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Daily News

June 25, 2003

The top Democrat on the House Ways and Means health subcommittee says CMS Administrator Tom Scully told his staff last night that CMS Actuary Rick Foster "would be fired" if he released information requested by the lawmaker about the House GOP Medicare drug bill would affect Part B premiums. A CMS spokesperson told Inside CMS that Scully never told Foster he would be fired if he provided the information, but did not address what Scully may have told the lawmaker's staff.

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In a rare win for Democrats, the Senate agreed in overwhelming fashion to add language to its Medicare bill yesterday (June 24) that would ensure that the drug benefits available to members of Congress do not exceed those offered to Medicare beneficiaries. The approval marked a rare success for Democrats as their efforts to change the prescription drug legislation have so far largely been quashed.

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Biotechnology Industry Organization (BIO) head Carl Feldbaum is urging biotechnology scientists to overcome their reluctance to lobby Congress and interact with the media. During BIO's annual meeting in Washington, DC, Feldbaum suggested that biotech experts could influence policy decision on issues important to industry such as genetic testing, embryo research, biotech crops, grants, reimbursement and intellectual property protections.

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Industry sources and organized labor disagree on the findings of a recent study published in the Journal of the American Medical Association (JAMA), which found that using a keyboard and mouse for less than 20 hours a week does not significantly contribute to the onset of carpal tunnel syndrome (CTS).

The study, funded in part by a grant from the Danish Medical Research Council, found that using a keyboard for less than 20 hours a week does not significantly contribute to the onset of CTS.

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FDA is writing two draft guidances on how the agency will conduct environmental assessments on transgenic animals, according to a top FDA official. Although FDA has yet to act on the precedent-setting transgenic salmon new animal drug application, FDA Deputy Commissioner Lester Crawford says agency officials are taking steps to keep the environment safe from genetically modified (GM) animals.

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A senior House Democrat is calling on the DOL Inspector General to conduct an investigation of whether Mine Safety and Health Administration (MSHA) chief David Lauriski should have recused himself from MSHA deliberation on proposed changes to coal mine standards because of his earlier involvement in the issue as an industry representative.

In a June 17 letter to DOL Inspector General Gordon Heddell, Rep. Nick Rahall (D-WV) says in 1997 Lauriski, then as a representative of industry, had petitioned MSHA to change the rules in question.

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President Bush stepped up his lobbying effort for House passage of a Medicare drug benefit June 25 in the face of defections from up to 20 Republicans and a last-minute push by conservative "Blue Dog" Democrats -- the potential swing votes -- for an alternative bill modeled after the bipartisan Senate Medicare legislation.

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The House Appropriations Committee June 25 passed an FDA spending bill that would prohibit the agency from using its funds to stop wholesalers, pharmacists and individuals from reimporting FDA-approved prescription drugs from Canada. Rep. Anne Northup (R-KY) introduced the reimportation amendment to the fiscal year 2004 agriculture appropriations bill, which passed by a margin of 34-22 despite opposition by the agriculture subcommittee chairman.

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June 24, 2003

Following consultations with the European Union on its moratorium blocking the marketing approval of biotechnology products, the U.S. announced June 19 that it will request a dispute settlement panel in the World Trade Organization, most likely in July. Given the EU's likely move to block that first panel request, the United States expects the panel request to go forward in a Dispute Settlement Body meeting at the end of August, a U.S. official said.

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European Union Trade Commissioner Pascal Lamy said the United States and EU will announce at this week's summit in Washington that they have agreed to regulatory cooperation in five areas: cosmetics, food additives, nutritional labeling, automotive safety and metrology. European officials said the agreement will not involve a detailed commitment on any particular regulation in these areas, but will serve instead as a promise to cooperate on new regulatory issues and look for ways to coordinate rulemaking between U.S. and EU agencies.

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The rump group of five GOP House Energy and Commerce Committee members will formally introduce its Medicare reform legislation today (June 24), according to a staffer for Rep. Charlie Norwood (R-GA), who indicated that at least 10 additional lawmakers would cosponsor the bill. Although elements of the bill were included in the Medicare reform bill passed by the committee last week, the rump group hopes to gain a floor vote on its entire alternative package.

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With the House slated to vote on Medicare reform legislation this week, Democrats in that chamber today (June 24) stepped up their opposition to the Republican-drafted plan by issuing fresh criticism that the bill would be particularly harmful for rural beneficiaries.

At a press briefing, Democrats reiterated claims that the GOP plan has "huge" coverage gaps, does not curb high drug prices, privatizes Medicare and fails to provide a guaranteed, defined set of costs and benefits -- problems which are magnified in rural areas, said House Minority Leader Nancy Pelosi (D-CA).

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President Bush lambasted the European Union for blocking bioengineered food and trade lawyers for running up health care costs with frivolous lawsuits in remarks he made at the Biotechnology Industry Organization's annual conference Monday (June 23). Bush also commended the biotech industry for helping to fight bioterrorism and used the subject as a segue to trumpet the war on terrorism and justify the Iraq War.

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A tentative agreement splitting a $12 billion pot between Democratic and Republican Medicare priorities has won the support of conservative Senate Republicans and is waiting for a sign-off from lead Finance Committee Democrat Max Baucus (MT) and other Democrats needed to secure Senate passage of a prescription drug benefit.

The deal could potentially secure the votes of close to half of Senate Democrats as well as support from conservative Republicans worried there is too little push towards using private insurers to provide Medicare benefits.

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A new bipartisan House Energy and Commerce Committee staff report on reimported drugs faults FDA for not seeking legislation that would allow the agency to deny entry of most drugs being mailed into the United States. FDA today (June 24) reasserted its view that the agency lacks power to stop such drugs, disagreeing with a Democratic lawmaker's view that the agency already has the authority to reject drugs mailed into the country that do not conform to the agency's guidelines for personal drug imports.

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June 23, 2003

Key Senate Democrats have introduced long-awaited legislation that would dramatically increase penalties for some safety and health violations resulting in fatalities. While the bill has not attracted GOP support, the legislation's author says he has discussed the bill with two Senate Republicans.

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Durable medical equipment suppliers are backing a seven-year freeze on inflation adjustments in the Senate Medicare bill as the lesser evil compared to the House plan to use competitive bidding to establish prices.

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Both Senate and House Medicare reform bills would prevent CMS from applying a controversial "functional equivalency" policy to reduce Medicare reimbursement rates for drugs in the pass-through system. The move is good news for biotechnology companies, which lobbied hard for the policy shift.

The legislative move follows an unsuccessful effort by several lawmakers from both chambers of Congress to get CMS to withdraw the standard.

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FDA does not plan to ban plant-made pharmaceuticals in food crops because the agency does not feel it could justify such action, according to FDA Deputy Commissioner Lester Crawford. The recent ProdiGene incident is the only example FDA has to use for a risk assessment, and Crawford views ProdiGene as a success. Crawford said for now FDA continues to base its regulation of drug crops on the draft guidance that the agency and the U.S. Department of Agriculture jointly issued.

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FDA plans to require growers of drug crops to submit applications for investigational new drugs (INDs) or investigational device exemptions (IDEs) that describe control measures for crop growth, according to an FDA source. When asked separately about "biopharming" regulation FDA Deputy Commissioner Lester Crawford said the agency has "considerable authority" to regulate drug crops during the IND stage.

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