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Daily News

January 02, 2003

With the fate of a voluntary ergonomics rule pending, organized labor is threatening that it will not support an international safety meeting hosted by the National Safety Council (NSC) if the group scraps the voluntary rule, while industry sources say if the rule is approved business leaders will not be as enthusiastic to support the safety and health summit.

NSC President Alan McMillan said any threats to the group because of its work on the voluntary ergonomics standard are "outrageous."

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The incoming chairman of the Senate Finance Committee is considering legislation that would amend provisions in federal law that require trade advisory committees to be "fair and balanced," a key congressional source says. The revisions could limit statutory requirements that have been used by environmentalists to alter the makeup of several all-industry committees through court challenges, and a settlement in one case has prevented an important chemical sector trade advisory committee from meeting until the Bush administration appoints an environmentalist.

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Siding with CMS and arguing that drug manufacturer Amgen lacks standing, a federal court has dismissed the company's lawsuit on reduced government reimbursement rates for the drug Aranesp in the agency's new hospital outpatient prospective payment system (OPPS).

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With projected deficits over the next couple of years and the stunning downfall of provider payment legislation in the 107th Congress, health care lobbyists are facing a dramatically different landscape in 2003 than in previous years on provider givebacks.

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March 05, 2002

Three influential Senate Democrats want DOL to provide them with the names of White House officials that are involved in the Bush administration's looming announcement on its approach to ergonomics, according to a congressional letter obtained by Inside OSHA.

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The Biotechnology Industry Organization (BIO) is pushing for legislation that would allow biotechnology companies to bring in outside experts during the transition from phase II to phase III studies to help FDA with such decisions as the appropriate endpoints and size of clinical trials, according to Carl Feldbaum, BIO president. The proposal is part of BIO's negotiating stance on the reauthorization of the Prescription Drug User Fee Act (PDUFA).

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Pharmaceutical industry representatives have approached FDA with the idea of allowing drug companies to pay an optional user fee in order to secure more pre-application submission meetings with the agency, a food and drug lawyer says. Although some patient advocates and FDA have been considering a similar idea of establishing a premeeting fee that all companies would pay for equal treatment, this proposal would allow companies to pay an optional, or extra, premeeting fee for special attention.

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There appears to be a growing consensus between FDA and patient groups that the Prescription Drug User Fee Act (PDUFA) should in the future require industry to fully pay for the early consultation meetings they have with FDA. While the drug industry appears willing to consider the idea, it has its own ideas of how such meetings should be paid for.

Patient and consumer groups assert that the agency spends a lot of time and money as a consultant in these pre-meetings and that they should be covered by user fees.

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A provision tucked into the Senate version of the farm bill has reignited the debate over whether irradiation should be marketed to the public as "pasteurization." The definition of "pasteurization" would be redefined to include "irradiation," and all other processes that HHS has approved to improve food safety, if a newly added provision in the Senate version of the bill makes it through conference.

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As Congress gets ready to reauthorize the Prescription Drug User Fee Act (PDUFA), Public Citizen is urging lawmakers to investigate why FDA approved three high-profile drugs that were later withdrawn from the market. In a new position paper on PDUFA, the group outlines what aspects of the drug approvals and market removals it wants Congress to investigate and specifically whom Congress should question as witnesses.

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A consumer advocate group and a chemical workers' union are taking OSHA to court over what they say is an unreasonable delay to propose and finalize a new exposure limit for hexavalent chromium. The groups ask the court to mandate the agency issue a proposed permissible exposure limit (PEL) within 90 days and finalize such a PEL within a year of a proposed rule.

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A key Senate Democrat is rejecting AARP's proposal to use the Medicare Trust Fund to finance a comprehensive prescription drug benefit. The lawmaker's statements will likely end speculation on whether the trust funds will be touched to craft a drug benefit, since GOP House leaders also oppose the funding plan.

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For the first time ever, the Congressional Budget Office (CBO) has told Congress that Medicare pays more for enrollees in Medicare+Choice (M+C) than it would if those beneficiaries were in the fee-for-service (FFS) program. CBO has also radically changed its forecast for the M+C program, projecting that enrollment will dwindle by 2012.

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March 04, 2002

A federal court of appeals recently heard oral arguments in a case that could have a significant impact on OSHA's jurisdiction as the agency and an industry group clashed over whether OSHA has the right to mandate how products should be designed.

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DOL Secretary Elaine Chao has lashed out at a powerful labor organization in response to criticism of OSHA's regulatory agenda. Chao says workers are better served with a streamlined agenda that accurately reflects which regulatory actions the agency can undertake in a one-year period than with an agenda that misrepresents OSHA's activities.

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Industry sources are claiming that recent guidance letters on ergonomics, which Washington State's Department of Labor and Industries (L&I) has sent to selected employers, contradict the state's ergonomics regulation. These officials allege that in order to attract a major company to the state, L&I has agreed to relax its ergonomics standard for this firm. A top L&I official strongly refutes these allegations.

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With the pharmaceutical industry already promising a fight, Sen. Byron Dorgan (D-ND), chair of a Senate Commerce and Transportation subcommittee, is planning to introduce a bill that would allow pharmacists and wholesalers to reimport drugs from Canada. The bill is likely to reignite controversy over reimportation, as the Pharmaceutical Research and Manufacturers of America (PhRMA) has promised to fight the impending bill, and an FDA source says the agency has safety concerns regarding the approach.

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A close relationship that is developing between the biotechnology industry and the Department of Defense (DOD) post-Sept. 11 could create new dynamics between FDA's review function and DOD's need for cutting-edge biotech products such as vaccines and wound therapies, according to a top official at the Biotechnology Industry Organization (BIO).

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The state of Maine has won round one against a pharmaceutical industry bid to quash the state's prescription drug discount program for low-income residents.

In a Feb. 25 decision, the U.S. District Court for the District of Columbia has ruled in favor of the Healthy Maine Prescription Program (HMP), authorized by HHS to reduce prescription drug costs for needy residents ineligible for Medicaid.

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Montana is taking several drug manufacturers to court over what the state believes is an abuse of the average wholesale price (AWP) system that it claims has cost Montana millions of dollars.

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