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Daily News

March 11, 2003

FDA's soon-to-be-unveiled bar code labeling proposed rule likely will not require drug companies to include the expiration date or lot release number, according to sources familiar with the proposal. In addition to covering prescription drugs, the proposed rule likely will require bar coding for over-the-counter (OTC) drugs used in hospitals, the sources say, though it is not clear if medical devices will be included.

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March 10, 2003

The White House is refuting media reports on the out-of-pocket prescription drug protection outlined under President Bush's Medicare framework for beneficiaries remaining in traditional fee-for-service Medicare.

"Virtually every number you have read including the so-called $5,000 to $7,000 number… is a total and utter fabrication," Doug Badger, the White House's top health care policy advisor, told the U.S. Chamber of Commerce last week. The White House has not specified what this coverage is, Badger noted during his March 6 Chamber address.

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Senate Finance Committee Chairman Chuck Grassley (R-IA) says he expects the Bush administration to proceed with a challenge of the European Union's biotechnology moratorium in the World Trade Organization once the United States has received the necessary support in the United Nations for an attack on Iraq.

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During a recent briefing unveiling administrative steps FDA will take to address ephedra concerns, HHS Secretary Tommy Thompson said he would back changing the law to let FDA temporarily suspend marketing of dietary supplements while the agency gathers proof it needs to take the products off the market.

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FDA is weighing how to define metabolites of dietary ingredients, and the outcome could impact which products are classified as dietary supplements as metabolites of dietary ingredients are considered supplements.

The agency's Food Advisory Committee's dietary supplement subcommittee will discuss the issue on March 25, according to a Federal Register notice.

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President Bush's BioShield legislative plan would indemnify companies that HHS contracts with for researching biodefense products, according to draft legislation. However, biotechnology and drug industry lawyers say the bill does not seem to protect companies manufacturing biodefense products against civil suits.

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Nearly unanimously, Republican members of the House Energy and Commerce Committee are calling on House Budget Committee Chairman Jim Nussle (R-IA) to include funding proposed by the White House for Medicaid reform in the House GOP funding blueprint.

In a March 10 letter, chairman Billy Tauzin (LA) and all subcommittee chairmen emphasize their support for reforming the program and allocating additional funds as proposed by the Bush administration. Only four GOP committee members did not sign the letter.

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March 07, 2003

Congressional investigators are considering a review of the effectiveness of the National Cancer Institute (NCI), which is under pressure to overhaul its research agenda to focus on prevention and the development of alternatives to cancer-causing chemicals. At the same time, academics have released a report that the ranking member on the House Judiciary Committee, Rep. John Conyers (D-MI), is citing as evidence that the research priorities of the institute are influenced by industry.

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Two national groups of safety specialists are calling on Americans to be prepared for all kinds of emergencies, including those resulting from further attacks on the U.S.

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A federal appeals court has upheld an Occupational Safety and Health Review Commission (OSHRC) decision regarding a drowning accident in Ohio, ruling that employers "cannot count on employees' common sense...."

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Food groups are urging FDA to issue a rule before implementing a provision of the bioterrorism act that allows FDA to mark imports refused entry into the United States. Earlier, the food industry groups had said that the agency lacks the authority to promulgate such a rule. But now that legislation has been enacted explicitly giving the agency the authority to enforce the provision, the groups want a chance to shape the policy through notice-and-comment rulemaking.

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In an unprecedented move, the Federal Trade Commission (FTC) has reached an agreement with Bristol-Myers Squibb Corporation (BMS) that would bar the brand-name pharmaceutical company from obtaining a 30-month stay for patents listed in the Orange Book after a generic drug company has filed a generic drug application.

The move comes at a time when FDA is changing its long-standing interpretation of the 30-month stay provision of drug patent law Hatch-Waxman. FDA's proposed rule would restrict brand-name drug maker to only one 30-month stay per generic drug application.

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FDA's long-awaited proposed rule on dietary supplement good manufacturing practices (GMPs) would require manufacturers to test the final product to make sure it contains the amount of ingredients it claims to have. Companies must also maintain records of their quality control procedures and product testing for up to three years, food center head Joseph Levitt said.

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March 06, 2003

On March 3 U.S. Trade Representative Robert Zoellick struck a more conciliatory note than he previously had over the European Union's moratorium to the approvals of new varieties of biotechnology crops after meeting with EU Trade Commissioner Pascal Lamy.

Zoellick said the U.S. was "eager to see what progress" the Commission is able to make on getting member states to lift the moratorium.

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The Defense Department needs dozens of new systems and technologies to improve its ability to defend the homeland and effectively combat terrorism, according to a top official in the office of the assistant secretary of defense for special operations/low intensity conflict.

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California health officials have rejected industry objections to a proposed listing of phenol as a developmental and reproductive toxin under the state's toxics labeling law, known as Proposition 65. Sources argue the listing would subject the manufacturers of phenol and phenol-related products to warning requirements, which opens the door to a variety of possible legal actions by people exposed to the chemical or by private legal groups.

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A drug industry plan to replace paper drug labels with computerized versions at pharmacies has a key pharmacy group worried that the cost of the change would fall to pharmacists. FDA officials also want to see more details about the idea, being pilot tested by a key drug industry trade group, before signing on.

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One of the public representatives of the National Advisory Committee on Occupational Safety and Health (NACOSH) has criticized OSHA over its regulatory agenda, claiming the agency is working only on "very small-impact regulations."

At the Feb. 27 NACOSH meeting, Letitia Davis of the Massachusetts Department of Public Health argued that OSHA is a "regulatory agency first and foremost," following a presentation by Steve Witt, the agency's director of standards and guidance.

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A leading opponent of Medicare's soon-to-be-implemented outpatient therapy caps believes the findings of a long-awaited congressionally mandated report could further bolster the campaign to repeal the $1,500 therapy limits, according to an industry source.

The report, recently released by CMS, studied utilization patterns of Medicare outpatient therapy services between calendar years (CY) 1998 and 1999 with 2000 -- from before the therapy caps went into effect and after their suspension by Congress.

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President Bush has limited HHS' ability to use a 1950s liability indemnification executive order. Under the amendment HHS must consult the Department of Homeland Security before using the order to protect manufacturers of biodefense products against civil suits.

In October 2001 Bush added HHS to the list of departments that can use public law 85-804, and HHS later used it to indemnify Acambis and Wyeth for their smallpox vaccines.

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