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Daily News

April 18, 2003

OSHA has enlisted help from unions and trade groups to develop draft ergonomics guidelines for the shipyard industry by the end of the year, marking the fourth set of ergonomics guidelines planned by the agency.

Guidelines for the nursing home have recently been completed and OSHA plans to soon announce draft guidelines for the retail grocery and poultry processing industries.

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OSHA says a new strategic partnership between the United States Postal Service (USPS) and two postal worker unions that offers reduced penalties and fewer inspections for those sites participating in a program to prevent ergonomic injuries shows what is needed to curb musculoskeletal disorders (MSDs).

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Projections sent by the Congressional Budget Office (CBO) to lawmakers drafting a Medicare prescription drug benefit show the $400 billion budgeted for Medicare reform covers less than a quarter of the amount Medicare beneficiaries are expected to spend during the first eight years of coverage.

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April 17, 2003

The brand-name drug industry is urging FDA to clarify when pharmacovigilance efforts above and beyond post-marketing spontaneous adverse event reporting (AER) are warranted. The group says FDA's concept paper on good pharmacovigilance practices does not lay out what criteria FDA will use to decide when additional efforts are necessary.

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As serious doubts arise over the likelihood that a September World Trade Organization ministerial will produce substantive progress in agriculture and other areas of the Doha negotiations, it is becoming increasingly likely that a deal giving developing countries access to cheaper copies of patented drugs will be the achievement of the meeting, according to trade officials and private-sector sources.

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The Agriculture Department's continuing concerns about a long-awaited dioxin risk study by the Environmental Protection Agency may trigger congressional requirements forcing the study into a National Academy of Sciences (NAS) review unless other agencies cannot secure USDA's support, sources say. FDA, earlier a strong critic of the study, now appears to be willing to back EPA.

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A federal court in Colorado has temporarily stopped a state law from going into effect that would have excluded legal immigrants from receiving Medicaid benefits.

In an April 1 order, the United States District Court for the District of Colorado granted the motion for a temporary restraining order, and indicated in doing so that there is a "substantial likelihood" that the plaintiffs would prevail when the case is decided.

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A government employees union is calling on OSHA to finalize its tuberculosis (TB) rulemaking, claiming final action on the standard that was proposed six years ago is long overdue.

In an April 14 petition to DOL Secretary Elaine Chao, American Federation of State, County, and Municipal Employees (AFSCME) President Gerald McEntee says OSHA has unreasonably delayed action on the rulemaking and should finalize a standard "immediately."

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April 16, 2003

The National Organization for Rare Disorders (NORD) is urging FDA to base user fee waivers on individual U.S. sales of each orphan drug or biologic, not on total worldwide sales of the company. NORD says requiring small companies to pay user fees based on their gross annual revenue results in high application costs for products that have low annual revenue.

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The chair of the House Ways and Means health subcommittee has asked the Congressional Budget Office to examine the potential cost savings to Medicare of better managing the treatment of the chronically ill. Rep. Nancy Johnson (R-CT) is drafting a proposal to have Medicare, under its fee-for-service plan available to all seniors, institute a chronic disease management plan, a spokesman said.

That proposal would be part of the overall Medicare reform plan, including prescription drug coverage that the committee offers this year.

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A coalition of consumer groups is charging that a Senate bill meant to improve access to animal drugs for minor species and minor uses could speed unsafe transgenic animals to the market. The bill may encounter resistance from Senate health committee ranking member Edward Kennedy (MA), who has major concerns about how the legislation would affect transgenic animals and antibiotic resistance

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A meeting with CMS Administrator Tom Scully and a subsequent letter from CMS have laid to rest Rep. Lee Terry's (R-NE) concern that CMS colluded with one particular vendor in crafting a hospital performance survey, a source close to Terry said. Terry, at the request of The Gallup Organization, recently asked the House Energy and Commerce Committee to investigate if CMS gave an unfair advantage to a Gallup competitor in crafting the survey and if Scully "violated rules of conduct" in an e-mail to a Gallup official.

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Advocates for Mexican workers intend to ask the governments of the United States, Canada and Mexico to add a subcommittee to its Tri-national Occupational Safety and Health Working Group that would examine the performance of the North American Free Trade Agreement's (NAFTA) labor side agreement.

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The National Electrical Manufacturers Association (NEMA) is urging FDA to clarify how the third-party inspection provisions of the new medical device reform law work, and wants FDA to give third-party inspectors up to five working days to report potential manufacturing problems to FDA.

NEMA outlined its concerns in comments it recently submitted to FDA on the Medical Device User Fee Act (MDUFMA).

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April 15, 2003

The Senate Environment and Public Works Committee will mark up several security-related bills, including the Bush administration's anticipated chemical security legislation, in a session that will occur soon after the Senate returns from spring recess late this month, according to an environment committee aide.

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A key House committee chairman is drafting BioShield legislation that would allow drug companies to sell biodefense products developed under the proposed initiative to foreign markets, according to a source close to the process. The legislation also would ensure that the companies do not have to share their profits with the U.S. government.

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The HHS Office of the Inspector General (OIG) is seeking a $1 million penalty from a California company for misusing the word "Medicare" in marketing materials. A top Senate Republican welcomed the move as a deterrent to others seeking to gain from misrepresenting themselves as being backed by Medicare.

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Dietary supplement firms will meet with Sen. Richard Durbin's (D-IL) staff in the next week or so to raise concerns about Durbin's bill that would require supplement makers to get certain supplements approved by FDA before going to market and to report adverse events to the agency, industry sources say. The bill also would revamp the Dietary Supplement Health Education Act (DSHEA) to impose a premarket approval scheme for all supplements containing stimulants other than caffeine, sources say.

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Rehabilitation therapy providers are pushing for CMS to delay implementation of a $1,500 cap for outpatient speech and physical therapy, even as they gear up to support legislative efforts that would lift the cap.

The National Association for the Support of Long Term Care (NASL) is asking CMS to push back to Jan. 1, 2004, its July 1 target to put the therapy caps in place, arguing the CMS program memorandum implementing the cap is confusing and does not allow sufficient lead time for implementation.

The group says the problems are threefold:

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April 14, 2003

Organized labor is calling on OSHA to finalize within two months a final rule that would require employers to pay for their workers' personal protective equipment (PPE). The request follows a letter from the Congressional Hispanic Caucus (CHC) also calling on DOL to issue the regulation, which OSHA proposed four years ago but subsequently put on the back burner.

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