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Daily News

September 18, 2003

The U.S. delegation is urging a Codex Alimentarius committee on nutrition to allow companies to make dietary fiber and nutrient content claims on the basis of serving size. The Codex guidelines themselves provide for serving size as an option for declaring nutrient content, the U.S delegation states in its draft position paper.

Making claims on a per serving basis is the best option to help U.S. consumers construct healthful diets, the U.S. delegation says.

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September 17, 2003

A recent federal Massachusetts court opinion could discourage the drug industry from promoting off-label uses of their drugs, according to a drug industry source, even if FDA does not take enforcement action. The judge said a drug company's truthful off-label promotion is vulnerable to an action under the False Claims Act if the firm sets a "foreseeable" chain of events in motion that causes Medicaid to reimburse drugs prescribed for off-label uses.

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The medical device industry believes that a major new liability protection law could actually increase liability risk for device companies by creating a Catch-22 that keeps them from being shielded under either the new law or a 1950s liability indemnification executive order. To avoid this unintended consequence, the Advanced Medical Technology Association is urging the Bush administration to broadly interpret the relationship between the two laws.

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Congressional sources are predicting a replay of the traditional Labor, HHS, and Education Appropriations conference dispute between Republicans and Democrats over OSHA training grants as House and Senate conferees prepare to hash out a final fiscal year 2004 Labor spending bill.

The House bill recommends $4 million for training grants, a $7 million decrease from FY 03. The Senate bill recommends approximately $11 million for the grants. The full Senate's passage of the bill last week sets the stage for conference deliberations between the two congressional chambers.

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In the latest chapter on the states' battle to curb escalating prescription drug prices, pharmacy benefit managers (PBMs) are following in the drug industry's footsteps to try to legally block a pioneering Maine law aimed at altering their business practices to achieve cheaper drugs.

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CMS is weighing whether to remove its Medicare non-coverage policy of positron emission topography (PET) for rare cancers and instead leave the coverage decision up to local carriers.

Medicare covers PET for a range of cancers, such as lung breast cancer, but not for less common types of the disease. CMS is currently considering up to 10 requests from clinicians across the country to expand Medicare coverage of PET for rare cancers.

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September 16, 2003

Senate Republicans are considering a "technical correction" to the third-party inspection section of new medical device law that would essentially eliminate a requirement that industry says makes the program impossible to implement, according to an industry source. At issue is the current law's requirement that foreign countries recognize FDA inspections.

FDA also is considering issuing a guidance that would clarify how companies get foreign government endorsements for third-party inspections, according to an FDA official.

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The American Medical Association (AMA) has joined with a professional society advocating a switch to a new coding system for diagnosis and billing and the corporation that developed the new coding standard to advocate specific legislative language on the issue for the Medicare conference report.

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A new FDA advisory that warns consumers to avoid consuming teas brewed from star anise is intended only to address bulk spice sales, and is not aimed at prepackaged teas or dietary supplement capsules, according to an FDA spokesperson. This may come as good news to a key herbal products trade group, which has been confused about the scope of the consumer warning.

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Two health professional organizations are urging OSHA to create a separate respiratory protection regulation by simply renaming the tuberculosis (TB) respirator protection standard. The groups assert this would allow OSHA to incorporate all airborne infectious diseases into the standard. But labor officials disagree.

Labor officials say such a move would leave healthcare workers inadequately protected from infectious diseases such as severe acute respiratory syndrome (SARS), which they say require worker protection measures much more stringent than called for under the TB rule.

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Medicare conferees are heading towards a compromise on specialty hospitals that stops short of the Senate bill's ban on physicians referring patients to new, so-called boutiques hospitals in which they have ownership stakes but goes beyond the House bill's call for further study of the issue, Sen. John Breaux (D-LA) told reporters today (Sept. 16).

Breaux, the author of the ban on physician self-referral, said he would accept a modification of his proposal but indicated some of it would survive conference.

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September 15, 2003

As the congressional appropriations committees head into conference on the Labor-HHS-Education spending bill for fiscal year 2004, the Bush administration is hoping conferees will restore $98 million cut from the House bill's CMS program management budget. The funding at issue is included in the Senate bill.

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CANCUN -- Mexican Foreign Minister Luis Ernesto Derbez, the chairman of the World Trade Organization's fifth ministerial, defended his decision to bring the conference to a close when he did following criticism from WTO members that he had done so prematurely.

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CANCUN -- The fifth ministerial of the World Trade Organization collapsed yesterday afternoon (Sept. 14) when countries could not strike a compromise on the so-called Singapore issues. A pending compromise, ultimately rejected by developing countries, envisioned negotiations on trade facilitation only, unbundling it from the other three issues of investment, competition and transparency in government procurement.

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Congressional Medicare conference negotiations have turned back to drug patent reform issues, with renewed debate over a House provision that would limit amendments and supplements to generic drug applications.

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OSHA Administrator John Henshaw and Director of Enforcement Programs Richard Fairfax are defending OSHA's ergonomics enforcement stance in the wake of controversial ergonomics-based citations that a high-profile ergonomics coalition says contradict the agency's earlier stated policy. The officials clarified that facilities are culpable if they are not following a company's ergonomics guidelines -- a stance they say is consistent with the agency's past comments.

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As the battle between state labor and industry over whether to repeal the state of Washington's ergonomics standard heats up, political jockeying by the two camps has taken on a circus-like atmosphere with tit-for-tat allegations about fundraising, legitimacy and outright motive.

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September 12, 2003

The Federal Trade Commission (FTC) is calling for changes to pro-competition legislation pending in the House that would require optometrists to give patients their prescriptions and verify contact lens prescriptions for Internet sellers and third-party sellers who offer contact lenses at lower prices. FTC, which would enforce the new requirements, urges lawmakers to specify whether they prefer an active or a passive approach to verification.

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As doubt over final passage of a Medicare prescription drug benefit percolates, advocacy groups pushing hard for drug coverage have upped the ante through vocal lobbying campaigns pressing Congress for action.

AARP members descended on Washington, DC last week to pressure Congress to "keep its promise," "finish the job" and "fix and pass" the benefit. The scene was played out at two similar AARP rallies across the country.

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More than 100 House members this week urged their chamber's Medicare conferees to drop the House bill's cut to the hospital market basket update, emphasizing that the provision will undermine the payment boost for rural hospitals that was crucial in securing the one-vote victory margin for the chamber's Medicare prescription drug legislation.

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