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Daily News

January 09, 2003

A key medical device manufacturer has crafted a list of data it says reprocessors should submit for FDA premarket review of cleaning, processing and sterilization of certain 510(k) reprocessed devices under the new device user-fee law. Absent from the list are design data, which the original equipment manufacturer (OEM) industry had sought to include before the law was enacted. FDA has resisted requiring submission of design data on the grounds that doing so would make it impossible for hospitals to reuse single-use devices.

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The Washington State Supreme Court is pushing back the due date for the state's Department of Labor and Industries (L&I) reply brief in the ongoing legal battle over Washington's ergonomics standard.

This past November, Washington Employers Concerned About Regulating Ergonomics (WE CARE) appealed a July Thurston County Superior Court ruling that upheld the L&I ergonomics rule. In the decision, the court found that the state had the authority to promulgate an ergonomics standard and used the best available science to do so.

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FDA Commissioner Mark McClellan has decided to shift roughly around one-third of the biologics center's review resources to the drug center this fiscal year to carry out his controversial plan to transfer most biologics therapeutic reviews to the that center. While the drug center will gain 208 full-time equivalents (FTEs) from the biologics center, it will not get all the supporting management resources.

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Although FDA's biologics center will technically retain overall responsibility for therapeutic vaccines, the drug center will play a joint role in regulating these products, according to an email by Commissioner Mark McClellan unveiling the second phase of agency's reorganization plan. McClellan directs the biologics center to fully coordinate its review of therapeutic vaccines with the drug center, and asks the two centers to craft a plan to conduct and pay for these consultations.

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A prominent women's health group is praising FDA's "prompt effort" in revising the labeling of estrogen and estrogen-containing products to provide new safety information to women. The group is particularly pleased with FDA's move to extend the labeling changes to other hormone therapy products, according to a representative of the group. However, the representative says it is unfortunate that the reproductive health advisory committee had not been formed in time to give input to the agency on this issue.

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Attacking the European Union as anti-technology, U.S. Trade Representative Robert Zoellick said Jan. 9 the United States should launch a case in the World Trade Organization against the EU's moratorium on approving new genetically engineered crops in the near future. But he said he couldn't say if a decision on whether to bring such a case would be made within the month, or whether there would be a cabinet-level meeting this month to discuss the issue.

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Rep. Thomas Allen (D-ME), an outspoken lawmaker on prescription drug pricing, is one of four new House Democrats appointed to the Energy and Commerce Committee. Reps. Janice Schakowsky (IL), Jim Davis (FL) and Hilda Solis (CA) are the other new Democrats on the panel.

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House Energy and Commerce Committee Chairman Billy Tauzin (R-LA) "has a few reservations" about recently introduced legislation that would overturn CMS' physician payment regulation, according to a committee aide. But sources say that the Energy and Commerce Committee informed the American Medical Association (AMA) last night that it will likely endorse Rep. Bill Thomas' (R-CA) legislation.

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The Department of Justice (DOJ) Jan. 9 filed suit against Tenet Healthcare, alleging that the hospital chain violated the False Claims Act by upcoding inpatient claims submitted to Medicare.

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January 08, 2003

The U.S. government will argue both for and against a Maine drug discount program scheduled for Supreme Court review this month. Having successfully petitioned the court to take part in the Jan. 22 hearing, the Office of the Solicitor General will present divided arguments on the Maine Rx plan, said a spokesperson for the federal government's top lawyer.

The drug industry has appealed to the high court over the state's drug law, which would require drug makers to pay Medicaid-priced rebates for drugs sold to all residents, not just those eligible for Medicaid.

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FDA's Center for Veterinary Medicine (CVM) is scrapping plans to publish a proposed rule that would require animal drug manufacturers to gather data on antibiotic use in food animals, according to FDA's semi-annual regulatory agenda. The agency suggests that the proposal has been put on the backburner because of possible difficulties in getting the rule past the Office of Management and Budget (OMB) and a desire to instead focus on the recent antibiotic resistance guidance.

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Senate Republicans are expected to announce later this week the appointment of four new Finance Committee members including Majority Leader-elect Bill Frist (TN) and Sens. Rick Santorum (PA), Jim Bunning (KY), and Gordon Smith (OR), congressional sources said. Bunning and Santorum each gave up seats on the Armed Services Committee in order to be eligible to serve on Finance, because of a GOP rule that prevents members from serving on more than one of the four "Super-A" committees simultaneously.

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OSHA today (Jan. 8) extended the comment period for its plan to eliminate or revise provisions in 23 health standards, following through on a pledge to organized labor it would give stakeholders an extra 30 days to file comments on the standards improvement project, according to a key source.

The deadline for stakeholders to submit comments officially ended Dec. 30, 2002, but OSHA announced in a Jan. 8 Federal Register notice that it will accept comments until Jan. 30.

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A bipartisan group of House lawmakers is planning to ask leaders from both parties to make it a "high priority" to address provider reimbursement issues "as soon as possible." In a letter to be sent to House Speaker Dennis Hastert (R-IL) and House Minority Leader Nancy Pelosi (D-CA), lawmakers say they "are seriously concerned that many Medicare beneficiaries...are losing access to vitally important health care services due to the inadequacy of current Medicare payment rates."

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National health care spending rose 8.7 percent to $1.4 trillion in 2001 -- the largest jump in a decade, according to a new federal report. It is the fifth consecutive increase in annual health care spending.

Released today (Jan. 8), the CMS report states that an increase in the quantity and intensity of health care services used, particularly hospital services and prescription drugs, coupled with steady price increases contributed to the acceleration.

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As House Republicans once again move to pass legislation that would avert looming Medicare cuts to physicians, Senate lawmakers will likely oppose the House plan and instead pursue a comprehensive approach to increasing provider payments, according to key Senate sources. Senate lawmakers are worried that Rep. Bill Thomas' (R-CA) plan to overturn CMS' physician payment rule could have negative, unintended consequences, the sources add.

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January 07, 2003

In a move surprising OSHA stakeholders, Eugene Scalia is stepping down as acting DOL solicitor. Scalia, who was a recess appointee to the solicitor's position after then Senate Majority Leader Thomas Daschle (D-SD) indicated that Scalia would not get a Senate floor vote, will leave DOL Jan. 17.

Deputy Commissioner Howard Radzely will take over for Scalia as acting director of the department's top legal post, DOL announced.

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The future of therapeutic cloning is growing dim as Sen. Bill Frist (R-TN), who supports banning therapeutic cloning, becomes the Senate majority leader. A biotechnology industry source says the recent announcement by a religious sect claiming -- without evidence -- that they have cloned a human likely will spur Frist to take up legislation by Sen. Sam Brownback (R-KS) that would do away with all cloning.

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Despite ongoing court action, CMS is moving ahead with its Medicare-endorsed prescription drug discount card program.

The agency intends publishing its official drug card sponsor solicitation soon in the Federal Register. Applications will be due March 7, according to a draft copy of the notice published last month.

CMS plans to announce those entities it has chosen to endorse in May, following which card sponsor enrollment will begin Sept. 30, the draft notice states.

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The Bureau of Labor Statistics (BLS) has announced that occupational injury and illness rates have dropped to an historic low. While DOL Secretary Elaine Chao applauded the data, an organized labor official said the numbers do not match other indicators measuring workplace injuries and illnesses.

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