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Daily News

March 13, 2003

The Senate Finance Committee's Medicare reform bill will include a prescription drug discount card as an interim step to immediately reduce seniors' drug costs, Sen. Chuck Grassley (R-IA) told Inside CMS this week.

A Medicare discount card has been a cornerstone of the Bush administration's bid to lower beneficiaries' drug costs, but has to date been legally stymied by stiff opposition from pharmacy groups.

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FDA's proposed bar code labeling rule would not require drug companies to include the expiration date or lot release number on drugs, nor would it require bar codes on medical devices. Along with the bar coding proposal, FDA today issued a 483-page proposed rule that would change the way drug and biologic manufacturers report adverse events.

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The Energy and Commerce Committee version of patient safety legislation that passed the House this week may provide less protection to medical error information than would have been the case under a rival Ways and Means Committee bill, some congressional sources say. The House passed the House Energy and Commerce version of the bill by a vote of 418-6 March 12 after the House leadership decision not to bring the Ways and Means version to the floor.

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Rep. Edward Markey (D-MA) has asked President Bush for an update on the administration's development of guidelines for distributing potassium iodide to the public, as required by law.

In certain cases, potassium iodide can protect the thyroid from radiation-induced cancer; the guidelines could provide information on when to take potassium iodide tablets if terrorists attack a nuclear power plant, releasing radiation, the lawmaker wrote in a Feb. 28 letter.

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March 12, 2003

Implementing a section of the recently reauthorize pediatric exclusivity law, FDA has begun posting summaries of agency medical and clinical pharmacology reviews of pediatric studies conducted as a part of the pediatric exclusivity law. The Best Pharmaceuticals for Children Act (BPCA) directs the agency to make the summaries of these reviews available to the public.

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The American Medical Association (AMA) is opposing FDA's plan to allow conventional food manufacturers to carry qualified health claims. The physician group charges that the agency does not have the statutory authority to use a lesser standard than "significant scientific agreement" and that the plan will mislead consumers.

The group also reiterates its concerns about qualified health claims for dietary supplements. Specifically the group argues that FDA should not authorize claims about how a supplement can treat an existing disease.

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Despite widespread concern from the Bush administration and Congress that chemical facilities may be a target of terrorist attacks, most major chemical companies have decided to forgo buying terrorism insurance being offered under a new federal law intended to make such coverage available. Industry officials say that chemical companies have been deterred from buying the policies due to the erratic prices being quoted by insurance firms, the narrow scope of the coverage being provided under the new law, and the availability of other policies being offered by off-shore mutual insurers.

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Providers face murky prospects for payment increases this year, with tight budget constraints, the possibility of war and recent recommendations from Congress' Medicare payment advisory panel all posing early lobbying hurdles.

While many sources say it is too early to tell what will happen in terms of provider reimbursements this year, key health care observers note that the Medicare Payment Advisory Commission (MedPAC) has dealt an early blow with its call for modest or zero updates for most providers.

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March 11, 2003

Agricultural trade advisory committees representing meat producers and exporters and the planting seed industry have demanded that the United States obtain certain objectives related to sanitary and phytosanitary barriers and biotechnology before finalizing the U.S.-Chile Free Trade Agreement. The ATACs made these demands in reports submitted recently to the administration that were also critical of the tight secrecy rules surrounding discussion of the documents.

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FDA should include available pediatric dosing and safety information on labels for oncologic products that are approved for use in adults but are being used on children, an FDA advisory panel recommends. Data demonstrating the clinical relevance of using the product in the pediatric population along with differences, if any, between the adult and pediatric safety data should also be included in the label, the panel suggests.

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The brand-name drug industry is asking FDA to consider new comments on a generic drug access proposed rule, even though the comment period ended three months ago. The Pharmaceutical Research and Manufacturers of America (PhRMA) is offering a new legal theory on why brand-name drugmakers should have an opportunity to obtain a 30-month stay if a generic drug manufacturer changes from a paragraph III to a paragraph IV certification.

Last week FDA Commissioner Mark McClellan told House appropriators the final rule is expected this spring.

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FDA's Anti-Infective Drugs Advisory Committee is suggesting a list of seven criteria for judging when FDA could approve new indications for drugs that treat drug-resistant diseases with fewer clinical trials. FDA is strongly considering approving new indications in certain cases with only one new trial if there already is good supporting data for another indication.

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Key House panels with similar competing bills on patient safety and medical error reporting are trying to resolve differences between the two bills in time for a House floor vote March 12, congressional sources say. The final bill will likely be voted on under suspension, allowing it to skip the Rules Committee process but requiring a two-thirds majority vote for passage, sources say.

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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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