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Daily News

January 22, 2003

The veterinary drug industry is asking FDA and the U.S. Trade Representative (USTR) to urge Japan to reconsider its possible plans to prohibit the use of certain antibiotics in animal feed, according to industry and FDA sources. FDA has sent Japan information from its risk assessments on antibiotic resistance, and industry hopes the data will encourage the Japanese to use a similar "good science" approach, and not the precautionary principle.

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The Biotechnology Industry Organization (BIO) has launched a bid to join the Product Quality Research Institute (PQRI), hoping to play a role in the FDA/drug industry group's work on good manufacturing practices (GMPs), according to sources. If successful, BIO would be the first group on the steering committee to solely represent the biotechnology industry.

PQRI is a non-profit group designed to provide a neutral environment where FDA and industry can collaborate on pharmaceutical product quality research and develop information supporting drug regulatory policies.

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The recently crafted Senate omnibus appropriations bill includes a funding provision for an ergonomics standard and would reinstate worker safety and health training grant funding the Bush administration sought to eliminate, according to congressional documents.

Congress left last year without having voted on a series of spending bills, instead passing a continuing resolution to keep the government running. Lawmakers are now trying to consolidate the unfinished appropriations bills into an omnibus spending bill.

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Greece's Ambassador to the United States says the European Union could review a moratorium on approval of new genetically modified crops during Greece's six-month tenure in the EU presidency, but would not likely agree on a package of mid-term reforms to the EU's Common Agriculture Policy. However, neither of these issues is among the Greek Presidency's priorities, which focus on the pending entry of 10 new members into the EU, Ambassador George Savvaides told the National Press Club Jan. 14.

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Sen. Bob Graham (D-FL) and other lawmakers will seek to attach language to the Senate spending bill that would overturn a Dec. 20, 2002, CMS letter that they say reverses agency policy by limiting coverage of emergency care by states and managed care plans. Hospital groups strongly support the measure and are criticizing CMS for failing to consult them on the new policy.

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CMS Administrator Tom Scully Jan. 22 refused to take sides on whether the Bush administration favors the fix proposed by the House or Senate to the agency's physician payment formula. Speaking at the National Health Policy Conference, Scully said the House and Senate are engaged in "trench warfare" on the issue but asserted that doctors and beneficiaries want to see the formula fixed and "couldn't care less how it's done."

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In the wake of congressional pressure, CMS Administrator Tom Scully is reversing a new agency policy that would have allowed states and managed care plans to limit coverage of emergency services. In a Jan. 22 letter to Senate Finance Committee Chairman Chuck Grassley (R-IA), Scully says the agency will be notifying the states it is rescinding the policy and "the previous guidance is to be followed."

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January 21, 2003

CMS, which repeatedly has tried to integrate cost-effectiveness into its Medicare coverage determination process, is now claiming that Congress gave the agency this authority in the Benefits Improvement and Protection Act (BIPA). This policy decision is extremely significant because it could radically change how CMS sets coverage policies.

While agency lawyers have decided CMS has the authority to use cost as a coverage criterion, CMS has not yet done so, an agency official told Inside CMS.

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OSHA's highly anticipated National Advisory Committee on Ergonomics (NACE) will meet for the first time this week (Jan. 22) and sources say that American Society of Safety Engineers-nominee Carter Kerk will likely be named chairman at the meeting.

In its inaugural meeting, the 15-member panel will be addressed by OSHA Administrator John Henshaw and National Institute for Occupational Safety and Health Director John Howard. In addition, the committee will be briefed on OSHA's activities on ergonomics.

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Makers of the extended-release expectorant guaifenesin have been lobbying FDA hard to keep their products on the market without filing a new drug application (NDA). Representatives of several guaifenesin product manufacturers met with FDA Chief Counsel Daniel Troy and the head of the drug centers office of compliance Nov. 26, 2002, then met with representatives of FDA's commissioners office in December, urging the agency to withdraw the 70 warning letters demanding that the manufacturers withdraw their products.

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FDA's Anti-infective Drugs Advisory Committee says antibiotics used in humans as a sole therapy likely should be more strictly limited for use in food animals.

The committee is gathering information to make recommendations to FDA as the agency further develops guidance that establishes a new scheme for assessing the risk of animal-drug use leading to antibiotic resistance in humans.

Committee members heard heated debate this month between the animal-drug industry and those who want antibiotics used in humans to be banned from routine use in animals.

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Prior to the first meeting of OSHA's new National Advisory Committee on Ergonomics (NACE), a key industry coalition says in order to carry out its mission the panel must "grapple with real scientific controversies and unanswered questions."

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Berlin -- European Agriculture Commissioner Franz Fischler says a U.S. decision to challenge a de facto moratorium on biotechnology approvals in the World Trade Organization would have no positive result for the United States even if it were to win the legal case.

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A freshman House member is drafting legislation to replicate Maine's pioneering Maine Rx law on a nationwide basis. Rep. Michael Michaud (D-ME) announced plans Jan. 21 to create "America Rx," a national initiative to rein in pharmaceutical costs for residents without drug coverage.

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January 17, 2003

A new House subcommittee to address health issues under the Committee on Government Reform is in the works, according to congressional sources. The subcommittee was requested by outgoing full committee chairman Rep. Dan Burton (R-IN), who is likely to head the new panel, sources say.

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A key consumer group is touting legislation introduced by Sen. Richard Durbin (D-IL) in late December as a way to plug holes in FDA's authority to regulate transgenic animals. While FDA and the biotechnology industry say the agency's authority is adequate, the consumer group says Congress should clarify FDA's authority to address ecological impacts of transgenic animals and make the regulatory process transparent.

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FDA's food center hopes to publish proposed rules laying out new requirements for food registration and prior notice of imports within the next few weeks, in time for a planned Jan. 29 public meeting on the recently enacted bioterrorism law. However, if the regulations are not published in time, the center will push back the meeting.

The bioterrorism law gives the agency new authority covering food registration, prior notice of imports, administrative detention and recordkeeping. The agency is required to issue regulations to implement these sections of the law.

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The chairman of the Senate Foreign Relations Committee this week said a pending White House decision on whether to bring suit in the World Trade Organization over the European Union's moratorium on approval of new biotechnology products should not be tied to U.S. efforts to win European allies for its Iraq policy.

But Sen. Richard Lugar (R-IA) did not endorse mounting a legal challenge, arguing there remained a slim hope that diplomacy could lead the EU to lift the moratorium. He also cast doubt on whether a legal case would lead to a lifting of the moratorium.

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The United States has publicly outlined a series of conditions that must be met in order for it to continue its unilateral moratorium on mounting legal challenges in the World Trade Organization against countries that export generic copies of patented drugs to treat serious infectious epidemics.

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Prospects appear dim for a new European Union initiative to break a deadlock on World Trade Organization talks on access to medicines, as developing countries, the World Health Organization and health activists criticized last week's proposal by the EU to allow the WHO to decide what diseases should be covered beyond an initial list of 23 infectious diseases.

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