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Daily News

September 04, 2003

The Medicare conference report will provide more flexibility for providers to implement electronic prescribing, stepping back from a 2007 mandatory deadline, Ways and Means health subcommittee chair Nancy Johnson (R-CT) said Sept. 4.

"The final bill will not be as rigid as the House bill in its mandatory-ness. I'm not sure exactly how," Johnson said a symposium by the Institute for Molecular Technologies. "I'm the strongest proponent of mandatory electronic prescribing and I'm prepared to step back."

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A House subcommittee will hold a hearing Sept. 17 on a controversial GOP proposal aimed at easing restrictions on small companies' ability to recoup attorneys fees in OSHA enforcement cases, according to a congressional source. The proposal is one of three OSHA reform provisions that were stripped from a broader legislative package passed by the subcommittee in June because they were considered too contentious.

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September 03, 2003

FDA unveiled four new draft guidances and one final guidance today (Sept. 3) as a part of an announcement detailing the progress it has made in a year-old initiative to revamp the drug manufacturing practices (GMP) program. The agency released draft guidances on process analytical technology (PAT); sterile drug products produced by aseptic processing; dispute resolution; and comparability protocols for biotechnology products.

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Governors have been asked to recommend five people from their states to receive security clearances as part of the ongoing effort to enhance communication among state, local and federal officials, Homeland Security Secretary Tom Ridge said Sept. 2.

One of the department's primary objectives is to share information about terrorist-related threats with state and local officials, he said during a speech at the American Enterprise Institute in Washington.

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The White House's Office of Management and Budget (OMB) is asserting a more active role in the government's review of public complaints regarding data used by regulators, by proposing that it be involved on a case-by-case basis with challenges that pose broad policy implications. The new OMB role is outlined in proposed guidelines intended to establish first-time, government-wide standards for conducting peer reviews on information used to establish regulatory and other public policies.

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The president and CEO of the National Safety Council (NSC) says the organization will reduce its role as secretariat for voluntary standard-setting committees, citing philosophical changes in the realm of regulation as well as financial and litigation concerns as reasons for the organization's pull back. NSC is currently secretariat for six American National Standards Institute (ANSI) committees accounting for potentially 30 standards, including an ANSI ergonomics standard for which the group is entangled in litigation.

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The Senate health committee plans to mark up this month legislation designed to encourage manufacturers to market animal drugs for minor uses and minor species. The bill's sponsors will offer an amendment at the markup that excludes transgenic animals from the bill, consumer and veterinary sources say. But lawmakers are still negotiating how to address concerns that the bill could exacerbate antibiotic resistance, despite FDA's assertions that the bill will not do so, the sources add.

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Three pharmacy trade groups are lobbying conferees charged with crafting a Medicare drug benefit compromise to strip Senate-passed language that would set up a one-year FDA pharmacy compounding advisory committee. The groups argue that state boards, not FDA, should examine compounding safety issues.

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House and Senate GOP leaders of the Medicare conference will try tomorrow (Sept. 4) to kick start faltering talks aimed at reconciling rival prescription drug bills amid expectations that President Bush will up the pressure on conferees to come up with a compromise bill this session.

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September 02, 2003

AARP is urging FDA to require that dietary supplement companies report to the agency consumer complaints related to good manufacturing practices (GMPs). The agency's recent proposal suggests that firms send this information to FDA, but does not mandate such reporting as called for by AARP. AARP also wants FDA to require that firms refer consumer complaints about a supplement product's safety to the agency's MedWatch program.

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FDA sent its final rule on registering food firms to the Office of Management and Budget Aug. 19, which means the agency also should be sending the final rule on prior notice to the OMB soon, according to a food industry source. The registration and prior notification final rules, which are key components of the bioterrorism law, must be issued by mid October.

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A key anticounterfeiting task force formed about a year ago by FDA and the drug industry identified key problem areas during its final meeting -- held last week just days after FDA opened a public docket asking for input on the agency's anticounterfeiting initiative.

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OSHA Administrator John Henshaw late last month told a key lawmaker he agrees there is a need to improve the quality of chemical hazard information provided to workers and pledged to pursue initiatives to strengthen elements of the agency's hazard communication standard, specifically material safety data sheets (MSDS).

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With a compliance deadline looming, health care providers are pushing CMS to take immediate action to prevent potential payment disruptions arising from new federal electronic transaction standards set to take effect in October. The lobbying comes as some in the industry are also questioning whether CMS can and will act, or if a last-ditch legislative effort should instead be launched.

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August 29, 2003

GENEVA--The World Trade Organization General Council this afternoon (Aug. 29) Geneva time resumed its deliberations on a deal to provide cheaper copies of patented drugs to nations with no or insufficient manufacturing capacity. The General Council was formally suspended late last night when members could not agree on how to handle a chairman's statement the United States considered critical to the final deal (Inside U.S. Trade, Aug. 29, p1).

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The Congressional Budget Office (CBO) has released a report that could hurt Eli Lilly's argument that the 180-day generic drug exclusivity provision in the Senate Medicare drug bill would cost consumers by delaying generic competition. CBO maintains that the while the provision would delay generic competition for some drugs, it would encourage generic competition for other drugs, and the costs and benefits of the changes would balance out.

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FDA has extended the comment period for its advance notice of proposed rulemaking (ANPR) for over-the-counter (OTC) antigingivitis/antiplaque drug products in response to a request for additional time from trade groups representing the OTC drug and cosmetic industries. Although the agency did not give the groups everything they asked for, a source from the Consumer Healthcare Products Association (CHPA) says the trade group is pleased with the extension.

In July CHPA and the Cosmetic and Toiletry and Fragrance Association requested a 90-day extension of the comment period.

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Oncologists are mounting increased pressure on Medicare conferees to radically scale back proposed cuts in drug reimbursement even as CMS last week put forward a proposed revision to the Average Wholesale Price (AWP) reimbursement system that heightens pressure on cancer physicians to reach a deal with the conferees.

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CMS last week proposed cuts in reimbursement for blood clotting factor used by hemophiliac beneficiaries combined with a new payment to hemophilia treatment centers and homecare companies that deliver the product.

The inclusion of clotting factor in the proposed rule revamping the Average Wholesale Price (AWP) system contrasts with the approach in the House Medicare reform bill, which exempts the product from reimbursement cuts. The Senate bill does not carve out clotting factor, though both bills propose a study to determine appropriate delivery payments.

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August 28, 2003

Seeking access to the Medicare market, the manufacturer of a new stair-climbing wheelchair has approached CMS in the hope of securing Medicare coverage of the new technology and is slated to meet with agency staff to discuss the proposal, company and CMS officials say.

FDA recently hailed the Independence iBOT 3000 Mobility System as an innovative advance, approving it Aug. 13 after an expedited review. The iBOT climbs stairs and also elevates to enable the occupant to reach high objects and hold eye-level conversations with people who are standing. It costs $29,000.

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