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Daily News

July 25, 2003

The Senate plans to adopt the House BioShield funding provision during conference, according to a key congressional source. The source says Sen. Robert Byrd (D-WV) will accept the House funding scheme, which would establish a special fund for purchasing biodefense products and would authorize Congress to appropriate $5.6 billion to the fund for the next 10 years without requiring annual appropriations.

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A major effort by Philip Morris to generate congressional momentum behind tobacco legislation combining new FDA authority with a federal buyout is likely to stall in the House, and may face obstacles in the Senate. The idea of giving FDA explicit jurisdiction over tobacco has hit a roadblock with House Energy and Commerce Committee chair Billy Tauzin (R-LA) opposing legislation, sources say. In the Senate, health committee chair Judd Gregg (R-NM) and ranking committee Democrat Edward Kennedy (MA) are haggling over how to fashion a bill giving FDA oversight of tobacco.

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Sen. Richard Durbin (D-IL) is asking dietary supplement makers who advertise their products as "ephedra free" to provide safety information about their products. Durbin charges that supplement makers are substituting chemical ingredients similar to ephedra in their products. Durbin also criticizes HHS for not banning ephedra despite having received the results of the RAND study and comments on the ephedra proposed rule.

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July 24, 2003

The Senate health panel unanimously passed patient safety legislation July 23 after committee chair Judd Gregg (R-NH) and ranking Democrat Edward Kennedy (MA) brokered a compromise hours before the markup. Unlike the earlier version of the bill, the chairman's mark does a better job of providing whistleblower protection to state hospital employees who report medical errors to patient safety organizations (PSOs), a Senate Democratic staffer says. The revised bill also more narrowly defines what information PSOs could make confidential, congressional staffers say.

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Late Wednesday (July 23), the Senate unanimously passed a modified version of legislation passed earlier by the Senate health committee that would reinstate FDA's controversial pediatric rule. The revised bill closes a possible loophole in the committee-passed bill that pediatric groups said would have let hundreds of deferred and pending pediatric studies slip through the cracks. The pediatric rule, struck down by the courts, allows FDA to force drug companies to conduct pediatric trials on their products.

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House Republicans passed three OSHA reform bills on a party-line vote July 24, despite Democratic charges the bills would help employers avoid OSHA citations and create additional costs to the government. But Democrats did not offer any amendments to the legislation during the subcommittee markup.

In a move aimed at helping small businesses, the bills would increase the size of the Occupational Safety and Health Review Commission (OSHRC), offer companies more leeway in filing objections to agency citations and clarify the commission's role as an independent arbiter.

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FDA Commissioner Mark McClellan resisted lawmakers' efforts to get the agency on record as needing more statutory authority to regulate dietary supplements during a House Energy and Commerce Committee hearing Thursday (July 24). McClellan said FDA has never tested the "unreasonable risk" standard of the dietary supplement law, and the agency wants to make sure it has a solid case before taking additional action.

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Medicare conferees today (July 24) reached a tentative deal on the bulk of differences between the House and Senate regulatory reform packages.

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In the latest missive on Medicare reform legislation, a group of centrist Senate Democrats and House Blue Dogs have teamed up to urge congressional leaders to forge a conference report adopting key elements of the Senate-passed plan in order to gain strong bipartisan backing rather than a slim majority. The lawmakers repeat previous Democratic calls for the retention of the Senate government fallback option and added low-income protections, among other demands.

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July 23, 2003

The U.S. Chamber of Commerce and other industry groups are worried that mold litigation will become "the next asbestos" controversy. Strongly criticizing trial lawyers and the media, the Chamber says science does not support the public's perception "that mold causes 'toxicity' in doses found in home environments."

Employers link asbestos litigation to numerous bankruptcies and the Senate is currently working on litigation that would establish an industry-sponsored trust fund exceeding $100 billion to pay off pending asbestos claims.

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Medicare legislation passed by the House and Senate last month both cost more than the allotted $400 billion budget mark, new cost estimates reveal, worsening the headache for Medicare conferees tasked with melding the competing bills. Tagged at $461 billion over 10 years, the Senate score was boosted in large part by a lone $40 billion pharmacy benefit manager (PBM) disclosure provision -- casting serious doubt over the amendment's future.

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A group of occupational health professionals is calling on the author of House OSHA reform legislation to limit the scope of the bill to small businesses. The group, however, supports most of the professions to be marked up tomorrow (July 24).

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FDA will receive $5 million to support a new food security research program, HHS Secretary Tommy Thompson and FDA Commissioner Mark McClellan announced Wednesday (July 23). The agency will use the new funds to develop prevention and mitigation technologies and strategies; identify agent characteristics needed to develop these prevention technologies; and craft ways to assess foods for contamination with chemical, microbiological and radiological agents.

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Key House Democrats are using this week's Energy and Commerce Committee hearing on ephedra to press for changing the Dietary Supplement Health and Education Act, while Republicans are resisting changes to DSHEA, arguing that ephedra is an isolated product that needs stricter regulation. California Democrats Susan Davis and Henry Waxman are working on a bill that would increase FDA's authority to regulate dietary supplements, but it will be different from legislation sponsored on the Senate side by Sen. Richard Durbin (D-IL).

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July 22, 2003

Midwest senators, including Finance Committee Chairman Charles Grassley (R-IA), are promising to restore funding for the Department of Agriculture to implement new requirements for food to be labeled with its country of origin, after the House voted this week to eliminate funding for the program.

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China plans to formally make good on its intention to extend its interim system of approving sales of genetically modified crops until April 2004, thereby avoiding a disruption of U.S. soybean exports this fall, according to a U.S. government source.

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Non-binding report language included in the House appropriations bill calls on OSHA to combat airborne infectious diseases in an effort to protect health care workers, stating the agency should consider promulgating a standard on the issue.

Rep. David Obey (D-WI), ranking member of the House Appropriations Committee, recommended that OSHA create an airborne infectious disease standard with the appropriated funds and Republicans agreed to include language in the House report.

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Seeking higher Medicare reimbursement rates, a key patient advocacy group is urging Congress to add language to the Medicare conference report to exclude rare disease therapies from Medicare's hospital outpatient prospective payment system (OPPS). The National Organization for Rare Disorders (NORD) says the policy change would help ensure patient access to such products -- access it contends is restricted under Medicare's current hospital outpatient system.

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The chairmen of three key committees involved in the debate over medicare reform have pledged to hold Congress' final reform bill within the $400 billion target.

The Congressional Budget Office (CBO) said July 22 that the House and Senate Medicare reform bills would exceed the near half-trillion-dollar mark.

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July 21, 2003

Some consumer groups are complaining that legislation soon to be introduced by Sen. Richard Durbin (D-IL) on genetically engineered foods does not go far enough in protecting the food supply. The groups are upset that a draft version of the bill would allow the use of food crops as pharmaceutical agents, despite its call for food-safety controls on such products. The groups are also opposed to Durbin's plan to let HHS waive premarket approval requirements for certain GE food categories the department decides would not pose a safety risk.

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