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Daily News

January 21, 2003

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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Two large unions representing first responders and health care workers yesterday (Jan. 16) asked President Bush to delay the smallpox vaccination of civilians, arguing that unresolved medical and compensation questions need to be addressed before going forward with the project.

In separate letters, Service Employees International Union (SEIU) President Andrew Stern and American Federation of State, County and Municipal Employees (AFSCME) President Gerald McEntee petitioned Bush to delay the smallpox vaccination letter.

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January 16, 2003

The American Hospital Association (AHA) is protesting the Medicare Payment Advisory Commission's (MedPAC) call late yesterday (Jan. 15) for Congress to provide below-inflation payment updates for hospitals. MedPAC voted to give hospitals 2004 Medicare payment updates equal to the market-basket rate minus 0.4 percentage points for inpatient payments and the market-basket rate minus 0.9 percentage points for outpatient payments, according to AHA, which calls the recommendation "misguided."

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CMS Administrator Tom Scully quietly hired a long-time AARP official last month, sparking speculation that the move could help the Bush administration's effort to enact a prescription drug benefit this year.

Marty Corry, who worked for AARP as its director of federal legislation, is now a special assistant to Scully. He will work on long-term care policies as well as other issues, according to an agency official. Several CMS stakeholders who attended recent CMS meetings said they were surprised to learn that Corry joined the agency in December.

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A joint state cooperative developed to tackle soaring prescription drug prices is extending its reach from one side of the nation to the other. Informed sources say Hawaii is in the process of joining forces with the National Legislative Association on Prescription Drug Prices, which to date consists of all six New England states, New York, Pennsylvania and the District of Columbia.

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Congressional officials are refuting recent media articles reporting that Senate Republicans seriously considered naming Sen. Trent Lott (R-MS) chairman of the Senate Finance Committee.

Prior to the start of the new Congress, it was reported that Sen. Chuck Grassley (R-IA) balked at the idea of giving Lott the Finance Committee chairmanship following Lott's resignation as Senate majority leader. But congressional sources say that the news accounts are inaccurate and a spokesperson for Grassley said, "There's nothing to it."

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Rep. Henry Waxman (D-CA) plans to introduce legislation creating a special smallpox vaccine injury compensation program because it is unclear how, or if, someone injured by the vaccine would be compensated. Waxman's staff has spoken to the staff of Sens. Bill Frist (R-TN) and Edward Kennedy (D-MA), but the congressmen themselves have not yet spoken about the possible legislation, according to a congressional source.

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In a move that likely will be welcomed by the dietary supplement industry, the Office of Management and Budget (OMB) has cleared FDA's long-awaited dietary supplement good manufacturing practices (GMP) rule, according to an FDA official. The proposed rule needs to be typeset and will be published sometime in the coming weeks, the official adds.

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FDA has established an internal task force that will develop guidance documents over the next six months answering key questions about how the agency will implement a plan to allow conventional foods for the first time to carry qualified health claims. Within six months, the task force will report on how to apply the "weight of evidence" standard for qualified health claims on conventional foods, develop a framework of regulations, identify procedures and organizational staffing needs, and craft a consumer studies research agenda.

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A short-term remedy to prevent looming Medicare physician payment cuts was introduced in the Senate Jan. 15 as part of the fiscal year 2003 omnibus appropriations bill unveiled by Senate Republicans. The provision, which differs from a House plan, would hold Medicare physician rates at 2002 levels from March 1 until Sept. 30.

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January 15, 2003

California's attorney general has proposed controversial changes to the state's toxic labeling law in an effort to reduce the number of enforcement lawsuits filed by private citizens against industry. The changes would require plaintiffs under the labeling law, referred to as Proposition 65, to provide more documentation of alleged violations and establish reporting requirements on out-of-court settlements.

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