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Daily News

March 27, 2003

A GOP lawmaker is asking the House Energy and Commerce Committee to investigate whether CMS Administrator Tom Scully "violated rules of conduct" in an e-mail sent to a Gallup official, and to determine if the agency has engaged in "questionable conduct" in selecting the methodology favored by one company to run a hospital quality evaluation pilot program. However, CMS pointed out that the methodology only applies to the pilot program, that the agency is welcoming input and that the "process is still open."

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CMS is laying plans to lift its controversial ban on Medicare contractor-based outreach and education efforts, CMS and congressional sources say. The ban, which CMS says was imposed due to budget uncertainties, was strongly opposed by certain House and Senate lawmakers and prompted a General Accounting Office (GAO) investigation into whether the move violated the Congressional Review Act (CRA).

A CMS source says Congress' passage of a fiscal year 2003 appropriations bill provides enough funding for the agency to put the outreach program back in place.

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High-ranking FDA officials indicate they may support changing the law to institute a federal definition of what constitutes a valid prescription that would be needed in order for Internet pharmacies to dispense drugs. The officials say that the multitude of state definitions of prescriptions has made it more difficult for the agency to initiate civil and criminal cases.

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A health care worker union is urging the White House to suspend its pre-event smallpox vaccination program until compensation legislation is enacted that meets workers' needs. The union sent the letter to Bush March 26 following the first fatality of a vaccinated health care worker. Another health care worker died March 27.

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The administration's new BioShield proposal to finance research for biodefense products that the government would ultimately purchase is raising questions about who should get the profits from unintended markets. The goal of the BioShield plan is to get the private sector to develop biodefense products that have no market, but both lawmakers and industry representatives seem to feel that there is a decent chance such products could be commercialized for other uses.

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The drug industry trade association is renewing its press for antitrust waivers that would allow firms to collaborate in making biodefense products without violating antitrust laws. Meanwhile the biotechnology and drug industries are urging Congress to include a provision in BioShield legislation indemnifying makers of biodefense products.

Industry trade groups also told Congress they want longer contracts, and a "dual-use" provision allowing companies to commercialize biodefense products if a market other than the government emerges.

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March 26, 2003

Breast cancer activists could be granted greater influence over the direction of government breast cancer research, as the result of a new federally funded report on how the government can better study the connections between breast cancer and environmental factors, such as exposure to chemicals.

A government official involved in the project says that of the report's various recommendations, one that will have the greatest impact on national breast cancer research policy is the proposal calling for more community and activist input into the research process.

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A key consumer group says FDA's concept paper on good pharmacovigilance practices does not give drug safety experts the independent authority to require safety labeling changes or remove the product from the market. This authority is still within the drug review section, a Public Citizen source says.

Earlier this month FDA released concept papers outlining the agency's approach on risk management, good pharmacovigilance practices and premarket risk assessment.

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The National Human Genome Research Institute may look into how genomics applies to disease and drug response once it completes its work on sequencing the human genome. The new research could ultimately impact drug development.

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President Bush's proposed supplemental budget request has sparked a debate among local officials about how increased funds for first responders should be distributed. While both state and local officials agree that more first-responder money is needed beyond the president's request to address heightened security concerns, some city officials favor the immediate need for an allocation system that would allow cash-strapped cities to apply directly to the federal government for increased funds.

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FDA is rejecting an HHS Office of Inspector General (OIG) recommendation that the agency make regulatory changes needed to post on its website the agency's rationale for denying new drug applications. The agency says Congress would have to change the law before FDA could publicize information about denials and "approvable" letters.

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In the wake of controversy over potential changes to Medicare's appeal process, House lawmakers have taken steps to ensure the independence of administrative law judges (ALJs) hearing Medicare coverage appeals.

The House Energy and Commerce Committee and Ways and Means health subcommittee have both approved language stipulating that ALJs are to be separate from CMS when their appeals function is transferred from the Social Security Administration (SSA) to HHS.

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Health care providers and advocacy groups are rallying to stave off potential Medicaid cuts under the House-passed budget resolution -- launching an intense lobbying bid aimed at pressuring budget conferees to drop the House language.

At press time, at least 20 provider groups ranging from the American Hospital Association (AHA) to the American Medical Association were slated to call on lawmakers in both chambers to urge budget conferees to adopt the Senate's Medicaid budget language.

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March 25, 2003

In an effort to rebut consumer groups' opposition to a petition that would allow irradiation of ready-to-eat foods, a key food processors' trade group says scientific evidence does not show that irradiated food has mutagenic or toxigenic effects on human subjects.

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A recent Supreme Court decision affirming the right of victims suffering from asbestosis to collect damages for their fear of getting cancer has increased the urgency for Congress to enact legislation that would limit liability claims, according to industry and congressional sources. While the decision was a ringing defeat for industry efforts to limit asbestos litigation through judicial action, the ruling also recommends congressional action to limit the spread of liability claims that could threaten bankruptcy for some sectors of industry.

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FDA is developing a formulary of biodefense medical devices because the managers of the National Pharmaceutical Stockpile program overlooked the importance of medical devices in responding to a biological terrorist attack, according to a Federal Register announcement March 17. FDA also is compiling a list of device manufacturers from which emergency response personnel could directly buy certain sophisticated devices not sold by distributors, such as ventilators, defibrillators and portable x-ray machines.

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A U.S. Agriculture Department official has laid out conditions under which USDA would continue to provide assurances for foreign importers of U.S. wheat that genetically modified wheat is not under commercial production in the United States even after genetically modified wheat varieties are approved for planting in the United States. Such assurances could prevent future disruption in U.S. exports.

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State and city officials have adjusted their lobbying strategy for increased homeland security funds after Bush administration officials announced efforts to seek more money for first responders as part of a wartime supplemental budget. But the key question still remains on how the money should be distributed, with emergency responders calling for a new block-grants program that would provide funds directly to local governments and cites.

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The long-running campaign for state fiscal relief has taken a symbolic step forward following a call by 80 senators to include at least $30 billion -- half of that for Medicaid -- in an economic growth package. The move sends a message of significant Senate support for state aid, which could help combat potential House GOP opposition during economic stimulus conference talks.

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Bipartisan leadership of the House Energy and Commerce Committee is asking FDA if the agency has the authority to regulate -- or take off the market -- the increasingly popular dietary supplement version of anabolic steroids. Committee leadership sent a letter March 25 to FDA and the Drug Enforcement Administration (DEA) requesting their position on "pro-steroid" and "precursor steroid" supplements.

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