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Daily News

February 14, 2003

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Congress is urging FDA to move forward on an April 2001 draft guidance encouraging print drug advertisements to disclose risk information in language that consumers can understand. The draft guidance says that drug sponsors can use FDA-approved 'patient labeling' to meet the agency's 'brief summary requirement.'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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A bill introduced in the Connecticut state legislature late last month would require employers to establish a written ergonomics policy.

The legislation, which was introduced by the Committee on Labor and Public Employees in January, would require employers to review their injury and illness data "to determine whether there is a pattern of ergonomic-related injuries or illnesses in certain job or work tasks."

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Fearing the fall-out of state Medicaid cuts, AARP Feb. 13 called on President Bush and Congress to provide temporary fiscal relief to the states and spoke out against the Bush administration's Medicaid reform plan. AARP's call for relief adds further clout to the long-running campaign for an immediate Medicaid federal funding boost.

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February 12, 2003

A week after advising health care practitioners not to follow FDA's guidelines for administering the smallpox vaccine, a Centers for Disease Control and Prevention (CDC) advisory committee changed its position to be in line with FDA's. After FDA refused to change the package insert for Wyeth's Dryvax vaccine, a top CDC official said, the committee decided its recommendations should match the labeling information approved by FDA.

FDA licensed Dryvax in November 2002, but the agency is still reviewing applications for smallpox vaccines by Acambis' PLC and Aventis Pasteur.

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Following widespread criticism of the Bush administration's draft plan to reform Medicare, congressional Republicans are urging the White House not to propose a specific prescription drug proposal. Instead, GOP lawmakers want the administration to release vague principles on Medicare reform -- as it did in 2001.

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The Congressional Budget Office (CBO) has scored the physician provisions of the recently brokered House-Senate provider payment deal at $54 billion for the 2003-2013 period over the objections of House Ways and Means Committee Chairman Bill Thomas (R-CA), who has maintained that the language should be scored as "zero cost." It is unclear whether CBO's score will force appropriators to strip the provisions from the omnibus spending bill but sources say the projection has certainly not helped the prospects of the ph

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A key medical device industry group says FDA should not charge medical device companies user fees if the first "module" of a premarket approval (PMA) application was submitted before Oct. 1, 2002, the starting date for the user fee program. The Advanced Medical Technology Association (AdvaMed) is worried that FDA might charge user fees for pieces of PMAs submitted after that date, even though the first module of the PMA was submitted prior to that date.

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Progress on legislation for a smallpox vaccine injury compensation plan has slowed as key Senate Republicans wait to meet with the White House to form their plan and Democrats remain split on their own package, according to congressional and health care union sources. A Monday (Feb. 10) meeting between staff of Senate health committee chair Judd Gregg (NH) and ranking Democrat Edward Kennedy (MA) was cancelled, and sources do not know when it will be rescheduled.

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The recently negotiated House-Senate deal on Medicare provider payments cleared a major hurdle Feb. 12 when it overcame a new estimate from the Congressional Budget Office (CBO) that projects that the physician provisions cost $54 billion, according to sources.

Following this estimate, proponents of the provider language were scrambling to keep the provisions intact and indicated they were hopeful Congress would approve the payment hikes. But rumors circulated throughout the day that the CBO score would kill the entire provider payment package.

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