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Daily News

February 19, 2003

The recent introduction of a compromise cloning bill by key senators has significantly decreased the possibility the Senate will pass Sen. Sam Brownback's (R-KS) anti-cloning bill. Neither bill has enough votes to pass through the Senate, a congressional source says.

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OSHA says the closing of a Maine agency office is only temporary after state lawmakers and members of the Maine's congressional delegation strongly objected to a potential move to consolidate the state's local offices.

An OSHA spokesperson stated that the agency "will temporarily close its Bangor, Maine office space on Feb. 14 due to the General Service Administration's mandate that OSHA give up its current space...to make way for another tenant. Planning and research for another location for OSHA's Bangor office continues."

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The Small Business Administration's (SBA) regulatory watchdog branch has prioritized CMS' one-hour restriction on the use of patient restraints in hospitals for regulatory reform in a bid to reduce the burden on small businesses.

The one-hour provision, which is currently under CMS review, is one of three CMS rules identified by SBA's Office of Advocacy (Advocacy) in a Feb. 6 letter to the Office of Management and Budget (OMB) as high priorities for reform. The agency's certificates of medical necessity and Medicare physician fee schedule were also highlighted.

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Two key Senate Democrats are attacking an American Bar Association (ABA) plan that is backed by industry and would establish medical criteria for asbestos plaintiffs, a proposal that is the crux of a new Republican bill to curb the spread of asbestos lawsuits. The criticism may signal growing opposition among Senate Democrats against industry-backed efforts to limit asbestos claims, which are also opposed by such key Democratic constituencies as organized labor and the trial lawyers.

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Pediatric groups have failed to convince a federal appeals court to expedite a review of whether a district court erred in striking a controversial FDA rule that required biologics and drug firms to test their drugs on children.

Earlier this month, the federal appeals court denied the pediatric groups' "motion to expedite" the appeal, which would have allowed the parties to skip the dispositive motion stage and start filing the opening briefs.

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The Senate health committee hopes to hold either a hearing or a markup later this month on legislation to reinstate FDA's pediatric rule that required manufacturers to conduct studies of drugs and biologics on children, according to a congressional and health advocacy group sources. Meanwhile, pediatrics groups are fighting an idea that has been circulating on Capitol Hill to use the pediatric rule legislation as a vehicle to also make the pediatric exclusivity incentive permanent.

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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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