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Daily News

November 07, 2003

CanaRx, the company that Springfield, MA, is using to reimport drugs, is arguing that FDA's reimportation policy violates international trade agreements, fails to protect the public, and flouts Congressional findings that led to the original reimportation law in 2000 -- which was never enacted because FDA determined it impossible to ensure that the law would result in no loss of protection.

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With Medicare negotiations in the final throes, Senate Democrats are now reframing the drug debate as a battle to save Medicare, a message being peddled to justify their possible blockage of a prescription drug bill should it include measures they strongly oppose.

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November 06, 2003

An upcoming report by an influential advisory panel created by Congress will for the first time outline measures that policymakers and industry officials could take to improve security at chemical plants and other critical infrastructure facilities, sources familiar with the panel's efforts say. The report could form the basis of new legislation, and it may take a position on a chemical security bill that is pending in the Senate.

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Senate Medicare conferees have been meeting with members of the House Blue Dog Coalition to find a way to pass a Medicare bill in the House that would also satisfy Senate Democrats.

Sens. Chuck Grassley (R-IA) and Max Baucus (R-MT) have met with the fiscally conservative Democrats at least three times in the past few weeks in an effort to neutralize the controversial demands of House GOP conservatives, various congressional sources have told Inside CMS.

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In an unusual move, the head of an FDA advisory panel has asked the agency to reject his panel's two-week old recommendation that silicone gel breast implants be put back on the market following an 11-year FDA-induced hiatus.

In a letter dated Oct. 31, advisory panel chairman Thomas Whalen voiced his strong reservations with the panel's recommendation to FDA Commissioner Mark McClellan. Whalen urged McClellan to deny a premarket approval application from Inamed for silicone gel breast implants.

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The Senate passed on Wednesday (Nov. 5) Sen. Richard Durbin's (D-IL) amendment to the agriculture appropriations bill that would give FDA $250,000 to finish the review of adverse events and rulemaking related to ephedra, congressional sources said. At the same time, Durbin has also introduced a sense of Congress resolution urging the HHS secretary to ban ephedra.

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In a strong backlash, state attorneys general, a top-ranking senator and healthcare safety net groups are pressing CMS to abandon a plan that would allow drug manufacturers to destroy their pricing data used to set Medicaid drug rebates after three years, claiming it could hamper fraud enforcement efforts.

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A federal judge is shutting down all Rx Depot and Rx of Canada operations, pending the outcome of the actual trial. The ruling indicates that the judge believes FDA is likely to win its lawsuit against the companies.

FDA has been holding off suing Springfield, MA, for its reimportation plan, but sources have said that FDA is using the Rx Depot suit to better define its authority before going after any state or local governments planning to reimport.

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November 05, 2003

Early returns from the state of Washington's Nov. 4 election show an industry-sponsored ballot initiative to repeal the state's ergonomics standard leading organized labor's bid to save the embattled rule. But the final fate of the state's yet-to-be-enforced regulation will be determined when voters' absentee ballots are added to the final tally.

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Medicare conferees remain deadlocked on key issues, with each political party this week taking the opportunity to blame the other for the continued delays. Senate Majority Leader Bill Frist (R-TN) now hopes to get a Medicare conference agreement, which he calls a "must-do bill," to the floor before the Senate adjourns the Friday before Thanksgiving (Nov. 21).

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As Medicare conferees struggle to breach their prescription drug bill differences, Senate Democrats are taking the offensive to reinforce their opposition to GOP-led conference proposals they say they will fight to stop. The stance casts increasing doubt over the likelihood of Congress passing a Medicare prescription drug bill this year, and increases pressure on the White House to break the deadlock.

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The animal feed industry is calling on FDA to institute a third-party inspection program for feed facilities as part of the agency's planned risk-based animal feed safety system. The Animal Feed Industry Association (AFIA) also asks FDA to prioritize risks to the feed system from high to low and to concentrate its resources on areas of greatest risk.

FDA "could recognize a third-party certification program that is accredited to certify for a particular standard," AFIA states in Oct. 24 comments on FDA's proposed risk-based animal feed safety system (AFSS).

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A new report by the president's National Council on Radiation Protection and Measurements (NCRP) along with a position statement from the Health Physics Society (HPS) may boost pressure on the federal government to establish regulations to lower exposure to radiation emitted by baggage scanning and security checkpoint devices. The papers -- calling for reduced radiation levels -- come as OSHA, Food and Drug Administration (FDA), National Institute for Occupational Safety and Health (NIOSH), and Transportation Security Administration (TSA) are weighing whether new standards are needed.

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As the political rhetoric over the Medicare conference report ramps up, Medicare conferees are now hoping to resolve remaining issues -- including those that have deadlocked talks so far -- early next week in the hope of having a final package late Tuesday that is ready for a vote, according to Senate Finance Committee chair Chuck Grassley (R-IA).

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November 04, 2003

A trade association representing drill shaft contractors is set to recommend OSHA exclude dedicated pile drivers, commonly known as drill rigs, from the agency's forthcoming safety standard for cranes and derricks.

The International Association of Foundation Drilling, now called ADSC, is preparing a position paper to present to OSHA's cranes and derricks negotiated rulemaking advisory committee (C-DAC) at the panel's Nov. 5-7 meeting, according to an ADSC source.

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Medicare conferees are considering capping spending on prescription drugs and outpatient services at 45 percent of Medicare spending unless 60 senators vote to lift a proposed cap on general revenue spending for the program.

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Sen. Edward Kennedy (D-MA) will hold off reintroducing his bill on human subject protection this year, and will instead resume negotiations with Sen. Judd Gregg (R-NH) on a bipartisan bill, according to a congressional source. Gregg is currently working on legislation on the topic, congressional sources say.

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FDA will consider on a case-by-case basis if foreign firms selling food products in the United States can tap their embassies to meet a requirement under the bioterrorism law's new registration rule that such companies identify a U.S. agent. FDA will contact the State Department when it receives such requests, but generally would prefer to avoid having diplomats act as agents, an agency spokesperson clarified.

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Today (Nov. 4) CMS placed ads in newspapers comparing local home health agencies (HHAs) in 69 markets nation-wide as part of an initiative to help beneficiaries gauge the quality of competing HHAs.

At a public announcement Nov. 3, CMS Administrator Tom Scully and HHS Secretary Tommy Thompson said the new initiative will significantly improve the services and choices for home care patients and their families.

"You can't have market-based health care unless you have information...unless you have a way for people to make choices," Scully said.

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Lawmakers have reached agreement on how to reconcile differences between the House and Senate versions of legislation that would set up an animal drug user fee program where animal drug companies would give FDA's veterinary center funds for faster reviews. The House passed the plan Nov. 4 by voice vote and the Senate is expected to vote on the revised bill soon, which will pave the way for President Bush to sign the bill.

The plan adopts the Senate bill's number -- S. 313 -- and the House bill's text, according to an animal drug industry source.

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