the FDA. Is there an appropriation to this bill to fund the added mandate to the FDA? There is not.
The bill requires counterfeit-proof packaging for many of the drugs that will be reimported to the United States. And yet there is not any guarantee that the counterfeit technology
itself will not be counterfeit or tampered with. This is happening in the United States today as we debate this bill. This is an example of a hologram that has been tampered with. You and I would not know the difference. The FDA would. My mother would not.
We have to remember that nearly 20 years ago the gentleman from Michigan (Mr. Dingell) introduced and passed the prescription drug marketing law. He did so on the heals of a multiyear investigation by oversight and investigations of the Committee on Commerce. We should not give up this safety. What my fear is is that we have so taken for granted the efficacy of pharmaceuticals that we are willing to let it go tonight. Vote against this bill.