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Daily News

February 07, 2002

Concerns over the health impacts of handling irradiated mail could boost the prospects of a chemical fumigant already used to sterilize medical equipment as an alternative method to cleansing mail of potential bio-contaminants.

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OSHA and several other federal agencies, led by the National Response Team (NRT), are developing a technical assistance document on anthrax cleanups that is intended to provide guidance on detection, cleanup and worker protection in the fight against bioterrorism.

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Hoping to curb the use of inappropriate patents as a means of delaying generic drugs from coming to market, the Generic Pharmaceutical Association (GPhA) is asking FDA to change its regulations to require brand-name drug manufacturers to explain in detail why a patent belongs in FDA's Orange Book. GPhA suggests that the agency could then use this detailed explanation as a basis to refuse to list a patent that does not meet criteria established by Hatch-Waxman drug patent law.

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As lawmakers are becoming increasingly interested in ways to bring generic drugs to market faster, the Generic Pharmaceutical Association (GPhA) submitted a paper to FDA late last month suggesting the agency could administratively establish a pathway to approve generic versions of biologics. The trade association says FDA already has the legal authority to approve generic biologics, even if the innovators' products are regulated by the Center for Biologics Evaluation and Research (CBER).

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During a hearing investigating the Enron collapse, Senate Democrats today pressed DOL Secretary Elaine Chao to commit to a date for an ergonomics hearing after she had repeatedly turned down prior dates. The lawmakers also criticized the top DOL official for not complying with congressional requests for a staff meeting on the issue.

Sen. Edward Kennedy (D-MA), chairman of the Health, Education, Labor and Pensions (HELP) Committee, began a hearing on the collapse of energy giant Enron by asking Chao about setting an ergonomics hearing date, sources say.

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The Democratic-controlled Senate may seek to trump House Speaker Dennis Hastert's (R-IL) recent call for a $300 billion Medicare reform bill by calling for more funds to be devoted to a prescription drug benefit, according to congressional sources.

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February 06, 2002

Lawmakers of both parties and beneficiary groups are reacting with skepticism to the administration's proposal to reform Medicare and craft a comprehensive prescription drug program with a net of $190 billion. Congress is expected to significantly increase this figure as lawmakers are calling for at least $300 billion for a drug benefit.

The administration has floated its $190 billion proposal recently and has laid out its plans for Medicare reform, a discount card and prescription drug coverage in a Jan. 28 White House fact sheet.

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AARP, which has been criticized in the past for not taking a firm stance on various prescription drug bills, is vowing to be more vocal this year and might endorse specific bills.

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A new bipartisan prescription drug bill has been introduced in the House but Republicans and conservative Democrats are not embracing the measure.

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White House officials are looking to the states to help control government reimbursement for prescription drugs, according to an administration official. This strategy shows that the Bush administration is more confident that it can make more progress on drug pricing issues in the states instead of attempting to set new pricing policies in Washington.

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The top Democrat on the House Energy and Commerce health subcommittee says prescription drug user fees should go toward FDA postmarket safety activities. Rep. Sherrod Brown (D-OH) plans to use both this issue and the possibility of generic drug reforms as leverage in upcoming talks with the prescription drug industry over how to craft a Prescription Drug User Fee (PDUFA) reauthorization bill.

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In a major development, a powerful House GOP lawmaker is demanding that the Bush administration quickly provide Congress with many more details on the Medicare policies outlined in the president's fiscal year 2003 budget request. HHS Secretary Tommy Thompson has agreed to comply with the request, signaling that the White House will unveil new plans on the government's policy regarding reimbursements to providers.

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In a move that will likely shelve debate on the nation's economic recovery package, a Senate attempt to force a vote on the Democrat's slimmed-down stimulus proposal failed today [Feb. 6]. As expected, a move by Senate Majority Leader Thomas Daschle (D-SD) to end ongoing debate on the proposal fell shy of the required 60 votes. Daschle called for the debate halt in an effort to bring discussion and amendments on the package to a close and move the measure to a vote. The attempt failed by four votes, drawing 56 votes to 39.

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DOL Secretary Elaine Chao is eyeing major changes to OSHA's enforcement system. Citing a lack of consistency, Chao suggested this week that she wants federal policymakers to have a larger role in the OSHA enforcement process.

The details of how Chao will change OSHA's enforcement system are unclear. The Bush administration did not propose changes to enforcement in its fiscal year 2003 budget proposal. However, it is clear that top policymakers within DOL are considering changes to the enforcement of the OSH Act.

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February 05, 2002

Six nongovernmental organizations (NGOs) are asking the World Trade Organization (WTO) to recognize a limited exception to patent rights under Article 30 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The groups argue that patents should not prevent the export of technology for health purposes, and that compulsory licenses may be granted under this section of TRIPS without certain conditions having to be met by the exporting country.

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FDA's food center has pegged as its top priority ensuring the safety and security of the nation's food supply following recent bioterrorism scares. The new emphasis on security is in part due to FDA's increased funding for security, which is resulting in more food inspectors in the field and development of new methods for inspections at laboratories.

Food center chief Joseph Levitt has carved out several "A-list" priorities for increasing food security. The food center expects to complete nine out of 10 of the 92 items put on the A-list so far.

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The Bush administration is again relying on an unpopular user-fee proposal to help fund CMS' program management budget. HHS Secretary Tommy Thompson is driving the initiative -- outlined in President Bush's fiscal year (FY) 2003 budget -- and hopes to convince Congress to authorize the plan that is opposed by physicians and hospitals.

At a Feb. 4 briefing, Thompson revealed he is again spearheading plans to charge Medicare providers user fees for paper-filed or duplicate claims -- a proposal that critics call a "hidden tax."

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A slew of consumer and industry groups are urging President Bush to repeal the $1,500 therapy caps on Part B services, claiming the limits would force some seniors to pay high out-of-pocket costs or forgo necessary care.

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The future of the politically charged economic stimulus debate is on the line -- and with it states' hopes for increased Medicaid federal funding. The Senate is scheduled to vote Feb. 6 to continue debating the Democrat's slimmed-down stimulus proposal, which includes federal medical assistance percentage (FMAP) hikes for states battling budget woes.

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February 04, 2002

In a preview of the political roadblocks ahead, top House Republican and Democrat health care aides are divided over the coupling of a Medicare prescription drug benefit with wider Medicare reform measures in 2002. The policy rift, compounded by budget constraints and election-year politics, puts passage of a drug benefit on shaky ground just days into the new congressional session.

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