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Daily News

February 06, 2003

The Bush administration plans to allow members of the general public to be inoculated with the smallpox vaccine by mid-to-late summer, but is still struggling with which version of the vaccine to make available and who would administer it, according to a top official from the Centers for Disease Control and Prevention (CDC).

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Public Citizen is suing FDA for not seeking public comments on alternatives to its voluntary patient information program, such as requiring that pharmacists provide MedGuides for all drugs. The group argues that the agency disregarded a 1996 law when it decided that it would continue with the voluntary approach despite data showing that the leaflets do not meet the law's usefulness criteria.

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OSHA is planning to engage in a partnership, aimed at reducing musculoskeletal disorders (MSDs), with the United States Postal Service (USPS). The initiative is expected to last three years, according to an OSHA official, and an agency spokesperson said USPS would invest $8 million in the effort to reduce MSDs.

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The Bush Administration early this week indefinitely postponed a cabinet-level debate on whether it should challenge a European Union moratorium on biotechnology approvals in the World Trade Organization to avoid straining the bilateral relationship at a time the United States needs allies for its Iraq policy, and because of administration preoccupation with its other priorities.

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February 05, 2003

As CMS weighs whether to appeal its latest prescription drug discount card defeat, two key lawmakers have asked the General Accounting Office (GAO) to investigate how much federal money the Bush administration has spent on the initiative -- including its court costs.

In a Jan. 31 letter to GAO, Reps. Pete Stark (D-CA) and Sherrod Brown (D-OH) request an analysis of how much the administration has spent on its court action over the drug card program and devoted to the proposal's development.

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PUERTO RICO -- FDA drug center chief Janet Woodcock says the agency will unveil this month its progress on implementing two pieces of a broad effort to revamp the good manufacturing practices (GMP) program. The two pieces are: 1. a plan to give the drug center the lead on electronic records, nicknamed part 11 for the section of the code of regulations where it is found; and 2. an expansion of the comparability protocol that allows brand-name manufacturers to make certain manufacturing changes without having to conduct clinical trials.

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PUERTO RICO -- A Barr Laboratories official says FDA should use some of the $13 million increase requested by the administration for the generic drugs program in fiscal year 2004 to ease a bottleneck in the release of pharmaceutical raw materials imported into New York harbor. The official says the agency should also spend some of that increase on an expert who would share the job of signing off on the reviews of the first generic version of a brand-name product, which is currently performed by one person.

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A senior United Kingdom agriculture official says a potential U.S. challenge to the European Union's moratorium on genetically modified crops in the World Trade Organization could hurt efforts to reform the EU Common Agricultural Policy. Member states opposed to overhauling the CAP could use a potential U.S. challenge as an argument against it, and thereby also slow the WTO agriculture negotiations, according to Margaret Beckett, the UK's secretary of state for environment, food and rural affairs.

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Bush Administration officials have again postponed a cabinet-level meeting to decide whether to proceed with a World Trade Organization challenge to the European Union's moratorium on approval of new biotechnology crops, according to informed sources. The meeting was scheduled for Feb. 3.

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Senate Finance Committee Chairman Chuck Grassley (R-IA) says he was pleasantly surprised by new government estimates on Medicare beneficiary drug spending, adding that he expected the projections to be much higher.

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One of Congress' leading watchdogs on health care fraud today (Feb. 5) announced plans to pursue legislation to give Congress the right to review False Claims Act (FCA) settlements before they are approved.

Sen. Chuck Grassley (R-IA), chair of the Senate Finance Committee, says the proposal would inject an "added layer of verification" into the FCA process. The health care fraud hawk has been an outspoken overseer of the FCA and last year repeatedly probed CMS and Department of Justice (DOJ) officials about their handling of such cases.

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In its first drug approval using a new "animal efficacy rule," FDA Feb. 5 approved pyridostigmine bromide as a pretreatment for troops to increase their survival after exposure to Soman nerve gas. The June 2002 animal efficacy rule allows use of animal data to show a drug's effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans.

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February 04, 2003

In a surprising new development which could provide new momentum for the enactment of a drug benefit this year, the Congressional Budget Office (CBO) last night informed Capitol Hill officials that it is estimating only a slight increase in aggregate spending for outpatient prescription drugs used by Medicare beneficiaries over the next 10 years. In a Feb. 3 memo obtained by Inside CMS, CBO states that spending for Medicare beneficiaries will total $1.84 trillion between 2004-2013, which is only a 4 percent increase over that projected for 2003-2012.

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President Bush's decision to include animal drug user fees in his FDA budget request for fiscal year 2004 may energize efforts to get user fee legislation through Congress this year. The unveiling of the budget request comes as Senate health committee and House Energy and Commerce Committee staff are discussing procedural issues about how to reintroduce legislation needed to authorize such a user fee program, according to an animal drug industry source.

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Several industry groups and companies are appealing the American National Standards Institute (ANSI) ergonomics standard, arguing the procedures for the consensus rulemaking have not been followed.

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FDA's new medical device user fee program could need up to $65 million in direct appropriations in fiscal year 2005 to stay afloat if Congress were to pass the president's FY 04 budget request for the device center. The president's FY 04 request would leave the device center $20 million short of baseline funding, and under the user fee law Congress must give the device center on average $15 million annually above baseline-funding between FY 03 and FY 05.

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FDA plans to "proactively seek candidates" to switch from prescription drug (Rx) to over-the-counter (OTC) status if Congress approves an extra million dollars requested in the president's fiscal year 2004 budget for FDA's OTC drug review program. The agency's goal is to increase Rx-to-OTC switches by 50 percent.

FDA also plans to use the money to add and train new reviewers to speed OTC drug reviews.

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The day before he gave his State of the Union address President Bush sent a letter to the Generic Pharmaceutical Association (GPhA) praising the group for its efforts to provide affordable medicines, maintaining that generic drugs save consumers billions of dollars in prescription drug costs.

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February 03, 2003

CMS Administrator Tom Scully said he hopes the agency never has to use its inherent reasonableness (IR) power, asserting that just having the authority to significantly lower Medicare payments will force suppliers to voluntarily lower their prices.

Scully's Jan. 22 statement is likely to ease the concerns of device groups but could attract criticism from Capitol Hill. Over the last several years, CMS' IR policies have been closely monitored by health care groups in Washington, DC and investors on Wall Street.

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The European Union told World Trade Organization members last week that its proposal to break a deadlock in negotiations on access to generic medicines would not limit the scope of diseases covered by a solution, but was designed to use input from the World Health Organization to allay U.S. fears about an overly broad application of the more flexible patent rules under discussion.

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