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Daily News

April 16, 2004

A World Trade Organization dispute settlement panel last week rejected European Union claims that the United States failed to meet international standards in presenting its challenge against the EU's de facto moratorium against the approval of genetically modified organisms, according to informed sources. The EU had charged that the U.S. request for a panel failed to show what type of measures were covered by the de facto moratorium and had therefore fallen short of what is required to make a case.

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The Senate is expected to vote next week on an amendment designed to rebuff portions of the Department of Labor's rulemaking proposal to overhaul overtime qualifications. However, a Republican congressional source contends President Bush, along with the House, will not allow the amendment to become law.

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A California Senate committee defeated this week by one vote a bill that would require food firms that claim their foods are "low in saturated fat" or "reduced saturated fat" to also disclose any trans fat, but the committee will reconsider the legislation on Monday (April 19). The food industry is lobbying to stop the bill on the grounds that California cannot impose food-labeling requirements that differ from FDA's.

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The Senate health committee, which has jurisdiction over drug reimportation, has no plans to mark up reimportation legislation introduced last week by Finance Committee chair Charles Grassley (R-IA), a congressional source close to the issue says. Health committee chair Judd Gregg (R-NH) -- who disagrees with Grassley's use of the tax code to discourage companies from impeding imports and his plan to allow imports of unapproved drugs -- will introduce his own bill in a few weeks and hold a hearing, the source says.

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State prescription drug programs will be able to use their ability to supplement the new Medicare drug benefit to encourage competing drug plans to provide steeper drug discounts, more open drug formularies and less restrictive pharmacy networks, the head of one state plan told Inside CMS.

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The Office of the U.S. Trade Representative has appointed Ralph Ives as an assistant USTR for pharmaceutical policy to address such issues as foreign drug price control systems and the reimportation of drugs, and has created a separate and expanded office of China affairs. Informed sources view the Ives' appointment as an effort by USTR to appease House Speaker Dennis Hastert (R-IL), who has criticized USTR for not tackling reimportation and price controls more aggressively.

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April 15, 2004

House Democratic staff have begun discussions on inserting pending chemical security bills into upcoming authorization legislation for the Department of Homeland Security (DHS), Democratic staffers say.

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The poultry industry is urging FDA to allow chicken litter in cattle feed, as long as the litter is from chicken that have not been fed meat and bone meal from cattle (MBM), industry sources say. If poultry have not been fed MBM there is no danger that they are carriers of Bovine Spongiform Encephalopathy (BSE) or mad cow disease, sources say.

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The national association representing chain drug stores is pushing the Federal Trade Commission (FTC) officials to launch a broader investigation into the possible conflicts of interests of pharmacy benefit managers (PBMs) that operate mail-order pharmacies. The National Association of Chain Drug Stores (NACDS) says a newly launched FTC study -- mandated under last year's Medicare prescription drug act -- needs to look at a wide array of payments received by PBMs that boost the cost of drug coverage to health plans.

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An orphan drug firm is urging FDA to resume a several-year-old press to eliminate the need for batch testing of U.S. drugs before they can be released in Canada and the European Union, this time through memoranda of understanding with the two countries. EU batch testing would have been eliminated under the U.S./EU pharmaceutical Mutual Recognition Agreement (MRA) signed in 1997, but the controversial agreement has yet to be implemented.

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In a major win for FDA and industry, the California Supreme Court has ruled that FDA labeling requirements for over-the-counter (OTC) smoking cessation products pre-empt warnings called for by the state's controversial Proposition 65 law. The case has been closely watched by FDA-regulated food and drug industry officials as a bellwether for when federal food and drug requirements override state laws.

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April 14, 2004

Successful biomonitoring programs across the country may lead to a significant number of state chemical bans, supporters and opponents of the efforts agree, prompting fears from the chemical industry, which is trying to mobilize scientists and lobbyists to challenge any proposed bans or reviews that it believes will be based on unsound science or unproven assumptions.

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CMS' decision to withdraw a controversial policy bulletin on coverage criteria for power wheelchairs leaves unanswered exactly what standard the agency will use to determine if the device is warranted, providers say.

In a recent open door forum with providers and beneficiary groups, CMS officials said there was "no bright line" they could provide for when Medicare will cover the devices.

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A pharmacy group is urging the Bush administration to be flexible in determining the position of the 1-800 number for adverse event reporting on drug packages, which will be required in an upcoming FDA rule, an industry source says. Adding the number to an already crowded prescription drug label would distract patients from the other important information on the label, the source says, and lead consumers to call FDA instead of their doctor when they suffer an adverse reaction to a drug, the source argues.

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HHS is asking its drug importation task force to consider if the government should allow unapproved foreign drugs to be legally sold in this country, according to a new list of more specific and controversial questions HHS has asked the panel to tackle. However, panel members today (April 14) seemed skeptical of the idea and FDA reportedly is concerned about legislation that would allow for such imports.

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CMS' controversial proposal to pre-approve states' Medicaid budgets before sending them federal matching funds will not be implemented for states' fiscal year (FY) 2005 budgets, according to a state official tapped by the agency to chair a task force on the plan.

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OSHA expects to propose a hexavalent chromium standard by a federal appeals court's October deadline, according to an agency official. The agency this week told the court that the Small Business Administration's review of the rule's impact on small employers will be completed by April 20.

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Americans will no longer be able to use their MasterCard or Visa credit cards to buy drugs from some Canadian Internet pharmacies, Governor Jim Doyle (D) told HHS' importation task force April 14.

Spokespersons for Visa and MasterCard clarified that the companies recently sent Internet pharmacy guidelines to its member banks, and some of those banks may have decided to not do business with certain Internet pharmacies based on those guidelines.

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April 13, 2004

A pharmaceutical supply company says prescription drugs could be safely imported into the United States through a closed system if distributors buy drugs directly from the manufacturer and transfer products between their own distribution centers in different countries. An FDA official says the agency had not heard of the idea before it was raised during an agency taskforce meeting last week, and will consider it.

However, the move may not result in cost savings for U.S. consumers, a representative for the company says.

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Senate Republican leaders are facing a revolt within their own party over legislation that would replace asbestos lawsuits against industry with a federally managed system for compensating exposure victims. Recent concerns by fiscal conservatives over the creation of a multi-billion dollar federal trust fund, which is backed by Senate Republican leaders, combined with long-standing opposition from most Democrats makes passage of the bill a long-shot, according to congressional and industry sources.

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