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Daily News

August 05, 2003

Senate Finance Committee Chairman Charles Grassley (R-IA) may draft new legislation to amend the tax provisions of an asbestos injury bill currently awaiting floor debate if his committee is not granted jurisdiction to revise these provisions.

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A Clinton appointee, Thomasina Rogers, received an additional six-year term as the Senate confirmed two Occupational Safety and Health Review Commission (OSHRC) members last week.

Scott Railton and Rogers were confirmed July 31. A source close to OSHRC said Rodgers' confirmation is indicative of her political clout. "She is a Democratic woman in a conservative administration, it's pretty outstanding that she got through."

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FDA sought and received assurances from the Department of Justice that phone calls agency officials made to House lawmakers just hours before the chamber passed drug reimportation legislation were legal, agency sources say. Some lawmakers complained both prior to and following the vote that FDA's tactics to dissuade lawmakers from supporting the bill were "unprecedented" and possibly illegal.

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A former Federal Trade Commission official and prominent critic of pharmacy benefit managers is taking issue with the Congressional Budget Office (CBO) assessment that pricing transparency provisions in the Senate Medicare bill will discourage rebates on pharmaceuticals and add $40 billion on to the new drug benefit, arguing that more transparency will instead increase competition for better prices.

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HHS says it will reopen the bidding process for a contract under its nursing home quality initiative in the wake of charges by the General Accounting Office (GAO) that CMS Administrator Tom Scully improperly retaliated against a CMS subcontractor that was slated to research inconsistencies in the agency's nursing home survey. Senate Finance Committee chair Chuck Grassley (R-IA) complained to HHS Secretary Tommy Thompson on Monday (Aug. 4) that Scully's actions were "unacceptable."

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Medicare conferees have struck a tentative agreement on the structure of a prescription drug discount card, removing another relatively non-controversial item from Congress' aggressive Medicare conference agenda. The deal moves the Bush administration one step closer to its twice-thwarted goal of giving seniors a discount card to access cheaper drug prices.

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August 04, 2003

The United States is considering the idea of requesting a special session of the World Trade Organization's Dispute Settlement Body to hear its first request for the establishment of a panel against the European Union's moratorium on approvals of biotechnology products, according to sources. A special session to consider the request is necessary if the United States wants the WTO to establish the panel prior to the Cancun ministerial, as the last scheduled DSB meeting prior to the ministerial is set for Aug. 29.

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A future Codex ad hoc biotechnology task force may address topics such as transgenic animals, cloning animals and adventitious presence (AP), according to sources from the food industry and consumer groups. The Codex commission recently asked Japan, which chaired the previous biotechnology ad hoc task force, to come back with a proposal on the scope and mission of a new task force.

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The Codex Alimentarius Commission is asking a food labeling committee to take another look at starting work on an international standard mandating country-of-origin labeling for ingredients. The food labeling panel decided not to work on such a standard, however, and the commission is overruling that decision.

A food industry source says it is unusual for the Codex Commission to overturn a committee's decision.

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The BioShield report language of two key House committees links the health risks of emerging antibiotic-resistant organisms and infectious diseases to a "material threat" to national security, according to one of the reports. This marks the first formal pitch by lawmakers for the Bush administration to treat antimicrobial resistance and infectious diseases as security issues under the new bioterrorism program, a source following the issue says.

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A coalition of major corporations with retiree health plans is urging Medicare conferees to adopt the more generous subsidy for employer-sponsored retiree drug coverage under the Senate bill, but must overcome a Congressional Budget Office (CBO) finding that the bill would provide a 50 percent subsidy instead of the 70 percent payout projected by employer groups.

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An ergonomics citation issued to a Missouri warehouse appears to contradict OSHA's rhetoric that the agency would not cite companies with ergonomics programs in place and is causing a stir in the employer community, which is following the development with concern.

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A powerful industry coalition is considering establishing a legal defense fund to contest recent ergonomics citations. The employer community has grown increasingly concerned over OSHA's most recent enforcement efforts on ergonomics, and one industry source said business owners "should be terrified" in light of the recent developments.

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August 01, 2003

A group of House Democrats, backed by consumer groups, is touting a six-part legislative package aimed at tightening FDA controls over genetically engineered food and animals, including a bill that would ban the use of genetic engineering on food crops to produce drugs or industrial chemicals.

Another one of the six bills would mandate that food companies label all foods that contain, or are produced from, genetically engineered (GE) material.

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FDA should provide guidance explaining how to handle off-label information in drug medication guides given to patients, industry representatives said at a July 31 public meeting. The guidance should also clarify what the agency would like to see on a consumer MedGuide. Representatives from pharmacy groups, drug industry and information provider groups were unanimous in their request for guidance.

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Medicare conferees last week touted a tentative deal on regulatory reform as a signal of bipartisan, bicameral cooperation as they embarked on an ambitious, two-month schedule to settle more contentious differences, even though the deal leaves the House and Senate still divided over a handful of issues in the regulatory package.

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With more than $24 billion at stake, rural lawmakers are calling on President Bush to help fortify their campaign to preserve House and Senate rural provider payment increases in the final Medicare conference bill.

More than 60 members, most from the House Rural Health Care Coalition (RHCC) and the Senate Rural Health Caucus, urged Bush in a July 24 letter to "ensure" the inclusion of payment boosts contained in the House and Senate-passed bills to remedy rural reimbursement inequities.

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As Medicare conferees gear up to negotiate a compromise drug patent reform plan, the Justice Department Aug. 1 charged that a key element of the Senate plan is unconstitutional. The last-minute move against the Senate's "declaratory judgment" prompted an outcry from the bill's author Sen. Charles Schumer (D-NY), who vowed that he would not stand by to watch the bill watered down during the Medicare conference.

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July 31, 2003

The Congressional Budget Office (CBO) predicts the House Medicare bill's controversial premium support plan would save the government only $700 million from 2010 to 2013, with the bulk of those savings coming from higher beneficiary premiums for private plans and little coming from a slight shift of beneficiaries to cheaper HMOs.

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Public Citizen today (July 31) urged FDA to replace the current voluntary MedGuide program with a federally regulated effort. The consumer group says it has collected data showing that patients are receiving incomplete and potentially misleading information because of the government's reliance on the private sector to implement the prescription drug information program.

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