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Daily News

June 27, 2003

The United States and the European Union announced their support for a redesigned Transatlantic Business Dialogue during their annual summit meeting June 24 despite the fact that businesses had yet to reorganize the dialogue as European officials had asked them to two months ago.

U.S. Undersecretary of Commerce Grant Aldonas said the fact that no chairmen were named for either the U.S. or EU business sides was not unexpected and did not mean that businesses were not working hard for the TABD. "This was really part of the design," Aldonas said during a June 24 press briefing.

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FDA released counterfeit Viagra into the market after it had been detained because competing priorities like homeland security and bovine spongiform encephalopathy took up the agency's resources, a senior FDA official told a House panel June 24. FDA's Florida district office is revising its standard operating procedures and will have regular meetings with the Bureau of Customs and Border Protection (BCBP) to prevent future mistakes, the official said.

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A Sen. Orrin Hatch (R-UT) staffer indicated at a recent conference that generic biologics is high on Congress' agenda. The staffer said the high cost of prescription drugs and biologics would come under increased scrutiny after Congress passes a Medicare prescription drug benefit.

Meanwhile, an industry lawyer says the staffer's speech signals that Hatch is probably planning legislation on generic biologics. Hatch staffer Bruce Artim spoke at the Biotechnology Industry Organization's annual conference June 23.

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In the interest of striking a deal before the Cancun ministerial, U.S. trade officials have publicly signaled they are backing off an approach that has led to a deadlock in the international fight over giving developing countries access to cheap copies of patented drugs for fighting public health crises. Instead of insisting that the agreement limit the scope of diseases, the United States now seems focused on trying to limit the number of countries that would be eligible to take advantage of the deal and to curb the risk of diversion to other markets, the trade officials said.

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June 26, 2003

The House Rules Committee late last night merged the Medicare legislation passed separately by the Ways and Means and Energy and Commerce committees and added generic drug access and reimportation provisions similar to those in the Senate bill.

The new bill, H.R. 1, would reimburse oncologists and other specialists at 112 percent of the average sales price of the drugs they administer in 2005 and 2006, the more generous formula passed by the Energy and Commerce Committee.

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The HHS newly formed Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) is considering the enormous task of planning a cohort study that would gather genotype and phenotype information on a large group of Americans to better understand how genetics contribute to human disease. SACGHS is asking the Institute of Medicine (IOM) to assess the scientific feasibility of such a study.

SACGHS met for the first time two weeks ago. The group replaces the Secretary's Advisory Committee on Genetic Testing, which had a narrower charter.

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OSHA officials attending a recent roundtable discussion involving unions, industry, academia and federal agencies offered contradictory opinions whether regulatory action is needed to reduce workplace accidents resulting from chemical explosions. The meeting came a day after organized labor petitioned OSHA to issue a more-stringent process safety management (PSM) standard, the main standard to prevent hazards resulting from chemical explosions.

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FDA is making its biodefense team in the Office of Commissioner a permanent part of the agency's structure, and the team will report to policy chief Bill Hubbard, according to FDA Deputy Commissioner Lester Crawford. Before Crawford headed up the commissioner's office bioterrorism shop, there had been three security teams, but Crawford consolidated them and had the new team answer to him.

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The House earlier today (June 26) passed largely along party lines the rule rule for tonight's debate on Medicare reform legislation. The rule, which allows Democrats to offer their prescription drug benefit as a substitute, passed 221-203. Democrats Collin Peterson (MN) and Ralph Hall (TX) crossed party lines and supported the measure while Republicans Roscoe Bartlett (MD), Jeff Flake (AZ), Joel Hefley (CO) and Pat Toomey (PA) voted against the rule.

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A key FDA official says the agency has not decided what to do in a situation where a brand-name sponsor sent patent information when it filed an NDA before the generic drug rule's effective date in late August, but later submits patent information to reflect an approval after the implementation date. It is unclear if the patent information sent in this scenario will be dealt with under the old or the new rules, according to FDA Chief Counsel Daniel Troy, who suggested that interested lawyers could write the agency on the issue.

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The House Select Committee on Homeland Security today (June 26) amended the House BioShield bill to allow the government to use BioShield funding to build a drug manufacturing facility to develop, test and market biodefense measures. Rep. Billy Tauzin (R-LA) tried to strip the provision from the substitute amendment, but committee chair Christopher Cox (R-CA) -- the only Republican opposing the measure -- cast the deciding vote to block Tauzin's effort.

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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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