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Daily News

June 25, 2003

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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The House Ways and Means and Energy and Commerce committee leaders are negotiating over language in their Medicare bills on functional equivalence, with Energy and Commerce Committee Chairman Billy Tauzin (R-LA) seeking to permanently bar CMS from setting lower reimbursement rates for new drugs with the same therapeutic effect, a House GOP aide said today (June 23).

The Energy and Commerce Committee amended the Medicare legislation at its June 19 markup to bar CMS from applying a new functional equivalence standard to any drugs not already subject to the standard.

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FDA's gene therapy shop will continue to rely on the Division of Clinical Trial Design and Analysis for clinical reviews despite the division's move to the drug center, a senior FDA official says. FDA's newly formed Office of Cellular, Tissue, and Gene Therapies (OCTGT) is one of the few parts of the office of Therapeutics Research and Review (OTRR) that will not move from the the biologics to the drug center and there have been questions about where the office will get its clinical review.

OCTGT will also develop its own clinical expertise, another senior FDA official says.

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The House authors of Medicare legislation are looking to follow the Senate lead by tacking on legislation easing importation of pharmaceuticals from Canada and scaled-back legislation speeding the market entry of generic drugs, a House GOP aide said.

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A conservative think-tank and a patient advocacy group are arguing that companies should be allowed to market drugs to a limited group of dying patients after completing the first phase of clinical trials if the company has some case history data from a modest number of people that the drug works. The groups outline several conditions that sponsors would have to meet to participate in the proposed program.

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June 20, 2003

SAN ANTONIO, TX -- FDA Commissioner Mark McClellan is calling for other nations to increase their contribution to drug research and development. The United States bears the major burden for research and development costs, McClellan says, and this is resulting in fewer innovative medical treatments coming into the market.

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SAN ANTONIO, TX -- An FDA representative says it may be possible to approve some follow-on biologics with an "AB" or "interchangeability" rating allowing doctors to prescribe the follow-on instead of the brand-name product without clinical study.

Anthony Mire-Sluis, an official at the drug center's Office of Pharmaceutical Sciences, focused on the scientific issues surrounding follow-on therapeutic proteins at the Defense Information Association's meeting this week.

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