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Daily News

October 10, 2003

Medicare conferees are considering expanding CMS' Center for Beneficiary Choices (CBC) so it can administer Medicare's prescription drug benefit and private plans instead of creating a new HHS agency to do the job, according to informed sources.

The idea is to have a beefed-up CBC gradually assume the new function. It would build upon CBC's existing infrastructure rather than establish an entire new agency by early next year as called for under the House and Senate plans.

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Justice Department lawyers finished their arguments for a preliminary injunction against Rx Depot and Rx of Canada Thursday morning, though the judge did not rule on the motion. Both sides have until Oct. 31 to submit proposed findings of fact and conclusions of law, after which the judge plans to quickly issue a written order.

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October 09, 2003

In an unexpected result, the House this week soundly rejected a Republican motion instructing Medicare conferees to use means testing to help defray the cost of Congress' prescription drug bill. The defeat comes as Medicare conferees mull proposals to charge wealthier beneficiaries more under Medicare.

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Medicare conferees have reopened an agreement in principle reached last week to extend Medicare prescription drug coverage to beneficiaries who are also Medicaid eligible, pending agreement on how to claw back more of the savings from state Medicaid programs and how the change would affect benefits for the near-poor, advocates and congressional sources said.

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The House Ways and Means Committee is floating the possibility of a steeper cut to hospitals' 2004 Medicare reimbursements, proposing to trim 0.55 percent off the inflation adjustment for inpatient reimbursements instead of the 0.4 percent cut now in the House bill, according to informed sources.

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The future of a controversial voluntary ergonomics standard-setting effort is highly uncertain following an Oct. 7 decision by the American National Standards Institute's (ANSI) executive counsel that throws into question whether the National Safety Council (NSC) will continue to lead the effort. NSC's role in the ANSI standard-setting process has long been under fire from industry officials who claim NSC violated numerous ANSI procedural requirements.

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The National Academy of Sciences (NAS) is calling for increased government and private sector oversight of biotechnology research, including a role for national security specialists, to ensure research findings don't get into terrorists' hands.

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The government has entered into a consent decree with a handful of dietary supplement firms directing them to stop marketing products carrying drug claims involving weigh-loss and erectile dysfunction, claims the companies continued to make despite earlier FDA objections.

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FDA has made several changes in its interim final rule on prior notice of imported food shipments to the delight of the food industry, a source says. One of the biggest concerns -- time frame for submission of prior notice -- has been altered to accommodate different modes of transportation. FDA also says companies can submit prior notice information through the Customs and Border Protection (CBP) system.

[Click here to see he prior notice and registration rules.]

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October 08, 2003

A study by environmentalists that attracted national attention and found potentially dangerous levels of fire retardants in human breast milk is unlikely to prompt further EPA action or the passage of congressional legislation to ban the pervasive chemicals, activists and agency sources say. A senior FDA official says the agency has not yet looked into the issue but may consider looking into it.

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FDA Chief Counsel Dan Troy says he believes the Trade Secrets Act bars FDA from revealing to a generic drug firm if it is the first generic drug applicant to file an application with a paragraph IV certification, which makes it eligible for 180-day generic drug exclusivity. When pressed on the issue, Troy said he would be happy to review a white paper on the topic.

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FDA has contracted with the New Mexico State University to develop a risk-based automated drug import examination system that would allow the agency to determine which imports need to be targeted for risky drugs, a university source says. The automated system would process huge amounts of data culled from various sources to predict which imports are most likely to contain counterfeit or unapproved drugs, the source says.

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FDA's office in charge of orphan drugs is considering when biodefense products could be offered orphan drug status, a senior FDA official told FDA Week. FDA's Office of Chief Counsel asked the Office of Orphan Products Development to explore applying orphan drug incentives to biodefense products without changing the regulations, the official says.

The idea was floated during a meeting between the FDA Office of Chief Counsel, the commissioner's office and the bioterrorism office to discuss ways to encourage development of bioterrorism countermeasures.

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October 07, 2003

FDA is asking lawmakers negotiating a drug patent reform deal as part of the Medicare reform conference talks to ensure that provisions limiting treble damages and allowing innovators to view a generic applicant's confidential data do not impose new burdens on the agency, according to FDA Chief Counsel Dan Troy. The agency is also asking the conferees to change the effective date of the 30-month stay provision.

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FDA Chief Counsel Daniel Troy says lawmakers charged with reconciling the House and Senate versions of the drug patent reform provisions in the Medicare bill should not rehash areas where the two bills are identical. Troy's statement, according to a drug industry source, signals the agency does not support brand-name drug company Eli Lilly's proposal to overhaul the bills' 180-day generic drug exclusivity provisions of the bills, despite the fact that the two are identical.

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For the first time in nearly three decades, the nation's primary occupational safety and health research organization has conducted a nationwide survey on how stress affects the health of workers. The National Institute for Occupational Safety and Health (NIOSH) is still compiling data from the survey conducted in the spring and summer of 2002, and an agency source says the data promise to yield interesting results.

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Environmentalists are preparing to fight a potential Republican compromise on chemical security legislation, saying that any new bill should have language that would require at least some facilities to reduce their toxic chemical use and narrow an exemption in a previous Republican proposal for plants that are currently following industry trade association security guidelines.

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Industry officials are criticizing a new draft of European chemical legislation that was revised to make the policy more industry friendly, saying that while the changes are welcome, overall the revisions do little to reduce the potential burden on chemical companies and their customers. Industry officials also fear that the European Parliament will reverse these changes in the new draft when it reviews the policy, which will likely be at the beginning of next year.

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FDA plans to reopen the comment period on trans fat nutrient content claims and a label footnote when the National Academy of Sciences (NAS) comes out with a report on daily reference intakes, the agency told food industry trade groups today (Oct. 7). The groups had asked FDA to push back the Oct. 9 deadline until after the NAS study is completed. FDA will not extend the deadline, but as a compromise agreed to reopen the comment period when the report comes out.

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In an effort to combat the increasing obesity problem in the United States, FDA has scheduled a public meeting to discuss behavioral and medical intervention treatment options, as well as possible changes in product labeling to fight obesity in America. The administration will also address a number of questions of general public concern as FDA attempts to revamp its strategy against obesity.

The meeting will discuss FDA's role in the Bush administration's new effort to fight obesity.

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