Henry Bonilla

Mr. BONILLA

Mr. BONILLA. Mr. Chairman, I yield 2 minutes to the distinguished gentleman from Wisconsin (Mr. Obey).

Mr. BONILLA. Mr. Chairman, I rise in opposition to the amendment, and I yield myself such time as I may consume. The gentleman seeks to solve one problem by creating another, and I am going to cite some very, very serious testimony here from the Food and Drug Administration that was presented in front of the gentleman from Pennsylvania (Mr. Greenwood) and his Subcommittee on Oversight and Investigations just last month. At the hearing, the FDA stated, and I quote: ``From a public health standpoint, importing prescription drugs for personal use is a potentially dangerous practice. FDA and the public do not have any assurance that unapproved products are effective or safe or have been produced under U.S. good manufacturing practices. U.S.-made drugs that are reimported may not have been stored under proper conditions or may not be the real product, because the U.S. does not regulate foreign distributors or pharmacies. Therefore, unapproved drugs and reimported approved medications may be contaminated, subpotent, superpotent, or even counterfeit.'' The FDA also said, and I quote: ``Under FDA's personal importation policy, FDA inspectors may permit the importation of certain unapproved prescription medications for personal use. The current policy permits the exercise of enforcement discretion to allow entry of an unapproved prescription drug if: the product is for personal use, (a 90-day supply or less, and not for resale); the intended use is for a serious condition for which effective treatment may not be available domestically (and, therefore, the policy does not permit inspectors to allow foreign versions of U.S.-approved drugs into the U.S.); or there is no known commercialization or promotion to U.S. residents by those involved in the distribution of the product.'' There are several other points here, but the bottom line is, this could be a dangerous threat to consumers in this country. This is ironclad testimony from the FDA on indicating that this could be potentially dangerous. The FDA has not officially permitted the importation of foreign versions of U.S.-approved medications, even if sold under the same name, because these products are unapproved, and the agency has no assurances that these products are safe or effective. I would like to inform my colleagues that both the Committee on Energy and Commerce, which is the authorizing committee for the FDA, and the administration strongly oppose this language and any other language allowing for importation of drugs. So I rise in strong opposition. We will be hearing from other good Members from the Committee on Commerce as well in just a few minutes. Mr. Chairman, I reserve the balance of my time.

Mr. BONILLA. I yield to the gentlewoman from Ohio.

Mr. BONILLA. Mr. Chairman, I want to acknowledge the good amendment that the gentleman from New York is offering, and tell him that we are delighted to accept the amendment.

Mr. BONILLA. Mr. Chairman, I ask unanimous consent to strike the last word.

Mr. BONILLA. Mr. Chairman, I rise to simply state that I am not opposed to the gentlewoman's amendment. A similar provision was included in the conference agreement last year as section 743 of our bill, without any objection of which I am aware. I would hope that we can quickly move to a vote on this issue, and commend the gentlewoman's work on this very important issue.

Mr. BONILLA. Mr. Chairman, I ask unanimous consent to strike the last word.

Mr. BONILLA. I yield to the gentlewoman from Ohio.

Mr. BONILLA. Mr. Chairman, just briefly, I would like to acknowledge the gentlewoman's hard work on this issue and commit to working with her as we move to conference to addressing the needs of our good 4-H people around the country.

Mr. BONILLA. Mr. Chairman, I move to strike the last word.

Mr. BONILLA

Mr. BONILLA. Mr. Chairman, I reserve a point of order. We have not seen this amendment.

Mr. BONILLA. Mr. Chairman, I move that the Committee do now rise.

Mr. BONILLA. Mr. Chairman, I yield myself such time as I may consume. I rise in opposition to the amendment. As with the prior two amendments, we have fully funded FDA's budget request for this activity. Additional money for food labeling will come from other vital areas. I ask rhetorically, from which priority would the gentleman prefer to delete the $250,000? From blood safety, from developing methods to detect food pathogens, or even generic drug review? I oppose this amendment and urge my colleagues to do the same. Mr. Chairman, I yield back the balance of my time.

Mr. BONILLA. The Chair is correct.

Mr. BONILLA. Mr. Chairman, I ask unanimous consent that all debate on this amendment be limited to 20 minutes and that the time be equally divided.

Mr. BONILLA. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I rise in opposition to the amendment. The bill that the committee has presented to the House includes a very carefully balanced recommendation for funding for the Food and Drug Administration. The $39 million provided in this bill for generic drug activities includes a 17 percent increase for generic drug review, generous by any standard. I should also note that the funding for generics includes the only FDA program increase above the President's budget, which certainly demonstrates our commitment to affordable, effective, and safe generic drugs. So, again, I rise in opposition to the amendment. Mr. Chairman, I yield back the balance of my time.

Mr. BONILLA. Yes, Mr. Chairman.

Mr. BONILLA. Mr. Chairman, I ask unanimous consent that all debate on this amendment be limited to 20 minutes and that the time be equally divided.

Mr. BONILLA. Mr. Chairman, I would ask the Chair if the gentlewoman from California (Mrs. Davis) is going to withdraw her amendment.

Mr. BONILLA. Mr. Chairman, if the gentlewoman will yield, we would have no objection to that, and she would be allowed to do that.

Mr. BONILLA. Mr. Chairman, I reserve a point of order on this amendment.

Mr. BONILLA

Mr. BONILLA. Mr. Chairman, I make a point of order against the amendment, because it proposes to change existing law and constitutes legislation in an appropriations bill, and, therefore, violates clause 2 of rule XXI. The rule states, in pertinent part, an amendment to a general appropriation bill shall not be in order if changing existing law. The amendment includes an emergency designation under section 251 of the Balanced Budget and Emergency Deficit Control Act of 1985, and, as such, constitutes legislation in violation of clause 2 of rule XXI. I ask for a ruling from the Chair.

Mr. BONILLA. Mr. Chairman, I do.

Mr. BONILLA. Mr. Chairman, I have a parliamentary inquiry. Is the gentlewoman from Connecticut (Ms. DeLauro) withdrawing her amendment?

Mr. BONILLA. Mr. Chairman, I continue to reserve my point of order, and I reserve the balance of my time.