Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2006--Continued
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2006--Continued
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The Senator from Illinois [Mr. DURBIN], for Mr. Reid, proposes an amendment numbered 1747.
Mr. DURBIN. Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:
(Purpose: To provide for minimum prices for milk handlers)
On page 173, after line 24, insert the following:
SEC. 7__.(a) Section 8c(5) of the Agricultural Adjustment Act (7 U.S.C. 608c(5)), reenacted with amendments by the Agricultural Marketing Agreement Act of 1937, is amended by adding at the end the following:
``(M) MINIMUM MILK PRICES FOR HANDLERS.--
``(i) APPLICATION OF MINIMUM PRICE REQUIREMENTS.--Notwithstanding any other provision of this section, a milk handler described in clause (ii) shall be subject to all of the minimum and uniform price requirements of a Federal milk marketing order issued pursuant to this section applicable to the county in which the plant of the handler is located, at Federal order class prices, if the handler has packaged fluid milk product route dispositions, or sales of packaged fluid milk products to other plants, in a marketing area located in a State that requires handlers to pay minimum prices for raw milk purchases.
``(ii) COVERED MILK HANDLERS.--Except as provided in clause (iv), clause (i) applies to a handler of Class I milk products (including a producer-handler or producer operating as a handler) that--
``(I) operates a plant that is located within the boundaries of a Federal order milk marketing area (as those boundaries are in effect on the date of enactment of this subparagraph);
``(II) has packaged fluid milk product route dispositions, or sales of packaged fluid milk products to other plants, in a milk marketing area located in a State that requires handlers to pay minimum prices for raw milk purchases; and
``(III) is not otherwise obligated by a Federal milk marketing order, or a regulated milk pricing plan operated by a State, to pay minimum class prices for the raw milk that is used for the milk dispositions or sales.
``(iii) OBLIGATION TO PAY MINIMUM CLASS PRICES.--For the purpose of clause (ii)(III), the Secretary may not consider a handler of Class I milk products to be obligated by a Federal milk marketing order to pay minimum class prices for raw milk unless the handler operates the plant as a fully regulated fluid milk distributing plant under a Federal milk marketing order.
``(iv) CERTAIN HANDLERS EXEMPTED.--Clause (i) does not apply to--
``(I) a handler (otherwise described in clause (ii)) that operates a nonpool plant (as defined in section 1000.8(e) of title 7, Code of Federal Regulations (as in effect on the date of enactment of this subparagraph));
``(II) a producer-handler (otherwise described in clause (ii)) for any month during which the producer-handler has route dispositions, and sales to other plants, of packaged fluid milk products equaling less than 3,000,000 pounds of milk; or
``(III) a handler (otherwise described in clause (ii)) for any month during which--
``(aa) less than 25 percent of the total quantity of fluid milk products physically received at the plant of the handler (excluding concentrated milk received from another plant by agreement for other than Class I use) is disposed of as route disposition or is transferred in the form of packaged fluid milk products to other plants; or
``(bb) less than 25 percent in aggregate of the route disposition or transfers are in a marketing area or areas located in 1 or more States that require handlers to pay minimum prices for raw milk purchases.
``(N) EXEMPTION FOR CERTAIN MILK HANDLERS.--Notwithstanding any other provision of this section, no handler with distribution of Class I milk products in the Arizona-Las Vegas marketing area (Order No. 131) shall be exempt during any month from any minimum milk price requirement established by the Secretary under this subsection if the total distribution of Class I products during the preceding month of any such handler's own farm production that exceeds 3,000,000 pounds.''.
(b) Section 8c(11) of the Agricultural Adjustment Act (7 U.S.C. 608c(11)), reenacted with amendments by the Agricultural Marketing Agreement Act of 1937, is amended--
(1) in subparagraph (C), by striking the last sentence; and
(2) by adding at the end the following:
``(D) EXCLUSION OF NEVADA FROM FEDERAL MILK MARKETING ORDERS.--In the case of milk and its products, no county or other political subdivision located in the State of Nevada shall be within a marketing area covered by any order issued under this section.''.
(c) Notwithstanding any other provision of this section or the amendments made by this section, a milk handler (including a producer-handler or producer operating as a handler) that is subject to regulation under this section or an amendment made by this section shall comply with any requirement under section 1000.27 of title 7, Code of Federal Regulations (or a successor regulation) relating to responsibility of handlers for records or facilities.
(d)(1) This section and the amendments made by this section take effect on the first day of the first month beginning more than 15 days after the date of enactment of this Act.
(2) To accomplish the expedited implementation schedule for the amendment made by subsection (a), effective on the date of enactment of this Act, the Secretary of Agriculture shall ensure that the pool distributing plant provisions of each Federal milk marketing order issued under section 8c(5)(B) of the Agricultural Adjustment Act (7 U.S.C. 608c(5)(B)), reenacted with amendments by the Agricultural Marketing Agreement of 1937, provides that a handler described in section 8c(5)(M) of the Agricultural Adjustment Act, reenacted with amendments by the Agricultural Marketing Agreement of 1937 (as added by subsection (a))), will be fully regulated by the order in which the distributing plant of the handler is located.
(3) Implementation of this section and the amendments made by this section shall not be subject to a referendum under section 8c(19) of the Agricultural Adjustment Act (7 U.S.C. 608c(19)), reenacted with amendments by the Agricultural Marketing Agreement Act of 1937.
Mr. DURBIN. Mr. President, I urge adoption of the amendment.
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AMENDMENT NO. 1748
Mr. DURBIN. Mr. President, on behalf of Senator Inouye, Senator Feinstein, and others, I send an amendment to the desk and ask for its immediate consideration.
The PRESIDING OFFICER. The clerk will report.
The assistant legislative clerk read as follows:
The Senator from Illinois [Mr. DURBIN], for Mr. Inouye, for himself, Mr. Akaka, and Mrs. Feinstein, proposes an amendment numbered 1748.
Mr. DURBIN. Mr. President, I ask unanimous consent that the reading of the amendment dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:
(Purpose: To limit the use of funds made available to the Animal and Plant Health Inspection Service)
On page 101, line 10, before the period at the end insert the following: ``: Provided further, That none of the funds may be used to demolish or dismantle the Hawaii Fruit Fly Production Facility in Waimanalo, Hawaii''.
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Mr. DURBIN. Mr. President, I urge adoption of the amendment.
AMENDMENT NO. 1749
Mr. DURBIN. I send an amendment to the desk on behalf of myself, Senator Enzi, and Senator Kennedy.
The PRESIDING OFFICER. Without objection, the pending amendments are set aside. The clerk will report.
The assistant legislative clerk read as follows:
The Senator from Illinois [Mr. DURBIN], proposes an amendment numbered 1749.
Mr. DURBIN. Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:
(Purpose: To insert provisions related to conflicts of interest among members of advisory panels of the Food and Drug Administration)
On page 173, after line 24, insert the following:
SEC. 7__X.(a) Subject to subsection (b), none of the funds made available in this Act may be used to--
(1) grant a waiver of a financial conflict of interest requirement pursuant to section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)(4)) for any voting member of an advisory committee or panel of the Food and Drug Administration; or
(2) make a certification under section 208(b)(3) of title 18, United States Code, for any such voting member.
(b) Subsection (a) shall not apply to a waiver or certification if--
(1) not later than 15 days prior to a meeting of an advisory committee or panel to which such waiver or certification applies, the Secretary of Health and Human Services discloses on the Internet website of the Food and Drug Administration--
(A) the nature of the conflict of interest at issue; and
(B) the nature and basis of such waiver or certification (other than information exempted from disclosure under section 552 of title 5, United States Code (popularly known as the Freedom of Information Act)); or
(2) in the case of a conflict of interest that becomes known to the Secretary less than 15 days prior to a meeting to which such waiver or certification applies, the Secretary shall make such public disclosure as soon as possible thereafter, but in no event later than the date of such meeting.
(c) None of the funds made available in this Act may be used to make a new appointment to an advisory committee or panel of the Food and Drug Administration unless the Commissioner of Food and Drugs submits a confidential report to the Inspector General of the Department of Health and Human Services of the efforts made to identify qualified persons for such appointment with minimal or no potential conflicts of interest.
Mr. DURBIN. Mr. President, the Scientific Advisory Committee system at the Food and Drug Administration is meant to provide the Agency with unbiased, independent, professional advice on the safety and efficacy of drugs, devices, biologics, food, and veterinary medicine.
To protect the objectivity and the integrity of advisory committees, members have long been subject to a number of conflict of interest laws and regulations. Unfortunately, the Food and Drug Administration has routinely granted waivers to scientists with financial ties to the manufacture of the products under consideration or their competitors. These waivers can compromise the integrity of this important advisory process. Let me give one example.
The February 2005 advisory panel considering whether painkillers, Celebrex, Bextra, and Vioxx, could safely be marketed to the public included 10 scientists who were granted conflict of interest waivers. Ten of the thirty-two members--that is 31 percent--consulted for or received research support from Pfizer, which makes Celebrex and Bextra; and Merck, which makes Vioxx; or Novartis, which is seeking approval for a similar painkiller.
Had the votes of those 10 scientists been excluded, the panel would have favored withdrawing Bextra from the market and blocking the return of Vioxx.
As the New York Times pointed out in a March editorial:
Unless the FDA makes a more aggressive effort to find unbiased experts or medical researchers start severing their ties with the industry, a whiff of bias may taint the verdicts of many advisory panels.
I, along with two of my colleagues, Senators ENZI and KENNEDY, have offered this amendment to the Agriculture appropriations bill, a bill which funds the Food and Drug Administration. It will increase the transparency of the process. It will ensure the FDA has searched for experts without conflicts of interest.
Specifically, our amendment requires the FDA to disclose any conflict of interest waivers on their Web site 15 days prior to the meeting of the advisory committee. They must detail the nature of the conflict of interest and the rationale for the waiver.
The amendment also requires the FDA to send a report to the Health and Human Services inspector general after each new advisory committee is convened. The report must detail the steps the FDA took to find scientists who were free from conflicts.
Finally, Senators ENZI, KENNEDY, and I will request that the Government Accountability Office conduct an in-depth study of the waiver process and provide recommendations on how it can be improved.
My amendment will increase the transparency of the waiver process and require the FDA to report to a third party about their efforts to identify scientists without conflicts. I think this will create a powerful incentive for the FDA to find more scientists without the potential for bias.
Let me close by saying that, over the years, it has been my good fortune to work with this important agency, the Food and Drug Administration. The American people don't know how much we rely on this tiny agency to decide that what is sold to us in drug stores and other places in our daily lives must be safe and they must be effective as advertised. It is an arduous and important process, and they get it right so often, but occasionally they do not. We have to make certain that we try to take out of this decision process any question that would be raised about the integrity of the Agency or the means they are using to reach their conclusions. I hope this amendment moves us in that direction.
I yield the floor.
http://thomas.loc.gov/