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Daily News

August 19, 2003

As OSHA prepares to officially withdraw its tuberculosis (TB) standard in September, organized labor is considering filing a lawsuit aimed at forcing the agency to finalize its TB standard, according to a source.

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Senate Judiciary Committee Chairman Orrin Hatch (R-UT) will likely accept changes requested by Finance Committee Chairman Charles Grassley (R-IA) to the tax provisions of an asbestos injury bill currently awaiting debate on the Senate floor, according to a key Senate Republican aide.

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The dietary supplement industry says it will cost companies much more than estimated by FDA to implement dietary supplement good manufacturing practices (GMPs) because of the product testing requirements proposed by the agency. Industry urges FDA to allow for a more flexible testing regime.

FDA has underestimated the cost of conducting analytical tests on every batch of the product, a key trade group says. The agency also has underestimated the total laboratory and testing costs, according to the group.

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The dietary supplement industry is split on FDA's plan to subject supplement ingredient suppliers to good manufacturing practices (GMPs). FDA does not have the right under the dietary supplement law to prescribe GMPs for ingredients, the Council for Responsible Nutrition (CRN) and American Herbal Products Association (AHPA) say. Another prominent supplement group, however, supports FDA's move, saying it is necessary to ensure quality ingredients.

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A dietary supplement industry group says FDA lacks broad legal authority to demand that supplement makers provide agency inspectors access to company records showing compliance with food laws. Accessing company records is a provision in the agency's proposed dietary supplement good manufacturing practices (GMP) rule.

The Council for Responsible Nutrition (CRN) says FDA can request access to such records only under limited emergency circumstances established in the recently enacted bioterrorism regulations.

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August 18, 2003

President Bush signed into law Aug. 15 legislation extending the availability of $2.7 billion of unspent State Children's Health Insurance Program funding, according to a White House statement. The 1998 through 2001 funding allotments are to be distributed among the states in line with language passed by the House and Senate just prior to the August recess.

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FDA Commissioner Mark McClellan is developing a strategy to beef up research that will result in medical breakthroughs, which includes setting up "research exemptions" that would allow industry and academics to share data on pharmacogenics and other studies. FDA also is working on a series of new guidance documents aimed at streamlining research in areas such as diabetes, obesity and cancer.

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The Federal Trade Commission (FTC) Sept. 26 will hold a hearing on hospital group purchasing organizations (GPOs) to examine issues including product bundling, lengthy manufacturer/GPO sole source contracts, and high hospital/GPO commitment contracts. FTC is reexamining the GPO issue following a health care workshop last September that explored GPO decision-making related to the influence of manufacturer rebates, weighing cost versus quality, and whether or not the proposed GPO Code of Conduct addresses the concerns raised about GPOs.

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The United Nations Codex Alimentarius Commission has sent a health claims and nutrition document back to the commission's food labeling committee to resolve a last-minute controversy regarding whether food advertising should be covered. The U.S. delegation called for the advertising language to be pulled, arguing that its last-minute inclusion fundamentally changed the document's scope.

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A California advisory panel on ergonomics recently told the state's safety and health board that the majority of the panel's members believe that no action should be taken to update the state's ergonomics standard. Panel members were commissioned earlier this year to examine how and if the state's ergonomics regulation should be strengthened.

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A coalition of patient groups are grappling with how FDA could speed patient access to promising drugs as the Washington Legal Foundation (WLF) and a patient group called Abigail Alliance For Better Access to Developmental Drugs are pressing FDA to dramatically expand the availability of investigational drugs. WLF and Abigail Alliance laid out their proposal in a June citizen petition and followed up with a lawsuit against the agency last month.

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OSHA's first status report to the court on its progress on a hexavalent chromium standard is receiving cautious approval from the group which sued the agency over its failure to update the metal's permissible exposure limit.

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August 15, 2003

Provider groups are asking Medicare conferees to pick the Senate's proposed seven-year consumer price index (CPI) freeze for durable medical equipment (DME) over the competitive bidding provision included in the House legislation.

In an open letter to Congress, the American Association for Homecare (AAHomecare) says the House's "so-called 'competitive bidding' provision would shop Medicare contracts out to the lowest bidder for [DME] at the expense of quality, restricting patient choice and access, and threatening thousands of small business jobs and local economies."

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FDA is pushing back to Sept. 5 the deadline for comments on the agency's policy for addressing confusing similarities in drug names. FDA pushed back the deadline in response to a request from the drug industry trade group that wanted more time to submit comments. FDA asked industry to comment on the methods the agency uses to evaluate look-alike and sound-alike drug names.

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The Pharmaceutical Research and Manufacturers of America (PhRMA) has joined 10 other business groups interested in protecting intellectual property in urging U.S. Trade Representative Robert Zoellick to resist any calls for reopening the Agreement on Trade-Related Intellectual Property Rights at the upcoming World Trade Organization Cancun ministerial.

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U.S. officials and the domestic meat industry have reluctantly agreed to adopt a voluntary labeling program for beef destined for Japan and South Korea to meet the demand of those nations that the United States certify its beef is not mixed with beef from Canada. Japan had said that due to concerns about mad cow disease in Canada, it would ban imports of U.S. beef beginning Sept. 1 unless the United States adopted a country-of-origin label certifying that the beef was American.

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In the latest strike against pharmacy benefit managers (PBMs), two pharmacy groups have taken legal action against the nation's largest PBMs, alleging in separate class action lawsuits that the drug benefit managers have illegally stifled competition.

The National Community Pharmacists Association (NCPA) and Pharmacy Freedom Fund today (Aug. 15) filed suits against AdvancePCS and Medco Health Solutions, Inc. in a Philadelphia federal court. The trade group and coalition of independent pharmacy owners argue that the PBMs have violated antitrust law.

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August 14, 2003

The metric that FDA is using to measure performance under its new initiative to reduce review times for certain premarket approval (PMA) applications covers only final approval decisions, not "approvable" decisions, according to FDA sources. The plan to cut reviews by 10 percent for the fastest half of innovative medical device applications is part of a larger FDA initiative being released today (Aug. 14) to reduce reviews agency-wide by 10 percent.

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A broad coalition of Senate lawmakers is asking the Medicare conferees to include provisions in the conference agreement that would boost payments to the Medicaid Disproportionate Share Hospital (DSH) program.

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In a notable bipartisan gesture, the nation's governors have united to officially urge Medicare conferees to back House language that would ensure all beneficiaries -- including those on Medicaid -- qualify for Medicare's new drug benefit. The call adds weight to a growing chorus of groups lobbying conferees for universal drug coverage.

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