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Daily News

February 18, 2003

A biotechnology industry group is voicing its concerns with CMS' interim final rule on inherent reasonableness (IR), urging the agency to keep the IR process transparent and to use its authority to increase unjust payments rates, not just to reduce those that may be too high.

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The U.S. government and its pharmaceutical industry are assessing a proposed WTO statement limiting the use of more flexible patent rules to see if it establishes legally binding limits that could inform a future dispute settlement panel, according to delegation and industry sources.

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The House Energy and Commerce Committee has not decided if it will pursue legislation on key FDA issues including requiring food firms to label food allergens in plain English, requiring companies to test drugs and biologics on children and establishing an animal drug user fee program, according to the committee' oversight plan. The panel plans to investigate breast implant safety and prescription drug approval, as well as FDA's implementation of the new bioterrorism and device user fee laws.

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A leading House Democrat has introduced legislation that aims to provide compensation for those injured by the Bush administration's smallpox vaccination program. In addition, the bill would also mandate that "safe" needles be used to administer the vaccine.

Rep. Henry Waxman (D-CA) introduced the legislation Feb. 13, saying in a floor statement he hopes it would provide a "starting place for discussion" and "begin a dialogue" on the issue that would culminate in passing a bipartisan bill on the issue.

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The Bush administration is proposing to slightly reduce OSHA's budget in fiscal year 2004, earmarking $450 million to fund the agency. The budget proposes a cut in safety and health standards and training grants but the administration plans to increase funding for compliance assistance.

While the budget proposal represents a $3 million cut over FY 03, the budget figures for the current fiscal year were not available until last week, when Congress passed an omnibus appropriations bill. Therefore OSHA could not compare its FY 04 proposal to its actual FY 03 funding.

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Four months after fiscal year 2003 began, Congress approved an FY 03 budget for OSHA that grants the agency a modest $10 million increase. Lawmakers also earmarked $3.2 million to extend funding for current training grant recipients.

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The Bush administration's Medicaid reform plan -- its first major initiative for the program -- could receive little traction on Capitol Hill judging by its lukewarm reception from key lawmakers and stakeholders.

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February 14, 2003

Senate Finance Committee Chairman Charles Grassley (R-IA) says he does not expect the Bush administration to challenge a European Union biotechnology moratorium until it has worked out its political problems regarding a war in Iraq.

"I expect until the political problems over the Iraq war with Germany and France and with Europe generally are over, there won't be a case filed," he told reporters on Feb. 12.

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A House Energy and Commerce Democrat is calling on the General Accounting Office (GAO) to "rule" that CMS acted illegally when it issued a policy memo that allegedly directs Medicare contractors to curb outreach and education efforts.

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Lawmakers are calling on FDA to spread awareness about the use of hormone therapy in the treatment of menopausal symptoms, which was not dealt with in a Women's Health Initiative (WHI). The study raised questions about the safety of three estrogen products for treatment of postmenopausal women.

Early in January, on the basis of results from a WHI study of Wyeth Pharmaceuticals estrogen products, FDA revised the labeling of estrogen and estrogen-containing products to provide new safety information to women.

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Congress is urging FDA to move forward on an April 2001 draft guidance encouraging print drug advertisements to disclose risk information in language that consumers can understand. The draft guidance says that drug sponsors can use FDA-approved 'patient labeling' to meet the agency's 'brief summary requirement.'

Lawmakers asked the agency to finalize this guidance in language accompanying the FDA portion of the omnibus funding bill for fiscal year 2003, which was passed on Thursday (Feb. 13).

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The Senate health committee is changing the way that it will handle public health issues: All public health issues other than substance abuse and mental health issues will be handled at the full committee level. The subcommittee on public health no longer exists, and in its place is a narrower subcommittee on substance abuse and mental health services.

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Jennifer Young, a top HHS legislative affairs official and former Capitol Hill staffer, is a leading candidate to replace Bobby Jindal as HHS Assistant Secretary for Planning and Evaluation (ASPE), according to an informed source.

Young, whose maiden name is Baxendell, has worked for the Senate Finance Committee, House Ways and Means Committee, National Governors Association and the American Association of Health Plans. Jindal this week resigned and sources have said he may run for governor of Louisiana (InsideHealthPolicy.com; Feb. 11).

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In a move that has triggered controversy, Senate Majority Leader Bill Frist (R-TN) has invited select health care experts to a high-profile meeting on Medicare reform, according to several sources. The Feb. 19 meeting, which is slated to run for 10 hours, has already attracted criticism because it will include neither Senate Finance Committee Chairman Chuck Grassley (R-IA), who was not involved in its planning, nor representatives of many health care groups who are wondering why they were not invited.

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February 13, 2003

The proposed compromise to deadlocked negotiations on access to medicines has the backing of key African countries but still needs a positive response from the United States if it is to be successful, according to the World Trade Organization official trying to broker the deal.

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Senate Majority Leader Bill Frist (R-TN) today (Feb. 13) said he does not view the tripartisan plan as the foundation for building a Medicare reform/prescription drug bill.

Seeking to build a bipartisan bill in the Senate Finance Committee from "the ground up," Frist said the tripartisan plan, like President Bush's Medicare reform principles, is a "good starting point" but added, "I would not view it necessarily as the base bill from which things are added or taken away."

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FDA plans to survey pharmacists on how risk management plans impact the practice of pharmacy amidst concerns by pharmacy groups that certain risk management efforts would change how pharmacies do business. The agency intends to survey approximately 5,000 pharmacists to evaluate pharmacists' knowledge of risk management programs and identify obstacles to compliance with the risk management programs, according to a Federal Register notice seeking outside comments on the plan.

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The House Energy and Commerce Committee marked up its patient safety bill on Wednesday (Feb. 12), likely reigniting last year's turf battle between two House panels that share jurisdiction over patient safety. Both the House Energy and Commerce Committee and the House Ways and Means Committee marked up their versions of the patient safety bill last year. However, Congress went out of session before the House Rules Committee could make a decision about the two competing bills.

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Following a flurry of industry lobbying and pressure from key lawmakers, at press time Congress was poised to increase FDA's device center funding by $4 million for fiscal year 2003. The $4 million would go toward the extra $45 million that Congress must give the device center by FY 05 if the medical device user fee program is to continue.

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Bobby Jindal, HHS assistant secretary for planning and evaluation, announced Feb. 13 that he is resigning to "consider" opportunities in Louisiana. InsideHealthPolicy.com reported Feb. 11 that Jindal was seriously considering leaving HHS to run for governor of Louisiana, his home state. His resignation is effective Feb. 21.

[Click here for Jindal's resignation letter.]

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