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Daily News

May 15, 2003

The National Governors Association's (NGA) Medicaid task force is still working to craft a proposal for reforming the Medicaid program and hopes to deliver a recommendation to the Bush administration and Congress by mid-June, a NGA spokesperson says. The news comes a day after NGA Chairman Kentucky Gov. Paul Patton (D) floated his own Medicaid reform proposal among task force members at a May 14 meeting in Washington, DC.

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The Senate voted overwhelmingly May 15 to add language to its tax bill that ensures half of the legislation's $20 billion in state fiscal aid will go directly to state Medicaid programs. The 95-3 vote is a significant step forward for proponents of the long-running campaign for state fiscal relief and a federal Medicaid funding hike.

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May 14, 2003

The Office of Management and Budget (OMB) is asking all agencies to submit their budget requests for fiscal year 2005 by Sept. 8, 2003. OMB directs the agencies to keep the requests within the FY 05 levels included in their FY 04 budgets, and to offset any increases for new initiatives with reductions in lower priority or ineffective programs.

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For at least the next five years employees being transferred from FDA's biologics center to the drug center can expect to keep their positions and pay, and research will continue to be as much a part of the review process as before the reorganization, according to FDA and union sources. For now it appears the union has signed off on the deal.

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House Ways and Means health subcommittee chair Nancy Johnson (R-CT) told Inside CMS today (May 14) a floor vote on Medicare reform will not occur before the Memorial Day recess, predicting a bill will be marked up and passed by the House in June. The House GOP leadership had set a Memorial Day deadline for marking up Medicare reform legislation.

While not providing specifics on the legislation, the lawmaker said the provider relief portion of the bill would be smaller than last year's $30 billion package but she indicated that Medicare+Choice payments would be included.

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GOP members of the House Energy and Commerce Committee are meeting this afternoon to try to close divisions within their ranks that have delayed the markup of a Medicare prescription drug bill, according to Rep. Jim Greenwood (R-PA), who downplayed the possibility the party could rally around a new drug plan proposed by a splinter group in the committee.

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In the latest development over the battle for state fiscal aid, Senate Democrats are seeking to double the relief funding included in the Senate GOP tax plan, and dedicate half of that to state Medicaid programs. The proposal is just one of many amendments Senate Democrats are expected to offer to the Republican stimulus bill, including a measure to postpone certain tax cuts until Congress passes a Medicare prescription drug benefit on par with that available to federal employees.

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May 13, 2003

FDA is contributing to the fight against severe acute respiratory syndrome by developing a list of medical products that need to be in greater supply, and by helping to search for a diagnostic test and therapies, develop a SARS vaccine and safeguard the blood supply. So far there are no marketing applications for a SARS diagnostic, vaccine or treatment because scientists are just beginning to understand the virus, according to Murray Lumpkin, FDA's principle associate commissioner.

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CMS has delayed until July 2 a pending coverage decision on the use of the colorectal cancer drug oxaliplatin but restricted the coverage decision to off-label use of the drug.

That means that the uses for the drug that have been tested and approved by FDA--for patients whose colorectal cancer has recurred or worsened and receive other specific drug treatments--will be covered by Medicare. This is a concession to pressure from cancer care providers and their congressional supporters.

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The Congressional Budget Office (CBO) plans to provide a cost estimate on an alternative prescription drug bill drafted by five key House Energy and Commerce Republicans after it completes a "score" on the closely held main House GOP Medicare reform legislation, sources say. The GOP leadership remains hopeful that drug coverage legislation patterned largely after last year's House-passed bill will move through the chamber by early summer.

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Organized labor is likely to oppose a legislative plan being crafted by Senate Judiciary Committee Chairman Orrin Hatch (R-UT) to limit the spread of asbestos lawsuits, according to a key union official. Opposition from the labor unions could jeopardize Hatch's effort to get the support of key Democrats for his proposal, which would create a trust fund, paid for by industry, that would distribute payments to asbestos plaintiffs outside of the court system.

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The Biotechnology Industry Organization (BIO) met last Tuesday with top officials at the National Human Genome Research Institute (NHGRI) to discuss policies surrounding gene patents, according to a biotechnology industry source. NHGRI officials indicated that they are considering non-exclusive licenses for diagnostic manufacturers, and the National Academy of Sciences (NAS) may conduct a study on gene patents.

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The biotechnology industry opposes changing patent law to state that academic researchers are exempt from gene patents. Certain academic institutions and medical centers may be renewing a push for legislation that explicitly exempts them from respecting gene patents in the wake of a recent patent court decision that only a very limited scope of research is exempt from patent law, according to a Biotechnology Industry Organization (BIO) source.

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U.S. Trade Representative Robert Zoellick May 13 announced the Bush Administration will seek consultation with the European Union on its moratorium on the approval of genetically modified organisms but emphasized that the administration will proceed to an actual challenge in the World Trade Organization should the consultations fail. Zoellick charged the EU's moratorium violates WTO rules by not being based on a risk assessment that reflects sound science principles and by failing to process approvals without undue delay.

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Senate and House lawmakers have decided to negotiate legislation revamping the childhood Vaccine Injury Compensation Program (VICP) in a "preconference," a move to avoid a potential deadlock in the Senate health committee and delays in the House. The Senate health committee had planned to mark up a draft bipartisan agreement May 14, following three previous markup cancellations due to committee disagreements.

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May 12, 2003

FDA is exempting food-packaging firms from the recordkeeping provisions of the bioterrorism act. But these firms are not exempt from administrative detention provisions, agency officials clarified.

FDA officials said food contact substances are considered food if packaging migrates to food at a May 7 satellite downlink meeting on the recently unveiled recordkeeping and detention rules. FDA officials said a possible terror attack could target the food packaging in which case it is important the agency have the authority to detain food packaging.

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The revolving door between the biotechnology and drug industry trade groups continues, with the Biotechnology Industry Organization (BIO) now hiring Sara Radcliffe, a biotechnology expert from the Pharmaceutical Research and Manufacturers of America (PhRMA). Radcliffe follows in the footsteps of Gillian Woollett, another biotech expert who left PhRMA for BIO this year. Sources indicate that Radcliffe's departure will likely leave a void at PhRMA's biotech group.

A drug industry source says Radcliffe recently submitted her resignation, and has yet to leave PhRMA.

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Senate Finance Committee Chairman Chuck Grassley (R-IA) has given the White House what he called an ultimatum, demanding that the administration set within the next two weeks a "date certain" for filing a World Trade Organization challenge against the European Union's moratorium on approvals of biotechnology. Grassley said if the administration cannot give him "good news" in two weeks, he would begin a public campaign from the Senate floor to demand White House action.

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Senate and House Republicans have begun to position Senate Democrats as the villains if a prescription drug and Medicare reform plan fails to win enough Democratic support to pass that chamber, charging that presidential politics will hinder efforts at a compromise.

"They're not serious about doing anything about Medicare reform," Sen. Orrin Hatch (R-UT) recently told reporters. Democrats "don't want to do anything that will give this president some credit. That's deplorable."

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OSHA Administrator John Henshaw appears to support a call by the National Advisory Committee on Ergonomics (NACE) for OSHA to organize a symposium of academic experts on ergonomics to discuss certain types of musculoskeletal disorders.

The proposal was debated and unanimously approved during a NACE meeting last week. During the meeting, Henshaw lauded the committee's recommendation as "an excellent idea."

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