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Daily News

February 13, 2003

A bill introduced in the Connecticut state legislature late last month would require employers to establish a written ergonomics policy.

The legislation, which was introduced by the Committee on Labor and Public Employees in January, would require employers to review their injury and illness data "to determine whether there is a pattern of ergonomic-related injuries or illnesses in certain job or work tasks."

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Fearing the fall-out of state Medicaid cuts, AARP Feb. 13 called on President Bush and Congress to provide temporary fiscal relief to the states and spoke out against the Bush administration's Medicaid reform plan. AARP's call for relief adds further clout to the long-running campaign for an immediate Medicaid federal funding boost.

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February 12, 2003

A week after advising health care practitioners not to follow FDA's guidelines for administering the smallpox vaccine, a Centers for Disease Control and Prevention (CDC) advisory committee changed its position to be in line with FDA's. After FDA refused to change the package insert for Wyeth's Dryvax vaccine, a top CDC official said, the committee decided its recommendations should match the labeling information approved by FDA.

FDA licensed Dryvax in November 2002, but the agency is still reviewing applications for smallpox vaccines by Acambis' PLC and Aventis Pasteur.

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Following widespread criticism of the Bush administration's draft plan to reform Medicare, congressional Republicans are urging the White House not to propose a specific prescription drug proposal. Instead, GOP lawmakers want the administration to release vague principles on Medicare reform -- as it did in 2001.

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The Congressional Budget Office (CBO) has scored the physician provisions of the recently brokered House-Senate provider payment deal at $54 billion for the 2003-2013 period over the objections of House Ways and Means Committee Chairman Bill Thomas (R-CA), who has maintained that the language should be scored as "zero cost." It is unclear whether CBO's score will force appropriators to strip the provisions from the omnibus spending bill but sources say the projection has certainly not helped the prospects of the ph

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A key medical device industry group says FDA should not charge medical device companies user fees if the first "module" of a premarket approval (PMA) application was submitted before Oct. 1, 2002, the starting date for the user fee program. The Advanced Medical Technology Association (AdvaMed) is worried that FDA might charge user fees for pieces of PMAs submitted after that date, even though the first module of the PMA was submitted prior to that date.

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Progress on legislation for a smallpox vaccine injury compensation plan has slowed as key Senate Republicans wait to meet with the White House to form their plan and Democrats remain split on their own package, according to congressional and health care union sources. A Monday (Feb. 10) meeting between staff of Senate health committee chair Judd Gregg (NH) and ranking Democrat Edward Kennedy (MA) was cancelled, and sources do not know when it will be rescheduled.

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The recently negotiated House-Senate deal on Medicare provider payments cleared a major hurdle Feb. 12 when it overcame a new estimate from the Congressional Budget Office (CBO) that projects that the physician provisions cost $54 billion, according to sources.

Following this estimate, proponents of the provider language were scrambling to keep the provisions intact and indicated they were hopeful Congress would approve the payment hikes. But rumors circulated throughout the day that the CBO score would kill the entire provider payment package.

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February 11, 2003

FDA should not require that all products containing Alpha Hydroxy Acids (AHA) carry a warning about increased susceptibility to sunburn, a key cosmetics trade group says. FDA's draft guidance fails to take into account that only products that use AHAs for their exfoliant properties have been shown to result in an increased sensitivity to sunburn, the group says. The group is asking FDA to revise the guidance.

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An orphan drug firm has submitted a petition asking FDA's drug center to stop requiring user fee payments while a waiver request is pending. The firm charges that the agency's current policy of requiring firms to pay user-fees before FDA decides if a waiver should be granted is unlawful. The company also asks the agency to transfer responsibility for the user-fee program from the drug center back to the commissioner's office.

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A federal appeals court says FDA lacks the authority to regulate the packaging of solid dosage dietary supplements and drugs to prevent poisoning caused by misuse of products. The appeals court, reversing a district court decision, took issue with a 1997 FDA regulation that requires manufacturers of iron-containing drugs and supplements to use unit-dose-packaging.

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A top HHS official is seriously considering leaving his post to enter the race to become the next governor of Louisiana, according to sources. Bobby Jindal, HHS assistant secretary for planning and evaluation, will soon decide whether he will launch the gubernatorial bid, the sources add.

Louisiana Gov. Murphy "Mike" Foster (R), who is in his last term, has publicly urged Jindal to run for his office and sources say the HHS official is very close to making a decision. Foster's term expires this year.

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FDA has ended a 1999 pilot program under which device manufacturers were given a chance to quickly correct quality system (QS), labeling and 510(k) violations or deficiencies in order to avoid receiving a warning letter. FDA says the pilot did not provide industry an incentive to promptly correct violations and the Office of Chief Counsel's new warning letter review addresses some of the concerns raised by industry, according to an FDA Federal Register notice.

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February 10, 2003

Getting Congress to pass President Bush's Project BioShield proposal will be difficult in large part because it would give the president the authority to spend money on biodefense products without congressional approval, according to a top HHS official. Legislation would also be required to implement the new FDA approval process proposed by the president for speeding biodefense products to market.

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A group of House Republicans led by House Speaker Dennis Hastert (R-IL) and Majority Whip Roy Blunt (R-MO) are urging President Bush to launch a challenge against the European Union's biotechnology moratorium in the World Trade Organization. Cabinet-level officials of the Bush administration were set to decide last week whether to bring a case against the EU, but the meeting was postponed indefinitely.

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Attempts by both the European Union and Japan to find a compromise to deadlocked World Trade Organization (WTO) talks on more flexible drug patent rules fell flat last week, as African countries rejected any limitations on the scope of diseases and the United States made no movement toward agreeing to a broader scope for an agreement.

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Washington's OSHA and AFL-CIO are asking the state's Supreme Court to uphold the decision of a lower court that rejected an industry challenge to Washington's ergonomics standard.

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FDA's device center has already written the guidance documents necessary to start collecting device user fees, but cannot release them until Congress passes FDA's fiscal year 2003 appropriations bill, according to a source following the process.

FDA also has opened a docket where stakeholders can submit comments on the new device user fee law. The agency is urging industry to comment on key aspects of the fee collection system, as well as comment on how the agency should collect safety information on pediatric devices.

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The chairman of the WTO Council on Trade Related Aspects of Intellectual Property Rights Feb. 10 asked the World Trade Organization General Council for another week to see if the United States and other key players will sign on to an agreement giving countries the right to source production of generic drugs abroad now that he has proposed a compromise designed to limit use of these rights to dealing with national emergencies.

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February 07, 2003

The latest proposal from some of the industry groups involved in the initiative to update OSHA's outdated permissible exposure limits (PELs) is stalling the progress of the working group, according to sources.

Late last year, stakeholders had predicted that the PEL working group, which is seeking to build a consensus on how to update the exposure limits, would fall apart, and a new industry proposal that one source called a "step backward" confirms that the effort has stalled.

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