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Daily News

September 09, 2003

A qualified claim about omega-3 fatty acids' and reducing the risk of coronary heart disease (CHD) will be the first to receive FDA consideration under the new qualified claim process spelled out in a July interim guidance, according to a food center spokesperson. The agency began accepting petitions to go through the new qualified health claim process on Sept. 1.

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Medicare conferees agreed on several key issues during a Sept. 9 meeting, including provisions setting up a prescription drug discount card program, revamping the outpatient formula for reimbursing hospitals for newly developed drugs, and imposing a one-year moratorium on therapy caps.

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September 08, 2003

As lobbying for universal Medicare drug coverage intensifies, a key House staffer in the Medicare conference talks has floated a compromise to retain the House bill's drug coverage of dual eligibles under Medicare while moving toward the Senate's more generous subsidy of the near poor.

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FDA unveiled four new draft guidances and one final guidance 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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FDA plans to issue a new electronic records and signature rule once it finishes re-examining "part 11" as a part of its good manufacturing practices (GMP) initiative. For now, the agency has released a final guidance stating that the agency will not enforce key elements of the current rule.

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FDA plans to use a specialized team of reviewers and inspectors to oversee drug firms that incorporate process analytical technologies (PAT) into their manufacturing plans. At issue are cutting-edge technologies that test products while they are actually being manufactured.

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Three consumer groups have taken their legal battle against Medicare's controversial therapy caps back to court following doubts that CMS gave beneficiaries sufficient notice of the policy change.

Just two months after reaching a partial settlement with CMS over implementation of the therapy caps, the Medicare Rights Center (MRC), Easter Seals and the American Parkinson Disease Association have asked a federal court to enforce the agreement or halt the caps until CMS proves it notified 90 percent of Medicare Part B beneficiaries of the caps before they took effect Sept. 1.

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House and Senate Medicare conferees tomorrow (Sept. 9) are expected to hold a series of votes that may chart the course for future negotiations on major ideological differences between the rival Medicare prescription drug bills and resolve contentious provider issues, including how to set payments for rural physicians and hospital reimbursements, according to industry and congressional sources.

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Top FDA officials are meeting with their European and Japanese counterparts to ensure that FDA's different approach to risk management and risk assessment does not become a trade barrier, according to a top agency official. The European Union, Japan and the World Health Organization (WHO) are adopting a stricter approach to separating government officials who assess and manage risk to ensure that risk managers do not unduly influence risk assessors.

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September 05, 2003

Late last month FDA's drug center and Office of Regulatory Affairs signed a memorandum of understanding (MOU) to set up a pharmaceutical inspectorate (PI) comprising experts in drug product manufacturing that will inspect high-risk firms. The agreement includes a "Level III" certification program for inspectors interested in participating in the program.

An FDA official says the scheme is aimed at increasing the frequency of inspections of high-risk facilities.

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FDA officials say the agency has revised its preapproval inspection program to give the field greater flexibility in deciding if a preapproval inspection is warranted, which will allow the field to focus more on high-risk facilities. Specifically, the agency has dropped submissions for "top 200 drugs" and "narrow-therapeutic-range" drugs from the categories of submissions that will automatically prompt a request for an inspection.

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OSHA Administrator John Henshaw along with Canadian and Mexican leaders of the Trinational Occupational Safety and Health Working Group have agreed to explore future cooperative activities -- including a workshop on ergonomics in the automotive industry and a globally harmonized system of classification and labeling of chemicals (GHS).

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Consumer group Public Citizen is opposing efforts by the U.S. government and the drug industry to change Paragraph 30 of the Declaration of Helsinki, according to a letter sent to the World Medical Association. The group argues that the proposed changes threaten the rights and health of study participants -- and one of the changes could nullify the paragraph.

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The new head of the National Governors Association (NGA) has no immediate plans to reconvene the group's Medicaid reform task force, which ground to a halt earlier this summer after Republicans and Democrats divided over how to overhaul the Medicaid program.

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In the wake of last weekend's deal granting developing countries increased access to cheaper, generic copies of patented drugs, countries expect a drawn-out debate on whether to make the deal a formal amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The deal as struck is formally a waiver from World Trade Organization rules until the end of 2003, at which point members should begin work toward adopting it as a TRIPS amendment within six months.

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An Environmental Protection Agency (EPA) risk assessment expected to be released by month's end on a widely used flame retardant found in thermal plastics will likely affect considerations by the Bush administration to weigh in on a similar European Union review that U.S. officials fear could impose an unfair ban on the chemical, according to a key administration official.

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September 04, 2003

Scott Railton, chairman of the Occupational Safety and Health Review Commission (OSHRC), has drawn up a new strategic plan to expedite case processing by, among other things, making it easier for cases to qualify for E-Z trial and settlement procedures. Railton also hopes to appoint an in-house committee to examine current OSHRC rules as well as comments that have been submitted over the past few years by the public and by OSHRC personnel, Railton told Inside OSHA in an Aug. 21 interview.

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Dietary supplement trade associations are lobbying against legislation by Sen. Richard Durbin (D-IL) that would require supplement makers to report adverse events to FDA, and they are telling lawmakers the key to improving FDA's oversight of supplements is to give the agency more money to enforce the current dietary supplement law instead of rewriting it.

The groups are pushing a bill introduced by Sens. Tom Harkin (D-IA) and Orrin Hatch (R-UT) that would give FDA funds to enforce the current law as an alternative to the Durbin bill.

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After months of searching, the Transatlantic Business Dialogue has finally located a company willing to take the reins of the U.S. co-chairmanship of the bilateral trade forum that is emerging from a massive reorganization unveiled earlier this year (Inside U.S. Trade, May 9, p13).

Coca-Cola CEO Douglas Daft will take over for Phil Condit of Boeing, a TABD source said. Unilever's Niall FitzGerald is the likely candidate for the European co-chair slot, the source said. That decision however is still pending because Unilever is in the process of approving the decision.

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In an unexpected move, the final price tag of a Senate provision to provide short-term Medicare coverage of certain self-injected drugs and biologicals has more than tripled, increasing the obstacles to securing the measure in Congress' final Medicare bill, health care observers say.

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