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Daily News

February 12, 2002

In what could signal a significant policy shift, a key Senate Democrat said today that a prescription drug benefit should be packaged with other Medicare reforms that would help finance comprehensive drug coverage. The lawmaker also indicated his opposition to "sunsetting" a prescription drug benefit, an idea floated last year by Sen. Edward Kennedy (D-MA).

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February 11, 2002

CMS Administrator Tom Scully is strongly criticizing the recent recommendations of a Medicare advisory panel, claiming the provider payment advice to Congress is out of touch with budget realities and shows a "stunning lack of restraint." But a key official on the committee says Scully's statements are off base because the panel is not supposed to analyze cost issues.

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The National Academy of Sciences (NAS) is calling for the federal government and private industry to work much more closely on developing drugs, vaccines and other products to counter bioterrorism. The recommendation comes at a time when there are differing opinions on whether a government-owned production facility should be set up for vaccines to counter bioterrorism.

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As the Senate launches into a major debate over the cloning issue, the top Republican on the Senate Judiciary Committee may be leaning towards supporting legislation that would allow for certain types of therapeutic cloning research, a congressional source says. Sen. Orrin Hatch's (R-UT) stand on the issue is important in that it could decide the type of cloning legislation that ultimately makes its way out of the committee and onto the Senate floor.

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OSHA is seeking to eradicate the Susan Harwood Training Grant Program by the end of fiscal year 2003, according to the agency's tightly held budget justification. The proposed elimination of the program is part of the Bush administration's effort to significantly scale back the funding for agency training grants, which were awarded to many union groups during previous administrations.

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The House Ways and Means Committee is strongly denying a published report that suggests the panel is drafting a provider payment bill that would cost $100 billion over 10 years.

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President Bush Feb. 11 touted the tripartisan Medicare reform plan that is expected to be formally introduced in the Senate later this month. While not formally endorsing the tripartisan proposal, Bush's statements are significant because they insinuate the White House clearly favors the plan that has attracted the support of Sens. John Breaux (D-LA), James Jeffords (I-VT), and Chuck Grassley (R-IA).

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February 08, 2002

In the midst of conflicting reports on the effects of irradiated mail on federal workers, U.S. Postal Service (USPS) officials told congressional lawmakers Wednesday (Feb. 6) they have lowered the amount of irradiation used to treat the mail. Just days earlier, the National Institute for Occupational Safety and Health (NIOSH) found that the symptoms reported by workers cannot be separated from symptoms of common winter illnesses.

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The Advanced Medical Technology Association (AdvaMed), a trade association representing medical device manufacturers, plans to lobby Congress for a funding increase for FDA's device center's premarket approval application (PMA) program, according to an AdvaMed source. The group is upset that the FY-03 budget request the president sent to Congress this week does not include an earmarked increase for PMA reviews.

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FDA met with patient-interest and health care groups Thursday (Feb. 7) on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The administration called the meeting to ensure that the groups are not left out of the negotiations as happened during the first reauthorization of the act.

PDUFA is a deal with the pharmaceutical industry that speeds drugs to market in exchange for drug companies paying fees to the agency.

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The long-brewing dispute between the United States and Europe over animal feed standards could come to a head this summer, according to both a top FDA official and a key member of the U.S. animal feed industry. The industry source believes the low limit set for dioxin in animal feed by the European Union (EU) could be construed as a trade barrier, and if Europe begins enforcing the dioxin limits by July 1 as planned, the two regions could find themselves embroiled in a trade war.

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U.S. Trade Representative Robert Zoellick yesterday (Feb. 7) took the toughest public line to date over the European Union's continued moratorium on allowing new genetically modified organisms to come to market, saying he was contemplating mounting a World Trade Organization challenge and was looking for allies in the fight.

Zoellick's Feb. 7 remarks came in response to question from Rep. John Tanner (D-TN) on the status of the EU moratorium, which has lasted three years and halted some $300 million in U.S. corn exports.

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February 07, 2002

Amid heightening alarm from federal workers, United States Postal Service officials are defending the irradiation process used to sanitize mail destined for Washington, DC. A top postal official said last week that mail irradiation does not pose a health risk and asserts that no scientific link exists tying the process to symptoms reported by federal workers and Capitol Hill staff.

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Concerns over the health impacts of handling irradiated mail could boost the prospects of a chemical fumigant already used to sterilize medical equipment as an alternative method to cleansing mail of potential bio-contaminants.

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OSHA and several other federal agencies, led by the National Response Team (NRT), are developing a technical assistance document on anthrax cleanups that is intended to provide guidance on detection, cleanup and worker protection in the fight against bioterrorism.

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Hoping to curb the use of inappropriate patents as a means of delaying generic drugs from coming to market, the Generic Pharmaceutical Association (GPhA) is asking FDA to change its regulations to require brand-name drug manufacturers to explain in detail why a patent belongs in FDA's Orange Book. GPhA suggests that the agency could then use this detailed explanation as a basis to refuse to list a patent that does not meet criteria established by Hatch-Waxman drug patent law.

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As lawmakers are becoming increasingly interested in ways to bring generic drugs to market faster, the Generic Pharmaceutical Association (GPhA) submitted a paper to FDA late last month suggesting the agency could administratively establish a pathway to approve generic versions of biologics. The trade association says FDA already has the legal authority to approve generic biologics, even if the innovators' products are regulated by the Center for Biologics Evaluation and Research (CBER).

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During a hearing investigating the Enron collapse, Senate Democrats today pressed DOL Secretary Elaine Chao to commit to a date for an ergonomics hearing after she had repeatedly turned down prior dates. The lawmakers also criticized the top DOL official for not complying with congressional requests for a staff meeting on the issue.

Sen. Edward Kennedy (D-MA), chairman of the Health, Education, Labor and Pensions (HELP) Committee, began a hearing on the collapse of energy giant Enron by asking Chao about setting an ergonomics hearing date, sources say.

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The Democratic-controlled Senate may seek to trump House Speaker Dennis Hastert's (R-IL) recent call for a $300 billion Medicare reform bill by calling for more funds to be devoted to a prescription drug benefit, according to congressional sources.

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February 06, 2002

Lawmakers of both parties and beneficiary groups are reacting with skepticism to the administration's proposal to reform Medicare and craft a comprehensive prescription drug program with a net of $190 billion. Congress is expected to significantly increase this figure as lawmakers are calling for at least $300 billion for a drug benefit.

The administration has floated its $190 billion proposal recently and has laid out its plans for Medicare reform, a discount card and prescription drug coverage in a Jan. 28 White House fact sheet.

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